You are the chairperson of a central IRB. You have learned that one of the sites in a study you oversee is achieving subject recruiting and retention rates far superior to that of other sites. An investigation has found nothing unethical or unusual about the site’s activities — the subjects just find the investigator’s personality irresistible. Read more
In this post, I continue my closer look at a few select areas of the revised Common Rule, which was published January 18, 2017 of this year, and is scheduled to go into effect January 19, 2018. One set of changes that has not gotten very much attention is that around the definition and categorization of “vulnerable” research subjects. In this post, I explain what those changes are and reflect a bit on their significance. Read more
In April, PRIM&R hosted the webinar Compensation or Inducement? What IRBs Need to Know about Paying Subjects for Participation. Presented by Alex John London, PhD, and Betsy Ripley, MD, MS, RAC, this webinar provided foundational knowledge about the underlying ethical principles that govern compensating tresearch subjects. Through case studies, examples, and review of existing guidance and regulations, attendees learned strategies for evaluating payment to subjects for their participation in studies. Here, the presenters answer some of the questions time didn’t permit us to answer live. Read more
by Meryn Robinson, education and membership services intern
Since its founding in 1974, PRIM&R’s highest priority has been to provide those charged with ensuring research protections, as well as those involved in the design and implementation of research protocols, with the education, practical tools, and cutting-edge strategies needed for their work protecting subjects. As we celebrate our 40th anniversary, we are reflecting upon four decades of connecting and protecting, and recounting some of the events that have shaped the field’s rich history in our 40 Years of Research Ethics series.
In 1951, Read more
by Emily A. Largent and Alan Wertheimer, PhD
How do institutional review board (IRB) members and human research protections professionals think about the relationship between payment, coercion, and undue influence?
This is a topic of obvious interest to the research community: Researchers routinely offer payment to prospective research participants as an incentive to enroll or as compensation for their participation in research. IRBs are, in turn, asked to review these payments for their ethical implications. Yet, there is little systematic data about attitudes toward payment in general, and specifically, when IRB members consider payment coercion or undue influence.
To address these questions, in 2010, we surveyed randomly selected PRIM&R [...] Read more
