Policies and Procedures

Institutional Review Board

 

Research Office

Office of Research Integrity

v. 1.1.1 – July 18, 2014

 

 

1. Institutional Review Board Office (top)
   

1.1Institutional Policy on the Institutional Review Board 

Oregon State University (OSU) fosters a research environment that promotes the respect for the rights and welfare of individuals recruited for, or participating in, research conducted by or under the auspices of OSU. In the review and conduct of research, actions by OSU will be guided by the principles (i.e., respect for persons, beneficence, and justice) set forth in Ethical Principles and Guidelines for the Protection of Human Subjects of Research, issued by the Office of the Secretary of the US Department of Health and Human Services (often referred to as the “Belmont Report”). The actions of OSU will also conform to all applicable federal, state, and local laws and regulations.

In order to fulfill this mission, OSU has established an Institutional Review Board (IRB). OSU has designated an Institutional Official (IO) who has overall responsibility for OSU’s IRB. The IO is responsible for ensuring that the IRB has the resources and support necessary to comply with all federal regulations and guidelines that govern research involving human subjects. The IO is legally authorized to represent the Institution, is the signatory official for all Assurances, and assumes the obligations of the Institution’s Assurance. It is through the Federal Wide Assurance that an Institution commits to the U.S. Department of Health and Human Services (DHHS) that, for all federally funded research, it will comply with the requirements in the HHS Protection of Human Subjects regulations at 45 CFR 46, also referred to as the “Common Rule.”

 

While the policies and procedures set forth in this document are primarily informed by the Common Rule, additional regulations, laws, or policies may apply, depending on the funding source, state laws, or the type or site of research. Similarly, for research that is not funded by DHHS, the policies and procedures may differ from those set forth in the Common Rule.

 

To conduct its responsibility effectively, OSU maintains one or more IRBs to review research protocols involving human subjects. The IRB is an autonomous administrative body established to protect the rights and welfare of human research subjects participating in research activities conducted under the auspices of OSU.

 

The OSU IRB(s) will review all research involving human subjects regardless of funding source or status, or performance site.

 

Research under the auspices of the Institution includes research:

• Conducted at this Institution

• Conducted by or under the direction of any employee or agent of this Institution (including students) in connection with his or her Institutional responsibilities

• Conducted by or under the direction of any employee or agent (including students) of this Institution using any property or facility of this Institution, and/or

• Involving the use of this Institution's non-public information to identify or contact human subjects

 

Agents include all individuals performing institutionally designated activities or exercising Institutionally delegated authority or responsibility. Determinations of whether or not an employee is acting as an agent of the Institution will be made in accordance with the OSU Conflict of Commitment Policy.

 

No research involving human subjects may commence until all required Institutional approvals (including IRB) are obtained. The results from studies conducted without obtaining IRB review and approval may not be published or distributed outside of OSU, nor can such data be used to satisfy honors theses, master's theses or doctoral dissertation requirements.

 

Representatives from the OSU administration may choose to review and disapprove the implementation of a research protocol that has been approved by the IRB. Those representatives may include the President and his or her designees, the Provost and his or her designees, the Senior Vice Provost for Academic Affairs, the Institutional Official, the Vice President for Research and his or her designees. However, no one at OSU shall approve or permit the implementation of any research protocol that has not been approved by the IRB.

 

All Institutional and non-Institutional performance sites for OSU, domestic or foreign, will be obligated by this policy to conform to ethical principles which are at least equivalent to those of this Institution or as may be determined by the DHHS Secretary.

 

The purpose of this document is to implement this policy.

 

This document is based on a template provided by The HRP Consulting Group and borrows extensively from the best practices of a variety of academic Institutions national-wide. Further, the information contained herein reflects advice received from federal regulators as well as leaders in ethics and responsible conduct of research.

1.2Institutional Authority

The policies and operating procedures in this document serve as the governing procedures for the conduct and review of all human subjects research conducted under the auspices of OSU. The authority to carry out these procedures as described comes from the President of the University via the Institutional Official.

Oregon State University faculty, staff and students engage in activities associated with innovative and high impact research, instruction and outreach/engagement, and are at the forefront of many new discoveries. The activities bear with them certain ethical and legal responsibilities. The University Administration is committed to the highest standards of integrity and resolves that such activities undertaken by OSU faculty, staff, and students should be conducted in accordance with strict ethical principles and in compliance with Institutional policies, federal and state laws and regulations, and other applicable requirements.

 

Adherence to high standards provides a framework for (i) achieving full compliance with applicable ethical, regulatory and University requirements and (ii) promoting an organizational culture that encourages ethical conduct and a commitment to compliance. Areas in which integrity is critical to success include, but are not limited to: human subject research; animal care and use; biosafety; chemical safety; radiation safety; occupational safety; export controls; conflicts of interest; diving safety; small boat safety; handling of hazardous, controlled or regulated substances; material transfers; environmental protection; and research misconduct.

 

The University, through its compliance committees and authorized officials, will issue and promulgate Institutional policies and procedures to ensure the appropriate and responsible conduct of all applicable activities at Oregon State University.

 

-Oregon State University President Edward J. Ray (May 2011)

 

These policies and operating procedures are made available to all OSU investigators and research staff and are posted on the IRB website http://oregonstate.edu/research/irb/.

1.3Mission

The mission of the IRB is to:

• Safeguard the health and welfare of human research subjects by ensuring that their rights, safety and well-being are protected;

• Provide guidance and support to the research community in the conduct of research with human subjects

• Assist the research community in ensuring compliance with the standards set forth in the Code of Federal Regulations by the U.S. Department of Health and Human Services

• Facilitate ethical research with human subjects

• Review and monitor research involving human subjects; and

The IRB includes formal and informal mechanisms to:

• Monitor, evaluate, and continually improve the protection of human research participants.

• Educate investigators, student researchers, and other study team members about their ethical responsibility to protect research participants.

• When appropriate, intervene in research and respond directly to concerns of research participants.

• Dedicate resources sufficient to carryout the above listed actions.

1.4Ethical Principles

OSU is committed to conducting research with the highest regard for the welfare of human subjects. It upholds and adheres to the principles of The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects in Research by the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research (1979). These principles are:

1. Respect for Persons, which is ensured by obtaining informed consent, consideration of privacy, confidentiality, and additional protections for vulnerable populations.

2. Beneficence, which is assured by ensuring that possible benefits are maximized and possible risks are minimized to all human subjects.

3. Justice, the equitable selection of subjects.

OSU’s IRB, in partnership with its research community, is responsible for ensuring the ethical and equitable treatment of all human subjects in research conducted under its auspices.

1.5Regulatory Compliance

The IRB is responsible for ensuring compliance with federal regulations, state law and Institutional policies. All human subjects research at OSU that is funded by a federal agency must be conducted in accordance with this policy and the regulations found in the 45 CFR 46 (the “Common Rule”) and 21 CFR 50 and 56 when applicable.

Unregulated research is conducted in accordance with these policies and procedures.

1.6Federalwide Assurance (FWA)

The IRB operates under the authority of its current Federalwide Assurance (00003920) and has designated two IRBs (registered as 00000122 and 00009613).

In its FWA, OSU has opted to limit the application of the Assurance to research funded by DHHS or federal agencies that have adopted the Common Rule.

1.7Research Covered by the IRB

The OSU IRB covers all research involving human subjects that is under the auspices of the Institution, whether or not that research is externally funded or conducted without direct funding.

Research. The Common Rule defines research as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalized knowledge.

For the purposes of this policy, a systematic investigation is an activity that involves a prospective study plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a study question.

Designed to develop or contribute means that the investigator intends to disseminate results to those outside of the University via the web, social networks or other electronic media, poster presentations, conferences, library placement, or publications. Examples that would not be seen as dissemination outside of the University include: presentation to a department in fulfillment of a university requirement; sharing results with the sponsor or a collaborator; or student presentations to a class or campus organization.

Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions. Knowledge gained may be applied to populations outside of the specific study population, it may be used to inform policy, or be analyzed for predictive value.

Research subject to FDA regulations. Research, as defined by FDA regulations, means any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the Federal Food, Drug, and Cosmetic Act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The terms research, clinical research, clinical study, study, and clinical investigation are synonymous for purposes of FDA regulations. [21 CFR 50.3(c), 21 CFR 56.102(c)]

 

1.8Written policies and procedures

This document details the policies and regulations governing all research with human subjects, regardless of funding source, and the requirements for submitting research proposals for review by the OSU IRB. This is not a static document. The policies and procedures are annually reviewed and revised by the Director of the Office of Research Integrity (ORI), the IRB Administrator, and designated members of the Institutional Review Board. These individuals will also make policy recommendations to the IO. Votes on these recommendations may occur at the discretion of the Chair, but will not be required. The IO will review and approve revisions to this manual on an annual basis and will review and approve new or revised policies as needed.

This manual will be available on the IRB website and this will serve as the mechanism for keeping the Institution’s research community apprised of new information that may affect the IRB, including laws, regulations, policies, procedures, and emerging ethical and scientific issues.

1.9Organization of the IRB

The IRB consists of various individuals, boards, and committees. The IRB Office is a unit of the Office of Research Integrity. The officials, administrative units and individuals outlined below have primary responsibilities for implementing the IRB.

1.9.1Institutional Official

The ultimate responsibility of the IRB resides with the Institutional Official (IO) of the program. The IO is responsible for ensuring that OSU’s IRB has the resources and support necessary to comply with all Institutional policies and with federal regulations and guidelines that govern human subjects research. The IO is legally authorized to represent OSU. He/she is the signatory of the FWA and assumes the obligations of the FWA.

The IO also holds ultimate responsibility for:

• Oversight of the Institutional Review Board (IRB);

• Oversight over the conduct of research conducted by all OSU investigators;

• Assuring the IRB members are appropriately knowledgeable to review research in accordance with ethical standards and applicable regulations;

• Assuring that all investigators are appropriately knowledgeable to conduct research in accordance with ethical standards and applicable regulations;

• Facilitating the development and implementation of an educational plan for IRB members, staff and investigators.

1.9.2 IRB Administrator

The IRB Administrator is selected by and reports to the Institutional Official (IO). The Administrator is responsible for:

• Developing, managing and evaluating policies and procedures that ensure compliance with all state and federal regulations governing research. This includes monitoring changes in regulations and policies that relate to human research protection and overseeing all aspects of the IRB program.

• Advising the IO on key matters regarding research at OSU.

• Implementing the Institution’s IRB policy.

• Submitting, implementing and maintaining an approved FWA through the IO and the Department of Health and Human Services (DHHS) Office of Human Research Protection (OHRP).

• Assisting investigators in their efforts to carry out the Institution’s research mission.

• Developing and implementing needed improvements and ensuring follow-up of actions, as appropriate, for the purpose of managing risk in the research program.

• Developing training requirements as required and as appropriate for investigators, subcommittee members and research staff, and ensuring that training is completed on a timely basis.

• Serving as the primary contact at OSU for OHRP and other federal regulatory agencies.

• Day-to-day responsibility for the operation of the IRB office, including supervision of IRB staff.

• Responding to faculty, student and staff questions.

• Working closely with the Chair of the IRB and on the development of policy and procedures, as well as organizing and documenting the review process.

