From the Director: The Promise and Puzzle of the Key Information Requirement

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3 Sep

Comments: 3

Some of the most significant changes in the revised Common Rule involve the provisions around informed consent, including the new requirement that informed consent begin with a “concise and focused presentation of key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research” [46.116(a)(5)(i)]—the “key information requirement,” for short. I welcome the key information requirement and think it has the potential to greatly improve informed consent, but it is bringing with it several complexities. Read more

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

25
May2017

Revisiting What to Call People Who Participate in Clinical Research

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25 May

Comments: 8

In early 2014, PRIM&R explored the topic of what we call individuals who volunteer for research in a post titled "What’s in a name? Research 'participant' versus research 'subject'." In this post, PRIM&R concludes that, on the whole, "subject" is the most appropriate title for those involved in research studies (recognizing, however, that in some instances "participant " may be appropriate; for example, in community-based participatory and participant-led research). Herein we present the contrasting points of view of three individuals. Read more