Study Volunteer Registries and Other Collections of Individuals’ Contact Information for Future Research
FSU researchers may see value in creating or having access to a pool of potential human research subjects who may be eligible for their future studies, and may implement and use different models or platforms (e.g., repository, database, listserve, archive, list) for collecting, storing, using and sharing these individuals’ names, contact and other additional information, such as for example preliminary screening information, affiliation, condition or status of interest. For ease of reference, we may collectively refer to these models or platforms as registries. Below is information about required IRB review of these registry activities.
General Regulatory Background and Rationale
Creating and maintaining a registry for use for future studies is considered "research" under federal law at Title 45 of the U.S. Code of Federal Regulation, Part 46 (45 CFR 46), as use of a registry is just one element among many in developing or contributing to generalizable knowledge: the registry provides a pool of potential human subjects from which a sample will be established. Also under 45 CFR 46, an individual who provides their name, contact and, in some cases other additional information that may be used for recruitment for future studies is considered a "human subject." For these reasons, IRB oversight is required for such a registry. For future studies for which registries will share their information and for which researchers will use registry information to screen or recruit potential human subjects, IRB oversight for those future studies is also required.
Related Federal Guidance
Guidance issued by federal regulatory agencies that pertain to required IRB oversight for the use of individuals' stored data (as well as individuals' tissues, or biospecimens) is based upon the 45 CFR 46 federal regulatory definition of a human subject, which includes in part, individuals about whom identifiable private information or identifiable biospecimens will be obtained, used, studied, analyzed, or generated for research purposes. The guidance provides that IRB review and approval is required for the collection, storage, sharing or use of registry information. Visit this federal guidance link.
FSU IRB Review
Regardless of the model or platform used by researchers and others, before individuals’ contact and other information may be collected, stored, shared or used for future studies, the following FSU IRB oversight is required:
- Creating and maintaining a one-time compilation of human subjects who participate in a specific study and who through that study's consent process indicate their willingness to be contacted by that study's researchers for future research conducted by those same researchers would generally not require separate IRB review and approval, provided that creating and maintaining such a compilation was reviewed and approved by the IRB for that specific study.
- Creating and maintaining an on-going compilation of individuals (whether or not these individuals participate in or their data are used for a study, such as for example individuals who take part in non-research activities, or individuals who request or receive non-research services) that will for future studies be developed or added to over time or used by more than one researcher or other researchers for their specific studies, requires submission for FSU IRB review of a separate (stand alone) Research Repository Protocol, available in RAMP IRB (or https://myramp.research.fsu.edu/) under the IRB, Library and Templates tabs, or here. Researchers are also required to provide documentation of individuals’ consent to having their information added to the registry and to be contacted about future research opportunities.
- For future studies for which researchers will obtain information from registries to screen or recruit potential human subjects, IRB oversight is required. Among other requirements generally applicable to such studies, the protocol must also describe the registry from which information will be obtained; what and how registry information will be obtained; and documentation that individuals in the registry consent to being contacted for future studies.
- If any individuals’ registry information is protected by the HIPAA Privacy Rule, the IRB would also expect that researchers will provide documentation that HIPAA authorization has been or will be obtained from these individuals for permission to collect, store, share or use their information and to be contacted about future research opportunities. Other HIPAA Privacy Rule requirements may apply.
Questions? Your registry-related questions may be directed to the FSU Office for Human Subjects Protection (OHSP) Director, T. Howard Stone, JD, LLM, CIP, at firstname.lastname@example.org.