TAG ARCHIVES FOR hipaa

8
Jan2020

Webinar Follow-Up: Assessing and Mitigating Risk in SBER

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8 Jan
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The risks associated with social, behavioral, and educational research (SBER) are often subjective, unpredictable, and hard-to-identify. Even the most experienced reviewers struggle with quantifying potential harms associated with SBER. On March 20, 2019, PRIM&R hosted a webinar, Assessing and Mitigating Risk in SBER. Presented by Amy Ben-Arieh, JD, MPH and Lara Sloboda, PhD, this webinar helped attendees understand risk as defined in the regulations and as applied to SBER; implement strategies for mitigating risk in SBER; and appreciate the complex nature of risk assessment and mitigation in SBER. Read more

13
May2019

Applying the new HIPAA Exemption: Are you in or out?

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13 May
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For investigators, IRB members, and IRB staff alike, the revised Common Rule’s new exempt category at 45 CFR 46.104(d)(4)(iii) was a dream come true. The so-called HIPAA Exemption eliminates IRB review for research use of retrospectively or prospectively collected “identifiable health information when that use is regulated by the HIPAA Privacy Rule as health care operations, research, or for public health activities […].” Applying the HIPAA Exemption is not quite as simple as it might seem, though, as I learned at the 2018 Advancing Ethical Research Conference (AER18) session, appropriately titled “Just When You Thought You Understood the Health Insurance Portability and Accountability Act of 1996.” 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

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
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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

20
Jun2018

Webinar Follow-Up: Forward-Looking Strategies for IRBs in the Genomic Age

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20 Jun
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On May 10, PRIM&R hosted a webinar, Forward-Looking Strategies for IRBs in the Genomic Age: Preparing for Shifting Concepts of Identifiability, to provide expert input on the impact of breakthroughs in genomics research on traditional notions of identifiability.The panel consisted of Jiayan Chen, JD, a partner at McDermott Will & Emery, LLP, and Suzanne Rivera, PhD, MSW, vice president for research and technology management at Case Western Reserve University. After the webinar, Ms. Chen and Dr. Rivera responded to some of the attendee questions time didn’t permit us to address live. We’re pleased to share those responses with the readers of Ampersand. Read more