Thursday, December 15, 2016

Calls for Ethical Pluralism

In separate essays, Nathan Emmerich and Igor Gontcharov argue for more flexible systems that would avoid imposing biomedical ethics on the social sciences. Emmerich calls for an emphasis on professional ethics, while Gontcharov seeks “a set of ethical principles that would better reflect the position of [social sciences and humanities] researchers and participants.” I am left unsure what either proposed reform would look like in practice.

[Nathan Emmerich, “Reframing Research Ethics: Towards a Professional Ethics for the Social Sciences,” Sociological Research Online 21, no. 4 (2016): 7, DOI: 10.5153/sro.4127; Igor Gontcharov, “A New Wave of Positivism in the Social Sciences: Regulatory Capture and Conceptual Constraints in the Governance of Research Involving Humans,” SSRN Scholarly Paper (Rochester, NY: Social Science Research Network, October 31, 2016), DOI: 10.2139/ssrn.2861908.]

Monday, December 12, 2016

Ten Years of Blogging

The Institutional Review Blog launched ten years ago today. I would like to think that with or without a new Common Rule, it’s done some good, but I would dearly love to see oral history liberated in the next 39 days.

Zach's cat trying to get in from the screen porch, with the humorous caption, 'Can I Has Regz?'

Friday, December 9, 2016

Big Data researchers call for IRB review, based on shaky premises

Jacob Metcalf of the Data & Society Research Institute and Kate Crawford of Microsoft Research, MIT Center for Civic Media, and New York University Information Law Institute (I think those are three different things) want to subject Big Data research to IRB review, at least in universities. Their argument rests on shaky premises.

[Jacob Metcalf and Kate Crawford, “Where Are Human Subjects in Big Data Research? The Emerging Ethics Divide,” Big Data & Society 3, no. 1 (January–June 2016): 1–14, doi:10.1177/2053951716650211.]

Wednesday, December 7, 2016

Will Cures Act Replace Common Rule Reform?

As of November 15, POLITICO thinks that Common Rule reform is dead:

HHS’s controversial revision of the Common Rule, the regulations that protect participants in clinical research, still hasn’t been sent to OMB for review. That’s not likely to get finished under Obama’s watch.

(David Pittman, “Obama’s HHS, Congress at Potential Odds over Pending Rule,” POLITICO, November 15, 2016)

On the other hand, Congress just passed the 21st Cures Act, which includes a provision for a Research Policy Board designed, as Science puts it, to “examine excessive regulation of research.”

In his September 29 testimony before the Subcommittee on Research and Technology, James Luther of Duke University suggested that the congressional effort could replace the executive one. He complained “that HHS is still trying to move forward with a final rule [for human subjects research] for which many of the proposals remain unchanged from the ANPRM despite overwhelmingly negative comments” about its provisions on biospecimens. And he suggested that a Research Policy Board might do a better job.

Perhaps such a board would attend to questions of concern to the social sciences and humanities, but I am not hopeful. Luther’s testimony cites the May 2016 analysis by the Council on Governmental Relations (COGR) and the Association of Public and Land-grant Universities (APLU) and the June report by the National Academies of Sciences, Engineering, and Medicine’s Committee on Federal Research Regulations and Reporting Requirements. Both of those documents mostly ignored the social sciences and humanities.

The sun never sets on the Ethical Empire.

Monday, October 31, 2016

Qualitative Sociologists Find Standard Randomness

Sociologists Sarah Babb, Lara Birk, and Luka Carfagna surveyed qualitative sociologists about their IRB experiences and heard many of the usual horror stories, from insistence on inappropriate consent forms to the dribbling out of concerns over several rounds of comments. Few of their respondents are happy with the present system, though getting the right people in key positions can help.

[Sarah Babb, Lara Birk, and Luka Carfagna, “Standard Bearers: Qualitative Sociologists’ Experiences with IRB Regulation,” American Sociologist, October 6, 2016, 1–17, doi:10.1007/s12108–016–9331-z. Note: I read a version of this article in manuscript and am so credited in the article.]

Tuesday, October 25, 2016

Final Rule in 2016?

Theresa Defino reports that OHRP “hopes to get ‘something’ out by year end.”

If OHRP were to liberate oral history on the 10th anniversary of this blog, that would be OK with me.

