The researcher must keep the IRB informed of any unexpected finding involving risks to research participants and to report any occurrence of harm to research participants. The perception of harm could be on the part of the researcher(s) or the participants. (See FAQ’s for more information)
The IRB has the authority to request more frequent continuing reviews or re-evaluation of research activities based on degree of risk or changes in the participant risk/benefit ratio. Examples of reasons for more frequent reviews may include the following:
- issues of participant risks or harm,
- participants’ complaints,
- changes of the Primary Investigator(s),
- notification of unforeseen problems or accidents, and
- notification of significant changes in the informed consent process, research plans and procedures and data collection methods.
This list of reasons is not to be considered exhaustive and the IRB will provide the researcher a statement of the reasons for more frequent reviews.
The IRB has the authority to suspend or terminate approval or any research activity that is not being conducted in accordance with IRB requirements or that has been associated with unexpected serious harm to participants. Should the IRB decide to suspend or terminate its approval of a research project, the IRB will provide a statement of the reasons to the researcher and the Associate Provost for Research and this statement will be recorded in IRBNet.