1.9.3Institutional Review Board (IRB)

OSU has two IRBs, appointed by the Institutional Official (IO). These IRBs prospectively review and make decisions concerning all human research conducted at OSU facilities, by its employees or agents, or under its auspices. Both Boards are responsible for the protection of rights and welfare of human research subjects at OSU. They discharge this duty by complying with the requirements of the Common Rule, state laws, the FWA, and Institutional policies.

Throughout this document, there will be references to “the IRB” and “IRB Chair” singular rather plural, as the number of registered Boards and Chairs may change, but all Boards and Chairs share a single charge.

1.9.4IRB Chairs and Vice Chairs

Each Board will have a Chair and a Vice Chair who will work closely with the Administrator to carry out the mission of the IRB. Details of their role appear in section 4.

1.9.5IRB Coordinators and Support Staff

IRB Coordinators are responsible for all aspects processing proposals involving human subjects. This responsibility includes the initial review of documents and screening of research proposals prior to its review by the IRB, as well as serving as liaisons between the investigators and the IRB. IRB Coordinators review the IRB minutes for accuracy and ensures proper documentation of discussions, including controverted issues and actions taken by the IRB during its convened meetings.

IRB Coordinators and support staff are responsible for providing administrative and clerical support to the IRB Chair and IRB Administrator as well as scheduling and coordinating all IRB functions. IRB Coordinators are also responsible for IRB record retention. IRB Coordinators are responsible for maintaining complete IRB files, records of all research protocols, IRB correspondence (including e-mails), as well as Research Credentialing records of investigators and research staff.

IRB Coordinators must be Certified IRB Professionals (CIP) within 24 months of hire.

The IRB Staff are required to complete the relevant CITI courses in the Protection of Human Research Subjects. Staff members will be provided with sufficient training opportunities to maintain their required certification (CIP). This training will include attendance at national or regional conferences at least annually, and periodic webinars.

1.9.6Unit Heads

Department Heads, Department Chairs, and Directors of Centers and Institutes (“Unit Heads”) are responsible for ensuring that the Principal Investigator (PI) is qualified by training and experience to conduct the proposed research.

Unit Heads are responsible for assuring that investigators have the resources required to conduct the research in a way that will protect the rights and welfare of participants. Such resources include but are not necessarily limited to adequate personnel, space, equipment and time to minimize risk and result in valid data.

1.9.7Investigators

The investigator is the ultimate protector of the human subjects who participate in research. The investigator is expected to abide by the highest ethical standards in the conduct and oversight of research and for developing a protocol that incorporates the principles of the Belmont Report. Investigators are expected to conduct research in accordance with the approved research protocol and to oversee all aspects of the research by providing supervision of all study team members, including oversight of the informed consent process. Unless consent is waived by the IRB, all subjects must give informed consent and the investigator must provide all research subjects within his/her responsibility with direct contact information to use in the event that they wish to contact the PI with questions or concerns.

In addition to complying with all the policies and standards of the governing regulatory bodies, the investigator must comply with Institutional and administrative requirements for conducting research. The investigator is responsible for ensuring that all research staff complete appropriate training and must obtain all required approvals prior to initiating research. When investigational drugs or devices are used, the investigator is responsible for providing written procedures for their storage, security, dispensing and disposal.

1.9.8Other Related Units

Committee on Conflict of Interest

The OSU policy for Conflict of Interest promotes objectivity in research by establishing expectations and disclosure requirements to ensure that the design, conduct and reporting of research will not be biased by a Significant Financial Interest of an individual. Communication between the IRB and CCOI is facilitated through four mechanisms:

 

• Applications that are received by the IRB which include a disclosure of a conflict of interest are forwarded to the COI Administrator for review. The study file is accessible to CCOI while under review and after it has been approved. IRB approval may be issued prior to a determination from the CCOI if the IRB has reviewed the relevant details and finds that the matter is appropriately managed within the protocol and, if applicable, the consent process.

• The IRB Administrator is alerted to disclosures made in the COI system when they involve, or appear to involve, research with human subjects. Any resulting management plan is accessible to the IRB.

• At the discretion of the Vice President for Research, a representative from the IRB will serve as a non-voting member of the CCOI.

• A representative from the CCOI will serve as a non-voting member of the IRB.

Institutional Animal Care and Use Committee

In the event that a research protocol involves both human and animal subjects, the Administrators for the IRB and the Institutional Animal Care and Use Committee (IACUC) will work together to ensure that information regarding the reviews is shared between committees.

Diving Safety and Small Boats: Pending information from DSO

In the event that a research protocol involves human subjects and scientific diving operations or small boat use, the IRB Administrator and the Diving Safety Officer will work together to ensure that information regarding reviews is shared between committees.

Office for Commercialization & Corporate Development

The Office for Commercialization & Corporate Development (OCCD) supports research development and commercialization of University intellectual property. Applications that are received by the IRB which include the transfer of biological materials to or from OSU are referred to the OCCD for consultation regarding the potential need for a Material Transfer Agreement (MTA). Similarly, researchers will be referred to the IRB if they indicate to OCCD that they plan to conduct research involving human subjects.

Office of Sponsored Programs

The Office of Sponsored Programs staff review and approve all research proposals and agreements with external sponsors. This Institutional review ensures that all terms of the award are in compliance with Institutional policies.

When the grant or contract agreement includes human research activities that will be conducted by investigators who are not employees or agents of OSU, a subcontract is executed between OSU and the collaborating Institution. The subcontract includes the requirement for the collaborating Institution to assure compliance with federal regulations for the protection of human subjects in research and to provide certification and documentation of current and ongoing IRB approval upon execution of the subcontract, and annual certification thereafter, during the life of the sub-award. The collaborating Institution must also ensure that key personnel involved in human subjects research are in compliance with the NIH policy on education in the protection of human research subjects and provide documentation of education of key personnel to OSU.

For all externally funded research, the IRB Office will include OSP on notices of exemption, approval, suspension, or termination sent to Investigators.

Office of Post Award Administration

The Office of Post Award Administration (OPAA) provides post award administration, reporting, and accounting for OSU researchers. For all externally funded research, the IRB Office will include the Office of Post Award Administration (OPAA) on notices of exemption, approval, suspension, or termination sent to Investigators.

Radiation Safety Committee

All research and teaching activities at OSU that require the possession and/or use of radioisotopes or radiation-emitting machines are governed by the provisions of a license and/or regulations issued by the State of Oregon. The Radiation Safety Program provides for these uses under the applicable laws and regulations of federal, state, and local agencies. Furthermore, the Program ensures that no risk from ionizing radiation shall be incurred except where justified by benefits from the activity and that radiation exposure shall be as low as reasonably achievable. The Radiation Safety Committee (RSC) must specifically authorize all uses of ionizing radiation and the authorized user has primary responsibility for all safety aspects of work under the program. This includes familiarity with and adherence to all regulations, personnel training, and the conduct of safe operations with the assistance of Radiation Safety.

 

Applications that are received by the IRB which include the use of radiation are forwarded to the RSC for simultaneous review. Once the IRB approves the application, the approval documents will be forwarded to the RSC so that they may be passed on to the State of Oregon. When State approval is obtained, the RSC will send a Radiation Use Authorization to the IRB Administrator for signature. At this point, the IRB will release the IRB approved documents to the PI.

Biological Safety Committee

In recognition of the necessity for conducting research utilizing potentially hazardous biological materials in a safe and secure manner, the Institutional Biosafety Committee (IBC) reviews biohazardous work conducted for any purpose by OSU personnel or in any OSU facility. The IBC has full authority to impose containment requirements or procedural safeguards, audit programs, and inspect facilities to ensure that biohazards are handled, used, and disposed of in a safe and compliant manner.

 

Applications that are received by the IRB which include the collection and/or use of biological samples are forwarded to the Biosafety Officer for review. IRB approval of a study will not be issued until and unless it is first approved by the Biosafety Officer.

Chemical Safety Committee

Applications that are received by the IRB which include the use of chemicals are forwarded to the Chemical Safety Officer (CSO) for simultaneous review. In turn, the CSO will send the IRB the approval documentation issued by that committee and indicate whether or not the protocol submitted for IRB review is consistent with the application materials reviewed and approved by the Chemical Safety Committee.

General Counsel’s Office

The OSU IRB relies on the Institution’s Office of General Counsel for the interpretations and applications of Oregon State law, and the laws of any other jurisdiction where research is conducted, as they apply to human subjects research.

1.9.9Relationship Between Components

The IRB functions independently of, but in coordination with, other Institutional compliance committees. The IRB, however, makes independent determinations about whether to approve or disapprove a protocol based upon whether or not human subjects are adequately protected. The IRB has review jurisdiction over all research involving human subjects conducted under the auspices of OSU.

Office of Research Integrity

Under the direction of the Associate Vice President for Research, and in accordance with University policies, procedures, and guidelines, the Director of ORI provides advice to senior management, staff, and employees to maximize compliance with statutory and regulatory requirements; regularly reviews compliance programs to identify areas of risk and works with senior administration to secure solutions that will manage or eliminate threats to research integrity; works with administrative units across campus to harmonize policies between ORI and other areas impacting the OSU research community; and collaborates with senior management and campus compliance areas to organize and provide a coordinated education and outreach program to promote the responsible conduct of research.

 

The Director of ORI provides leadership and coordination for the administration, support, monitoring, and assessment of a range of research compliance functions, including: the Institutional Review Board, Animal Care and Use Committee, Conflict of Interest Committee, Scientific Diving and Small Boat use for research, and the Biosafety Committee.

 

This position also provides the Research Office interface and linkage to the Environmental Health and Safety programs. The Director provides leadership to ORI by establishing and maintaining research compliance systems; embracing the vision and goals for research integrity and assuring those are aligned with those of the University; communicating the vision and goals to staff; developing a highly cohesive compliance work team; and enabling staff to perform effectively.

 

While the Director has a critical role for overseeing the compliance programs and for coordinating activities of the compliance groups broadly across campus, administrators and officers for each of the compliance units will have direct and unimpeded access to the Institutional Official (IO) at their discretion.

Research Integrity and Environmental Health and Safety

Administrators and Safety Officers from each of the ORI and EH&S units meet regularly. The group focuses on policy harmonization across units and works to identify areas of risk and vulnerability related to the conduct of research at OSU.

Institutional Compliance Office

The Institutional Compliance Office coordinates the network of compliance functions across the OSU campus, through the Compliance Partners Network. The Director of this office develops and coordinates the compliance program by obtaining periodic reports from the decentralized compliance units, conducting risk analyses to prioritize senior leadership focus for improvements, developing compliance policies and a central University-wide compliance calendar, and communicating with senior leadership, campus and compliance units.

 

The Director acts in an advisory capacity only. The IRB’s authority, autonomy, and reporting structure are not impacted by this office; however, the IRB Administrator provides the Director with information related to the IRB’s compliance functions as requested and participates in the network of compliance functions and offices across OSU.

1.10IRB Resources

In accordance with 45 CFR 46.103, the IO will ensure that the IRB has adequate meeting space and sufficient staff to support the IRB’s review and record keeping duties. The resources provided for the IRB and IRB office will be reviewed during the annual budget review process.