Sunday, October 2, 2016

Brazil calls for "equitable representation from the Social Sciences and Humanities"

Brazil is revising its research ethics standards in ways that will help tailor them to research in the social sciences and the humanities. The standards provide for greater representation by scholars in those fields when policies and decisions are made, and they decenter some of the medical assumptions that had previously governed all research. But they do not go as far as the Canadian TCPS2 in recognizing the legitimacy of critical inquiry.

[Iara Coelho Zito Guerriero, “Approval of the Resolution Governing the Ethics of Research in Social Sciences, the Humanities, and Other Disciplines That Use Methodologies Characteristic of These Areas: Challenges and Achievements,” Ciência & Saúde Coletiva 21, no. 8 (August 2016): 2619–29, doi:10.1590/1413–81232015218.17212016.]

Saturday, October 1, 2016

"One more impediment to getting a worthwhile project done"

A final horror story posted in response to Patricia Aufderheide’s essay, “Does This Have to Go Through the IRB?."

Brian Abel Ragen writes,

Eventually you will probably find a reasonable person to stop the nonsense. That was my experience when one of my graduate students was told that his plan to interview a writer for the New York Review of Books meant he was using “human subjects” and therefore needed to submit his thesis proposal to the IRB after filling out all the appropriate forms and applications. A student asking a professional literary critic why he had championed the reputation of a certain novelist was, quite rightly, seen as an interaction WITH a fellow human being, not research ON a human subject. But that should have been obvious from the beginning. What the whole process did for me as an English professor and my student in the humanities was to create just one more impediment to getting a worthwhile project done—this new obstacle laced with fear of getting in trouble with the Federal government if we made a mistake. It also protected a writer from hearing from someone who admired his work and wanted to explore it with him for a few weeks. So I would say that the limits of the IRB’s powers need to be more clearly drawn, so as to remove one more hazard from the already obstacle-strewn path to completing a degree or a research project. I won’t say that i can’t imagine projects in literary studies that don’t involve using people as actual “human subjects,” but I think the default assumption should be that any project that involves neither deception nor asking the interlocutor to do anything but talk about something is beyond the scope of an IRB.

An IRB need not block a project to discourage curiosity.

Friday, September 30, 2016

IRB consent form spooked respondents

Commenting on Patricia Aufderheide’s essay, “Does This Have to Go Through the IRB?,” a writer with the screen name “reinking” relates:

I was investigating a routine instructional intervention in a school district serving a large hispanic population. IRB required, not just that the consent form be translated into Spanish (not unreasonable if a consent form was necessary), but also that I develop several versions in different dialects. Nonetheless, when sent to parents, remarkably few were returned, and I eventually determined why. The standard template for IRB consent (modeled on far riskier medical research) indicated that any questions or concerns should be directed to me as “principal investigator.” “Investigator” was apparently a term (in English or Spanish) that set off alarm bells among parents in this hispanic community.

So much for IRB sensitivity to local conditions.

Monday, September 19, 2016

More failures of "local precedents"

Laura Stark’s 2012 book, Behind Closed Doors: IRBs and the Making of Ethical Research, devotes a chapter to what Stark calls “local precedents,” her term for “the past decisions that guide board members’ evaluations of subsequent research.” “By drawing on local precedent,” Stark claims, “board members can read new protocols as permutations of studies that they have previously debated and settled based on members’ warrants. The result is that IRBs tend to make decisions that are locally consistent over time.” (47)

But I keep getting stories about IRBs that are locally inconsistent.

Tuesday, September 6, 2016

A satisfied customer at American University

Patricia Aufderheide, University Professor of Communication Studies at American University, reports her satisfaction with the IRB at that institution. It’s great to hear some good news, and Aufderheide’s essay points to the importance of having the right people in positions of power. But it also raises questions about how good and how replicable AU’s experience is.

[Patricia Aufderheide, “Does This Have to Go Through the IRB?,” Chronicle of Higher Education, August 17, 2016.]

Thursday, August 11, 2016

"Vulnerable" participants may have the most to gain from talking

Seven qualitative researchers forcefully argue that IRBs mislead research participants when they demand consent forms stating that interview research has “no known benefits.” In fact, people labeled “vulnerable” by IRBs often gain a great deal by participating in projects the IRBs deem “risky.”

[Tara Opsal, Jennifer Wolgemuth, Jennifer Cross, Tanya Kaanta, Ellyn Dickmann, Soria Colomer, and Zeynep Erdil-Moody, “‘There Are No Known Benefits …’ Considering the Risk/Benefit Ratio of Qualitative Research,” Qualitative Health Research 26, no. 8 (July 2016): 1137–50, doi:10.1177/1049732315580109.]

