Ethical, legal, social, and policy issues in the use of genomic technology by the U.S. military.

Author:Mehlman, Maxwell J.
Position::IV. Research Issues A. Intramural Clinical Research 5. Follow-up with Subjects through X. Acknowledgments, with footnotes, p. 140-165 - Frederick K. Cox International Law Center Symposium: International Regulation of Emerging Military Technologies
 
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  1. Follow-Up with Subjects

    Another research controversy concerns whether researchers have a duty to contact subjects after a study is over to ascertain whether they are suffering any long-term or latent adverse effects, and to alert them to new information bearing on their health, such as the discovery of genomic risks that were not known at the time of the study or the availability of new treatments or preventive measures. The military has been criticized, for example, for not adequately following up with subjects in the "man-break" experiments on mustard gas during World War II. (94) Civilian researchers object that they should not have a long-term obligation to follow up with subjects because of the difficulties of keeping track of their whereabouts, but military researchers should be better able to keep track of military subjects, who may still be in the military or receiving care from the VA. In addition, the Army maintains a Volunteer Registry for all subjects in more-than-minimal-risk studies, one of the purposes of which is to enable the military to "exercise its obligation to ensure research volunteers are adequately warned of new risks and to provide new information as it becomes available," (95) and the US Army Medical Research and Materiel Command (USAMRMC) stores the information for a minimum of 75 years. In sum, the military should endeavor to contact subjects about future developments of significance to their health.

  2. Paying for Participation in Research

    Bioethicists are concerned that offering people substantial amounts of money or other items of economic value in return for serving as research subjects could compromise the voluntariness of informed consent, (96) but this is less of a concern in the military because DoD rules forbid paying research subjects on active duty except for drawing a blood sample, for which they may receive $50.97 (Off-duty personnel may receive compensation comparable to civilian subjects, (98) which under Health and Human Services (HHS) rules must be approved by an IRB and be a reasonable amount in accordance with prevailing local rates. (99)) Military IRBs must be on guard however against offering troops non-monetary benefits for enrolling in research studies, such as desirable assignments or commendations. DoD rules prohibit superiors "from influencing the decisions of their subordinates ... regarding participation as subjects", (100) but the rules could be more specific by defining what counts as "influence". Moreover, the prohibition against paying military subjects emphasizes the need to protect them from being exploited by being pressured to participate in disproportionately risky research.

    Another financial issue that arises in civilian biomedical research is whether subjects are entitled to a portion of the financial benefits that accrue to sponsors of studies that lead to the commercialization of a lucrative new medical product. Although withholding compensation has been criticized as unfair, there is a general consensus that sponsors can avoid compensating subjects if they disclose their policy to subjects during the informed consent process. (101) The argument for rewarding military subjects is weakened by their obligation to serve the national interest, but the issue is complicated by the fact that a substantial amount of the fruits of military research often redounds to the benefit of private enterprises that commercialize the resulting discoveries, including prostheses (102) and thermal imaging devices. (103) A solution might be for DoD to ensure that genomic discoveries with important medical value derived from research on military subjects were available to current and former members of the military through military medical services and the VA.

  3. Compensating Subjects for Experimental Injury

    The Common Rule governing human subjects research does not require researchers to compensate civilian subjects for injuries sustained as a result of their participation, (104) but subjects who have been injured by negligent investigators may recover monetary damages in a tort action. For example, the father of an 18-year-old subject who died in a University of Pennsylvania experiment aimed at developing a gene therapy for a genetic disease called ornithine transcarbamylase sued the investigators for negligently enrolling his son without proper safety testing. (The case was eventually settled for an undisclosed sum. (105)) No such remedy is available to military subjects, however, as a result of the so-called Feres doctrine. (106) DoD rules require researchers "to establish procedures to protect human subjects from medical expenses (not otherwise reimbursed)" that directly result from participation in more-than-minimal-risk military research, whereas civilian subjects may receive compensation for losses such as pain and suffering and reduced future earnings. (107)

    The application of the Feres doctrine in military research has been criticized. (108) It also runs counter to the principle of paternalism insofar as it shields the military from having to fully redress superiors" mistakes. But Congress has not seen fit to modify the doctrine to permit injured subjects to receive compensation, the courts have consistently given the doctrine a broad interpretation on the premise that immunity from suit is essential to maintain military discipline, and even some of the critics only want soldiers to be able to sue for intentional rather than merely negligent research misconduct. (109)

  4. Privacy and Confidentiality

    Protecting the privacy and the confidentiality of subjects" personal health information has long been a priority in civilian research, and its importance has been reinforced by the adoption of the privacy and security provisions of the Health Insurance Portability and Accountability Act (HIPAA) and its accompanying regulations. One of the requirements of informed consent under the Common Rule, for example, is giving potential subjects "a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained," (110) and the government recently has proposed strengthening data security and information protection requirements for federally sponsored research. (111) In addition, the GINA specifies that genetic information is protected under HIPAA. (112)

    As noted earlier, DoD has adopted the Common Rule/It also has subjected itself to HIPAA. (113) However, the privacy and confidentiality of members of the military is subordinate to military necessity. Michael Gross observes, for example, that "among one's own soldiers, the scope of the private sphere decreases and that of the public expands as collective welfare takes precedence over an individual's private good." (114) DoD rules accordingly permit commanders to obtain health information "to assure the proper execution of the military. mission", (115) and while service members have the right to an accounting of disclosures, there is no such right for disclosures for national security or intelligence purposes. (116)

    One of the chief reasons for protecting privacy and confidentiality in regard to genomic information is to prevent stigma and discrimination. The legal protections against workplace discrimination for civilian federal employees in the Rehabilitation Act of 1973 and GINA do not apply to uniformed members of the military. (117) Once warfighters leave the military, however, they come under GINA's protections against employment discrimination on the basis of genomic information. Furthermore, DoD policies implementing the National Defense Authorization Act of 2008 changed a previous policy that had denied health and disability benefits to service members who experienced injuries or illnesses during their time of service if the condition was "congenital or hereditary." (118) Now, service members are entitled to compensation and benefits so long as they do not have a disability that was noted at the time of enlistment, unless there is "compelling evidence or medical judgment" that the disability existed prior to enlistment. (119) However, United States Army Special Operations Command (USASOC) found that the two strongest fears among service members with respect to behavioral health treatment, including PTSD, were confidentiality, fear of being labeled, and negative impact on career. (120) As shown in Part I.B., the most recent research has shown a genetic contribution to PTSD and some scholars have raised concerns regarding "the display of pertinent genetic information ... may also generate stigma and affect individual career outcomes." (121)

    How should the status of subjects as members of the military affect the privacy and confidentiality of identifiable genomic information obtained in the course of military human subjects research? One approach might be that, given the reduced privacy and confidentiality within the military, the military should be able to use identifiable genomic information obtained in the course of conducting human subjects research on military subjects without the subjects" informed consent, so long as the information is used for a legitimate military purpose. But this approach conflicts with the spirit of the military's policy of requiring military subjects to give their informed consent to serve as research subjects. Another approach would be for IRBs to give the potential loss of privacy and confidentiality less weight when balancing risks and benefits in research on military subjects than in research on civilians. But the federal government is contemplating removing privacy and confidentiality concerns altogether as matters for IRB review and instead imposing mandatory data security rules on all human subjects research. (122) The best approach therefore is to rely on the principles of proportionality and paternalism described earlier and place the responsibility on commanders, including those overseeing research programs and...

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