Research involving the collection or study of biodata and on biological materials such as human tissues or specimens.
Harms that occur from research on biodata or biospecimens typically occur from a breach of confidentiality as most materials exist at the time the research is proposed or will exist in the future for non-research purposes. Risk of harm from research procedures utilized for the collection of biodata/biospecimes for research purposes will be evaluated apart from procedures employed during clinical practice for treatment purposes. Also see the Intervention methodology section.
Additional considerations for Biobank Repositories
A note about genetic studies: germline cell studies represent the inherited potential of the individual so the IRB may not only consider implications to the specimen-donor, but also to future immediate and extended family along with ethnic groups. Somatic cell studies of diseased tissues may carry mutations as a result of many extrinsic factors so their is generally little to consider with regard to others beyond the donor. Researchers should attempt to anticipate and facilitate the conversation surrounding these unique issues within their research plan.
Additional considerations for biodata obtained via Intervention.
Researchers often request assistance in determining whether their interaction-based research is eligible for exemption or if it will be reviewed under expedited procedures or by the full board. Protocols may be eligible under multiple categories; the most protective standard will be applied.
More on Levels of Review
De-identified data (exempt cat. 4)
More about Research on Data
NOTE: Research involving prisoners may not be exempt. Research to which FDA regulations or policies apply are not eligible for exemption categories 1-5.
Prospective collection of biological SPECIMENS for research purposes by noninvasive means (expedited cat. 3)
Collection of DATA through noninvasive procedures routinely employed in clinical practice (expedited cat. 4)
Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for NONRESEARCH purposes (such as medical treatment or diagnosis) (expedited cat. 5)
Research on biodata/biospecimens that do not fit into an exempt or expedited category must be reviewed and approved during a convened full board meeting.
Is this human subjects research? OHRP Guidance: