UW-Madison Human Research Protection Program: Policy

 

Review of Social and Behavioral Science Protocols with Genetic Testing Component

 

Adopted By: Human Research Protection Program Advisory Committee

Adoption Date: November 6, 2008

Revised: September 10, 2009

Only certain types of genetic testing research may be reviewed by the Social & Behavioral Science IRB (SBS IRB).  In order for a Social and Behavioral Science protocol involving a genetic testing component to be reviewed by the Social & Behavioral Science IRB, the following criteria must be met:

           

1)       The method of sample collection is cheek swab or other non-invasive procedure, although a simple blood draw may be used.

2)       The testing is not being done for establishing a new diagnosis but may be used to associate a behavior with a known condition.

3)       Results will not be shared with participants and no genetic counseling of participants will take place.

4)       Results of the genetic testing will not become part of a medical record.

5)       Genetic samples may not be banked for undetermined future use unless they are de-identified.

 

Proposals for social science research involving a genetic testing component that meets these criteria should be submitted to the Social & Behavioral Science IRB via its electronic protocol submission process. Any protocol involving a genetic testing component that does not meet these criteria must be submitted to the Health Sciences IRB for review.

 

Each protocol involving genetic research reviewed by the SBS IRB will also be reviewed by an expert in social science genetic research, who may serve as an ad hoc consultant to the IRB or be appointed as an SBS IRB member. 

 

This expert should attend, either in person or by telephone conference call, any IRB meeting at which genetic testing protocols are reviewed for the purpose of presenting his/her review and answering IRB members’ questions.  If the expert is unable to attend an IRB meeting in person or by telephone, the expert must provide, in advance of the meeting, a written report addressing, at a minimum, all the items listed in the “SBS IRB Member Review Guide for Genetic Research Protocols” http://my.gradsch.wisc.edu/hrpp/10236.htm.  This report will be distributed to IRB members with the meeting packet according to the IRB Meetings Policy, http://my.gradsch.wisc.edu/hrpp/10064.htm.  If the expert sends a written report and does not attend the meeting, any questions raised by IRB members at the meeting should be sent by the IRB office in writing to the expert who should provide written answers, unless he/she will attend the next IRB meeting, either in person or by telephone.