SENATE BILL REPORT

SB 6150

As of January 16, 2002

Title:  An act relating to disclosure of beneficial interests in drugs or products administered or provided to human subjects participating in human subjects research.

Brief Description:  Mandating disclosure of beneficial interests in human subject research.

Sponsors:  Senators Thibaudeau, Franklin, Deccio 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:  Conflict of interest may arise when professional judgment concerning a primary interest, such as patient welfare or valid scientific research, is unduly influenced by a secondary interest, such as financial gain.  Even the appearance of a conflict of interest may undermine public trust in human subject research.  It is thought that disclosure may minimize potential conflicts.

Washington law does not address conflict of interest in human subject research.  Although there are federal regulations concerning financial conflict of interest in human research, there is concern that these regulations are not uniform or comprehensive.  As national interest in financial relationships in clinical research has heightened, federal agencies and professional societies have begun developing additional policies.  Currently, however, there are no legal requirements that subjects in clinical trials be informed of investigators' or institutions' financial interests in the research.

Summary of Bill:  A licensed health care provider or a health care facility is prohibited from administering or providing a drug or other product to a human research subject without disclosing any ?beneficial interest," as defined in current law, in the drug, product, or entity promoting the drug or product.

Appropriation:  None.

Fiscal Note:  Not requested.

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