SENATE BILL REPORT
SB 5388
As Reported by Senate Committee On:
Health & Long Term Care, February 9, 2023
Title: An act relating to improving diversity in clinical trials.
Brief Description: Concerning improving diversity in clinical trials.
Sponsors: Senators Rivers, Cleveland, Muzzall, Conway, Frame, Hasegawa, Keiser, Lovelett, Lovick, Pedersen, Rolfes, Salda?a, Valdez and Wilson, C..
Brief History:
Committee Activity: Health & Long Term Care: 2/03/23, 2/09/23 [DPS-WM].
Brief Summary of First Substitute Bill
  • Establishes a diversity in clinical trials program at the Washington State Institutional Review Board.
  • Requires any entity receiving funding from the National Institutes of Health to conduct clinical trials of drugs or medical devices to adopt a policy concerning recruitment of persons who are members of underrepresented demographic groups, provide information in languages other than English, and to provide translation services..
  • Requires investigators in clinical trials to collaborate with community-based organizations.
SENATE COMMITTEE ON HEALTH & LONG TERM CARE
Majority Report: That Substitute Senate Bill No. 5388 be substituted therefor, and the substitute bill do pass and be referred to Committee on Ways & Means.
Signed by Senators Cleveland, Chair; Robinson, Vice Chair; Rivers, Ranking Member; Muzzall, Assistant Ranking Member; Conway, Dhingra, Holy, Padden, Randall and Van De Wege.
Staff: Kevin Black (786-7747)
Background:

The Washington State Institutional Review Board. An institutional review board is a federally-mandated entity that reviews research proposals to assure that the rights and welfare of human subjects are protected, risks to human subjects are minimized and not unreasonable, and that proposed study designs and methods are appropriate.

The Washington State Institutional Review Board (WSIRB) is the designated institutional review board for several state agencies, including the Department of Social and Health Services, Department of Health, Health Care Authority, and Department of Labor and Industries. WSIRB provides regulatory review, approval, and oversight of research that involves state agency clients, beneficiaries, patients, wards, and employees. WSRIB ensures the protection of human research subjects and maintains guidelines addressing various topics related to clinical trials.
 
Clinical Trials. Clinical trials are research studies involving human volunteers to evaluate medical products like medications, vaccines, or medical devices for safety and effectiveness. In 2016, the United States Food and Drug Administration released a guidance document containing nonbinding recommendations for the collection of race and ethnicity data in clinical trials.  The guidance addresses ways to collect more consistent demographic subgroup data by establishing minimum standards for maintaining, collecting, and presenting data on race and ethnicity.

Summary of Bill (First Substitute):

WSIRB must establish a diversity in clinical trials program to encourage participation in clinical trial of drugs and medical devices by persons who are members of demographic groups underrepresented in clinical trials. WSIRB may:

  • collaborate with medical facilities, health authorities, nonprofit organizations, and scientific investigators and institutions to assist in recruiting persons who are members of underrepresented demographic groups to participate in clinical trials;
  • establish a website to provide information concerning methods for identifying and recruiting persons who are members of underrepresented demographic groups to participate in clinical trials;
  • provide links to entities performing research relating to drugs or medical devices in Washington; 
  • apply for grants to fund the diversity in clinical trials program; and 
  • submit a biannual report starting July 1, 2024, to the health care committees of the Legislature.

 

Any state entity that receives funding from the National Institutes of Health (NIH) to conduct clinical trials of drugs or medical devices must adopt a policy concerning identification and recruitment of persons who are members of underrepresented demographic groups to participate in clinical trials. Investigators conducting clinical trials must collaborate with community-based organizations and use methods to recruit persons who are members of underrepresented demographic groups to participate in clinical trials recognized by the United States Food and Drug Administration. These entities must also provide information to trial participants in languages other than English and provide translation services or bilingual staff for trial screening.

 

Demographic groups underrepresented in clinical trials may include persons who are underrepresented by race, sex, sexual orientation, socioeconomic status, or age.

EFFECT OF CHANGES MADE BY HEALTH & LONG TERM CARE COMMITTEE (First Substitute):
  • Requires state entities that receive funding from NIH to provide information to trial participants in languages other than English.
  • Requires state entities that receive funding from NIH to provide translation services or bilingual staff for trial screening.
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 on Original Bill:

The committee recommended a different version of the bill than what was heard.  PRO: This adventure started six years ago. Applying the bill to all institutions that receive NIH funding is new this year. Thank you UW for working on language. We want to make sure pharmaceuticals work with the same efficacy on women and people of color as they work on the white male population. This will help to assure equity in health care. Over the interim our previous concerns about outreach were resolved. The University of Washington receives close to $1 billion in NIH grant funding and operates many clinical trials. Historical challenges and skepticism of clinical trials exist because of past transgressions; participation by our office of diversity and equity will help. Involving community-based organizations is key to success. Genetic ancestry makes certain patients more susceptible to different types of cancer, and causes them to metabolize drugs differently. All patients need the same opportunity to participate in new treatments. Patients lose early access to potentially life-saving treatments. Please consider other enhancements to the bill.

Persons Testifying: PRO: Senator Ann Rivers, Prime Sponsor; Adam Zarrin, Leukemia & Lymphoma Society; Kirsten Smith, Susan G. Komen; Ian Goodhew, UW Medicine.
Persons Signed In To Testify But Not Testifying: No one.