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)?
All investigators conducting research on human subjects must report any injuries or adverse events associated with the study procedures and/or problems involving the conduct of individuals associated with the study which occur during the course of their research project. This is called an adverse event and requires a report be submitted to the IRB (Form G). More information is available in the policy statement. Failure to report is a breach of the conditions under which IRB approval is given, and could result in suspension or revocation of approval. Suspension or revocation of approval could result in loss of support by funding agencies and loss of right to publish.
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 when the research study is completed?