 

2.Investigator Responsibilities(top)

2.1Policy

Principal Investigators are ultimately responsible for the conduct of research. Principal Investigators may delegate research responsibility. However, investigators must maintain oversight and retain ultimate responsibility for the conduct of those to whom they delegate responsibility.

The following procedures describe the investigator responsibilities in the conduct of research involving human participants.

2.2Investigators

Principal Investigators

OSU unclassified employees with the following appointments may serve as a Principal Investigator (PI), if they are otherwise sufficiently qualified to conduct and oversee the research:

• Academic Teaching and Research Faculty: Assistant, Associate, Professor (includes Clinical, Extension, Practice, Senior Research, Endowed Chair); Faculty Research Assistant; Instructor (includes ALS, ELS, PAC); Lecturer; Research Associate; Research Associate (Post Doc); Senior Faculty Research Assistant I or II; Senior Instructor I or II; paid Visiting Faculty.

• Non-teaching Administrative and Professional Faculty

• Federal

OSU unclassified employees with the following appointments are not permitted to serve as the PI on a study involving human subjects:

• Unclassified hourly

• Academic wage appointment

The following additional classifications are not permitted to serve as the PI on a study involving human subjects:

• Classified employees

• Temporary Support Staff

• Student Appointments: Student, Graduate Assistant, Postdoctoral Scholar, Clinical Fellow

• Unpaid: Affiliate, Courtesy, Emeritus, Postdoctoral Fellow, Graduate Fellow, unpaid Visiting Faculty

The IRB recognizes one Principal Investigator (PI) for each study. The PI is ultimately responsible for the conduct of the entire study and all study team members.

Protocols that require skills beyond those held by the PI must be modified to meet the investigator's skills or have one or more additional qualified faculty as Co-investigator(s).

Research Team

Any individuals who will interact with subjects or have access to individually identifiable data should be listed as study team members. When this is not a reasonable requirement for enhancing the protection of human subjects, or the individuals are not considered to be key personnel, the PI must follow the procedures below.

 

Procedures for Certifying Research Team Members

There are circumstances under which listing individual study team members on an IRB application is not a reasonable requirement for enhancing the protection of human subjects. Examples of such circumstances can include:

• Individual researchers will be identified in the field;

• The study involves community based participatory research and data collection is conducted by lay individuals and/or study participants;

• Individuals obtaining consent or conducting data collection are not considered to be key personnel because they will not contribute to the scientific development of the project or assist with data analysis.

While these individuals need not be listed on the application to the IRB, the PI is required to train, oversee, and certify these individuals as qualified members of the team. The protocol must include the following:

• A description of who these individuals will be (e.g., community members, regional high school teachers, Extension Agents, etc.)

• A description of the responsibilities and activities that these individuals will perform

• A detailed plan for training, oversight, and procedures for ensuring protocol adherence

• A copy of the certification document

At a minimum, certification documents must include a list of responsibilities, an acknowledgement of training, a commitment to protocol adherence and the protection of the rights and welfare of human subjects, and signature lines for the PI and study team member. A comprehensive list of these individuals and a copy of each certificate should be included at the time of each continuing review. A template for this certification is available on the IRB website.

Certification should be submitted to the IRB Office at the time of Continuing Review for non-exempt studies and with the Final Report for exempt studies.

2.3Responsibilities

In order to satisfy the requirements of this policy, investigators who conduct research involving human subjects must attest:

1. That the information contained in the application is accurate and complete;

2. That research involving humans, including recruitment, will not begin until IRB approval has been granted;

3. To the scientific merit and importance of this study;

4. To the competency and availability of the study team member(s) to conduct the project;

5. That facilities, equipment, and personnel are adequate to conduct the research.

 

Furthermore, investigators must agree to:

 

1. Comply with all IRB policies, decisions, conditions, and requirements;

2. Accept responsibility for every aspect of the conduct of this study;

3. Obtain prior approval from the IRB before amending or altering the study and/or study documents;

4. Report to the IRB in accord with current policy, any adverse event(s) and/or unanticipated problem(s);

5. Complete and submit continuing review documentation or a final report prior to the expiration date;

6. Notify the IRB immediately of the development of any potential conflict of interest not already disclosed.

2.4Training for Investigators

The OSU IRB is committed to providing training and an on-going educational process for investigators and members of their research team related to ethical concerns and regulatory and Institutional requirements for the protection of human subjects.

2.4.1Initial Education

The research community has a responsibility to ensure that the treatment of human subjects in research meets the highest ethical standards. Recognizing this responsibility, the National Institutes of Health (NIH) requires NIH funding recipients to certify training in the ethical use of humans in research. Endorsing the goals of such training, the OSU Institutional Review Board (IRB) requires education in the protection of human research participants for all researchers conducting research involving human subjects, not just those receiving NIH funding.

OSU study team members have two training options:

1. CITI Course

2. NIH Course

Non-OSU study team members have three training options:

1. CITI Course

2. NIH Course

3. Provide an electronic copy of the certificate of education found acceptable by the IRB at their home Institution.

If a non-OSU study team member is unable to complete, or provide proof of completion, of the above described training (for reasons such as illiteracy, inability to use or access the internet, or CITI training is not offered in the individual’s native language), they may contact the IRB Administrator for additional options.

Approval of research projects will not be issued until documentation of training has been received by the IRB for all study team members. Such documentation need only be submitted once. Study team members for whom the IRB has already recorded training completion will not be required to provide additional documentation of training.

2.5Investigator Concerns

Investigators who have concerns or suggestions regarding OSU’s Institutional Review Board (IRB) should convey them to the Institutional Official or other responsible parties (e.g. Director of ORI, college dean, departmental chair) regarding the issue, when appropriate. The Institutional Official or their designee will investigate the issue. When deemed necessary, the IO may convene the parties involved to form a response for the investigator or make necessary procedural or policy modifications, as warranted. In addition, the Chair of the IRB or the IRB Administrator will be available to address investigators’ questions, concerns, and suggestions.

3.Quality Assurance/Quality Improvement Activities(top)

The objective of the IRB Quality Assurance / Quality Improvement Activities are to maintain and improve the effectiveness of human research protections, and compliance with Institutional policies and procedures as well as applicable federal, state, and local laws.

3.1Investigator Audits and Compliance Reviews

Directed (“for cause”) audits and periodic (not “for cause”) compliance reviews will be conducted, as resources allow, to assess investigator compliance with federal, state, and local law, and Institutional policies, and to identify areas for improvement, and suggest recommendations based on existing policies and procedures. Directed audits of IRB-approved research studies are in response to identified concerns. Periodic compliance reviews will be conducted using a systematic method to review IRB-approved research. The results will be reported to the Administrator and the IRB Chair.

Activities of auditors during directed audits and periodic compliance reviews may include:

1. Requesting progress reports from researchers;

2. Examining investigator-held research records;

3. Contacting research subjects;

4. Observing research sites where research involving human research subjects and/or the informed consent process is being conducted;

5. Auditing advertisements and other recruiting materials as deemed appropriate by the IRB;

6. Reviewing projects to verify from sources other than the researcher that no unapproved changes have occurred since previous review;

7. Monitoring conflict of interest concerns to assure the consent documents include the appropriate information and disclosures;

8. Conducting other monitoring or auditing activities as deemed appropriate by the IRB.

3.1.1Independent Verification That No Material Changes Have Occurred

The IRB recognizes that protecting the rights and welfare of subjects sometimes requires that the IRB verify independently, utilizing sources other than the investigator, that no material changes occurred during the IRB-designated approval period. Independent verification from sources other than the investigator may be necessary at times, for example, in cooperative studies, or other multi-center research.

The IRB will determine the need for verification from outside sources on a case-by-case basis and according to the following criteria:

1. Protocols where concerns about possible material changes occurring without IRB approval have been raised, based on information provided in continuing review reports or from other sources

2. Protocols conducted by Principal Investigators who have previously failed to comply with federal regulations and/or the requirements or determinations of the IRB

3. Protocols subject to internal audit

4. Whenever else the IRB deems verification from outside sources is relevant

The following factors will also be considered when determining which studies require independent verification:

1. The probability and magnitude of anticipated risks to subjects.

2. The likely medical condition of the proposed subjects.

3. The probable nature and frequency of changes that may ordinarily be expected in the type of research proposed.

In making determinations about independent verification, the IRB may prospectively require that such verification take place at predetermined intervals during the approval period, or may retrospectively require such verification at the time of continuing review, review of amendments and/or unanticipated problems.

If any material changes have occurred without IRB review and approval, the IRB will decide the corrective action to be taken.

3.1.2Consent Monitoring

In reviewing the adequacy of informed consent procedures for proposed research, the IRB may on occasion determine that special monitoring of the consent process by an impartial observer (consent monitor) is required in order to reduce the possibility of coercion and undue influence.

Such monitoring may be particularly warranted where the research presents significant risks to subjects, or if subjects are likely to have difficulty understanding the information to be provided. Monitoring may also be appropriate as a corrective action where the IRB has identified problems associated with a particular investigator or a research project.

If the IRB determines that consent monitoring is required, the IRB Chair and the Administrator will develop a monitoring plan and submit it to the Board for approval. The consent monitoring may be conducted by IRB staff, IRB members or another party, either affiliated or not with the Institution. The PI will be notified of the IRB’s determination and the reasons for the determination. Arrangements will be made with the PI for the monitoring of the consent process for a specified number of subjects. When observing the consent process, the monitor will determine:

• Whether the informed consent process was appropriately completed and documented,

• Whether the participant had sufficient time to consider study participation,

• Whether the consent process involved coercion or undue influence,

• Whether the information was accurate and conveyed in understandable language, and

• Whether the subject appeared to understand the information and gave their voluntary consent.

Following the monitoring, a report of the findings will be submitted to the IRB, which will determine whether and what action will be taken.

3.2External Site Audits and Compliance Reviews

External directed audits and periodic compliance reviews may be conducted at external sites, where the Institution’s IRB serves as the “IRB of Record,” to assess compliance with federal, state, and local law, research subject safety, and IRB policies and procedures.

3.3Reporting and Disposition

The results of all quality assurance activities are reported to the Administrator, the IRB Chair, and the Director of ORI. Non-compliance will be handled according the procedures articulated in later sections.

If an audit or review finds that subjects in a research project have been exposed to unexpected harm, the reviewer will promptly report such findings to the Administrator, the IRB Chair, and the Director of ORI for immediate action. The Director of ORI will report such incidents to the Institutional Compliance Office.

In the event that evidence of scientific or scholarly misconduct is found during an audit or investigation, that information will be reported in accordance with the OSU Policy on Scientific and Scholarly Misconduct.

