|
|||||||
|
|
|
|
|
|
|
|
 |
|
COMMENT BY:
International Society for Environmental Epidemiology
Dear Honorable Lew: I write on behalf of the Councilors of the International Society for Environmental Epidemiology. We represent over 600 practicing epidemiologists employed in government, industry and academia. We are extremely concerned about the proposed A-110 revisions and the impact they are likely to have on the conduct and quality of research on the causes and prevention of disease in Americans. As epidemiologists, we endeavor to study and understand the disease process so that we may propose measures, behaviors and practices that can prevent and reduce the risk of disease among all Americans. To do so, we enlist the assistance of people throughout the US in providing information about details of their lives, activities, behaviors and medical and familial histories. This information is then reviewed, analyzed and used to increase our understanding of the disease process. We are fortunate that people are willing to provide highly personal information to help us understand the risks we all face every day. They do so with the assurance that such information will be kept confidential. This commitment of confidentiality is overseen and enforced by Institutional Review Boards (IRBs) whose responsibility is the protection of human research subjects. We recognize the need to provide public access to research data in a timely manner, but strongly feel the proposed mechanisms are not the way. The proposed modification of A-110 would remove the confidentiality protection of study subjects, and thereby undermine the credibility of research and make such life saving research impossible in the future. As researchers, we must respect and protect the confidentiality of our subjects. In addition, the proposed changes would force scientists to provide data prematurely. Release of preliminary, unverified data that could lead to misconceptions and misinterpretations of the risks for disease. It would be bad public health policy to misinform the American people by either intentional or unintentional misuse of research materials prior to their being properly organized, assessed, peer reviewed and presented to the public. The Councilors of the International Society for Environmental Epidemiology strongly urge you to implement these modifications but to reconsider and reformulate them. We stand willing to assist you in this process. Sincerely.
Daniel Wartenberg, Ph.D. |
|
