Health Sciences Institutional Review Boards: Policy

 

Exception to Five Year Renewal Policy

 

Exception By: All Campus IRB

Exception Date: February 9, 2006

 

The Health Sciences IRBs received an exception from the All Campus IRB to the UW-Madison’s policy that requires all non-exempt protocols involving research on human subjects to be closed by the IRB after 5 years. 

 

The Health Sciences IRBs agreed that in general protocols would be allowed to remain open beyond 5 years if they meet at least one of the following criteria:

1. Limit their activities to data analysis or cover the activities of a statistical analysis center for a multi-center trial
2. Limit their activities to long-term follow-up of subjects (e.g., for survival)
3. Cover training program grants, master grants, or umbrella grants
4. Will complete activities involving interaction with subjects before the next continuing review (i.e., a before a sixth year)

 

The Health Sciences IRBs would require closure and resubmission of protocols that:

1. Have not commenced research activities
2. Need to be updated to meet current IRB and regulatory standards
3. Have a complicated history that does not allow for clear tracking in the protocol file
4. Appear to have changed substantially from the IRB’s original understanding of the research study

 

At the time of continuing review, the Health Sciences IRBs will determine for protocols that are more than 5 years of age whether the protocol must be closed and resubmitted as an Initial Review Application.  This determination and rationale for the decision will be documented in the IRB minutes.  If the IRB agrees a protocol must be closed, the committee would allow researchers a grace period of six months to close their current protocols and obtain IRB approval of a new Initial Review Application, unless concerns arise about the immediate continuation of the protocol in its current form.  Investigators who fail to obtain approval of a new protocol within that timeframe will have their old protocol terminated unless they can demonstrate extenuating circumstances.