Contact: Richard D. Ackerman, President, The Pro-Family Law Center, 951-699-8144
TEMECULA, Calif., Sept. 6 /Standard Newswire/ -- The Pro-Family Law Center (PFLC) of Southern California has just discovered that the United States Food & Drug Administration (FDA) is considering new rules that would allow scientists and doctors to conduct "emergency research" on unconscious or other incapacitated patients. According to PFLC President, Richard D. Ackerman, "This is reminiscent of the days of Hitler and Dr. Mengele. The idea that research can be performed on a human being without informed consent is antithetical to the very meaning of human self-determination and dignity."
Such "emergency research" could be conducted without any informed consent from the patient or their designated representative. The proposed regulations known as "Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent for Emergency Research" are set for public hearing on October 11, 2006. According to the FDA, "Under the regulations in 21 CFR 50.24, and the conforming amendments . . . an exception may be requested from the requirement to obtain informed consent from each subject, or the subject's legally authorized representative, prior to enrollment in a clinical investigation. The narrow exception applies to emergency research . . ."
PFLC does not accept the idea that the
Ackerman says, "PFLC considers this newest battle to be one of the most important of our times. If a human being can be experimented on with absolutely no consent, we have lost all sense of human dignity. While our Nation long ago lost much of its respect for preborn children, we attempted to hold on to the principles of informed consent and human dignity for adults. These new regulations would chip away at the little remaining respect that our Nation has for human life. Enforcing the concept of informed consent as against the government is as important as any other human rights battle that has been fought in the past."
PFLC will be issuing an opinion letter to be submitted to President Bush and the FDA and will be organizing a petition drive to stop the FDA from implementing Nazi-like experiments on our citizens.
Those who wish to assist in this fight can make a contribution toward the PFLC petition drive and legal research for the opinion letter. Alternatively, anyone can express their own views on this issue to:
Good Clinical Practice Program (HF-34)
E-mail comments can be forwarded to: http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm?AGENCY=FDA.