3.4IRB Internal Compliance Reviews

A periodic review of the IRB may be conducted by parties internal or external to OSU, but not affiliated with the IRB through membership, reporting lines, or appointment authority. The results of the review will be reported to the IO, the IRB Administrator, the IRB Chair(s), and the Director of ORI. The reviewer(s) will be sufficiently knowledgeable of IRB processes and procedures to carry out the following activities:

 

1. Review of the IRB minutes to determine that adequate documentation of meeting discussions has occurred. This review will include assessing the documentation surrounding the discussion for protections of vulnerable populations as well as other risk/benefit ratio and consent issues that are included in the criteria for approval;

2. Assess the IRB minutes to assure that quorum was met and maintained;

3. Assess the current adverse event reporting process;

4. Assess if privacy provisions have been adequately reviewed, discussed and documented in the IRB minutes;

5. Evaluate the continuing review discussions to assure they are substantive and meaningful and that no lapse has occurred since the previous IRB review;

6. Observe IRB meetings or other related activities;

7. Review IRB files to assure retention of appropriate documentation and consistent organization of the IRB file according to current policies and procedures;

8. Review the IRB database or electronic system to assure all fields are completed accurately;

9. Review of evaluations by the IRB members;

10. Verify IRB approvals for collaborating Institutions or external performance sites;

11. Verify that IRB and institutional policies and procedures have been followed;

12. Review other activities deemed appropriate by the IO.

The Administrator will review the results of internal compliance reviews with the IRB Chair, the Director of ORI, and the Institutional Official. If any deficiencies are noted in the review, a corrective action plan will be developed by the Administrator and approved by the Director of ORI, and by the Institutional Official. The Administrator will have responsibility for implementing the corrective action plan, the results of which will be evaluated by the Institutional Official.

3.5Quality Improvement

All quality assurance reports, both research-related and IRB-related, will be reviewed by the Administrator, the Director of ORI, the IRB Chair, and the IO in order to determine if systemic changes are required in the IRB to prevent re-occurrence. If so, a corrective action plan will be developed, implemented and evaluated by the Administrator and IO.

4.Institutional Review Board(top)

4.1Policy

OSU has established an Institutional Review Board (IRB) to ensure the protection of human subjects involved in research conducted under the auspices of the Institution. All human subjects research conducted under the auspices of the Institution must be reviewed and approved (or acknowledged if exempt) by the IRB prior to the initiation of the research. The IRB will review proposed research involving human subjects for ethical considerations, scientific merit, and adherence to applicable federal regulations and IRB policies. The results from studies conducted without obtaining IRB approval may not be represented as having IRB approval and should not be published or used to satisfy the requirements for an undergraduate thesis, master's thesis or doctoral dissertation.

4.2IRB Authority

The IRB derives its authority from the Federal Regulations and from OSU Institutional policy. Under the Federal Regulations, the IRB has the authority to:

1. Approve, require modifications to secure approval, or disapprove all research activities overseen and conducted under the auspices of the IRB;

2. Suspend or terminate approval of research not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to participants;

3. Observe, or have a third party observe, the consent process; and

4. Observe, or have a third party observe, the conduct of the research.

Research that has been reviewed and approved by the IRB may be subject to review and disapproval by officials of the Institution. However, those officials may NOT approve research if it has not been approved by the IRB. Institution officials may strengthen requirements and/or conditions, or add other modifications to secure Institutional approval or approval by another committee, or may disallow continuation of the research project, or of components of the project involving human subjects research. If the Institution requires changes to previously approved research proposals and/or consent forms, these documents must be re-reviewed and approved by the IRB before initiating those changes or modifications.

4.3Number of Boards

OSU currently has two Boards. The IRB Administrator and the IRB Chairs will review the activity of the IRBs on at least an annual basis and make recommendations to the Director of ORI and the IO regarding any changes in the number of boards needed for the Institution.

4.4Board Composition

Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the Institution.

The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.

In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of Institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas.

If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.

Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the Institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession.

Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific¹ areas.

Each IRB shall include at least one member who is not otherwise affiliated² with the Institution and who is not part of the immediate family of a person who is affiliated with the Institution.

No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.

An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.

One member may satisfy more than one membership category.

On an annual basis, the IRB Chair and the Administrator shall review the membership and composition of the IRB to determine if they continue to meet regulatory and Institutional requirements. Required changes in IRB membership will be reported to the OHRP.

Members from one board may serve as expedited reviewers for another board, as needed.

4.5Board Membership

The structure and composition of the IRB must be appropriate to the amount and nature of the research that is reviewed. Every effort is made to have member representation that has an understanding of the areas of specialty that encompasses most of the research performed at OSU.

In addition, the IRB will include members who are knowledgeable about and experienced working with vulnerable populations that typically participate in OSU research.

4.5.1Appointment of Members to the IRB

The IRB Chair, Vice Chair and/or the Administrator of the IRB office, may identify a need for a new, replacement, or alternate member. Any Board or staff member may nominate candidates and provide the Administrator with the names of the nominees. Department Chairs may also forward nominations to the Institutional Official, the Administrator, or the IRB Chair. OSU faculty may also indicate their interest in serving on the Board by contacting the IRB Administrator or by selecting the IRB as one of their top choices in the faculty committee survey. Individuals selecting the IRB as one of their top three choices for Board service may be contacted by the IRB Administrator.

The final decision in selecting a new member is made by the Institutional Official, in consultation with the Director of ORI, the IRB Chair and the Administrator of the IRB office.

Appointments are made for a renewable three-year period of service. Any change in appointment, including reappointment or removal, requires written notification. Members may resign by written notification to the Chair or may be removed at the discretion of the IO.

4.5.2Chair of the IRB

The Institutional Official (IO) appoints the Chair and Vice Chair of the IRB to serve for renewable three-year terms. Any change in appointment, including reappointment or removal, requires written notification.

The IRB Chair should be a highly respected individual, from within the Institution, fully capable of managing an IRB, and the matters brought before it with fairness and impartiality. The task of making the IRB a respected part of the Institutional community will fall primarily on the shoulders of the Chair. The IRB must be perceived to be fair, impartial and immune to pressure by the Institution's administration, the investigators whose protocols are brought before it, and other professional and nonprofessional sources.

The IRB Chair is responsible for conducting the meetings and they are signatories for correspondence generated by the IRB. The IRB Chair may designate the Administrator or other IRB members to perform duties, as appropriate, for review, signature authority, and other IRB functions.

The IRB Chair advises the Institutional Official and the Administrator of the IRB office about IRB member performance and competence.

The performance of the IRB Chair will be reviewed on an annual basis by the Administrator of the IRB office in consultation with the Institutional Official. Feedback from this evaluation will be provided to the Chair. If a Chair is not acting in accordance with the IRB’s mission, policies or procedures, has an undue number of absences, or not fulfilling the responsibilities of the Chair, he/she may be removed by and at the discretion of the IO.

4.5.3Vice Chair of the IRB

The Vice Chair serves as the Chair of an IRB in the absence of the Chair and has the same qualifications, authority, and duties as Chair. In addition, the Vice Chair is responsible for the organization and presentation of continuing education offered to IRB members at full board meetings.

4.5.4Alternate members

The appointment and function of alternate members is the same as that for primary IRB members, and the alternate's expertise and perspective are comparable to those of the primary member. The role of the alternate member is to serve as a voting member of the IRB when the regular member is unavailable to attend a convened meeting or may attend according to a pre-arranged schedule (e.g., every other meeting). When an alternate member substitutes for a primary member, the alternate member will receive and review the same materials prior to the IRB meeting that the primary member received or would have received.

The IRB roster identifies the primary member(s) for whom each alternate member may substitute. The alternate member will not be counted as a voting member unless the primary member is absent. The IRB minutes will document when an alternate member replaces a primary member.

4.5.5Subcommittees of the IRB

The IRB Chair, in consultation with the Administrator, may designate one or more IRB subcommittees to perform duties, as appropriate, to review and undertake IRB functions, and to make recommendations to the IRB. The number and composition of the IRB Subcommittee members shall depend on the authority delegated by the IRB Chair to such IRB Subcommittee (e.g., limited to making recommendations versus decision-making authority).

4.6IRB Member Conflict of Interest³

Relevant regulation(s): §46.107(e) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.

 

No regular, alternate, or ex officio member may participate in the review of any research project in which the member has a conflict of interest (COI), except to provide information as requested by the Chair or other members present. It is the responsibility of each IRB voting and non-voting member to disclose any COI in a study submitted for review and recuse him/herself from the deliberations and vote.

 

OSU IRB members and consultants are responsible for disclosing to the Board any actual, potential, or perceived conflicts of interest (COI) concerning protocols reviewed by the IRB.

 

The Chair will ask the Board if any member present has a potential conflict of interest with any investigator or protocol that is under consideration on the day's agenda. This COI query by the Chair will be recorded in the minutes, along with any declarations of COI made by the members/consultants.

 

In the event that a member believes that she or he cannot provide an independent review, that member will leave the meeting room prior to final deliberation on that protocol. They will not vote on the outcome of the review, nor will they comment on the protocol unless relevant information is requested by a Board member. Members and consultants with conflicts of interest will leave the meeting room prior to the Board’s final deliberation and vote. If quorum is lost as a result, the protocol will be tabled until the next convened meeting of the Board. Their exit and re-entrance will be recorded in the minutes as a recusal.

 

If any member discloses a conflicting interest but indicates that they are able to provide an independent review, Board members will discuss the conflict and make a determination regarding the need for recusal. If there is disagreement on the need for recusal, the issue will be put to a vote. All members, including the member with the potential conflict may participate in the vote.

 

An IRB member or consultant may be considered to have a conflicting interest requiring recusal when they, or member of their family⁴, has any of the following:

 

1. Substantive involvement in the design, conduct, or reporting of the research

2. Direct supervisory line or mentorship of member of the study team

3. Ownership interest, stock options, or other financial interest related to the research

4. Agreement to receive compensation related to the research

5. Proprietary interest related to the research including, but not limited to, a patent, trademark, copyright or licensing agreement

6. Board or executive relationship related to the research

7. Any other reason for which the member/consultant believes that he or she cannot provide an independent review or which may lend itself to the perception of a conflicted interest. Reasons may include personal or professional relationships, minor consultation on study design.

 

IRB members are responsible for self-identifying any conflicting interests to the IRB Office before conducting review using the expedited procedure, so as to remove themselves’ from involvement in the review of the research.

4.7Duties of IRB Members

Members of the IRB and their designated alternates are expected to:

• Attend and participate in the majority of the convened IRB meetings;

• Review all materials provided in each meeting packet in advance of the convened meetings they attend;

• Review all materials relevant to study proposals assigned to them for an expedited review;

• Review and promptly inform the IRB staff of corrections or additions to convened board meeting minutes;

• Treat the research proposals, protocols, and supporting data confidentially

4.8Attendance Requirements

Members should attend all meetings for which they are scheduled. If a member is unable to attend a scheduled meeting, they should inform the IRB office. If the inability to attend will be prolonged, a request for an alternate to be assigned may be submitted to the Chair or the Administrator.

If an IRB member is to be absent for an extended period of time, such as for a sabbatical, he or she must notify the IRB at least 30 days in advance so that an appropriate replacement can be obtained. The replacement can be temporary, for the period of absence, or permanent if the member is not returning to the IRB. If the member has a designated alternate, the alternate can serve during the primary member’s absence, provided the IRB has been notified in advance.

4.9Education for IRB Members

A vital component of a comprehensive human research protection program is an education program for IRB members. OSU is committed to providing training and an on-going educational process for IRB members and the staff of the IRB office, related to ethical concerns and regulatory and Institutional requirements for the protection of human subjects.