Monday, August 8, 2016

Will TCPS2 Improvements Reach Researchers?

Canadian oral historian Nancy Janovicek applauds the ways that TCPS2 improves over TPCS’s treatment of oral history, but she warns that historians still must devote time to bureaucratic strategy that might be better spent exploring ethics and interviewing narrators.

[Nancy Janovicek, ,“Oral History and Ethical Practice after TCPS2,” in The Canadian Oral History Reader, ed. Kristina R. Llewellyn, Alexander Freund, and Nolan Reilly (Montreal and Kingston: McGill-Queen’s Press, 2015), 73–97.]

Friday, July 1, 2016

The Ethical Imperialism of the NAS

The National Academies of Sciences, Engineering, and Medicine’s Committee on Federal Research Regulations and Reporting Requirements has released the second part of its report, Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century. The new part includes a chapter on “Ethical, Legal, and Regulatory Framework for Human Subjects Research.” While presenting valid critiques of the NRPM, the chapter ignores the voices of scholars in social sciences and the humanities. Its proposals are unlikely to be adopted, and if they were they would continue the half-century history of marginalizing those disciplines.

Monday, June 13, 2016

Linguist condemns "moral depravity of ethics protocols"

George van Driem, Professor of Historical Linguistics at the University of Bern, minces no words in condemning the “moral depravity of ethics protocols.” He argues that human subjects rules primarily serve to cover the asses of Western universities while hampering linguists in the field and insulting the people they encounter. Paraphrasing couldn’t do justice to this marvelous essay, so enjoy the block quotations. Better still, read the whole thing.

[George van Driem, “Endangered Language Research and the Moral Depravity of Ethics Protocols,” Language Documentation & Conservation 10 (2016): 243–252,].

Wednesday, June 8, 2016

Strangers on a Train

In Patricia Highsmith’s novel, Strangers on a Train (adapted for the screen by Alfred Hitchcock), a sociopath plans to get away with murder. Rather than kill his own nemesis and risk arrest, he will kill the troublesome wife of a stranger, and expect that stranger to reciprocate by killing his detested father. Since each man could arrange to be out of town at the time of his relative’s murder, each alibi could be ironclad.

Ethnographers Staci Newmahr and Stacey Hannem think this is a good way to deal with the IRB. The idea might be stupid enough to work in some cases, but it is also a distraction from the hard work of regulatory reform.

[Staci Newmahr and Stacey Hannem, “Surrogate Ethnography Fieldwork, the Academy, and Resisting the IRB,” Journal of Contemporary Ethnography, May 10, 2016, doi:10.1177/0891241616646825.]

Sunday, June 5, 2016

Bioethicists learn from history

Now that I’ve had my rant about the Belmont Report’s year of publication, I can turn to the more substantive arguments of Barron Lerner and Arthur Caplan’s recent essay, “Judging the Past: How History Should Inform Bioethics." These scholars wisely argue against simplistic condemnations of past behavior, yet they also reject the other extreme of attributing all past misbehavior to the age rather than the individual. By understanding what choices were open to actors in the past, we can better assess the morality of their actions and the choices that we ourselves face.

[Barron H. Lerner and Arthur L. Caplan, “Judging the Past: How History Should Inform Bioethics,” Annals of Internal Medicine 164, no. 8 (April 19, 2016): 553–57, doi:10.7326/M15–2642.

Saturday, June 4, 2016

The Belmont Report was published in 1978, goddammit!

Bioethicists Barron Lerner and Arthur Caplan have published a nice essay about using history to make better decisions today. I will comment on their main points in a separate post, but I want to address separately the authors’ repetition of a common error: the suggestion that the Belmont Report was published in 1979.

The Belmont Report was published in 1978, goddammit!

[Barron H. Lerner and Arthur L. Caplan, “Judging the Past: How History Should Inform Bioethics,” Annals of Internal Medicine 164, no. 8 (April 19, 2016): 553–57, doi:10.7326/M15–2642.

Friday, June 3, 2016

Emmerich seeks case studies about social science ethics

Nathan Emmerich seeks case studies about social science ethics for the SAGE Research Method Cases.

