Recommendation 19. Investigators’ plans for disseminating results of research on human biological materials should include, when appropriate, provisions to minimize the potential harms to individuals or associated groups.
The Working Group concurs with this recommendation. In language accompanying Recommendation 19, NBAC highlights the need to consider the risk of violating privacy rights when publishing written descriptions of patients, pedigrees, and other clinical or potentially identifying information about individuals, families, and associated groups. Some of these concerns are addressed in OHRP’s Institutional Review Board Guidebook, Chapter 5 H (Human Genetic Research).
It is difficult to guarantee protection against identification of subjects, especially when publishing about an unusual or rare condition or about people from small groups. Strategies have been developed to reduce that risk, however, especially for presentation of pedigrees in the literature.
While it is difficult to ensure compliance with this recommendation, the Working Group believes that education of investigators regarding best practices can reduce risk to study subjects. It has also been noted that published materials do not always conform with professional editorial standards, such as those established by the International Committee of Medical Journal Editors in 1995.38 Journal editors should therefore be mindful of the role that they can play in minimizing potential harm to individuals and to groups when publishing results. Finally, members of a small geographic or ethnic group or of a family can sometimes help the researcher more effectively mask individual or group identities and thus minimize the risk of disclosure.39
No DHHS action is required.
Recommendation 20. Journals should adopt the policy that the published results of research studies involving human subjects must specify whether the research was conducted in compliance with the requirements of the Common rule. This policy should extend to all human subjects research, including studies that are privately funded or are otherwise exempt from these requirements.
The Working Group concurs with this recommendation, which is directed at journals and editorial boards. A statement indicating investigator compliance with federal human subject protection regulations will serve as a visible reminder to both researchers and journal editors of their ethical obligations with respect to the conduct and publication of research involving human subjects. Consistent editorial policies across all publications with respect to this issue will also serve to increase the likelihood that future studies, regardless of funding source, will be conducted in accord with the standards set forth in the Regulations.
No DHHS action is required.