4.9.1Orientation

New IRB members, including alternate members will meet with the IRB Chair and/or the Administrator for an informal orientation session. At the session, the new member will be given a binder that includes:

• Belmont Report and Nuremberg Code;

• OSU Policies and Procedures for the Protection of Human Subjects;

• Federal regulations relevant to the IRB

• Guidance documents relevant to the IRB

New members are required to complete the Initial Education requirement for IRB members before they may serve as a primary reviewer.

4.9.2Initial Education

IRB members will complete the relevant modules in the CITI Course.

4.9.3Continuing Education

To ensure that oversight of human research is ethically grounded and the decisions made by the IRB are consistent with current regulatory and policy requirements, training is continuous for IRB members throughout their service on the IRB. Educational activities include, but are not limited to:

• In-service training at IRB meetings;

• Annual retreats;

• Copies of appropriate publications;

• New information that might impact the IRB, including laws, regulations, policies, procedures, and emerging ethical and scientific issues;

• Unlimited access to the IRB office resource library.

Other training opportunities will be considered by the IO on a case-by-case basis, including attendance at the annual PRIM&R conference or regional conferences on human research protections.

4.10Review of IRB Member Performance

The IRB Members’ performance will be reviewed on an annual basis. IRB members will receive formal feedback on the results of this review, and exemplary service will be recognized by the IO in writing. The quality of service will be measured by engaged attendance and timeliness of reviews. Performance evaluations will be conducted by the Chair and Administrators and submitted to the IO for consideration. Members who are not acting in accordance with the IRB’s mission or policies and procedures or who have an undue number of absences may be removed at the discretion of the IO.

4.11Liability Coverage for IRB Members

The Institution’s insurance coverage applies to employees and any other person authorized to act on behalf of the Institution or acts or omissions within the scope of their employment or authorized activity.

4.12Use of Consultants

When necessary, the IRB Chair or the Administrator of the IRB office may solicit individuals from the Institution or elsewhere with competence in special areas to assist in the review of issues or protocols, which require appropriate scientific or scholarly expertise beyond or in addition to that available on the IRB. The need for an outside reviewer is determined in advance of the meeting by the Administrator or the Chair by reviewing the protocols scheduled to be reviewed at the convened meeting. The IRB office will ensure that all relevant materials are provided to the outside reviewer prior to the convened meeting.

Written statements of consultants will be kept in IRB records. Key information provided by consultants at meetings will be documented in the minutes. Written reviews provided by the outside reviewer will be filed with the protocol.

The Administrator of the IRB office reviews the conflicting interest policy for IRB members with consultants.

The consultant’s findings will be presented to the full board for consideration either in person or in writing. If in attendance, these individuals will provide consultation but may not participate in the vote.

Ad hoc or informal consultations requested by individual members (rather than the full board) will be requested in a manner that protects the researcher’s confidentiality and is in compliance with the IRB conflict of interest policy (unless the question raised is generic enough to protect the identity of the particular PI and research protocol).

4.13Reporting and Investigation of Allegations of Undue Influence

If an IRB Chair, member, or staff person feels that the IRB has been unduly influenced by any party, they may work with the Administrator to make a confidential report to the Institutional Official (IO). In the event that the Administrator is conflicted, the complainant may work with the Director of ORI to make the report to the IO. If both the Administrator and Director are conflicted, the complainant may make the report directly to the IO. If the IO is conflicted, the complainant may make the report directly to the University President. In any event, the report will follow the chain of IRB authority (i.e., Administrator and/or Chair, then Director of ORI, then IO, then the University President), rather than supervisory reporting lines.

The official receiving the report will conduct a thorough investigation and, when necessary, take corrective action to prevent additional occurrences.

5.Records and Documentation(top)

5.1Policy

IRB shall prepare and maintain adequate documentation of the IRB’s activities. All records must be accessible for inspection and copying by authorized representatives of the FDA, OHRP, sponsors, and other authorized entities at reasonable times and in a reasonable manner.

OSU IRB documents are not signed by the Chairperson or designee. Federal regulations do not require signatures on approval documents (see FDA Factsheet FAQ 1998). Therefore, the OSU IRB documents meet the regulatory requirements for notifications.

5.1.1IRB Records

IRB records include, but are not limited to:

1. Written operating procedures

2. IRB membership rosters

3. Records of research investigators, IRB members, and IRB staff that have fulfilled the Institution’s ethics/compliance training requirements

4. IRB correspondence (other than protocol related)

5. IRB Study Files

6. Documentation of Emergency Exemption from Prospective IRB Approval (21 CFR 56.104(c))

7. Documentation of Exceptions from Informed Consent Requirements for Emergency Use of a Test Article (21 CFR 50.23)

8. Documentation of exemptions

9. Documentation of convened IRB meetings minutes

10. Documentation of review by another Institution’s IRB when appropriate

11. Documentation of cooperative review agreements, e.g. Memoranda of Understanding (MOUs)

12. Federal Wide Assurances

13. Protocol violations submitted to the IRB

14. Quality assurance reviews

5.2IRB Study Files

The IRB will maintain a separate IRB study file for each research application (protocol) that it receives for review. Protocols will be assigned a unique identification number by the IRB Administrative Staff and entered into the IRB tracking system.

The IRB maintains a separate file for each research protocol that includes (when applicable), but is not limited to:

1. Protocol and all other documents submitted as part of a new protocol application

2. Protocol and all other documents submitted as part of a request for continuing review/termination of research application. This also includes progress reports, statements of significant new findings provided to participants, reports of injuries to subjects

3. Documents submitted and reviewed after the study has been approved, including reports of modifications to research/amendments and adverse event reports

4. Copy of IRB-approved Consent Form

5. DHHS-approved sample consent form document and protocol, when they exist

6. Review forms from IRB members (if exempt or expedited), scientific reviews, and consultants. Review forms are to be used as a guide for full board studies and not a reflection of final determinations.

7. Documentation of type of IRB review

8. Documentation of any determinations required by the regulations and protocol-specific findings supporting those determinations, including: waiver or alteration of the consent process, research involving pregnant women, fetuses, and neonates, research involving prisoners, and research involving children

9. Documentation of all IRB review actions

10. Notification of expiration of IRB approval to the PI and instructions for submitting relevant continuing review materials

11. Notification of suspension of research

12. Correspondence pertaining to appeals

13. Copies of approval letters and forms that describe what Principal Investigator must have before beginning the study

14. IRB correspondence to and from research investigators

15. All other IRB correspondence related to the research

16. For devices, a report of prior investigations

17. Reports of unanticipated problems involving risk to subjects or others and adverse events

18. Documentation of audits, investigations, reports of external site visits

5.3The IRB Minutes

It is the responsibility of the IRB Coordinator present to record the proceedings and take minutes of the meeting. The audio recording of the each meeting is destroyed after the minutes for that meeting are approved.

Proceedings must be written and available for review by the next regularly scheduled IRB meeting date. Once approved by the members at a subsequent IRB meeting, the minutes must not be altered by anyone, including a higher Institutional authority.

A copy of the minutes for each IRB meeting will be distributed to the IO via the meeting agenda packet.

Minutes of IRB meetings must contain sufficient detail to show each of the items below, as applicable:

1. Attendance

1. Names of members present

2. Names of members or alternate members who are participating through videoconference or teleconference and documentation that those attending through videoconferencing or teleconferencing received all pertinent material prior to the meeting and were able to actively and equally participate in all discussions

3. Names of alternates attending in lieu of specified (named) absent members. (Alternates may substitute for specific absent members only as designated on the official IRB membership roster)

4. Names of consultants present

5. Name of investigators present

6. Names of guests present

Note: The initial attendance list shall include those members present at the beginning of the meeting. The minutes will indicate, by name, those members who enter or leave the meeting. The vote on each action will reflect those members present for the vote on that item. Members who recuse themselves because of conflict of interest are listed by name and the reason documented.

 

1. The presence of a quorum throughout the meeting, including the presence of one member whose primary concern is in a non-scientific area

2. Business Items discussed

3. Continuing Education

4. Actions taken, including separate deliberations, actions, and votes for each protocol undergoing initial review, continuing review, or review of modifications by the convened IRB

5. Votes on these actions (Total Number Voting; Number voting for; Number voting against; Number abstaining; Number of those excused, Number of those recused)

6. Basis or justification for these actions including required changes in research

7. Summary of controverted issues and their resolution

8. Approval period for initial and continuing approved protocols, including identification of research that warrants review more often than annually and the basis for that determination

9. Risk level of initial and continuing approved protocols

10. Review of interim reports, e.g. unanticipated problems or safety reports; amendments; report of violation/deviations; serious or continuing non-compliance; suspensions/terminations, etc.

11. Review of Data and Safety Monitoring Board (DSMB) summary

12. Review of Plans for Data and Safety Monitoring

13. Justification of deletion or substantive modification of information concerning risks or alternative procedures contained in the DHHS-approved sample consent document.

14. Protocol-specific documentation that the research meets the required criteria [45 CFR 46.116(d)] when approving a consent procedure that does not include or that alters some or all of the required elements of informed consent, or when waiving the requirement to obtain an informed consent

15. Protocol-specific documentation that the research meets the required criteria [45 CFR 46.117(c)] when the requirements for documentation of consent are waived

16. When approving research that involves populations covered by Subparts B, C, or D of 45 CFR 46, the Minutes will document the IRB’s justifications and findings regarding the determinations stated in the Subparts or the IRB’s agreement with the findings and justifications as presented by the investigator on IRB forms.

17. Special protections warranted for other groups of subjects who are likely to be vulnerable to coercion or undue influence, such as mentally disabled persons, or economically or educationally disadvantaged persons, regardless of source of support for the research.

18. The rationale for significant risk/non-significant risk device determinations.

19. Determinations of conflict of interest.

20. Identification of any research for which there is need for verification from sources other than the investigator that no material changes are made in the research.

21. A list of research approved since the last meeting utilizing expedited review procedures.

22. An indication that, when an IRB member has a conflicting interest with the research under review, the IRB member was not present during the deliberations or voting on the proposal, and that the quorum was maintained.

23. Key information provided by consultants will be documented in the minutes or in a report provided by the consultant

5.4IRB Minutes and Public Records Requests

IRB meeting minutes are subject to the Oregon Public Records Rule. Rules regarding public records requests made to OSU are available in OSU’s Oregon Administrative Rules, at 576-004-0000 through 576-004-00020. All requests should be made directly to the Office of General Counsel. The procedures are available on the OSU website and Requests for OSU public records may be made by e-mail to this address: [email protected].

5.5IRB Membership Roster

A membership list of IRB members must be maintained; it must identify members sufficiently to describe each member's chief anticipated contributions to IRB deliberations. The list must contain the following information about members:

1. Name

2. Gender

3. Earned degrees

4. Affiliated or non-affiliated status (neither the member nor an immediate family member of the member may be affiliated with the Institution)

5. Status as scientist (physician-scientist, other scientist, non-scientist or social behavioral scientist).

6. Representative capacities of each IRB member; which IRB member is a prisoner representative (as required by Subpart C), and which IRB members are knowledgeable about or experienced in working with children, pregnant women, cognitively impaired individuals, and other vulnerable populations locally involved in research.