The Methodspace page explains:

This special collection will be edited by Dr Nathan Emmerich (  We are interested in cases that discuss substantive ethical issues or concern the process of securing ethical approval to conduct research. In both instances we seek accounts that will provide a description of ‘what really happened’ and offer lessons for those who are conducting similar research. These case studies will have significant pedagogical value whilst also engaging with current developments in the ethics of social science research. This includes the ESRC’s recently revised Framework for Research Ethics (FRE) and the generic principals of research ethics recently adopted by the UK’s Academy of Social Sciences.

If you are interested in publishing your experiences, disseminating your thinking and to promoting your research, or would simply like to discuss the possibilities further, please contact Dr Nathan Emmerich, at:

Monday, May 23, 2016

CITI Program is not unique in its mortifying stupidity

Writing in Slate, L. V. Anderson condemns simplistic, online training programs that are supposed to encourage regulatory compliance, but really just suck up time and money without improving behavior.

[L. V. Anderson, “Ethics Trainings Are Even Dumber Than You Think,” Slate, May 19, 2016.]

Anderson writes,

Regulators, managers, and employees are caught in a vicious cycle. Regulators pressure companies to implement training programs in hopes of reducing corporate crime and malfeasance. Executives implement training programs in hopes of protecting themselves against lawsuits and prosecution. Employees see through executives’ motivations and ignore, or even rebel against, the lessons of the trainings.

Although there’s not much research one way or the other, the online nature of compliance courses probably exacerbates this vicious cycle.

Anderson does not specifically mention the mortifyingly stupid CITI Program and its cousins in the IRB world, but everything she says applies to them.

Ethics of big data research are unsettled, and so are mechanisms

Sarah Zhang of WIRED uses the OKCupid data dump to explore the unsettled state of big data research ethics and mechanisms to promote them.

[Sarah Zhang, “Scientists Are Just as Confused About the Ethics of Big-Data Research as You,” WIRED, May 20, 2016.]

Friday, May 13, 2016

Medical researchers call for IRB clarity

Two medical researchers and a bioethicist, all affiliated with the UC Davis Center for Healthcare Policy and Research, call for IRBs to “reduce researchers’ frustrations and foster greater trust” by offering “transparency and accountability around IRB decisions.”

[Stephen G. Henry, Patrick S. Romano, and Mark Yarborough, “Building Trust Between Institutional Review Boards and Researchers,” Journal of General Internal Medicine, May 2, 2016, 1–3, doi:10.1007/s11606–016–3721–3.

Thursday, May 12, 2016

NPRM Comments Focus on Biospecimens

The Council on Governmental Relations (COGR), with support from the Association of Public and Land-grant Universities (APLU), has reviewed and analyzed (they don’t say “read”) all 2,186 public comments submitted in response to the 2015 NPRM. The analysis suggests that the debate over biospecimens is crowding out discussion of other proposed reforms.

[Council on Governmental Relations, “Analysis of Public Comments on the Common Rule NPRM,” May 2016. h/t Michelle Meyer.]

Wednesday, May 11, 2016

NSF Officer Misstates Belmont and Common Rule Standards

In the final contribution to the PS symposium, Lee Demetrius Walker, currently serving as program officer for the Political Science Program at the National Science Foundation, acknowledges the problems of applying a biomedical review system to social science. But he misstates the Belmont and Common Rule standards for assessing research.

[Lee Demetrius Walker, “National Science Foundation, Institutional Review Boards, and Political and Social Science,” PS: Political Science & Politics 49, no. 02 (April 2016): 309–12, doi:10.1017/S1049096516000263.]

Tuesday, May 10, 2016

Concern that IRBs will hinder field experiments

In his PS contribution, Brian Calfano worries that the Montana postcard fiasco will lead IRBs to impede political science field experiments, especially at teaching institutions.

[Brian R. Calfano, “‘I’ Does Not Mean Infallible: Pushing Back against Institutional Review Board Overreach,” PS: Political Science & Politics 49, no. 02 (April 2016): 304–8, doi:10.1017/S1049096516000251.]

Monday, May 9, 2016

Can community partners replace IRBs for field experiments?

In her contribution to the PS symposium, Melissa Michelson argues that “real-world practitioners” will often know more about relevant ethics and law than will the members of an IRB.

[Melissa R. Michelson, “The Risk of Over-Reliance on the Institutional Review Board: An Approved Project Is Not Always an Ethical Project,” PS: Political Science & Politics 49, no. 02 (April 2016): 299–303, doi:10.1017/S104909651600024X.]

