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.
After a study is initially deemed eligible for a “FLEX” category or process and has been approved or acknowledged, the Principal Investigator is responsible for submitting any project revisions to the HRPP office in advance of initiating any changes related to a study’s eligibility for FLEX Initiatives. If the eligibility changes as a result of the revisions, revisions to the protocol will be required to bring it into compliance with the Common Rule. An annual reminder of the above criteria will be sent to PIs 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.
FLEX Criteria and Eligibility
Studies eligible for Flex Initiatives must be determined to pose no more than minimal risk to subjects.
Studies excluded from Flex Initiatives are those with:
- 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)
- 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
- FDA-regulated research
- NIH-issued or pending Certificate of Confidentiality
- Prisoners or parolees as subjects
- Contractual obligations or restrictions that require the application of the Common Rule or which require annual review by an IRB
- Classified research
- Clinical research
- Flex A Exemption: Research meeting all flex criteria, that does not conform to a specific exempt category under 45 CFR 46 and involves one or more of the following:
- educational tests, surveys, questionnaires, interviews, focus groups and observation of public behavior involving minors; this includes observations of children when the researchers is participating in the activities being observed
- adults and/or minors performing tasks, such as computer programming, mind or concept mapping, participation in a game (real or virtual), journaling, watching and responding to visual or auditory stimulation (e.g., videos, music, pictures, etc.), usability or software testing, or the use of eye-tracking technology
Flex A is similar to exempt category 2, but expanded to include active tasks and applicable to children; observations of children when the researcher is participating in the activities being observed removes the restriction dictated by Subpart D.
Note: Observation of minors in school is not considered “public” because the researcher needs permission from school officials to observe students.
- Flex B Exemption: Research meeting all flex criteria and involving the collection or study of existing or prospectively accumulating data, documents, records, or biological specimens that exist or will exist for research or non-research purposes. Such data may be individually identifiable, so long as a breach of confidentiality would not pose more than a minimal risk to the research subjects.
- DMV records (if not already publicly available)
- Fishing or boating licenses (if not already publicly available)
- Marriage, divorce, and real estate transactions
- Datasets from previously approved minimal risk research
Excluded from this category are individually identifiable medical, mental health, school, and employment records, as a breach of confidentiality involving this information is not considered to be minimal risk and therefore does not meet the flex criteria. If the data is pre-existing and will be abstracted or recorded in such a manner that subjects cannot be identified, directly or indirectly, through variables linked to the subjects, an exemption under category 4 may be more appropriate.
Flex B is similar to exempt category 4 and expedited category 5 – adds individual identifiers and prospective collection to category 4.
- Extended Approval Period: Up to a three-year renewal period for studies determined to fall into expedited categories 3 through 7 only.
- Reasonable Safeguards for Pregnant Women: Research projects involving Pregnant Women, Human Fetuses and Neonates are subject to the requirements at 45 CFR 46 Sub Part B, including 45 CFR 46.204(d) which requires the research develop “important biomedical knowledge”. The requirement for important biomedical knowledge precludes most social and behavioral sciences research with pregnant women. While studies that involve greater than minimal risk or a physical intervention, and include pregnant women, human fetuses, or neonates will remain subject to the requirements of the Common Rule (Sub Part B) irrespective of the funding source, the requirement for important biomedical knowledge will be waived for minimal risk studies that are not funded or otherwise supported by a federal agency.
- Reasonable Safeguards for Parental Permission: Permit waiver of the requirement for parental permission 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 other applicable federal laws like FERPA and PPRA.