Institutional Review Board (IRB) - Continuing Review - Minnesota Dept. of Health

Institutional Review Board (IRB) - Continuing Review

The IRB must review a research project until the PI notifies the IRB that the study is complete. Approval for a research project is valid for no more than one year. The federal regulations require IRBs to conduct continuing reviews of research at intervals appropriate to the degree of risk, but not less than once a year.

Research protocols that required full IRB review initially and that have not completed data collection require full IRB review for continuation. The review must take place at a convened meeting of the IRB and action on the project must be approved by a majority of the members present. The researcher must meet the IRB’s stipulations, if any, before approval for continuation is granted.

The IRB focuses on research related to public health, which carries a lower level of risk to human subjects than clinical trials or drug and medical device studies. Therefore, an annual re-review is sufficient unless, in the IRB’s discretion, there are adverse events or other evidence to warrant more frequent or closer scrutiny. The IRB has the authority to observe or have a third party observe the consent process and the research. In full board reviews, the board will determine whether the risk is sufficient to require monitoring and what is needed to address the risk. The IRB will implement a monitoring plan when one is warranted.

Research protocols that initially required full IRB review, have completed collecting data, and are in the process of analyzing data may be reviewed using the expedited process. Research protocols that were reviewed initially using the expedited process may be re-reviewed using the expedited process as long as the degree of risk associated with the study has not increased.

Updated Friday, March 09, 2012 at 03:00PM