TAG ARCHIVES FOR human subjects research

4
Feb2020

AER19 Blog Squad: Let’s Talk About Sex

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4 Feb
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Women are two-thirds of the world’s blind population, and there is no clear evidence for the cause of this alarming statistic. Dr. Janine Austin Clayton’s keynote address, "It’s About Quality Construction—Advancing a Foundational Framework for Rigorous Research Relevant to the Health of Women," at AER19 began with this disturbing fact as she described her path from being an ophthalmologist to the Director for NIH’s Office of Research on Women’s Health (ORWH). As she discussed this, and other startling statistics regarding women’s health in the United States, it caused me to wonder why gender and sex are not routinely considered in study design. How are studies ensuring that women (and sex as a biological variable) are integrated into the design of animal and human research studies so that knowledge and treatments gained from these studies can be generalizable and effective for both men and women? Read more

11
Nov2019

Meet the AER19 Blog Squad – Sierra Verbockel

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11 Nov
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Meet Sierra Verbockel, BS, MPA, who'll be covering the 2019 Social, Behavioral, and Educational Research and Advancing Ethical Research Conferences (SBER19/AER19) as a member of the Blog Squad. Members of PRIM&R's Conference Blog Squad provide an insider's view of the conferences by sharing their experience before, during, and after the meeting. Read more

2
Oct2019

RAND Corporation Report on IRB Demographics and Function

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2 Oct
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In August, the RAND Corporation, a policy research organization, released the first comprehensive profile of IRB demographics and function in 20 years: a “Profile of Institutional Review Board Characteristics Prior to the 2019 Implementation of the Revised Common Rule.” The report investigates questions about IRB practices, efficiency, and effectiveness on the cusp of implementation of the revised federal regulations, including single IRB review. (In December of 2017, PRIM&R helped get the word out to potential survey respondents.) Read more

18
Sep2019

Join PRIM&R in Commenting on International Conference of Harmonization’s Revised Guideline

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18 Sep
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The International Conference of Harmonization (ICH), which is made up of the regulatory bodies and pharmaceutical trade associations of key drug developing countries, recently released their  revised “E8(R1) General Considerations for Clinical Studies” document. On September 16, PRIM&R submitted comments approving of ICH’s work to modernize their guidelines and suggesting that the document could benefit from a better discussion of the broad ethical principles that underlie many of the human subject protections the document details. We also recommend that the ICH consider reorganizing some of its guidelines to make it easier for those designing and conducting research to learn more about these fundamental ethical principles and related best practices. If you are based in the United States, we encourage you to consider submitting your own comments on the newly revised E8 document before the September 30 deadline. You are welcome to cite or quote PRIM&R’s comments. Read more

3
Sep2019

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