OSU’s decision to limit the scope of its Federal-wide Assurance (FWA) to federally funded research allows for an appropriate level of flexibility without compromising the protections of human subjects enrolled in research. Extra-regulatory procedures and policies, or “FLEX Initiatives”, provide protections equivalent to those found in the Common Rule (45 CFR 46), while also reducing administrative workload and regulatory excess.

The HRPP staff and/or members will determine the eligibility of studies and the applicability of FLEX Initiatives to each proposal.

FLEX Eligibility Criteria

Studies eligible for FLEX must be determined to pose no more than minimal risk to subjects.

Studies excluded from FLEX are those with:

  1. Federal funding or a plan for future federal sponsorship (e.g., proof of concept studies for federal RFPs, pilot studies intended to support a federal grant application, training and program project grants, no-cost extensions). This includes research funded or otherwise regulated by a federal agency that has signed on to the Common Rule, including all agencies within the Department of Health and Human Services
  2. FDA-regulated components
  3. NIH-issued or pending Certificate of Confidentiality
  4. Prisoners or parolees as subjects[1]
  5. Are there contractual obligations or restrictions triggered by a non-federal award that require the application of the federal regulations or which require that annual review be conducted by an IRB?
     
  6. Federally classified research (research procedures and/or results are legally knowable only by individuals with United States government security clearance)
  7. Clinical intervention regardless of funding source[2]
  8. Requirement to register with ClinicalTrials.gov[3]

After a study is initially deemed eligible for FLEX and has been approved or acknowledged, the Principal Investigator is responsible for submitting project revisions to the HRPP in advance of initiating any changes related to a study’s eligibility for FLEX Initiatives. If the revisions render the study ineligible for FLEX, the PI must revise the protocol to bring it into compliance with the Common Rule. The HRPP will send an annual reminder of the above criteria to researchers in an effort to assist them in complying with the policy. However, it is the responsibility of the PI to notify the HRPP of any changes related to eligibility for FLEX initiatives.

Studies eligible for FLEX will not be assigned an exempt or expedited category. Such studies will be approved if they have met the applicable criteria under 45 CFR 46.111. FLEX approvals will be valid for up to five years. If the research extends beyond that date, then the researcher must submit new application materials for review and approval.

FLEX Modification to Subpart B

Subpart B will not be applied to studies meeting all of the criteria for FLEX.

FLEX Consent Process

There is no IRB-related requirement for the researcher to obtain signed consent forms from participants. However, other laws or regulations, such as FERPA, may require that a signature be obtained.

Additionally, an IRB may approve a consent procedure that does not include, or that alters, some or all of the elements of informed consent; or waive the requirements to obtain informed consent, provided the IRB finds and documents that:

  1. The research involves no more than minimal risk to the subjects; and
  2. The waiver or alteration will not adversely affect the rights and welfare of the subjects
FLEX Modification to Parental Permission

A waiver of the requirement for parental permission may be granted if adequately justified by the Principal Investigator and consistent with any relevant requirements from the research site if minors are being recruited from or studied in a school, camp, or other similar setting. When appropriate, parental notification with a reasonable opt-out period should be utilized. A waiver can only be permitted if it is also consistent with the requirements under FERPA and PPRA. The OSU HRPP and IRB will defer to the OSU Office of the Registrar (or similar authority if the research is taking place at an external educational program or institution) regarding compliance with these laws.

FLEX Initiatives prior to January 19, 2018

Studies approved by a FLEX procedure prior to January 19, 2018 will be re-evaluated for eligibility under the new, broader policy described above. If eligible, revised approval documents will be issued. If ineligible, the previous approval documents will stand or the study will be re-reviewed to ensure compliance with the Common Rule.


[1]Incidental incarceration will not invoke subpart C of the Common Rule. The subjects continued participation is under the investigators overall responsibility to protect the rights and welfare of subjects.

[2]For the purposes of this policy, clinical intervention is defined as one that is intended to change or assess a health-related processes and/or endpoint. Examples include but are not limited to the use of drugs, dietary supplements, devices, blood draws, imaging (e.g., DXA, x-ray), delivery systems (e.g., telemedicine, face-to-face), diet, cognitive therapy, exercise, and any intervention that includes treatment, prevention, or diagnostic strategies. This definition has been adapted from one offered by NIH as part of their clinical trial FAQs.
 

[3]Studies must be registered with ClinicalTrials.gov if: (1) they involve drugs, devices, or biologics that are regulated by the FDA, or (2) they are funded by the NIH and meet the NIH definition of a clinical trial, or (3) there is a plan to publish the results in a medical journal and the study meets the International Committee of Medical Journal Editors (ICMJE) definition of a clinical trial. If “yes” to either (1) or (2) above, regulatory flexibility initiatives will not be applied to these studies.