RCW 69.78.010
325 words·~1 min read·
/wa/title-69/chapter-69-78/69-78-010·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(1)The legislature finds that controlled clinical trials provide a critical base of evidence for evaluating whether a medical product is safe and effective before the product is approved for marketing. The United States food and drug administration has evaluated demographic profiles of people participating in clinical trials for approved drugs and found that some groups, especially ethnic and racial groups, are not always well represented in clinical trials. Diversity in clinical trials is necessary to effectively determine how race, gender, and age impact how a person metabolizes a drug. Communities of color have been working diligently to establish a foundation of trust with government and clinical research with the goal of engaging more trial participants who are members of underrepresented demographic groups. Joining clinical trials is a difficult and complex process and the lack of trust and awareness of clinical trials and research, in addition to burdens related to transportation, geography, and access, limit trial participants. The lack of diversity in clinical trials compounds access to treatment disparities and limits our understanding of the impacts of studied interventions and conditions across the population.
(2)Therefore, it is the policy of the state to:
(a)Improve the completeness and quality of data concerning diverse demographic groups that is collected, reported, and analyzed for the purposes of clinical trials of drugs and medical devices;
(b)Identify barriers to participation in clinical trials by persons who are members of demographic groups that are underrepresented in such trials and employ strategies recognized by the United States food and drug administration to encourage greater participation in clinical trials by such persons;
(c)Make data concerning demographic groups that is collected, reported, and analyzed for the purposes of clinical trials more available and transparent; and
(d)Require certain entities conducting clinical trials to offer trial participants information in a language other than English and provide culturally specific recruitment materials alongside general enrollment materials.
[ 2023 c 426 s 1 .]