The policies and guidance put forth by the OSU Human Research Protection Program borrow extensively from the best practices of a variety of academic institutions, reflect the advice received from federal regulators, and are informed by input from leaders in research ethics. The information provided on this site builds on ideas freely shared between institutions and exists because of the generosity and collegiality demonstrated by the community of professionals who work in the field of human research protections.
General FAQs
The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.
The IRB is charged with the responsibility of reviewing, prior to its initiation, all research (whether funded or not) involving human participants. The IRB has the authority to approve, exempt, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy. The IRB shall have at least five members of varying backgrounds in order to provide complete and adequate review of human research and its institutional, legal, scientific, and social implications. The Board will also include at least one member who is not affiliated with the institution and one member who is not a scientist. The IRB can utilize consultants who advise the Board and are periodically involved in protocol review.
A Federal Wide Assurance (FWA) is the documentation of an institution’s commitment to comply with Federal regulations and maintain policies and procedures for the protection of human participants. An institution must have an FWA in order to receive Department of Health & Human Services (DHHS) support for research involving human subjects. This is the principal mechanism for compliance oversight by the Office for Human Research Protections.
The OSU IRB has been issued the following assurance number by the DHHS: FWA00003920
The expiration date for this assurance changes periodically; if you need the expiration date, visit this link, enter the FWA Number above, and click "Search".
Visit this page to learn if your study requires IRB review.
Research studies involving human subjects require IRB review. Evaluative studies and activities do not. However, it is not always easy to distinguish between these two types of projects and many projects frequently have elements of both. Therefore, the decision about whether review is required should be made in concert with the IRB.
If you think that your project is limited to evaluation activities and therefore not subject to IRB oversight, you can submit the initial sections of the new application form in Cayuse to receive a formal determination. More information on submitting new applications can be found here: "New Applications". Additional information for when IRB review is required can be found on the "Does your study require IRB review?" webpage. Specifically, the Comparison of Research Versus Non-Research Table found on this page may be useful.
Feasibility Study
"Feasibility studies are pieces of research done before a main study to answer the question ‘Can this study be done?’ They are used to estimate important parameters that are needed to design the main study”[1]. Data collected are not analyzed or included in Publications.
Examples
- Going to a potential site to see if the research is possible
- Checking to see what is the best approach to the research
- Going through a consent process with friends to see if the information is comprehensible
- Sending your survey instrument to a few experts in the field for their feedback as to whether or not the questions are appropriate for the topic and/or cohort of the research
- Feedback from colleagues and peers about research design
- Student researcher designs questionnaire for their study’s target population and asks someone from a different population to test the questionnaire
Scenario
A researcher planning to conduct interviews regarding landowner perspectives of land use regulations contacts the US Forest Service to ask how they have typically approached land owners in the past and asks for feedback on their planned questions.
Pilot testing
“A small scale-study conducted prior to conducting an actual experiment; designed to test and refine procedures.”
Examples
- Checking to see if the designed tool works
- Asking people to complete a survey to find out whether a question results in the requested information
- Testing the intervention with four people before trying it with 60 people
- Asking people to complete your survey and then revising the questions based on their responses
- Revising the study after analyzing preliminary data and determining that the data do not address their research question
- Student researcher designs questionnaire for their study’s target population, asks the population to try out the questionnaire, and the questions are revised based on the responses
Scenario
A researcher planning to conduct interviews regarding landowner perspectives of land use regulations conducts interviews with 5 people to test the questions and see if they get answers that make sense. The researchers will analyze the responses and may revise their interview guides based on the initial data collected.
Does my feasibility study/pilot testing require IRB Review?
A: The federal regulations indicate that pilot testing meets the definition of research involving human subjects and requires IRB review. However, feasibility studies typically do not meet the definition of research involving human subjects and therefore would not require IRB review.
In order for the IRB to determine whether your activities constitute a feasibility study or pilot testing, and subsequently, whether they require IRB review, please complete and submit the initial sections of the IRB application in Cayuse HE to request an oversight determination. Instructions can be found on the "New Applications" page. In the application, it is helpful to note with whom the study or testing is going to be done and how the data will be used.
