What happens if a human subject becomes a prisoner during the course of a research study?
If a human subject involved in ongoing research becomes a prisoner during the course of the study, and the relevant research proposal was not reviewed and approved by the IRB in accordance with the requirements for research involving prisoners under subpart C of 45 CFR part 46, the investigator must promptly notify the IRB. All research interactions and interventions with, and obtaining identifiable private information about, the now-incarcerated prisoner-subject must be suspended immediately, except as noted below. Upon receipt of the investigator’s report that a previously enrolled research subject has become a prisoner, if the investigator wishes to have the prisoner subject continue to participate in the research, the IRB must promptly re-review the proposal in accordance with the requirements of subpart C, and the institution(s) engaged in the research involving the prisoner subject must send a certification to OHRP and wait for a letter of authorization in reply. Otherwise, the p
Related Questions
- What happens if there are problems that result from my study (e.g., injuries to a subject, breach of confidentiality, failure to follow protocol/research design)?
- What happens if a human subject becomes a prisoner during the course of a research study?
- What happens to the information collected through the course of the research study?
