SENATE BILL REPORT

SB 5564

As Reported By Senate Committee On:

Health & Long-Term Care, February 20, 2003

Title: An act relating to research in the jurisdiction of a state agency.

Brief Description: Clarifying the definition of "research."

Sponsors: Senators Deccio, Thibaudeau and Franklin; by request of Department of Social and Health Services.

Brief History:

Committee Activity: Health & Long-Term Care: 2/11/03, 2/20/03 [DP].

SENATE COMMITTEE ON HEALTH & LONG-TERM CARE

Majority Report: Do pass.

      Signed by Senators Deccio, Chair; Winsley, Vice Chair; Brandland, Franklin, Keiser, Parlette and Thibaudeau.

Staff: Tanya Karwaki (786-7447)

Background: The Department of Social and Health Services houses the Washington State Institutional Review Board (WSIRB). Interagency agreements permit the Department of Health and the Department of Labor and Industries to use WSIRB to review human subjects research. As an institutional review board, WSIRB is 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.

Washington law defines the conditions that WSIRB must determine have been met before a state agency may disclose identifiable personal records (records containing information identifying an individual) for research purposes, without the research subject's informed consent. Confidentiality requirements for this type of disclosure are also specified in statute. Research professionals are prohibited from disclosing personally identifiable research records of state agency clients and employees unless a statutory exception is met.

Changes in federal law have prompted the Department of Social and Health Services to request that state law be harmonized with federal law and with current practices.

Summary of Bill: "Research" is defined in accordance with federal law. "Research in the jurisdiction of a state agency" is defined as: (1) research conducted by an employee or contractor of a state agency; (2) research sponsored by a state agency; or (3) research involving access to personal information.

The Department of Labor and Industries is added to the list of state agencies authorized to disclose personal information without consent, for research purposes.

A state agency director is authorized to designate the institutional review board of another state agency to review human subjects research for his or her agency.

Research professionals conducting research in the jurisdiction of a state agency are prohibited from disclosing personal identifiable research records of any research subject, unless a statutory exception is satisfied.

Appropriation: None.

Fiscal Note: Available.

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

Testimony For: This bill allows greater protections for research records. The institutional review board at the Department of Social and Health Services has been reviewing research for the Department of Labor and Industries for years, but the records do not have the same protections because L&I is not included in the statute.

Testimony Against: None.

Testified: Michael Garrick, DSHS (pro); Barbara Silverstein, L&I (pro).