4
Feb2016

PRIM&R’s Comments in Response to OHRP’s and FDA’s Draft Guidance on IRB Meeting Minutes

Tags:

4 Feb

Comments: 1

PRIM&R submitted comments to the Department of Health and Human Services’ (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) in response to their jointly released draft guidance on meeting minutes for institutional review boards (IRBs) who oversee human subjects research under the FDA and/or DHHS regulations. Read more

1
Feb2016

Guest Post: The History of Bioethics Series – National Bioethics Commissions

Tags:

1 Feb

Comments: 1

This piece, which originally appeared on blog.bioethics.gov, the blog of the Presidential Commission for the Study of Bioethical Issues, was written by the Bioethics Commission Staff and has been reposted with permission.

This is the first post in our "History of Bioethics" series in which we will examine some of the seminal events that shaped the landscape of bioethics and its practice in the world today. This first blog will focus on the creation of the national bioethics advisory bodies in the United States and their different iterations throughout the years.

From our [...] Read more

28
Jan2016

What Does the Public Need to Know About Research?

Tags:

28 Jan

Comments: 3

Since the launch of People and Perspectives (P&P) in 2013, we have interviewed a variety of individuals, from the founders of the research ethics field to those who have only been in it for a few years. But one thing we ask most of them is, "what do you think the general public needs to know about research?" Though their responses are different, many reference a common theme: people need to understand why research matters to them. (more…) Read more

26
Jan2016

A Quick (And Real) Dividend

Tags:

26 Jan

Comments: 3

Talk about a quick dividend! The dust hasn’t even settled on the travel bags that I carried to the 2015 SBER and AER Conferences, and yet I’m already applying the lessons learned to my responsibilities as IRB Chair at Providence College.

As you may recall from my previous Ampersand postings, my learning experiences at this year’s conferences focused on the difficult choices that are faced by researchers who are engaged in “big data” projects. These researchers find it impracticable to engage in routine [...] Read more

25
Jan2016

From the Director: Now that the (NPRM) Dust Has Settled…

Tags:

25 Jan

Comments: 1

The last few months have been a bit of blur. The long-awaited NPRM to revise the Common Rule was released in September, setting off something of a firestorm of commentary, concern, and clamor around what was in the proposal, and what wasn’t; what might work, and what wouldn’t; and of course, how it would all look in the "real world" of ethical research oversight. Here at PRIM&R we spent a good deal of time over the three-month comment period crafting our response to the NPRM, and [...] Read more

22
Jan2016

Research Ethics Roundup: Results of Ebola Clinical Trials, Concerns over Fatal French Clinical Trial, and More

Tags:

22 Jan

Comments: 1

Global research issues take center stage in this week’s Research Ethics Roundup. Recently, the Chinese government announced new draft regulations on lab animal welfare. The results of the Ebola trials are being analyzed and French officials are launching an investigation after a fatal clinical trial.

Ebola's Thin Harvest: In this special report for Science, Jon Cohen and Martin Enserink report on the results of the Ebola clinical trials. They point out, "Never before had the disease affected enough people to allow researchers to test Ebola drugs and vaccines in a real-world setting." Unfortunately, the findings from many of these trials are unclear.