TAG ARCHIVES FOR Common Rule

22
Feb2019

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

14
Feb2019

PRIM&R’s Comments on HHS “Request for Information on Modifying HIPAA Rules to Improve Coordinated Care”

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14 Feb
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The Office for Civil Rights (OCR) within the Department of Health and Human Services (HHS) recently put out a "Request for Information on Modifying HIPAA Rules to Improve Coordinated Care." PRIM&R submitted comments encouraging HHS to take this opportunity to harmonize the HIPAA Rules with the Common Rule to improve it's use in the research context. The research community has long argued that HIPAA is confusing, awkward, inconsistent, and unnecessarily burdensome as applied to human subjects research. Read more

12
Feb2019

Revised Common Rule at AER18: Takeaway Lessons

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12 Feb
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The 2018 Advancing Ethical Research Conference (AER18) presentation titled “It’s Not as New as You Think: Understanding How to Operationalize the Revised Common Rule” provided information regarding the history of the Common Rule and the recent changes to it. It is important that IRB professionals and staff become familiar with these revisions, as they have important implications for the oversight and the conduct of medical research. Presenters Jeffrey A. Cooper, MD, MMM; Kristin Craun, MPH, CIP; Jessica Huening, JD; Heather Pierce, JD, MPH, helped to clarify much of the confusion concerning the recently revised regulations. Key changes in the revised Common Rule were emphasized. An important part of the presentation delineated what happens as these revised rules become effective. This was helpful in understanding how to transition from the “original” Common Rule to the revised Common Rule. Read more

15
Jan2019

OHRP releases guidance on transitioning existing studies to the revised Common Rule

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15 Jan
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Despite the partial government shutdown, it’s business as usual at the Office for Human Research Protections (OHRP), and the revised Common Rule will go into effect, as planned, less than a week from today, on January 21, 2019. Last week, OHRP released a new draft guidance titled, “The Revised Common Rule Compliance Dates and Transition Provision (45 CFR 46.101(l))." Though it’s coming about six months later than would have been ideal, this is the most useful guidance related to the revised Rule released to date.   Read more

20
Dec2018

Ready, Set, Go: Implementing the Revised Common Rule

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20 Dec
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The US Department of Health and Human Services (HHS) (and other Federal Agencies) plans to implement the revised version of the Federal Policy for the Protection of Human Subjects, or “Common Rule,” on January 19, 2019. I arrived in sunny San Diego early morning Wednesday, November 14, for the 2018 Advancing Ethical Research Conference (AER18) on a mission to learn everything I could about these federal policy changes. Read more