DOE Human Genome Program Contractor-Grantee Workshop VIII
February 27-March 2, 2000  Santa Fe, NM

137. The Responsibility of Oversight in Genetics Research: How to Enable Effective Human Subjects Review of Public and Privately Funded Research Programs

Barbara Handelin

PRIM&R, 132 Boylston Street, 4th Floor, Boston, MA 02116

BHandelin@compuserve.com

There are 3 specific aims 1) to collect relevant materials such as informed consent guidelines, protocol review guidelines, review board development guidelines, etc. which have been developed by individual IRBs, biopharmaceutical companies or policy boards; and 2) to implement focus groups discussions which will seek to articulate the specific stumbling blocks to overcome in genomics protocol review as well as suggestions for tools to remove these blocks; and 3) to develop and seek review of tools to help IRBs and biopharmaceutical companies enhance the overall protection of human subjects in genetics protocols.

Aim 1: Materials have been collected from a fairly wide variety of academic institution IRBs as well as from biopharmaceutical companies which provide a good foundation for further development of materials. These are under review.

Aim 2: Five focus groups and individual interviews with IRB administrators and IRB members have been completed. In addition, one focus group and multiple individual interviews with biopharmaceutical company representatives have also been completed.

Aim 3: We are currently working to develop guidelines and tools for IRBs and industry users. These documents will be the subject of a small review panel workshop where we will seek input and modifications from select users.

We have presented some of our findings at a recent national IRB conference sponsored by PRIM&R (December 5-7, 1999; Boston, MA). Dr. Handelin gave a plenary talk and lead a workshop at this conference of 1300 IRB audience members. Feedback from these presentations supports our conclusions about the needs of IRBs and about the inherent conflicts between industry sponsors and IRBs in the contemplation of genetics protocols.

The work products of this grant are being developed currently, in the last phase of the project. We are developing guidelines and tools for IRBs and industry users. These documents will be the subject of a small review panel workshop where we will seek input and modifications from select users.