TAG ARCHIVES FOR human subjects research

18
Feb2020

This edition of Research Ethics Roundup covers “unkind science” and the public’s waning trust, international efforts to develop data sharing standards, lack of diversity in psychological research subjects, and digital phenotyping.  Read more

4
Feb2020

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 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

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

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