It’s been three months since the announcement of the new Common Rule. Some reactions so far:
Friday, April 21, 2017
Friday, February 17, 2017
This winter, the Institutional Review Blog passed two milestones. In December it turned 10 years old, and in January it reported on the largest reform in U.S. human subjects regulations since 1981. This seemed like a good time to archive another batch of postings, so I have deposited a second PDF with the the Mason Archival Repository Service. Now all postings from the start of the blog through the end of January 2017 can be found at http://hdl.handle.net/1920/8642. Many thanks to Wally Grotophorst, Associate University Librarian, George Mason University, for making this possible.
I am less sure about the future of this blog. In ten years I have posted about 445,000 words, a considerable investment of time and effort. I see no reason to formally close the blog, but I may be posting a good deal less frequently as I focus on completing my book about the Philadelphia riots of 1844.
Thursday, January 19, 2017
On 19 January 2007, Inside Higher Ed reported the launch of this blog. Here is the kicker from that story:
Schrag said that the problems with IRBs will probably remain for some time. “I think the regulations themselves are poorly drafted, with terms that are not well defined, and I anticipate problems until they are amended,” he said. “Perhaps until then, I’m going to have to keep up the blog.”
Ten years later, to the day, the amended regulations are in the Federal Register.
Should I consider piracy?
Inside Higher Ed reports that Felice J. Levine, executive director of the American Educational Research Association, is happy with the final rule. I’m curious about why; it doesn’t seem to give her anything she asked for in 2011.
[Scott Jaschik, “U.S. Issues Final Version of ‘Common Rule’ on Research Involving Humans,” Inside Higher Ed, January 19, 2017.]
[Edited at 11:12AM to mention the normal educational practices in penultimate paragraph.]
On 18 January 2017, sixteen federal agencies announced revisions to the Federal Policy for the Protection of Human Subjects. As I noted earlier, this marks a huge victory for historians, who have spent the last 20 years working to end the inappropriate interference of IRBs with oral history research.
In addition, the final rule includes several provisions of note to scholars in the humanities and social sciences. Here are some of them; I don’t claim it is a complete list.
Wednesday, January 18, 2017
This morning sixteen federal agencies announced revisions to the Federal Policy for the Protection of Human Subjects, effective 19 January 2018. The final rule preserves and clarifies the NPRM’s deregulation of oral history. This is a great victory for freedom of speech and for historical research.
Saturday, January 7, 2017
A proposed final rule on human subjects protections made it to the Office of Management and Budget on Wednesday, January 4.
Jeannie Baumann of Bloomberg thinks this means that we’ll see it in the Federal Register before January 20. But she also quotes Lisa Nichols, director of research and regulatory reform for Council on Governmental Relations, predicting that Congress will overturn the reform, since it appears on the House Freedom Caucus hit list.
Wake me up when it’s over.
[Jeannie Baumann, “White House Takes Final Steps to Revamp Medical Research Rule,” Bloomberg BNA, January 6, 2017.]
Monday, January 2, 2017
A group of 11 researchers and IRB professionals, most of them affiliated with the University of California, San Diego, report on a brainstorming session from early 2015. They argue that readable consent forms, expert review, a less punitive system, and more exemptions would better serve researchers and participants. While they present their ideas as “a human research protections system that is responsive to 21st century science,” the measures they propose are equally valid for research as it has been practiced for decades.
[Cinnamon Bloss et al., “Reimagining Human Research Protections for 21st Century Science,” Journal of Medical Internet Research 18, no. 12 (2016): e329, doi:10.2196/jmir.6634.]