In order to approve research involving human subjects, the IRB must find that a proposed study complies with institutional policies, state laws, and that all of the following requirements are satisfied:
- Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk and, (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
- Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
- Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
- Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by §46.116.
- Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117.
- When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
- When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
- When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
Visit this page to learn about common mistakes in an IRB application.
This guidance addresses the use of data collected for purposes other than the proposed research project.
Protocol
Description of research: Identify the purpose for which the data was collected.
Risk/Benefit assessment for adults and/or children: Evaluate the risk to the participants within the data set.
External research or recruitment site(s): If the data was collected at an external site, include information in this section. If the data originated from another institution or organization, documentation of permission for use of the data from the appropriate authority may be required (e.g. data use agreement).
Target populations(s): A description of the characteristics of the participants whose data will be included. Specify whether any of the populations are excluded or targeted. Specify age range of participants within the data set. If the exact age range is unknown, please indicate whether participants will be adults and/or children.
Consent/assent process:
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Waiving consent: If the study meets the criteria for a waiver of consent [§46.116(d)]: An explanation as to why it would be impossible to obtain consent from everyone in the data set or how obtaining consent would increase the risks to those individuals.
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Obtaining consent: Describe how consent will be obtained for the new use of the data. This section should not explain how consent was obtained for the original data collection, but it may be appropriate to indicate whether a reasonable participant would find that the current project was described to them in the original consent language.
Methods and procedures: Describe the methods to be used for the collection and analysis of the pre-existing data for the current study. This section should not describe the methods for the original data collection, but should instead include a brief explanation of the purpose of the original collection (e.g. the data was originally collected as part of a class project, medical record, Medicare prescription drug surveillance; etc.).
Risks and benefits: Describe the risks and benefits of the new collection and analysis, not the original data collection.
Consent document, when applicable
Purpose: Identify the purpose of the secondary data analysis.
Activities and time: Clarify that participating will involve no additional time, as the data was previously collected. This section should briefly identify the purpose of the original data collection. Sample sentence: We are asking your permission to use the information collected as part of your class project in a new research study. Your participation would be limited to providing permission for the use of the existing data; it will not involve additional time on your part or collection of new data.
Risks: Identify the risks of the secondary data analysis, not the original data collection procedures. The risk of a breach of confidentiality may apply if original data are individually identifiable.
Benefits: Identify the benefits of the secondary data analysis, not the original data collection.
Recruitment materials, when applicable
There are no unique requirements for the recruitment materials. However, please consider using a statement similar to the following: We are asking you to give permission for us to use your data collected for ____ in our research project. Participation will involve no additional time.
If the investigator obtains information from the study participant about a third party that is both private and individually identifiable, then the third party is considered a human subject.
IRB approval is required in order to collect data from, or use data about those subjects. In some cases, consent from third parties will be necessary. However, under certain circumstances, the IRB is permitted to grant a waiver of consent.
In order to grant a waiver of the requirement for consent, the IRB must find that all of the following are true:
- The research involves no more than minimal risk to the subjects;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects;
- The research could not practicably be carried out without the waiver or alteration; and
- Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Contextual information, such as familial or social relationships identified only by that association, age, body build, ethnic or cultural background, marital status, social networks, or occupation, would not be considered private information and would not make a third party a human subject.
This is the total number of people that will sign a consent form or agree to participate in the research. This should not be a range.
“Enrolled” means that these subjects have consented to participation in the study. These subjects count towards your total enrollment number even if they screen fail, withdraw, or are dropped from the study. The PI may submit a project revision form to increase the total enrollment number after IRB approval is obtained.
If total enrollment is exceeded prior to IRB approval, the data on those subjects cannot be represented as having been gathered with IRB approval. This creates a problem for the use of that data in publications, dissertations, theses, and the like. If there is a screening process, it is suggested that the enrollment number be increased to account for screen fails. This should be explained in the Target Enrollment section of the application. This FAQ is only relevant to greater than minimal risk or FDA-regulated research.
According to the federal regulations at §46.102(i), 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.
