Dear Clinical Researcher:
In 1993, medical science took a huge leap forward when Federal law first required that women be included in NIH-supported clinical research. This pivotal legislation, a section within the 1993 NIH Revitalization Act, codified in policy the notion that females are not merely a variation of males and that all people have unique health needs.
To do this, we need to be creative and savvy in addressing barriers to participation at the person level (e.g., gender affects our family and work obligations), at the systems level (e.g., the likelihood of being asked to participate in a clinical trial depends on where we receive medical care), and where multiple factors interact to influence participation. This electronic resource provides a wealth of tools, stories, and strategies that clinical researchers have deemed successful in conducting high-quality, respectful research studies with varied populations. Importantly, this resource goes well beyond a listing of policies and regulations, although these are included for reference purposes. Herein, you will find practical information: successful practices for engaging people in clinical studies, guidelines on conducting outreach with communities, and—among the most exciting content—a series of case studies that demonstrate real-life clinical research scenarios and provide suggested actions to meet the needs of both researchers and research participants.
Clinical research is one of the most important examples of the vitality of trust in biomedical research. What we learn from federally funded clinical research is the dividend of the public’s investment in science. Our results must be relevant—and thus tested rigorously—for the benefit of the public.
Janine Austin Clayton, M.D.
NIH Associate Director for Research on Women’s Health