On February 28, 2013, PRIM&R hosted a webinar titled Key Decision Points: Is it Research Involving Human Subjects? It is Exempt? Is IRB Review Required? Following the webinar, I had a chance to connect with the presenters, Karen Hale, RPh, MPH, CIP, and Daniel Nelson, MSc, CIP, to discuss some of the questions that came in that they were unable to cover during the allotted time. Below, they share their perspectives on a few of the questions.
Q: Why can't I determine if a study involves "human subjects" before I determine if it is "research"?
A: From a regulatory standpoint, the definition of a “human [...] Read more
by Anne Meade, senior manager for website and social media
Each member of the PRIM&R staff is responsible for making sure that PRIM&R runs smoothly, whether their job is answering calls and planning programs, or updating the website and talking to members. No matter which job function we fulfill, it’s important that we stay informed about research ethics, and so we periodically review pertinent articles during our [...] Read more
by Julie Fine, Legal Specialist, Legal Division, Pfizer Inc. (Please note: The views presented here are my own and do not reflect positions or policies of Pfizer.)
In the weeks following the 2012 Advancing Ethical Research Conference, what has lingered with me most has been the keynote speech on mental illness and stigma by Elyn Saks, JD, PhD. She discussed how [...] Read more
by Anne Meade, Senior Manager for Website and Social Media
In early 2012, the IRB Forum, a resource-rich online community for human research protections professionals, found a new home at PRIM&R. We were (and are!) delighted to have this online community as a part of PRIM&R’s network of rich educational and networking resources. The past year brought some changes to the [...] Read more
Punxsutawney Phil predicted that spring will come early this year, so to celebrate we’ve brought together the latest stories in the world of research ethics! In this Research Ethics Roundup installment, learn about burgeoning discussion of the use of placebos in developing countries, recent reports of government agencies funding redundant protocols, and much more!
Ethical controversy in human subjects research: The use of placebo as a control in clinical trials is typically considered unethical if an effective treatment for the condition under study already exists. However, in resource-scarce countries, individuals outside of clinical trials may not have access to those treatments. This blog post from Ruth [...] Read more