Visit this page to learn about exempt research categories.
When an initial application is received, the HRPP first determines whether the activities constitute research with human subjects according to the regulations in 45 CFR 46 and whether OSU is engaged in human subjects research. If the activities constitute research with human subjects and OSU is engaged, the study is then reviewed to determine if it qualifies for an exempt determination. If the study does not qualify for an exemption, the HRPP will then determine whether the study is eligible for expedited review, or requires review by the full board. Please use the links below to read more about exempt and expedited review categories.
Types of Review
Review times
Review times are based on several factors:
- The quality and completeness of the submission.
- The number of studies in the queue at the time of the submission. Studies are reviewed in the order in which they are received.
- The length of time it takes researchers to respond to review stipulations and requests for clarification. Submissions may be administratively withdrawn from review if the PI does not respond within 60 days.
- The availability of IRB members to review submissions.
Currently, average review times are 3-4 weeks for exempt determinations, 6-8 weeks for expedited reviews, and 12 weeks for full board reviews.
Cayuse
The HRPP has developed several resources to assist researchers with using the Cayuse HE system. Please visit our Cayuse HE Training & Advising page.
If you have comments or suggestions about the application form in Cayuse HE that you would like to relay to the OSU HRPP team, please visit this link: Survey.
Cayuse does not support a correspondence feature. Please send messages to the HRPP or study team members via email.
The HRPP will no longer stamp all approved study documents. Only Consent forms for Expedited and Full Board review studies will receive stamps.
Both the “COMPLETE SUBMISSION” and the “PI CERTIFICATION” steps must be completed in Cayuse HE in order for the application to be in the review queue. To verify both steps are completed, log in to Cayuse HE, select "Human Ethics" from the Products menu, and find the study in the "My Studies" box, and click on it. If there is a red or black banner above the title that says, "Unsubmitted" or "Awaiting Authorization", the application has not been submitted and/or the PI has not certified the application. Please see the Cayuse HE Training page for the "New initial applications" and "PI certifying submissions" screenshots. Once the status reads "Under Review", your application has been submitted and is in the review queue.
Principal Investigators and Study Team Members
The HRPP 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. If a protocol requires skills beyond those held by the PI, the IRB may require that the PI include one or more additional qualified persons as study team members to provide such skills.
OSU unclassified employees with the following appointments may serve as a PI, if they are otherwise sufficiently qualified to conduct and oversee the research:
- Academic teaching and research faculty (including instructors and senior instructors)
- Previously tenured faculty members who have relinquished tenure and who hold academic wage appointments (not to exceed three years past the date of tenure relinquishment)
- Non-teaching administrative and professional faculty
- USGS and ODFW leaders in the Cooperative Fish and Wildlife Research Unit
OSU employees with the following appointments are not permitted to serve as the PI on a study involving human subjects:
- Unclassified hourly
- Academic wage appointment other than those associated with tenure relinquishment
- Classified employees
- Temporary support staff
- Training and student appointments: student, graduate assistant, postdoctoral scholar, clinical fellow
- Unpaid: affiliate, courtesy, emeritus, postdoctoral fellow, graduate fellow, and visiting faculty not paid by OSU
Some exceptions may be made for research associates who are no longer postdoctoral scholars (trainees) and faculty who are granted courtesy faculty appointments prior to their permanent contract start date. Please contact the HRPP if you have questions.
