IRBs Misunderstand Researchers' Complaints

A study of IRB chairs, members, and staff finds that they understand that researchers regard them as powerful actors, "Yet IRBs may misperceive PI complaints."

[Robert Klitzman, "The Ethics Police?: IRBs’ Views Concerning Their Power," PLoS ONE 6 (2011): e28773. doi:10.1371/journal.pone.0028773. h/t Roberto Veloso]

Moskos Plugs Ethical Imperialism

Peter Moskos gives a a kind mention to Ethical Imperialism on his blog.

Moskos has nicer things to say about flogging than about IRB review.

Talk at NIH

On March 5 I will speak to the Bioethics Interest Group at the National Institutes of Health on the topic "Blunder at Belmont: The 1970s Origins of IRB Mission Creep."

Those familiar with my first book may appreciate the irony of my speaking in the William H. Natcher Building.

VA IRB is "Kafkaesque and Dickensian"

Writing in Bioethics Forum, a team of interview researchers describe the Veterans Administration IRB process as "Kafkaesque and Dickensian."

[Jenny E. Ostergren, Marguerite E. Robinson, Molly J. Dingel, Bradley Partridge, Barbara A. Koenig, "Kafkaesque and Dickensian: The Human Subjects Protection Maze," Bioethics Forum, 9 February 2012.]

Inside Higher Ed Interviews Stark

Laura Stark speaks about her new book, Behind Closed Doors, with Inside Higher Ed.

[Mitch Smith, "Behind Closed Doors," Inside Higher Ed, 8 February 2012.]

Stark explains, "It would seem that fairness is not the only criteria used in IRB evaluations."

"Informed Consent Is 20 Pages of Nothing"

Nature reporter Daniel Cressy writes that

Informing clinical-trial participants of the risks they face is a cornerstone of modern medical research, and it is enshrined as a human right in international codes of ethics. But an influential group of ethicists and medical researchers warned at a meeting in Brussels last week that the process has become a box-ticking exercise focused more on offering legal protection to a trial’s organizer than actually protecting patients.

[Daniel Cressey, "Informed Consent on Trial," Nature 482, 16 (2 February 2012) doi:10.1038/482016a]

Ethicists are particularly alarmed by the steady growth in the length of consent forms.

In many cases “the informed consent is 20 pages of nothing,” says Harry Bleiberg, an oncologist formerly at the Jules Bordet Institute in Brussels who is now a medical consultant for the pharmaceutical industry.

While consent forms have grown longer, it is not clear that they were ever anything other than "a box-ticking exercise focused more on offering legal protection to a trial’s organizer than actually protecting patients." Perhaps Cressey wrote "has become a box-ticking exercise" when he meant "remains a box-ticking exercise."

Biographer Decries IRB Assumptions

Craig Howes, professor of English and director of the Center for Biographical Research at the University of Hawai‘i, Manoa, acknowledges the ethical challenges of biographical writing but seems to doubt that IRB review is the appropriate tool for handling them.

[Craig Howes, "Asking Permission to Write: Human Subject Research," Profession (2011): 98-106, DOI: 10.1632/prof.2011.2011.1.98. h/t Steve Burt.]

Educator: Ethics Requirements Do Not Respect Ethnographic Participants

Kristen H. Perry, assistant professor of elementary literacy at the University of Kentucky College of Education, draws on her experience with refugees to argue that "Existing ethical guidelines may be inappropriate for the research designs qualitative researchers use and the communities they study, in part because they are based on positivistic, biomedical research paradigms."

[Kristen H. Perry, "Ethics,Vulnerability, and Speakers of Other Languages: How University IRBs (Do Not) Speak to Research Involving Refugee Participants," Qualitative Inquiry 17 (2011): 899–912, DOI: 10.1177/1077800411425006]