New Information and Important Changes

Conflict of Interest

Visitors to this site should review recent updates and information relating to conflict of interest as it relates to human subject research activities. See Items for Consideration to determine how this information might relate to the work you are conducting.

Recent News

Pacific Northwest National Laboratory (PNNL) Achieves First Accreditation of DOE and Battelle Human Subject Research Protection Programs

PNNL is the first Department of Energy Laboratory and Battelle Human Research Protection Program to complete a multiyear-long effort to successfully obtain accreditation by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP), a nonprofit organization headquartered in Washington, D.C. For additional information, see the AAHRPP website.

An influential federal panel recommends that the government loosen regulations that severely limit the testing of pharmaceuticals on prisoners, a practice that was all but stopped three decades ago after revelations of abuse. Read the New York Times article.

Office for Human Research Protections

The Office for Human Research Protections would like to make subscribers to its listserv aware that the Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) is seeking public input on a draft report, Policy Issues Associated with Undertaking a Large U.S. Population Cohort Project on Genes, Environment, and Disease.

The draft report raises some important issues related to the protection of human subjects in research. The draft report is available electronically.

In a 2004 priority-setting process, SACGHS determined that opportunities and challenges associated with conducting large population cohort studies aimed at understanding the relationships of genes, the environment, and common, complex diseases warranted in-depth study. The Director of the National Institutes of Health (NIH), Elias A. Zerhouni, specifically requested SACGHS's advice on the scientific, public, and ethical processes and pathways that might help NIH or HHS make decisions about undertaking such an effort. Dr. Zerhouni specified that the Committee could be most helpful to the Secretary by conducting an inquiry that includes the following steps:

Step 1: Delineate the questions that need to be addressed in order for policymakers to determine whether the U.S. Government should undertake, in any form, a large population project to elucidate the influence of genetic variation and environmental factors on common, complex disease.
Step 2: Explore the ways in which, or processes by which, the questions that are identified in Step 1 can be addressed, including the need for any intermediate research studies, pilot projects, or policy analysis efforts.
Step 3: Taking into account the possible ways in which the questions could be addressed, determine which approaches are optimal and feasible and recommends a specific course of action for moving forward.

SACGHS's draft report focuses on preliminary and intermediate questions, steps, and strategies in five areas that should be addressed before an informed decision can be made about whether the United States should undertake a large population cohort project on the interaction of genes, environment and disease. These five areas are research policy, research logistics, regulatory and ethical issues, public health implications of research results, and social implications of research results. The report also identifies options for how these issues might be addressed.

Comments on any aspect of the draft report are welcome. In particular, the Committee would appreciate the public's assessment of whether:

The policy issues identified in the draft report are appropriately focused;
Any policy issues have been overlooked; and,
The issues are organized in appropriate categories and addressed in such a way as to give policymakers sufficient understanding of why the issue is important. In addition, the Committee would value feedback on the sections of the draft report that discuss the importance of public engagement and the mechanisms that could be employed to achieve such engagement.

Please address comments to Reed V. Tuckson, M.D., SACGHS Chair, and send them to Ms. Amita Mehrotra at mehrotraa@od.nih.gov.

Comments may also be sent by fax to 301-496-9839 or by mail to:

Secretary's Advisory Committee on Genetics, Health, and Society
ATTENTION: Ms. Amita Mehrotra
NIH Office of Biotechnology Activities
6705 Rockledge Drive, Suite 750
Bethesda, MD 20892 (20817 for non-US Postal Service mail)

In order to be considered in the development of the final report, comments should be submitted by close of business Monday, July 31, 2006.

EPA Significantly Strengthens and Expands Protections for Human Studies Research—Pesticides Exposure to Pregnant Women and Children

Under new rules announced on January 26, 2006, all third-party intentional dosing research on pesticides involving children and pregnant women intended for submission to EPA is banned, and EPA will neither conduct nor support any intentional dosing studies that involve children or pregnant women for all substances EPA regulates. EPA also extends the ethical protections in the Federal Policy for the Protection of Human Subjects of Research (the Common Rule) to other human research involving intentional exposure of nonpregnant adults and has established an independent Human Studies Review Board to obtain expert peer review of both proposals for new research and completed third-party intentional dosing.

The Tuskegee Syphilis Study

This day (May 16) in history — In 1997 President Bill Clinton apologized on behalf of the United States of America, for the Tuskegee syphilis study, carried out by Tuskegee Institute, the African-American university founded by Booker T. Washington.

In the notorious human experiment, the Tuskegee Syphilis Study (1932 - 1972), 400 poor, mostly illiterate black sharecroppers from Tuskegee, Alabama became part of a study on the treatment of syphilis without their full knowledge, and were allowed to suffer and even die from the disease when treatment could have been given them.

The study was originally started as a study on the effectiveness of contemporary treatments (including Salvarsan, mercurial ointments and bismuth) which were considered harmful and ineffective, and an attempt to show that nontreatment was less harmful. By 1947, penicillin had been recognized as a safe and effective treatment for syphilis, yet the remaining members of the Tuskegee group of patients were allowed to sicken and die for another twenty-five years, and some were even actively blocked from effective treatments to allow scientists to study syphilis damage post mortem to better understand how the disease spreads and kills. (Text from Wikipedia whose content is available under GNU General Public Licence.)

The Tuskegee Syphilis Study was terminated in 1972, when it was exposed in the press.

CDC Tuskegee Syphilis Study Page
University of Virginia: Bad Blood: The Tuskegee Syphilis Study
Internet Resources on the Tuskegee Study

"To persuade the community to support the experiment, one of the original doctors admitted it 'was necessary to carry on this study under the guise of a demonstration and provide treatment.' At first, the men were prescribed the syphilis remedies of the day — bismuth, neoarsphenamine, and mercury — but in such small amounts that only 3 percent showed any improvement."

"These token doses of medicine were good public relations and did not interfere with the true aims of the study. Eventually, all syphilis treatment was replaced with 'pink medicine' — aspirin."