Sunday, May 8, 2016

Call for Chapters: Virtue Ethics in the Conduct and Governance of Social Science Research

Nathan Emmerich has secured a contract for a 2017 book on Virtue Ethics in the Conduct and Governance of Social Science Research. He seeks additional contributors. See the call for chapters.

Texas A&M IRB Imposed Review for Surveys of Public Officials

In their contribution to the PS symposium, Kenneth Meiera and Apolonia Calderona complain of IRB interference in work that is clearly exempt or not even human subjects research.

[Kenneth J. Meier and M. Apolonia Calderon, “Goal Displacement and the Protection of Human Subjects: The View from Public Administration,” PS: Political Science & Politics 49, no. 02 (April 2016): 294–98, doi:10.1017/S1049096516000238.]

Saturday, May 7, 2016

IRB Chair: "Nobody Really Knows" If IRBs Do Any Good

A former chair of the University of Wisconsin-Madison Education and Social/Behavioral Science IRB guesses that IRB review “most likely” protects subjects from harm, but concedes that “nobody really knows.” He also notes that it consumes tens of thousands of hours of work, mostly by researchers, at his university each year.

[Kenneth R. Mayer, “Working through the Unworkable? The View from Inside an Institutional Review Board,” PS: Political Science & Politics 49, no. 02 (April 2016): 289–93, doi:10.1017/S1049096516000226.]

Friday, May 6, 2016

Yanow and Schwartz-Shea: IRBs Miss Their Targets

The first IRB related article in the April 2016 issue of PS, and the only one not formally part of the symposium on IRBs, is Dvora Yanow and Peregrine Schwartz-Shea, “Encountering Your IRB 2.0: What Political Scientists Need to Know.” This essay is intended as an introduction to IRB issues for political scientists, and therefore presents material that will be familiar to readers of this blog.

In addition to this helpful introduction, Yanow and Schwartz-Shea make an interesting point about the scope of IRB review: on the one hand, it can be under inclusive, failing to cover serious ethical questions. On the other hand, mission creep continues apace, as universities impose restrictions not dictated by ethics or law.

[Dvora Yanow and Peregrine Schwartz-Shea, “Encountering Your IRB 2.0: What Political Scientists Need to Know,” PS: Political Science & Politics 49, no. 02 (April 2016): 277–86, doi:10.1017/S1049096516000202.]

Friday, April 29, 2016

Political Scientists Consider "Local Control and Realities" and IRB Oversight

The April issue of PS: Political Science & Politics features several items about political science and IRBs. Here’s a list; commentary will follow if I find the time.

University Research and Journalism: Distinctions Without Differences

Google Scholar belatedly alerts me a 2014 article in which two philosophers of education seek to distinguish investigative journalism from university-sponsored community research. They suggest it makes sense to require IRB oversight of the latter but not the former, but their arguments rest on factually doubtful claims of uncertain relevance, and they fail to show that IRB oversight makes sense for either type of research.

[Anne Newman and Ronald David Glass, “Comparing Ethical and Epistemic Standards for Investigative Journalists and Equity-Oriented Collaborative Community-Based Researchers: Why Working for a University Matters,” Journal of Higher Education 85, no. 3 (2014): 283–311, doi:10.1353/jhe.2014.0013.]

Thursday, April 28, 2016

U of Maryland Scapegoats IRB and Researcher for PR Foul Up

The University of Maryland has released a report on the problematic December 2015 press release, which included unsubstantiated claims about the benefits of a sports drink based on chocolate milk. While the press release was indeed a disaster, the university report fails to hold to account the people most responsible. Instead, it makes matters worse by accusing the researcher and the IRB of transgressions they did not commit, and by recommending drastic changes that are unnecessary and burdensome.

Sunday, April 17, 2016

The Cost of Ethical Review, Part III: Hindering HIV Prevention

Risk-averse IRBs are hindering potentially life-saving research, write Brian Mustanski and Celia Fisher. “Critical advances in HIV prevention among AMSM [adolescent men who have sex with men],” they note, “have been impeded by the failure of IRBs to apply federal regulations permitting adolescents to self-consent to research without parental involvement.”

[Mustanski, B., & Fisher, C. B. (2016). HIV Rates Are Increasing in Gay/Bisexual Teens: IRB Barriers to Research Must Be Resolved to Bend the Curve. American Journal of Preventive Medicine, In Press. doi:10.1016/j.amepre.2016.02.026.]