Investigators play a crucial role in protecting the rights and welfare of human subjects and are responsible for carrying out sound ethical research consistent with research plans approved by an IRB. Along with meeting the specific requirements of a particular research study, investigators are responsible for ongoing requirements in the conduct of approved research that in summary include:
- Acknowledging and accepting their ethical and legal responsibilities for protecting the rights and welfare of human research subjects and for complying with all applicable policies, guidance and determinations of the IRB;
- Providing training and oversight for all study-team members;
- Ensuring the compliance of all co-investigators, student investigators, and research staff members with the IRB decisions, conditions, and requirements;
- Following the ethical principles that guide the university in the conduct of human research during all phases of the project;
- Conducting the research as presented in the protocol and approved by the IRB;
- Obtaining and documenting informed consent of subjects or subjects’ legally authorized representatives prior to the subjects’ participation in the research, unless these requirements have been waived by the IRB (§46.116; §46.117);
- Obtaining prior approval from the IRB for any modifications of the previously approved research, including modifications to the informed consent process and document, except those necessary to eliminate apparent immediate hazards to subjects ( §46.103(b)(4)) ;
- Ensuring that progress reports and requests for continuing review and approval are submitted to the IRB in accordance with the policies, procedures, and actions of the IRB as referenced in the institution’s OHRP-approved Federalwide assurance ( §46.103(b)(4), §46.109(e), §46.115(a)(1));
- Providing to the IRB prompt reports of any unanticipated problems involving risks to subjects or others §46.103(b)(5);
- Providing to the IRB prompt reports of serious or continuing noncompliance with the regulations or the requirements or determinations of the IRB ( §46.103(b)(5));
- Submitting a Final Report when all human subject research activities have been completed, including recruitment and data collection/analysis;and
- Keeping certain records as required by the HHS regulations for at least three years after completion of the study ( §46.115(b)).
Federal regulations do not distinguish between self-experimentation and the participation of other human subjects in research. If you participate in your own research, you are an enrolled subject. The IRB reviews self-experimentation research for the following reasons:
- Protecting researchers from unwarranted risks, and
- Allowing a neutral third party to raise concerns, if any, regarding the credibility of resulting data
Applications involving self-experimentation should explain how consent will be obtained from all research participants, including the researcher-participant.
Adapted from Johns Hopkins Medicine and the University of Wisconsin-Madison. Sample researcher-participant consent form (University of Wisconsin-Madison).
Studies in which the researcher proposes to enroll their own children should provide clear justification as to why their children should be enrolled and should explain how they plan to protect their own children and the integrity of the research.
Suggestions for minimizing pressure on your child and protecting data integrity include:
- Have another member of the study team obtain consent and collect data
- The other parent of the child gives consent, rather than the researcher-parent
- If the researcher-parent will give permission for their child to participate in the research, it is suggested that a third party who is not involved in the research be present during the consent process.
- Have another study team member interact with the child of the researcher or review data relating to the researcher's child and their participation
Questions to consider when proposing to conduct research with your own children include[1]:
- Why do I want my child to participate in my study?
- How will participation affect my relationship with my child in the present or future?
- Is this a joint decision that both parents support?
- Might my child feel pressure from me to participate?
- How will I avoid my child’s feeling that s/he has let me down if s/he decides not to participate or to withdraw before the study is over?
- What procedural safeguards will I implement to ensure that the data related to my child is handled and analyzed in the same way as data collected from other participants?
Questions for consent monitors to discuss with the child when obtaining assent and parental permission include:
- Why do you want to be in this study?
- Do you feel that you can say “no” if you do not want to be in this study?
- Do you feel like you could choose to stop being in the study whenever you wanted to?
- Your mom or dad might hear or see information gathered from you in this study. Is that okay with you?
- Would you feel comfortable with me checking in with you again? (for studies with more than one visit.)
[1] Children Enrolled in Parent’s Research: A Uniquely Vulnerable Group in Need of Oversight and Protection. IRB Ethics and Human Research
Funding
The IRB is charged with the responsibility of reviewing, prior to its initiation, all research (whether funded or not) involving human participants.
If your funding source requires that you share your data or make it publicly available, the protocol should describe what level of data will be shared, in what format, and where it will be stored. Disclosures should also be included in the consent documents to inform participants of the data sharing.
Data Security
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 three 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 three 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 three 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
Please also see the IRB Data Security Guidance for additional information on data transfer and storage.
If you do not wish to collect IP addresses when using Qualtrics, please see the Qualtrics page for step-by-step instructions to anonymize responses.
Informed Consent
The consent document should be written at a level easily understood by your target population.The Flesch-Kincaid readability score of the form should be more than 50 (the higher the score, the easier your document is to read). Studies targeting the general public should have a consent form written at or below an 8th grade reading level.
