Institutional Review Boards.
An Institutional Review Board (IRB) is a formally designated group that reviews and monitors research involving human subjects. Research that involves human subjects must receive IRB approval. An IRB is responsible for reviewing research protocols and related materials to ensure protection of the rights and welfare of human subjects in research and may approve, require modifications, or disapprove research.
Washington State Institutional Review Board.
The Washington State Institutional Review Board (Review Board) is a designated IRB for a number of different Washington state agencies, including the Department of Children, Youth, and Families; Department of Health, Department of Corrections, Department of Social and Health Services, Health Care Authority, Department of Labor and Industries, and the Office of Financial Management. The Review Board also serves as a designated IRB for other local and state agencies. The Review Board is responsible for providing the requisite regulatory review, approval and oversight of research that may involve these state agencies' clients, beneficiaries, patients, wards and state agency employees or these individuals' state agency personal records, in order to ensure the protection of the rights and welfare of human subjects in research.
Andy Hill Cancer Research Endowment.
The Andy Hill Cancer Research Endowment (Endowment), also known as the Andy Hill CARE Fund, makes grants to public and private entities for the promotion of cancer research. The Endowment evaluates requests for funding based on a variety of factors, including:
The Endowment is governed by a 13-member board and administered by a private, non-profit corporation with expertise in conducting or managing research granting activities, funds, or organizations.
The Andy Hill Cancer Research Endowment (Endowment) must evaluate requests based on the following factors in addition to the current considerations:
The Washington State Institutional Review Board (Review Board) for state agencies is codified and defined as the review board established pursuant to 45 C.F.R. Part 46, as the designated Institutional Review Board for the Department of Social and Health Services, the Department of Health, the Department of Labor and Industries, and other state agencies. Any submissions or proposals submitted to the Review Board must include the same four items the Endowment must evaluate above, which the Review Board must consider.
The University of Washington, Washington State University, and any state agency or hospital that receives funding from the National Institutes of Health to conduct clinical trials of drugs or medical devices must adopt a policy concerning the identification and recruitment of persons who are members of underrepresented demographic groups to participate in clinical trials of drugs and medical devices. The policy must include requirements to:
"Underrepresented community" or "underrepresented demographic group" means a community or demographic group that is more likely to be historically marginalized and less likely to be included in research and clinical trials represented by race, sex, sexual orientation, socioeconomic status, age, and geographic location.
The sections related to the Review Board constitute a new chapter in Title 69.
The substitute bill:
(In support) Clinical trials are the first step for developing new drugs for cancer and other conditions. Joining a medical trial is a complex problem and the lack of diversity in trials is problematic in several ways. It compounds access to treatment disparities, and it limits the understanding of the impacts of a drug or medical device across all populations.
Communities of color are diligently working to build and ensure trust between communities of color, the government, and research. This bill is an attempt to create a foundation of trust to bring in more trial participants. Many patients from communities of color do not trust clinical trials because of the history of research in this country. Without increasing the diversity in clinical trials and providing culturally appropriate education and outreach, individuals from underrepresented communities will not have trust in the trials or know that they are safe. Individuals from communities of color need to participate in trials to help find treatments that will work for everyone no matter their color. This bill would be the first in that nation and it will connect more diverse patients with clinical trials.
It is important that all people have access to new and exciting treatments. Clinical trials have the opportunity to give early access to lifesaving medications. Many potential patients do not have access to clinical trials, and this is particularly true for communities of color. Participating in trials is also difficult and is often harder for people who are older or do not live in urban areas. There are many barriers to clinical trial participation and some are working currently to fund projects that address some of these barriers.
There should be more outreach for clinical trials and work to reach groups in a more accessible way, including materials for communities of color and the availability of materials in languages other than English. Biases should not stand in the way of health care, which is a right for all. Federal rules only require translation when the trial targets populations with limited English proficiency. The fiscal impact for large research institutions with a high number of new trials each year will be significant because the institution assumes that translation is needed for every trial.
This bill could be improved in three ways. First, the definition of underrepresented groups does not include people with restricted liberty. This population has been generally excluded from trials in the recent past. Second, the trials covered by this bill should be broader than just drugs and medical devices, which account for only 10 percent of all trials. Finally, the bill should be strengthened to require these things, unless the research can justify why they are excluding the population because it is either too onerous or unnecessary.
As compared to the substitute bill, the second substitute bill:
(In support) This bill is a top priority for patient groups. Diversity in clinical trials is key in the development of treatments and medicines to acknowledge how treatments impact people differently. The quality of research can improve when understanding how trials impact different populations.
The research institutions are working on getting more people to participate in clinical trials. Federal regulations currently require institutions to provide outreach for participation in trials that target certain participants for specific research; the bill requires outreach for all clinical trials. The outreach and translation services cost money. An amendment is being worked on to address concerns and achieve a common goal to increase diversity in clinical trials.