Although not finalized, the proposed regulations providing special protections for persons institutionalized as mentally disabled give us a model for the proper approach to research involving these potential human subjects. Confined in institutional settings, their freedom and rights may suffer limitations. Because of certain impairments, they may not comprehend sufficient information to give truly informed cornet. Sometimes they may lack the legal competence to cornet of their own participation in research. At the same time, DHHS recognizes the importance of research into the factors that cause mental disability and into effective treatments. Hence, DHHS proposed regulations to permit responsible investigation while providing safeguards for this group of vulnerable potential subjects.

Research involving persons institutionalized as mentally disabled fits into four categories.

1. Research with no greater than minimal risk: If the proposed research involves no greater than minimal risk, then the subject must give informed consent to participate. If the subject lacks this ability, then he or she may participate by assenting or by not objecting to participation, with the subject’s legally authorized representative also giving consent. If the subject objects to participation despite consent by his or her representative and authorization by a court of competent jurisdiction, then permission to include the subject requires that the research procedure hold prospect of direct benefit to the subject or include a monitoring procedure required for the subject’s well-being.

2. Research with greater than minimal risk and prospect of direct benefit: For research that presents risks while providing possible direct benefit or monitoring procedures necessary for the subject’s well-being, the requirements are more stringent.  The potential benefits must justify the risks and do so in as favorable a prospect as alternative approaches. If the subject cannot give informed consent, the researcher must secure consent of the subject ’s representative and any applicable authorization from the appropriate court after certification that the intervention or monitoring procedure is available only n the context of the research. If the subject is a child (under 18 years old), the researcher must obtain parental permission. CRP may direct that a consent auditor witness all consent proceedings to ensure their adequacy.

3. Research with greater than minimal risk and no prospect of direct benefit: Where no prospect of direct benefit accrues to the subject, the research must represent only a minor increase over minimal risk. Equally important, the anticipated knowledge must have vital importance to understanding or ameliorating the type of disorder or condition under study or hold reasonable expectation of benefitting subjects in the future. If the subject lacks the capacity to cornet, then the researcher must receive the subject’s assent and the consent of the subject’s legal representative.  If the subject lacks the capacity to assent, but does not object to the participation, the researcher must obtain consent from the subject’s legal representative and from a court of competent jurisdiction. Child subjects also require parental consent to participate.  Researchers may not involve subjects in this class of research over their objections.  CRP will appoint a consent auditor to ensure the adequacy of all consent proceedings.  CRP may also consider appointing a subject advocate to approve of the participation of individual subjects. 

4. Research presenting an opportunity to understand or alleviate serious problems: If the research is not approvable under one of the preceding categories but offers an opportunity to understand, prevent, or alleviate a serious problem affecting he health or welfare of persons institutionalized as mentally disabled, it must receive both IRB approval and approval of the Secretary of DHHS (upon finalization of these proposed regulations). The Secretary, in consultation with experts and after opportunity for public review, would determine that the research presents the appropriate opportunities; that its conduct will accord with the ethical principles set forth in the Belmont Report; and that the project makes adequate provisions for suitable consent procedures involving, as applicable, the subject, his or her legal representative, parents of children, courts of competent jurisdiction, a consent auditor, and a subject advocate.

In reviewing research involving subjects institutionalized as mentally disabled, CRP must add criteria to those general criteria of approval.  The proposed regulations would require an evaluation of the appropriateness of the research methods to the objectives, of the competence of the investigators, and of the quality of the research facilities. Assuming that applicable studies in nonhuman systems already exist, there must still be good reason to involve institutionalized subjects rather than alternative non institutionalized populations. Researchers must reduce risks of harm or discomfort not only by using wherever possible procedures performed for diagnosis or treatment of the subject. The project must protect the subject’s privacy and maximize the confidentiality of data handling, retention, and dissemination.

CRP must also ascertain that the research will select subject equitably, avoiding especially a disproportionate burden of research participation upon those least able to consent or assent and other unfair inclusions and exclusions.  Professionals responsible for the health care of the subject must determine and certify that approach to potential subjects and participation in the research will not interfere with care of the subject. CRP may also appoint a consent auditor and a subject advocate to ensure that the consent and research procedures give adequate consideration to patient rights, safety, and well-being.

Every propose alternative must give due regard tot the Belmont Report principles of respect for persons, beneficent, and justice in its research procedures and in its approach to securing informed consent for the subjects to participate. So that CRP can evaluate the proposed set of procedures, the researcher should in Form B describe fully the special sensitivities for vulnerabilities of the subject population and the measures designed to protect them.



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