What are the procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB?
Understand the Problem
The question asks about the procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB (Institutional Review Board). The question requires identifying the correct procedure among the given options, relating to ethical guidelines in research involving human subjects.
Answer
The procedures are determined by the institution's policies and procedures.
The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are determined by the institution in its written policies and procedures.
Answer for screen readers
The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are determined by the institution in its written policies and procedures.
More Information
Institutional Review Boards (IRBs) are responsible for ensuring the safety and ethical conduct of research involving human subjects. Each institution develops its own policies and procedures for reporting unanticipated problems to comply with federal regulations and ethical guidelines.
Tips
A common mistake is assuming that federal regulations dictate the exact procedures for reporting unanticipated problems. While regulations provide a framework, institutions have the autonomy to develop their own specific procedures.
Sources
- Unanticipated Problems Involving Risks & Adverse Events ... - hhs.gov
- Unanticipated Problems | Office for the Protection of Research ... - oprs.research.illinois.edu
- Unanticipated Problems Involving Risks to Subjects or Others - pbrc.edu
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