In order to increase the readability of your consent forms, we recommend using the resources provided in the Consent and Assent Guidance and Templates.
Consent forms should be written directly to the reader, as though you are explaining the facts in person. Consent language should be written in the second person (“you”), not in the first person (“I”).
Consent forms should avoid the passive voice whenever possible in favor of active voice. Example of passive voice: “A summary of results will be sent to all study participants.” Example of active voice: “We will send you a summary of the results.”
Reporting Requirements
All OSU employees are required to consult with the University Title IX Coordinator in the Office of Equal Opportunity and Access if they receive information about sexual misconduct or discrimination that meets one or more of the following criteria, even if such information is received outside the research setting:
- Is alleged to have been perpetrated by an OSU student, staff, or faculty member, agent/volunteer OR
- Has occurred on OSU property or during an OSU activity, OR
- Has created continuing effects in the educational setting
Please see the OSU policy on responding to disclosures of sexual misconduct or discrimination for more detailed information.
How Does This Impacts My Research at OSU?
The requirement to consult with the Office of Equal Opportunity and Access applies to all OSU employees (except those exempted by law), which includes GTAs and GRAs. Other student researchers and non-employees who learn of reportable events should discuss this information with the Principal Investigator (PI) on the study. It is then the responsibility of the PI to contact the Title IX Coordinator.
If the research topic is sexual misconduct or discrimination, or includes open-ended prompts about personal trauma
If there is a reasonable expectation that the target population will disclose information triggering the need for consultation with the Office of Equal Opportunity and Access, a plan for this circumstance must be included in the research protocol and the consent form.
If individually identifying information about the research participant is then disclosed to the Office of Equal Opportunity and Access or other non-study team members, this would constitute an anticipated adverse event. The Principal Investigator must submit an Incident Report to the HRPP within 30 days of the disclosure. Please see the 'Post Approval' page for information on submitting reportable incidents.
If the research topic is not sexual harassment or sexual violence
If a research participant discloses information triggering the need for consultation with the Office of Equal Opportunity and Access, this constitutes a reportable event to the HRPP office since it was unanticipated. The Principal Investigator must complete and submit an Incident Report in Cayuse HE within three days of learning of the issue.
What are the reporting requirements if my study participants are anonymous?
If your study participants are anonymous, in the event a reportable disclosure is made you should still reach out to the University Title IX Coordinator in the Office of Equal Opportunity and Access, so that they can make the determination of whether a disclosure is actionable based on the specifics of the case. Contact the HRPP for additional guidance once the report has been made.
Resources
Below are links to additional information that is available through the Office of Equal Opportunity and Access and through Student Health Services.
OSU policy on sexual misconduct and discrimination
All employees of higher education institutions are considered "mandatory reporters" of child abuse or neglect, even outside of OSU research or academic settings.
In situations where child abuse or neglect might be expected to be revealed to OSU researchers during a study, mandatory reporters should make this requirement known to study participants during the consent process. If you are planning a human subject research study and the nature of the study or target population lends itself to the possibility that mandatory reporting may be required of the study team, please contact the HRPP Office regarding how to address the potential need for reporting in your initial application.
In the event a study team member received information about potential child abuse or neglect which was not reasonably expected, this constitutes a reportable event since it was unanticipated. The Principal Investigator must complete and submit an Incident Report in Cayuse HE within three days of learning of the event.
Student researchers (who are not also OSU employees) are not considered “mandatory reporters.” However, Principal Investigators overseeing student-driven research are responsible for complying with the law.
In cases where the identities of participants may not be known to researchers, the Principal Investigator must still contact the State of Oregon Department of Human Services (DHS) or law enforcement to allow authorities to make the determination of whether a report is actionable.
For more information on child abuse and neglect reporting requirements and procedures, please refer to the FAQs developed by Human Resources or the Office of Youth Safety and Compliance.
For Participants
The U.S. Department of Health and Human Services offers digital and print brochures in English and Spanish for potential volunteers that cover topics such as:
- Learning about research participation
- Questions to ask when thinking about joining a research study
- Educational tools for community engagement
- Protecting research volunteers (infographic)