Flexibility Policy
The College of Charleston limited the scope of its Federalwide Assurance (FWA) in 2008 to apply only to federally funded research as permitted under federal regulations. Unfunded research projects outside the scope of the FWA must be afforded protections commensurate with risk as determined by the IRB through policies and procedures, but there is flexibility in the applications of specific provisions of the federal regulations.
A new Federal Policy for the Protection of Human Subjects (Common Rule) was issued on January 19, 2017 with an effective date of July 19, 2018. The revised Common Rule has included some provisions that reduce burden in the management of minimal risk research studies. Until the effective date of the revised Common Rule, at which time Revised College of Charleston Policies and Procedures for Human Participant Research will become effective, the College Human Participant Protections Program has chosen to be guided by the new regulations in the establishment of this Flexibility Policy for minimal risk studies.
This policy does not change the requirement that all human subjects research projects conducted or supported at the College of Charleston are subject to IRB policies and review. However, in line with the revised Common Rule, certain studies falling under the categories of oral history, journalism, biography, literary criticism, legal research, and historical scholarship are now be excluded from the purview of IRB Review.
When questions of applicability arise, studies will be reviewed on a case by case basis by the Research Protections and Compliance Manager in consultation with the IRB Chair as needed.
Limits of the Policy:
This policy is limited to unfunded studies involving no greater than minimal risk to research participants. Under no circumstances will federally funded or FDA regulated research be reviewed under this policy.
Should the funding status of a study reviewed under this policy change, it is the responsibility of the Principal Investigator to notify the IRB.
Exclusions:
- Federally funded studies, including no-cost extensions
- Projects where a student is paid/supported from a federal training grant or otherwise paid/supported directly from the Faculty Advisor’s federal funds
- Federal sponsorship, including federal training grants
- Studies with greater than minimal risk to research participants whether funded or not.
- Studies with FDA-regulated components
- Studies with contractual obligations or restrictions that preclude eligibility in this policy
- Studies with clinical interventions
- Studies using prisoners as subjects
- Studies seeking or obtaining Certificates of Confidentiality
Provisions of this Policy
Submission of an IRB application is not required for oral history, journalism, biography, literary criticism, legal research, and historical scholarship.
A new exemption has been added concerning research involving benign behavioral interventions* in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
- The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; OR
- Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation.
*For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing.
Examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.
If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.
Annual Review and Final Report are not required for minimal risk research which has been approved following Expedited or Full Board Review unless the IRB specifies that continuing review and final report are required for a reason that must be clearly specified to the Principal Investigator. Annual review (or more frequent review as determined by the IRB) and Final Report are still required for projects that are approved following Full Board Review and deemed to be more than minimal risk.
Reporting Requirements
Research projects reviewed outside the scope of the FWA are not subject to the same federal reporting requirements as federally funded projects. For projects conducted under the flexibility policy, the IRB follows internal reporting requirements for serious or continuing non-compliance, suspensions or terminations, or reporting of unanticipated problems involving risk to subjects or others.
Review of Minor Personnel Changes
For research projects outside the scope of the FWA, minor changes to personnel will only require administrative review. This includes adding research assistancts and Co-PIs. A change in PI or the addition of external personnel thorugh a reliance agreement will still require review by the IRB chair or designee.
Expansion of Research Involving Minors Now Eligible for Minimal-Risk Review
Children involved as subjects in research: The Subpart D regulations are not applied when a minor subjects is involved in minimal-risk, anonymous survey research (exemption category 2). Such research can qualify for exempt review if all other criteria for exempt review are met.
Parental permission is no longer required for matriculated, post-secondary college students who are 17 years old. Parental permission is still required for all other minors.
February 10, 2017
Revised: November 11, 2022