TAG ARCHIVES FOR human subjects research

19
Jan2021

Last year, Heather H. Pierce, JD, MPH and I shared some thoughts about the Belmont Report at 40, and about the evolution and flexibility of the Belmont principles of respect for persons, beneficence, and justice in the face of changing circumstances. As we leave behind the extraordinary year of 2020, I have been thinking about how the pandemic, together with the Black Lives Matter social justice movement, has shone new, and I would say welcome, light on the principle of justice in research. Read more

15
Dec2020

On October 29, the Final NIH Policy for Data Management and Sharing was published. It will require “researchers to prospectively plan for how scientific data will be preserved and shared through submission of a Data Management and Sharing (DMS) Plan” and will apply to any NIH-funded or -conducted research that generates scientific data. It will be effective as of January 25, 2023. The final rule isn’t perfect: there is no mandate to share data, and grantees will need guidance on crucial questions of communicating these complex issues to participants. Nevertheless, the rule represents a positive step toward expanded, responsible sharing of data, which is critical to both good science and just treatment of research subjects.  Read more

13
Oct2020

On June 18, 2020, PRIM&R hosted a webinar, Complexity in Clinical Trial Design: A Primer on Adaptive and Platform Trials. During this webinar, Luke Gelinas and Marianne Kearney Chase defined key terms, explored ethical and regulatory challenges, and provided strategies and examples to bridge the gap between IRBs and researchers in understanding adaptive trial designs. Following the webinar, Luke and Marianne reflected on the session and attendee feedback; we're pleased to share their response with the readers of Ampersand. Read more

14
Aug2020

During the first day of the 2019 Advancing Ethical Research Conference, I had the good fortune of hearing Janine Austin Clayton, MD, from the Office of Research on Women's Health, an NIH organization that was created with the goal of finding answers on why certain diseases affect women more than men. The data she shared on health gaps between men and women should spark a fire in all of us to encourage our government and employers to do more. Read more