Hospital Blocks Access to 18th Century Records

Pennsylvania Hospital has refused a graduate student's request to see 18th century medical records, citing HIPAA concerns.

[Melissa Dribben, Health-record privacy impeding medical research," Philadelphia Inquirer, 13 March 2012. h/t Michelle Meyer.]

SBS White Paper Calls for Drastic Reform

Weighing in at 72 pages, the "Social and Behavioral Science White Paper" is the most detailed response to the ANPRM from scholars in the social sciences. The paper presents a grim picture of the state of IRB review and is generally supportive of the ANPRM's goal of reform. But it offers detailed, helpful warnings about the potential effects of the proposed "excused" category and the adoption of HIPAA as a model for confidentiality requirements. Though it shies away from the toughest questions about the IRB system, it is a good expression of the frustrations felt by so many researchers in the social sciences and humanities.

[American Educational Research Association et al., "Social and Behavioral Science White Paper on Advanced Notice for Proposed Rulemaking (ANPRM), Federal Register 44512-531 (July 26, 2011); ID Docket HHS-OPHS-2011-0005," 26 October 2011.]

Health Researcher Complains of "Social Science Types" and HIPAA

Since I have frequently documented the complaints of social scientists who suffer from inappopriate conditions imposed by medically oriented IRBs, it seems fair to report a story going the other way, related on a Scientific American blog by Judy Stone, MD:

This past summer, I went to India to volunteer at a hospital and to try and help them with their self-identified problem with tuberculosis. There was considerable debate as to whether or not IRB approval was necessary—my infectious disease colleagues felt it was not, as it was part of a public health initiative and the "research" was no different than that conducted every day in public health departments. The social science types at the U.S. university I was working with all insisted we obtain IRB approval, a time-consuming and, in some settings, expensive process. (Many IRBs levy an administrative charge of $1-2,000 per study). And the folks in India could have cared less, nor did they understand the fuss, as there is next to no patient privacy in their crowded facility, nor was it culturally relevant. All they wanted was help caring for their patients.

Stone does not relate what happened next: whether she did, in fact, seek IRB approval, and--if so--what level review she received or what kinds of restrictions she faced.

Ultimately, Stone blames not the social science types but flaws in the regulations and laws, especially HIPAA, which she blames for "failing to provide any protection for clinical research subjects [while] increasing research costs and probably reducing participation . . ." She hopes "that reason will prevail, and the HIPAA rules will be eliminated for clinical research."

AHA Warns of ANPRM's HIPAA Proposals

Rob Townsend of the American Historical Association warns of the ANPRM's idea of subjecting a broad range of data to protections bassed on the provisions of the Health Insurance Portability and Accountability Act (HIPAA). If this proposal is implemented carelessly, historians could find themselves barred from some archival research.

"Could History Become an Information Risk'?," AHA Today, 28 September 2011.

ANPRM: May I Be Excused?

One of the boldest proposals in the ANPRM, and one of enormous importance to social scientists, is the idea of replacing the current category of exempt reseach with a new category of "Excused" research. This proposal could reduce IRB and IRB-office intrusion into a great deal of social research. But, depending on the details, it could instead convert an enormous amount of presently exempt research into research subject to expedited or even full-board review.

Social scientists will need to be very careful as they respond to this proposal.

I See Dead People

A history professor at Central Connecticut State University and one of his graduate students, a retired corporate lawyer, spent months persuading the state Freedom of Information Commission to release medical records from hospitalized Civil War soldiers and veterans.

[Thomas B. Scheffey, "A Legal Skirmish Over Civil War Records," Connecticut Law Tribune, 26 April 2010. Thanks to Josh Gerstein for the reference.]

The case is a reminder that ethics rules can interfere with the scholarly study of not only the living, but also the dead. For an excellent introduction to this issue, see Susan C. Lawrence, "Access Anxiety: HIPAA and Historical Research," Journal of the History of Medicine and Allied Sciences 62 (2007): 422-460.