News Release

New in Ethics & Human Research, May-June 2021

Underrepresented populations in clinical research, and more

Peer-Reviewed Publication

The Hastings Center

American Indian and Alaska Native Enrollment in Clinical Studies in the National Institutes of Health's Intramural Research Program
Dejonna Vigil, Ninet Sinaji, and Barbara Karp

This is the first study to provide data about the inclusion of American Indians and Alaska Natives in the National Institutes of Health's Intramural Research Program (NIH-IRP), which provides eligible individuals with access to innovative research treatments that may not otherwise be available. The program's mission is to include all Americans. This study analyzed data from more than 1,800 NIH-IRP protocols active in 2014 and 2017. While the number of American Indian/Alaska Native enrollees increased, it remained at 1% of all participants, a disproportionately low level. The number of clinical studies that enrolled American Indian/Alaska Native individuals also did not change. The authors outline their plans for further research to aid in the ethical inclusion of American Indian and Alaska Native enrollees in clinical research.

Also in the May-June 2021 issue:

"Advance Research Directives: Dementia Researchers' Views on a Prototype Directive and Implementation Strategies," Nola Ries, Elise Mansfield

"Stakeholder Experiences with the Single IRB Review Process and Recommendations for Food and Drug Administration Guidance," Amy Corneli, Carrie B. Domeck, Kevin McKenna, Sara B. Calvert

"SARS-CoV-2 Human Challenge Trials: Rethinking the Recruitment of Health Young Adults First," Kenji Matsui, Yusuke Inoue, Keiichiro Yamamoto

Commentary: "Human Infection Challenge Experiments: Then and Now," Franklin G. Miller, Jonathan D. Moreno


For more information, contact:
Susan Gilbert
Director of Communications
The Hastings Center
845-424-4040 x 244

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