7. Role on the IRB (Chair, Co-Chair, etc.)

8. Voting status (Any ex officio members are non-voting members)

9. For alternate members, the primary member or class of members for whom the member could substitute

The IRB office must keep IRB membership list current. The Administrator of the IRB office must promptly report changes in IRB membership to the Office for Human Research Protections, Departments of Health and Human Services.

5.6Documentation of Exemptions

Documentation of verified exemptions consists of the reviewer’s citation of a specific exemption category and written concurrence that the activity described in the investigator’s request for satisfies the conditions of the cited exemption category. The exempt determination is reported at the next convened IRB meeting and documented in the Minutes.

5.7Documentation of Expedited Reviews

IRB records for initial and continuing review by the expedited procedure must include: the specific permissible category; that the activity described by the investigator satisfies all of the criteria for approval under expedited review; the approval period and any determinations required by the regulations including protocol-specific findings supporting those determinations.

5.8Access to IRB Records

The IRB has policies and procedures to protect the confidentiality of research information:

1. When unattended, all paper IRB records are kept secure in locked cabinets or locked storage rooms.

2. Ordinarily, access to all IRB records is limited to the Director of ORI, IRB Chair, IRB members, IRB Administrator, IRB staff, authorized Institutional official, and officials of Federal and state regulatory agencies (OHRP, FDA). Research investigators are provided reasonable access to files related to their research. Appropriate accreditation bodies are provided access and may recommend additional procedures for maintaining security of IRB records. All other access to IRB records is limited to those who have legitimate need for them, as determined by the IO and Director.

3. Records are accessible for inspection and copying by authorized representatives of Federal regulatory agencies during regular business hours.

4. IRB staff will provide copies of records for authorized personnel if requested.

5. All other access to IRB study files is prohibited.

5.9Record Retention

OSU’s IRB has adopted a consistent and conservative approach to the retention of human subjects research review records. A list of relevant references appears at the end of this section. All research-related records, regardless of funding source and review level, will be retained for a minimum of seven years post-study termination.

All records described in this policy shall be accessible for inspection and copying by authorized representatives of the IRB, by authorized representatives of the federal funding agency, if any, and any federal oversight body with relevant authority.

Records retained by the IRB. Records document the review of research proposals that involve the use of human subjects. Reviews may be made by the entire review board (IRB), by selected members, the board’s chair, or by IRB staff. Records will be retained for seven years post-study termination and may include, but are not limited to; approved protocols and consent forms; samples and/or approved test instruments; copies of grant proposals; review summaries; and related memoranda and correspondence.

 

IRB minutes are retained permanently. The electronic (born-digital) version is considered the record copy.

 

In accordance with 45 CFR 46.115 and 21 CFR 56.115, the IRB shall also prepare and maintain adequate documentation of IRB activities, including the following:

• Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects.

• Minutes of IRB meetings.

• Records of continuing review activities.

• Copies of all correspondence between the IRB and the investigators.

• A list of IRB members in the same detail as described in 45 CFR 46.103(b)(3).

• Written procedures for the IRB in the same detail as described in 45 CFR 46.103(b)(4) and 45 CFR 46.103(b)(5), 21 CFR 56.108(a) and (b).

• Statements of significant new findings provided to subjects, as required by 45 CFR 46.116(b)(5) and 21 CFR 50.25.

Records retained by the Principal Investigator. The principal investigator shall have primary responsibility for curating their research records for a minimum of seven years post-study termination, including signed consent forms and completed surveys, research notebooks, as well as digital records or other media form.

 

For FDA-regulated research. In accordance with 21 CFR 312, an investigator or sponsor shall retain the records and reports for 2 years after a marketing application is approved for the drug; or, if an application is not approved for the drug, until 2 years after shipment and delivery of the drug for investigational use is discontinued and FDA has been so notified.

 

In accordance with 21 CFR 812, An investigator or sponsor shall maintain the records required by this subpart during the investigation and for a period of 2 years after the latter of the following two dates: The date on which the investigation is terminated or completed, or the date that the records are no longer required for purposes of supporting a premarket approval application or a notice of completion of a product development protocol.

 

Departing faculty. In the event of exigent circumstances where the investigator cannot retain research records, or if the investigator intends to leave their position at the university, the investigator and their Department Head or Dean (not the IRB) should identify the successor responsible for maintaining those Institutional records, and for determining whether the original records or verified copies shall be retained by the university. In the event a researcher leaving their position at the university removes the original research data from the university, they must leave a verified copy and agree to provide access to the university to the original data, as well as to other individuals or entities having a legitimate need for access.

 

Relevant references:

 

• 45 CFR 46.115 IRB Records

• 21 CFR 56.115 IRB Records

• 21 CFR 312 Investigational New Drug Application

• 21 CFR 812 Investigational Device Exemptions

• 42 CFR 93.317 Retention and custody of the research misconduct proceeding record

• OMB Circular A-110 Uniform Administrative Requirements for Grants and Agreements With Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations (part 50, Reports and Records)

• US Department of Health and Human Services, Office of Research Integrity, on Responsible Conduct of Research – Lab Management/Notebook and Data Management

6.IRB Review Process(top)

6.1Sponsored Research

6.1.1Policy

It is OSU’s policy that any sponsored research conducted under the auspices of the Institution is conducted in accordance with federal guidelines and ethical standards.

The following describe the procedures required to ensure that all sponsored research meets this requirement.

6.1.2Definitions

Sponsor. Sponsor means the company, Institution, individual donor, or organization responsible for the initiation, management, or financing of a research study.

Sponsored research. Sponsored researchmeans research funded by external entities through a grant or contract that involves a specified statement of work (e.g., the research proposal) with a related transfer of value to the sponsor, including clinical trials involving investigational drugs, devices or biologics.

6.1.3Responsibility

1. Grants and contracts will be reviewed by the IRB staff for the following:

1. Indication that the information in the grant or contract is consistent with the protocol and consent form.

2. Indication that the investigator will follow the protocol, applicable regulations and its ethical standards.

3. Identification of entity responsible for research related injuries.

4. Indication that, if monitored and the study monitor uncovers information that could affect the safety of participants or their willingness to continue participation, influence the conduct of the study, or alter the IRB’s approval to continue the study, the sponsor will make sure that the information is communicated to the IRB.

5. Indication that if the sponsor discovers results that could affect the safety or care of subjects, the sponsor will make sure the IRB is notified.

6. Conflicts of interest, including those related to recruitment incentives (see “finders fees” and “bonus payments”).

1. The IRB will forward a copy of the approval letter to the Office of Sponsored Programs and the Office of Post Award Administration for any sponsored research, regardless of funding source.

6.2Conflict of Interest in Research

6.2.1Policy

It is the IRB’s policy to preserve public trust in the integrity and quality of research at the Institution by minimizing actual or perceived conflict of interest in the conduct of research.

The following describe the procedures by which this responsibility is carried out.

6.2.2 Definitions

Conflict of Interest. A financial or other business interest in the source(s) of funding, materials, or equipment related to a research study. These interests are exclusive of the costs of conducting the research.

Examples of potential conflicts of interest in research involving human subjects may include, but are not limited to:

• An investigator or family member participates in research on a technology, process or product owned by a business in which the faculty member holds a financial interest. Any interest should be disclosed to the IRB, regardless of whether it meets the threshold of a “significant financial interest,” as defined by the Public Health Service (PHS).

• An investigator or family member has a financial or other business interest in an entity that is supplying funding, materials, products, or equipment for the current research project.

• An investigator or family member serves on the Board of Directors of a business that is supplying funding, materials, products, or equipment for the current research project.

• An investigator receives consulting income from an entity that is funding the current research project.

• An investigator participates in research on a technology, process or product developed for which the investigator has intellectual property rights (e.g., copyrights, trademarks, patents, or trade secrets) or receives royalties.

Non-financial Conflict of Interest. Non-financial conflict of interest may exist when an individual serves dual roles, such as health care provider and investigator. Other interests such as publication, promotion or tenure, can also become conflicts of interest that may affect an individual's judgment. Membership in oversight committees, such as the IRB, as well as positions of authority may pose potential conflicts of interest. Any position that includes responsibilities for the review and approval of research projects or contracts other than his/her own may potentially affect the design of, decisions made and/or action taken surrounding a specific study.

Investigator. For the purposes of this policy, “investigator” refers to any member of the study team or a member of their immediate family.

Equity Interest. Stock, stock options or ownership interest as determined through reference to public prices or other reasonable measures of fair market value during the time the investigator is carrying out the study and for 1 year following completion of the study.

Immediate Family Member. Immediate family member is defined as anyone having a relationship to a person as a spouse or domestic partner; the parent, child, or sibling of the individual or domestic partner; or any person for whom the individual has a legal support obligation.

6.2.3Investigator Conflicts of Interest

These procedures apply to both financial and non-financial conflicts of interest and promote objectivity in research to ensure conflict of interests do not adversely affect the protection of participants.

For clinical studies involving the use of new human drugs and biological products or medical devices, certifications and disclosure requirements are defined in Food and Drug Administration (FDA) regulations, Title 21 CFR Part 54.

Conflicts of interest should be eliminated when possible and effectively disclosed and managed when they cannot be eliminated.

The research application asks protocol-specific questions regarding conflict of interest for all study team members and their immediate family members. Applications that are received by the IRB which include a disclosure of a conflict of interest are forwarded to the COI Administrator for review. The study file is accessible to COI Committee while under review and after it has been approved. IRB approval may be issued prior to a determination from the COI Committee if the IRB has reviewed the relevant details and finds that the matter is appropriately managed within the protocol and, if applicable, the consent process.

 

Evaluation of COI

At initial review of the research protocol and COI disclosure, the IRB also determines whether the financial or non-financial interest affects the protections of research participants.

Management of COI

The IRB will determine if the rights and welfare of human research participants will be better protected by one or more of the following:

1. Disclosure to subjects through the consent process

2. Modification of the research protocol or safety monitoring plan

3. Monitoring of research by independent reviewers

4. Disqualification of the conflicted party from participation in all or a portion of the research

5. Appointment of a non-conflicted Principal Investigator

6. Prohibition of the conduct of the research at OSU

6.2.4Recruitment Incentives

Payment arrangements among sponsors, organizations, investigators, and those referring research participants may place participants at risk of coercion or undue influence or cause inequitable selection. Payment in exchange for referrals of prospective participants from researchers (physicians) (“finder’s fees”) is not permitted. Similarly payments designed to accelerate recruitment that is tied to the rate or timing of enrollment (“bonus payments”) is also not permitted.

6.2.5Institutional Conflict Of Interest

The policy of the IRB is to ensure that the welfare of human subjects and the integrity of research will not be compromised, or appear to be compromised, by competing Institutional interests or obligations.

Although the IRB policy has separated OSU Foundation functions from the University functions, circumstances may exist in which separation of function is not sufficient to avoid the appearance of Institutional conflict of interest.

6.2.6Identification of Institutional Conflict of Interest

The Conflict of Interest Committee will make all disclosures and management plans accessible to the IRB Administrator and Chair. If the Administrator and Chair determine that the I-COI is related to the research, information about the I-COI will be disclosed to all IRB members for consideration regarding the impact on new or ongoing studies.

