SENATE BILL REPORT

SB 6147

As of January 16, 2002

Title:  An act relating to institutional review boards.

Brief Description:  Providing requirements for the composition of institutional review boards.

Sponsors:  Senators Thibaudeau, Franklin, Deccio, Winsley, Fairley and Kohl‑Welles.

Brief History:

Committee Activity:  Health & Long‑Term Care:  1/17/02.

SENATE COMMITTEE ON HEALTH & LONG‑TERM CARE

Staff:  Tanya Karwaki (786‑7447)

Background:  An institutional review board (IRB) is any group formally designated by an institution, or authorized by law, to review biomedical research involving humans as subjects and to approve the initiation of and conduct periodic review of such research.  IRBs are responsible for protecting the rights and welfare of human research subjects and assuring that the risks of proposed research are reasonable in relation to the potential benefits.  In carrying out its obligations, an IRB may approve, disapprove, or require modifications to research protocols.  An IRB may also suspend or terminate its approval of ongoing research.

IRBs are required by federal law for most human subject research funded or conducted by the federal government.  Federal regulations provide for the establishment and composition of these required IRBs.  The same regulations do not necessarily apply to privately funded research that falls outside the jurisdiction of the Food and Drug Administration.  Washington law does not address the composition of IRBs.

Summary of Bill:  For any IRB operating in Washington, representation on the IRB is expanded.  More than one nonscientific member and more than one noninstitutional member must be on the board and participate in any portion of a board meeting where research plans or protocols are discussed.  The same person may not qualify as the nonscientific and the noninstitutional board member.  Scientists must compose at least one-third of the members on the board, but no more than two-thirds. 

No board member shall vote on research in which he or she has a property or fiscal interest.  If such a vote occurs, it is invalid.

Appropriation:  None.

Fiscal Note:  Not requested.

Effective Date:  Ninety days after adjournment of session in which bill is passed.