Human Subjects Research Protections
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Contents
Vocab
- Human Subjects Research (HSR)
- living person
- data through intervention or interaction
- identifiable private information
- Research - a systematic investigation designed to develop or contribute to generalizable knowledge.
- Clinical research protocols
- Institutional Review Board (IRB) - a regulatory committee that must approve HSR before it begins.
- Office of Human Subjects Research Protections (OHSRP)
Links
- Roles and Responsibilities of Laboratory Investigators Serving on Clinical Research Protocols course
Module 1: What is HSR and what permissions are required
- IRB approval is required BEFORE you start working with human subjects or data.
- Only commence work on an IRB-approved protocol
- Required for PIs, AIs, collaborators, using NIH infrastructure.
- HSR defined by
- Have access to identifiable human data or specimens from living individuals, or coded specimens that you can link to the subjects' identity
- Interact or intervene with human subjects to collect their materials or data for the purposes of research
- All HSR requires IRB review before the research may commence and at least annually while the protocol is ongoing
- IRB focuses on
- Ethical concerns related to participant's rights, safety, welfare, and their ability to freely choose to participate or not.
- The protocol that describes the research plan
- informed consent document used to inform human subjects about the research when they join a study
- 12 IRBs at the NIH
- IRB meetings are open