6.2.7Management of Conflict of Interest

Decision making

A key aspect in decision-making is to analyze when it would be appropriate and in the public interest to accept and manage a COI, rather than require that the COI be eliminated prior to the initiation of research. In some cases, the benefits of conducting a proposed research activity at the Institution will be potentially high, and the risks will be low. In other cases, the scientific advantages of conducting the research may be speculative and the risks may be great. In these latter instances, the conflict should be avoided by disapproving the research application.

Evaluation of risk

Each case should be evaluated based upon the following:

1. The nature of the science;

2. The nature of the interest;

3. How closely the interest is related to the research;

4. The degree of risk that the research poses to human participants; and

5. The degree to which the interest may be affected by the research.

Potential actions

Potential actions to be considered to better protect subjects are any (or a combination) of the following:

1. Public disclosure of the financial interest;

2. Not conducting proposed research at that Institution, or halting it if it has commenced;

3. Reducing or otherwise modifying the financial (equity or royalty) stake involved;

4. Increasing the segregation between the decision-making regarding the financial and the research activities;

5. Requiring an independent data and safety monitoring committee or similar monitoring body; or

6. Establishing a research monitoring process, so that the research can be closely scrutinized to ensure that potential conflicts do not undermine the integrity of the work and of the Institution.

6.3Levels of Review

All human subjects research conducted under the auspices of OSU must meet the criteria for one of the following methods for review:

• Exempt

• Expedited Review

• Full Committee Review

The IRB will ensure that the research meets all required ethical and regulatory criteria for initial and continuing review and any modifications of approved research.

The following describe the procedures required for the review of research by the IRB.

6.4Exempt Studies

Studies determined to be “exempt” are acknowledged rather than approved by the IRB. Before they will be acknowledged, exempt studies must be found to be ethical and in compliance with the policies articulated in this manual. Although exempt research is not covered by the federal regulations, the ethical principles articulated in the Belmont Report continue to apply. The individual making the determination of exemption will determine whether to require additional protections for subjects in keeping with the Belmont Report.

Exempt determinations are made by the Chair of the IRB or his/her designee. The designee may be a voting member of the board or an IRB staff member (regardless of voting status). Identification of the designee will be made in writing.

In order to be deemed exempt, all research activities must fit into one or more of the exempt categories.

6.4.1Limitations on Exemptions

Children: Exemption for research involving survey or interview procedures or observations of public behavior does NOT apply to research in children, except for research involving observations of public behavior when the investigator does not participate in the activities being observed.

Prisoners: Exemptions do NOT apply. Full board review is required. Expedited categories 8 and 9 may apply to continuing reviews.

Risk: If the study presents a risk not articulated in the categories of exemption, such as the risk of causing distress to the subject, the IRB may review the study by an expedited or full board procedure. 

6.4.2Categories of Exempt Research

With the above exceptions, research activities not regulated by the FDA in which the only involvement of human subjects will be in one or more of the following categories are exempt from full board review:

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:

1.  

   1. Research on regular and special education instructional strategies, or

   2. Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

1. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:

1. Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and

2. Any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, or reputation.

Note: At the discretion of the IRB, non-federally funded studies qualifying for an exemption in this category may include activities that supplement or help to inform procedures in this category. Additional activities must be without risk and physically passive in nature. The inclusion of additional activities that are physically active in nature, such as performing a task, will generally result in the study being reviewed by an expedited procedure.

Examples of passive tasks include: watching a video, looking at pictures, listening to an audio file or lecture, free listing, mapping activities, and computer programming or software testing as long as these activities supplement or inform the tests, surveys, or interviews.

Examples of active tasks: engaging in a physical activity such as walking, riding, driving, or exercise.

1. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2), if:

1. The human subjects are elected or appointed public officials or candidates for public office; or

2. Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

The “note” in exempt category 2 above applies here as well.

1. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

Note: In order to be eligible for this exemption, all of the materials have to exist at the time the research is proposed.

1. Research and demonstration projects which are conducted by or subject to the approval of federal department or agency heads, and which are designed to study, evaluate, or otherwise examine:

1. Public benefit or service programs;

2. Procedures for obtaining benefits or services under those programs;

3. Possible changes in or alternatives to those programs or procedures; or

4. Possible changes in methods or levels of payment for benefits or services under those programs.

5. The program under study must deliver a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutrition services as provided under the Older American Act).

6. The research demonstration project must be conducted pursuant to specific federal statutory authority, there must be no statutory requirements of IRB review, the research must not involve significant physical invasions or intrusions upon the privacy of subjects’, and the exemption must be invoked only with authorization or concurrence by the funding agency.

1. Taste and food quality evaluation and consumer acceptance studies,

1. If wholesome foods without additives are consumed; or

2. If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

6.4.3FDA Exemptions

The following categories of clinical investigations are exempt from the requirements of IRB review:

1. Emergency use of a test article, provided that such emergency use is reported to the IRB within 5 working days. Any subsequent use of the test article at the Institution is subject to IRB review. [21 CFR 56.104(c)]

2. Taste and food quality evaluations and consumer acceptance studies, if wholesome foods without additives are consumed or if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural, chemical, or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture. [21 CFR 56.104(d)]

6.4.4Procedures for Exemption Determination

Exempt determinations may take place during a meeting between the IRB Chair (or designee) and the Principal Investigator, or they can take place via electronic submission. Regardless of the setting for the review, investigators must submit:

1. The appropriate IRB application;

2. All recruitment materials (e.g., letter of invitation, recruitment script, flyer),

3. Consent form (when appropriate),

4. All surveys, questionnaires, instruments, etc.,

5. Letter(s) of support from each non-OSU site of performance (when appropriate)

6. If sponsored, one copy of the grant application(s) and/or contract

All members of the research team must have completed the required ethics training.

The IRB Chair (or designee) reviews all requests for exemptions and determines whether the request meets the criteria for exempt research.

To document the IRB reviewer’s determination of exempt status, he/she completes the appropriate reviewer worksheet. The IRB reviewer verifies whether the submission meets the definition for both research and human subject. The reviewer indicates whether the project is exempt. If the project is determined to be exempt, the reviewer will also note the rationale for the determination by identifying the category under which it was permitted.

Any issues related to the project will be communicated to investigators in writing, in person, or over the phone. Depending upon the nature of the issues, the IRB could designate any of the following individuals or groups of individuals to determine that the issues have been resolved:

• The IRB Chairperson or designee for exempt reviews;

• Another IRB member or group of IRB members with particular subject matter expertise or experience;

• A consultant with particular subject matter expertise who is not an IRB member; and/or

• The IRB Administrator or other qualified IRB administrative staff person, who need not be an IRB member.

 

This designation must be appropriate to the type and nature of the issues. Once determined to be resolved, the IRB staff may issue a Notification of Exemption to the investigator. In the event that the resolution of issues was to be verified by the Administrator or IRB staff, the notification may be issued without further review by the Chair or designee.

 

Annual renewal applications are not required for exempt research. The exemption is valid for five years⁵. If the research extends beyond that date then the researcher must submit new application materials and request another exempt determination. Investigators should submit a final report on or before the expiration date.

The Chair or designee will review all new exempt applications and project revisions by the above procedure. Final reports will be reviewed and acknowledged by the Administrator or IRB staff. Reportable events, such as deviations and unanticipated events, will be reviewed by the procedure described for review of those events regardless of review level.

 

Decisions related to exempt studies will be communicated in writing to the investigator and the IRB. Documentation must include the specific categories justifying the exemption.

 

All members of the IRB will be apprised of all exempt determinations via written monthly reports. Any IRB member can request to review the full protocol by contacting the IRB Office.

6.5Expedited Review

An IRB may use the expedited review procedure to review either or both of the following:

1. Some or all of the research appearing on the list of categories of research eligible for expedited review and found by the reviewer(s) to involve no more than minimal risk,

2. Minor changes in previously approved research during the period (of one year or less) for which approval is authorized

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

6.5.1Categories of Research Eligible for Expedited Review

[63 FR 60364-60367, November 9, 1998]

The activities listed below should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.

The categories in this list apply regardless of the age of subjects, except as noted.

The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

The expedited review procedure may not be used for classified research involving human subjects.

The standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited or convened--utilized by the IRB.

Research Categories one (1) through seven (7) pertain to both initial and continuing IRB review:

1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met.

1. Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)

2. Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

1. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

1. From healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or

2. From other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week. [Children are defined in the DHHS regulations as "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted."][45 CFR 46.402(a)]

1. Prospective collection of biological specimens for research purposes by noninvasive means.

Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gum base or wax or by applying a dilute citric solution to the tongue;(f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.

1. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)

Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject’s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

1. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). [NOTE: Some research in this category may be exempt from the DHHS regulations for the protection of human subjects. See Exempt Categories and 45 CFR 46 101(b)(4). This listing refers only to research that is not exempt.]

2. Collection of data from voice, video, digital, or image recordings made for research purposes.

3. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. [NOTE: Some research in this category may be exempt from the DHHS regulations for the protection of human subjects. See Exempt Categories and 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.]

4. Continuing review of research previously approved by the convened IRB as follows:

1. Where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or

2. Where no subjects have been enrolled and no additional risks have been identified; or

3. Where the remaining research activities are limited to data analysis.

Note: Category (8) identifies three situations in which research that is greater than minimal risk and has been initially reviewed by a convened IRB may undergo subsequent continuing review by the expedited review procedure.

For a multi-center protocol, an expedited review procedure may be used by the IRB at a particular site whenever the conditions of category (8)(a), (b), or (c) are satisfied for that site. However, with respect to category 8(b), while the criterion that "no subjects have been enrolled" is interpreted to mean that no subjects have ever been enrolled at a particular site, the criterion that "no additional risks have been identified" is interpreted to mean that neither the investigator nor the IRB at a particular site has identified any additional risks from any site or other relevant source.

1. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

Note: The determination that "no additional risks have been identified" does not need to be made by the convened IRB.

6.5.2Expedited Review Procedures

Under an expedited review procedure, the review may be carried out by the IRB Chair or by one or more reviewers designated by the Chair from among members of the IRB. IRB members who serve as designees to the IRB Chair for expedited review will be matched as closely as possible with their field of expertise to the study.

All trained, voting members of the IRB are eligible to conduct expedited reviews. The IRB Staff will select expedited reviewers from the roster who have the qualifications, experience and knowledge in the content of the protocol to be reviewed, as well as knowledge of the requirements to approve research under expedited review. IRB members with a conflict of interest in the research disclose the COI to the IRB staff upon receipt of the assignment and the study will be re-assigned to a non-conflicted member.

When reviewing research under an expedited review procedure, the IRB Chair, or designated IRB member(s), should receive and review all documentation submitted by the PI. The reviewer will also receive and complete the appropriate reviewer worksheet(s) which will serve as documentation of the expedited category or categories as well as whether the research meets the regulatory criteria for approval. If the research does not meet the criteria for expedited review, then the reviewer will indicate that the research requires full review by the IRB and the protocol will be placed on the next agenda for an IRB meeting.

In reviewing the research, the reviewers will follow the review procedures described later in this section and may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the non-expedited procedure set forth below.

Reviewers will indicate approval, required modifications, or requirement for convened board review on reviewer worksheet and return the worksheet to the IRB Office. If modifications are required the IRB staff will inform the investigator in writing.

In the event that expedited review is carried out by more than one IRB member and the expedited reviewers disagree, the IRB Administrator and/or IRB Chair may make a final determination. Upon the discretion of the IRB Administrator or IRB Chair the protocol will be submitted to the full board for review.

6.5.3Informing the IRB

All members of the IRB will be apprised of all expedited review approvals via written monthly reports. Any IRB member can request to review the full protocol by contacting the IRB Office.

6.6Convened IRB Meetings

All human subjects research involving greater than minimal risk will be reviewed at a convened meeting of the full board, except when an expedited review procedure is permitted by regulation.

6.6.1IRB Meeting Schedule

The schedule for IRB meetings may be found on the IRB website. Special meetings may be called at anytime by the Chair or the Administrator.

6.6.2Preliminary Review

An IRB Coordinator will perform a preliminary review of all protocol materials submitted to the IRB office for determination of completeness and accuracy. Initial pre-review sent from staff to the PI (prior to review by an IRB member) will include clarifying questions; requests for missing documents, or letters of support or permission; discrepancies and inconsistencies; missing sections or elements in sections of the documents; missing training; and clear regulatory or policy issues.  Only complete submissions will be placed on the IRB agenda for review. The investigator will be informed in writing of missing materials. IRB Coordinators will also conduct a preliminary review of each submission for compliance with federal regulations and IRB policies. Any issues identified during this preliminary review will be noted for the reviewers on the worksheet.

6.6.3Primary and Secondary Reviewers

After it has been determined that the protocol submission is complete, an IRB Coordinator, in consultation with the IRB Administrator, will assign protocols for review paying close attention to the scientific content of the protocol, the potential reviewer’s area of expertise and representation for vulnerable populations involved in the research. At least one reviewer will be assigned to each protocol and a reviewer may be assigned several protocols or other research items for review. Reviewers are assigned to all protocols requiring initial review, continuing review, and review of modifications. Initial protocols requiring full board review will reviewed by a primary and secondary reviewer, with a consultant on an as-needed basis. All other submissions will be reviewed by a primary reviewer, with a secondary reviewer or consultant on an as needed basis. When the IRB is presented with a protocol that may be outside of the knowledge base or representative capacity of the IRB members, a consultant will be sought. Protocols for which appropriate expertise cannot be obtained for a given meeting will be deferred to another meeting when appropriate expertise can be achieved.

Primary reviewers are responsible for:

1. Having a thorough knowledge of all of the details of the proposed research.

2. Performing an in-depth review of the proposed research.

3. Leading the discussion of the proposed research at the convened meeting and leading the IRB through the regulatory criteria for approval.

4. Making suggestions for changes to the proposed research, where applicable.

5. Completing all applicable IRB reviewer forms.

Secondary reviewers are responsible for:

1. Having a thorough knowledge of all of the details of the proposed research.

2. Performing an in-depth review of the proposed research with a particular focus on the documents and methods related to consent and recruitment.

3. Making suggestions for changes to the proposed research that differ from, or were not identified by, the primary reviewer.

4. Completing all applicable IRB reviewer forms.

An absent reviewer can submit their written comments for presentation at the convened meeting, as long as there is another reviewer present at the convened meeting, who has read the materials and can serve as the reviewer.

All of the IRB members receive and are expected to review all studies, not just the ones they are responsible for reviewing.

6.6.4Pre-Meeting Distribution of Documents

All required materials need to be submitted two weeks prior to the convened meeting for inclusion on the following IRB agenda. The meeting agenda will be prepared by an IRB Coordinator under the supervision of the IRB Administrator and distributed to the IRB members and the IO prior to the meeting. IRB members receive the agenda and materials for review one week prior to the scheduled meeting. At a minimum, agenda packets include the agenda, minutes from the previous meeting, and any study submissions for review.

6.6.5Materials received by the IRB

Each IRB member receives and reviews the following documentation, as applicable, for all protocols on the agenda:

• Complete application form

• Internal or external protocol

• Proposed Consent / Parental Permission / Assent Form(s) or Guides

• Recruitment materials

• Data collection instruments

• Grant proposal or contract

• Approval documents from external IRB

• Investigator’s brochure

• Scientific review from sponsor or review committee

• Letters of support or permission from external sites

If an IRB member requires additional information to complete their review they may contact the investigator directly or may ask the IRB Office to make the request of the investigator.

6.6.6Quorum

A quorum consists of a simple majority (more than half) of the voting membership, including at least one member whose primary concern is in a non-scientific area. If research involving an FDA-regulated article is involved, a licensed physician must be included in the quorum. The IRB Chair, with the assistance of the IRB staff, will confirm that an appropriate quorum is present before calling the meeting to order. The IRB Chair will be responsible for ensuring that the meetings remain appropriately convened.

At meetings of the IRB, a quorum must be established and maintained for the deliberation and vote on all matters requiring a vote. The IRB Chair, with the assistance of the IRB staff, will confirm that an appropriate quorum is present before calling the meeting to order and that quorum is maintained until the meeting is adjourned. If a quorum is not maintained, the pending action item(s) must be deferred until quorum is established or until the next meeting. The IRB Staff will document, in the minutes, the time of arrival and departure for all IRB members and notify the IRB Chair if a quorum is lost.

IRB members are considered present and participating at a duly convened IRB meeting when either physically present or participating through electronic means (e.g., teleconferencing or video conferencing) that permits them to listen to and speak during IRB deliberations and voting. When not physically present, the IRB member must have received all pertinent materials prior to the meeting and must be able to participate actively and equally in all discussions.

Opinions of absent members that are transmitted by mail, telephone, facsimile or e-mail may be considered by the attending IRB members but may not be counted as votes or to satisfy the quorum for convened meetings.

In some cases, primary members may not count towards quorum for every meeting. For example, the Prisoner Representative only counts towards quorum when his/her presence is required for the review of a protocol involving incarcerated subjects. Other members may serve similar roles and their impact on quorum will be noted in the roster filed with OHRP.

6.6.7Meeting Procedures

The IRB Chair, or Vice-Chair in the event that the IRB Chair is absent, will call the meeting to order, once it has been determined that a quorum is in place. The IRB will review and discuss the IRB minutes from the prior meeting and determine if there are any revisions or corrections to be made. If there are no changes to be made, the minutes will be accepted as presented and considered final. If it is determined that revisions or corrections are necessary, the minutes will be amended. If the amendments are considered to be minor (e.g., typographical errors, revised language provided by members present), then the minutes will be considered approved after the IRB Staff makes the changes. If the amendments are considered to be major, they will be presented again at the following IRB meeting for a second vote.

The Chair or Vice-Chair will query the members about any conflicts of interest with the items appearing on the agenda and will remind members to recuse themselves from the discussion and vote by leaving the room when that agenda items is being reviewed.

The IRB reviews all submissions for initial and continuing review, as well as requests for modifications. The Primary and Secondary Reviewer present an overview of the research and lead the IRB through the regulatory criteria for approval. All voting members present at a convened meeting have full rights, except in the case of a conflict of interest. In order for the research to be approved, it must receive the approval of a majority of those voting members present at the meeting and meet all of the criteria for approval.

It is the responsibility of the IRB Coordinator present to record the proceedings and take minutes of the meeting. The audio recording of the each meeting is destroyed after the minutes for that meeting are approved.

6.6.8Guests

At the discretion of the IRB, the Principal Investigator may be invited to the IRB meeting to answer questions about their proposed or ongoing research. The Principal Investigator will be asked to leave for the discussion and subsequent vote on their research proposal.

In accordance with the Oregon’s Public Meetings Law, the public may attend IRB meetings and will be given notice of the time and place of these meetings. The meetings will be accessible to everyone, including persons with disabilities. The Public Meetings Law guarantees the public the right to view government meetings, but not to participate in them. While guests are permitted to attend IRB meetings, they may not participate unless requested by the IRB Chair or Administrator to do so and must sign a Non-member Confidentiality Agreement and Conflict of Interest Disclosure form prior to the meeting.

 

Executive sessions, which exclude the public, may be called during any regular, special, or emergency meeting. Such sessions will be convened and conducted in accordance with Oregon’s Public Meetings Law.

6.7Collaborative Research Projects

In the conduct of cooperative research projects, OSU acknowledges that each Institution is responsible for safeguarding the rights and welfare of human subjects and for complying with applicable federal regulations. When a cooperative agreement exists, OSU may enter into a joint review arrangement, rely on the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort. A formal relationship must be established between OSU and the other Institution through either a Cooperative Agreement or a Memorandum of Understanding. This relationship must be formalized before OSU will accept any human research proposals from the other Institution or rely on the review of the other Institution.

It is the policy of OSU to assure that all facilities participating in a human subjects study receive adequate documentation about the study in order to protect the interests of study participants. Before a study can begin, it must be approved by the IRB of record for each participating facility and, where appropriate, the IRB of record for the coordinating facility.

For collaborative research, the PI must identify all Institutions participating in the research, the responsible IRB(s), and the procedures for dissemination of protocol information (IRB initial and continuing approvals, relevant reports of unanticipated problems, protocol modifications, and interim reports) between all participating Institutions.

When OSU relies on another IRB, the Administrator of the IRB office will review the policies and procedures of the IRB to ensure that they meet OSU standards.

When OSU reviews research conducted at another Institution, the particular characteristics of each Institution’s local research context must be considered, either (i) through knowledge of its local research context by the OSU IRB or (ii) through subsequent review by appropriate designated Institutional officials, such as the Chairperson and/or other IRB members.

If OSU is the coordinating facility, the Principal Investigator must document how the important human subject protection information will be communicated to the other participating facilities engaged in the research study. The investigator is responsible for serving as the single liaison with outside regulatory agencies, with other participating facilities, and for all aspects of internal review and oversight procedures. The investigator is responsible for ensuring that all participating facilities obtain review and approval from their IRB of record and adopt all protocol modifications in a timely fashion. The investigator is responsible for ensuring that the research study is reviewed and approved by any other appropriate committees at the coordinating facility and at the participating facilities (e.g. VA Research and Development Committee approval) prior to enrollment of participants.

The PI must follow these procedures when OSU is the coordinating facility:

• During the initial IRB submission of the multi-site study, the investigator indicates in writing on the application form or in an application letter that OSU is the coordinating facility of a multi-site study.

• The investigator submits the following information in their IRB application materials:

  • Whether research activities at participating Institutions are defined as engagement

  • Name of each participating facility

  • Confirmation that each participating facility has an FWA (including FWA number)

  • Contact name and information for investigator at each participating facility

  • Contact name and information for IRB of record at each participating facility

  • Method for assuring all participating facilities have the most current version of the protocol

  • Method for confirming that all amendments and modifications in the protocol have been communicated to participating sites

  • Method for communicating to participating facilities any serious adverse events and unanticipated problems involving risks to subjects or others

  • Method of communicating regularly with participating sites about study events

• The investigator submits approval letters from all the IRB of record for all participating sites.

• The investigator maintains documentation of all correspondence between participating sites and their IRBs of record.