TAG ARCHIVES FOR National Academies

22
Feb2019

From the Director: Why We Need to Keep the Term “Research Subject” in Our Research Ethics Vocabulary

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22 Feb
Comments: 2

It’s been suggested by some that it is time to jettison the term “research subject” from our research ethics vocabulary—including in the regulations—and  exclusively use the term “research participant” to refer to those who enroll in research. While there are many compelling arguments for using "participant" instead of "subject" in the modern research context, PRIM&R's executive director, Elisa A. Hurley, PhD, argues that we need to keep both research "subject and research "participant" in our shared vocabulary. Read more

17
Dec2018

Webinar Follow-Up: Return of Individual Research Results

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17 Dec
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The question of whether and how to return individual research results to subjects has been an ongoing area of uncertainty for investigators and research institutions. The recent report from the National Academies of Science, Engineering, and Medicine (NASEM), Return of Individual-Specific Research Results to Participants: Guidance for a New Research Paradigm, offered recommendations for “a process-oriented approach to returning individual research results that considers the value to the research subject, the risks and feasibility of return, and the quality of the research laboratory.” On October 3, 2018, PRIM&R hosted a webinar to summarize the recommendations of the report, and provide guidance specifically on its potential implications for IRBs. Read more

11
Sep2018

From the Director: Taking a look at the National Academies’ report on returning individual research results to participants

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11 Sep
Comments: 5

In July of this year, the National Academies of Science, Medicine, and Engineering (NASEM) released a report titled, “Returning Individual Research Results to Participants: Guidance for a New Research Paradigm.” It’s a comprehensive report that raises many important considerations and proposes a number of thoughtful recommendations on this very timely topic. I won’t be able to do justice to all of its details and nuance here. Instead, I’ll share what I take to be some key themes and takeaways, including for IRBs. Read more

1
Jun2017

Cross Post: A Fresh Look at the Rules for Returning Research Results

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1 Jun
No comments

As the biomedical research enterprise increasingly moves to a more participatory model of research, where research participants are treated more as partners than passive subjects, we can expect greater emphasis on returning individual-level results of research to participants. A prominent example is the All of Us Research Program. Read more

1
Jul2016

From the Director: National Academies Report Recommends Withdrawing the NPRM and Calls for a New Belmont Report

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1 Jul
Comments: 1

On June 29, the National Academies of Science, Medicine, and Engineering released Part 2 of their report, Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century. The report, written by the Committee on Federal Research Regulations and Reporting Requirements in response to a Congressional request, examines the impact of regulations and policies governing federally funded academic research in the United States. Part 1, released in September 2015, concluded that the continued expansion of federal regulations is “diminishing the effectiveness of the U.S. research enterprise, and lowering the return on federal investment in basic and applied research by diverting investigators’ time and institutional [...] Read more