SB 6506

This analysis was prepared by non-partisan legislative staff for the use of legislative members in their deliberations. This analysis is not a part of the legislation nor does it constitute a statement of legislative intent.

As of January 30, 2018

Title: An act relating to improving diversity in clinical trials.

Brief Description: Concerning improving diversity in clinical trials.

Sponsors: Senators Rivers, Becker and Fain.

Brief History:

Committee Activity: Health & Long Term Care: 1/30/18.

Brief Summary of Bill

  • Requires the Washington State Institutional Review Board (WSIRB) to establish a diversity in clinical trials program.

  • Requires state entities that conduct clinical trials for drugs or medical devices to adopt a policy for identifying and recruiting participants from underrepresented demographic groups.


Staff: LeighBeth Merrick (786-7445)

Background: The WSIRB is a designated institutional review board for a number of Washington State agencies and research institutions. Research under the jurisdiction of Department of Social and Health Services, Department of Health (DOH), and the Department of Labor and Industries cannot begin until the WSIRB approves the proposed research protocols. The WSIRB must ensure the rights and welfare of individuals who participate in research are protected; that the risks to individuals are minimized, are not unreasonable, and are outweighed by the potential benefits to the individual or by the knowledge to be gained; and that the proposed research design and methods are adequate in light of the stated research objectives.

Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. Governmental organizations; academic or research institutions; or pharmaceutical, medical device, or biotechnology companies may undertake a clinical trial. The United States Food and Drug Administration (FDA) regulates the conduct of clinical trials.

Summary of Bill: The WSIRB is required to establish a diversity in clinical trails program. The goal of the program is to encourage more participation from underrepresented demographic groups in clinical trials of drugs and medical devices. Demographic groups that may be underrepresented include race, sex, sexual orientation, socioeconomic status, and age. When developing the program, the WSIRB may:

State entities, including the University of Washington, that conduct clinical trials of drugs or medical devices must adopt a policy for identifying and recruiting participants from underrepresented demographic groups. The policy must require collaboration with community-based organizations, and utilization of methods recognized by the FDA.

Appropriation: None.

Fiscal Note: Available.

Creates Committee/Commission/Task Force that includes Legislative members: No.

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

Staff Summary of Public Testimony: PRO: Low participation from various demographic groups can result in medications only being effective for certain demographics. This bill would ensure that all people can benefit from the medications and medical devices that come from clinical trials.

Persons Testifying: PRO: Senator Ann Rivers, Prime Sponsor.

Persons Signed In To Testify But Not Testifying: No one.