In the May 2024 Reminders, Updates, and Some Data for Participant Inclusion blog post, Dr. Mike Lauer, NIH’s Deputy Director for Extramural Research, and Dawn Corbett, NIH’s Inclusion Policy Officer, shared updates and reminders about clinical research inclusion policies at NIH and resources to access inclusion data.
The post condenses over three decades of history about NIH policies on appropriate inclusion of women and members of racial and ethnic minority groups in NIH-supported clinical research, along with—more recently—individuals of all ages (except in studies that present scientific or ethical reasons to exclude children or older adults). You can check out links to relevant NIH inclusion policies, resources, and data reports. Because of public interest in the characteristics of study populations and the parallels with people impacted by specific health conditions, NIH has started sharing inclusion data publicly on an annual basis, instead of once every 3 years.
A central goal of these policies is to ensure that the demographics of participants in our clinical research will inform clinical practice to benefit people who are affected by the disease or condition under study. Clinicians, as well as people affected by a disease or health condition, may feel more confident about treatments that were studied in people who share common characteristics with their patient populations. NIH has continued to seek input on demographic characteristics that common data elements should incorporate to make results more translational.
Find more details on appropriate inclusion of research participants, including a deep dive into policies and data, in the Reminders, Updates, and Some Data for Participant Inclusion blog post.