Document text
Machine-read from the scan, so expect some errors. Lines that couldn’t be read are left out.
Page 1
OFFICE OF THE DIRECTOR OF DEFENSE RESEARCH AND ENGINEERING MEMORANDUM FOR PRINCIPAL DEPUTY, ASSISTANT TO THE SECRETARY OF SUBJECT: Advisory Committee on Human Radiation Experiments Request for Information This memorandum responds to questions posed by Mr. Dan Guttman, Executive Director of the Advisory Committee on Human Radiation Experiments (ACHRE), in a letter dated May 2, 1995 (attached). The questions emanated from the Committee's review of DoD-funded, extramural studies of the acute health and performance effects of high dosage total body irradiation. Question 1. If future opportunities for conducting nontherapeutic research in conjunction with either therapeutic research or innovative therapy arose, would institutional review boards (IRBs) or ethical review in DoD consider the full scope of the subject-patient's experience with the intervention in Response 1. Yes, IRBs would consider the entire spectrum of the subject's status in cases where non-therapeutic research is to be performed in conjunction with therapeutic research. Scientific and ethical evaluations of proposed studies consider the disease state involved, the likelihood of pain, the risks and benefits of the research, the unique demands placed on the subjects and their families by the disease state, the standard care to be provided, any proposed additional therapeutic interventions, and any proposed nontherapeutic manipulations of subjects. Only if the whole project, under the particular conditions associated with the study population, is scientifically meritorious and ethically sound will a protocol be Question 2. Would IRBs or other DoD reviewers consider the (potentially detrimental) effect of Federal funding for the add-on research on patient care decisions, regardless of whether the underlying treatment itself is experimental or standard? Response 2. Yes, both civilian and military IRBs consider any potentially detrimental and potentially beneficial effects of research added to standard therapy. The protection of human
Page 2
subjects, rather than the source of funding for a specific research study, is the focus of IRB reviews. The sources and availability of funds are not considered until after scientific merit and ethical precautions have been satisfied. Question 3 . Do DoD's policy guidelines for IRB review address the question of multiple-purpose research, particularly with respect to the underlying care, directly? Response 3. DoD policy does not directly address the question of multiple-purpose research. However, Service guidelines do not differentiate between therapeutic and nontherapeutic research, with respect to the level of scrutiny to which protocols are subjected. No research protocol may be conducted that does not have an acceptable risks-to-benefits ratio. Furthermore, the Department is constrained by Title 10, U.S. Code Part 980 from the conduct of research that does not benefit the subject, unless the subject personally consents to Environmental and Life Sciences