Monday, April 11, 2016

Wynn Calls for Department-Level Review of Student Research

L. L. Wynn, an anthropologist at Macquarie University and a member of that university’s Human Research Ethics Committee, spoke to 40 teachers and administrators at 14 Australian universities. She finds that “opportunities for independent undergraduate human research are being eroded by expanding ethics bureaucracies” and that “the ethics review process [is] a significant obstacle to universities and teachers who wish to incorporate original human research into the curriculum.” (7) She calls for the devolution of ethics review to individual departments.

[L. L. Wynn, “The Impact of Ethics Review on a Research-Led University Curriculum Results of a Qualitative Study in Australia,” Journal of Empirical Research on Human Research Ethics, Published online before print, March 16, 2016, doi:10.1177/1556264616636234.]

Thursday, April 7, 2016

Oral Historians as Ethical Proofreaders

Kevin Bradley and Anisa Puri of the Australian Generations Oral History Project explain that the ethical challenges they faced came after they had conducted the interviews.

[Kevin Bradley and Anisa Puri, “Creating an Oral History Archive: Digital Opportunities and Ethical Issues,” Australian Historical Studies 47, no. 1 (2016): 75–91, doi:10.1080/1031461X.2015.1122072.]

Thursday, March 31, 2016

IRB Manager Laments “Unhappy Marriage” with Ethnography

Writing for Contexts, Abigail Cameron, an IRB manager for the Texas State Department of Health Services, laments that “IRBs and ethnographers often ‘talk past each other’ resulting in confusion, delays, and frustration—i.e., a very unhappy marriage.” She rightly blames faulty federal regulations as the prime cause of this unhappiness, yet she downplays IRB misbehavior as a contributing factor.

[Abigail E. Cameron, “The Unhappy Marriage of IRBs and Ethnography,” Contexts, accessed March 24, 2016, h/t Rob Townsend.]

Monday, March 21, 2016

First, Do Some Harm, Part IV: Fake Submission to Fake Conference Yields Fake Charge of Misconduct

Professor Jim Vander Putten, who spent six years as chair of the University of Arkansas Little Rock (UALR) IRB, is now charged with violating university rules by conducting research without that board’s approval. The case highlights several problems with the current system, most notably its failure to provide standards for studies designed to expose misbehavior.

[Peter Schmidt, “A Scholar’s Sting of Education Conferences Stirs a Hornet’s Nest,” Chronicle of Higher Education, March 14, 2016, paywalled.]

Saturday, March 19, 2016

New Book: The Ethics Rupture

The University of Toronto Press has published The Ethics Rupture: Exploring Alternatives to Formal Research-Ethics Review, edited by Will C. van den Hoonaard and Ann Hamilton. My chapter is entitled, “Ethical Pluralism: Scholarly Societies and the Regulation of Research Ethics.”

Monday, February 8, 2016

Fifty Years of IRBs

As has been widely not reported, today marks the fiftieth anniversary the issuance of U.S. Public Health Service Policy and Procedure Order (PPO) #129, which mandated that each recipient of a PHS grant involving human beings secure prior review by “a committee of his institutional associates.” From this document flowed all subsequent IRB policies, in the United States and in several other countries.

To honor the occasion, I have posted a PDF of the order on my page of IRB documents.

(Not really. A correspondent was looking for a copy, and I posted it for her.)

Thursday, January 21, 2016

Advice on Scholarly Blogging

Alice Dreger is soliciting advice “for a young scholar thinking of starting a blog.” My wife and I have each maintained blogs for several years, and here’s what we’ve come up with.

Sunday, January 17, 2016

Political Scientists Complain about Lost Exemption

Political scientists and law professors are protesting the proposed elimination of the current exemption for research about public officials and candidates for office. The drafters may have eliminated the exemption by mistake, thinking that such research was exempted by other provisions of the proposed rule, which turns out not to be the case.

Friday, January 1, 2016

My NPRM Comments

Perhaps 2016 will be the year when OHRP makes good on its 2007 promise to “give more guidance on how to make the decision on what is research and what is not,” in the form of a promulgated revision to the Common Rule. If so, Happy New Year, OHRP!

Wth these hopes, I have submitted my own comments on the NPRM. I have posted a copy of the PDF I submitted, and below is a web version with links.