DoD consent clause Terry A. May 27 Oct 1994 20:15 EST
Celia Walker presents an interesting problem for consideration. The clause does not appear to me to be unreasonable, depending upon what the intent actually is. It would appear that the intent is to provide health care to the subject, at no cost to the subject, for problems directly resulting from the protocol. For most drug & device trials sponsored by companies, they will agree to this in various ways. I assume that DOD is not willing to do this. Am I correct on that point? If so, then the organization responsible to conduct the trial would assume responsibility. The actual nature of the protocol is not provided so it is impossible to assess whether or not it is an in-patient trial nor the risk involved. DOD may be assuming that the BAA will result in submissions by medical centers / facilities that could decide to agree to the care at no charge, because they also would presumably be gaining some benefit by providing a new option for health care. I certainly would want the option to edit the consent language to make it clearer to understand - the local IRB has ultimate responsibility and I doubt that an outside agency can mandate specific language. I do not know if or where this requirement is mandated by DOD, but I would first check 32 CFR 219 - Protection of Human Subjects (DOD) (219.116 General requirements for informed consent). The common rule published 06/18/91 did not contain anything like that language. I believe the FAR & DOD implementing regulations are also not different. Therefore, I would guess there is no regulatory basis for the requirement. If there is, I too would be interested in the citation. I would like to hear more about CO's limited liability clause, because I assume that University liability is covered by the state for all sponsored projects, this being no exception. In this situation, we are talking about medical insurance for this project, I assume. Finially, I see no reason why the insurance could not be charged to the project if approved by the agency. A-21 J.21.a - says that "Costs of insurance required or approved, and maintained pursuant to the sponsored agreement, are allowable". I know that professional liability insurance is a problem with DHHS but more in the context of an inclusion in the indirect cost pool. There, it is an allocation problem. Good Luck - Terry A. May, Ph.D. Voice: 602-523-6788 Director of Research Administration FAX: 602-523-1075 Office of Grant & Contract Services INTERNET: xxxxxx@nauvax.ucc.nau.edu 100 Babbitt Admin. Ctr., Box 4130 Northern Arizona University Flagstaff, AZ 86011-4130