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.
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:
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.
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.
PRO: There are challenges increasing diversity in clinical trials. Diversity in clinical trial participants isn't required by the federal government unless those participants are a subject of the clinical trial. This would allow us to recruit participants and interpret and translate for trials. The volume of trials at UW is why the fiscal note is so high. Black women are dying at higher rate of cancer and heart disease. The longer drugs are prescribed that are not tested on that population, the more those numbers will continue to rise. The fiscal note is significant because there are challenges to increasing diversity participation in clinical trials. This is an estimate of what it would take to both recruit participants, then translate and interpret for them in trials.