Innovation in Medical Technology: Ethical Issues and Challenges

Appendix C. Description of Department of Health and Human Services Regulations for the Protection of Human Subjects

At Title 45, Code of Federal Regulations, Part 46 (45 CFR Part 46), the U.S. Department of Health and Human Services has codified its regulations for the protection of human subjects. There are four subparts: Subpart A (last revised June 18, 1991) is the Basic DHHS Policy for Protection of Human Research Subjects. Sixteen other federal departments and agencies are also formally bound to identical text by statute, regulation, or executive order. Subpart B (last revised November 3, 1978) identifies Additional DHHS Protections Pertaining to Research, Development, and Related Activities Involving Fetuses, Pregnant Women, and Human in Vitro Fertilization. Subpart B is currently undergoing review in the department. Subpart C (last revised November 16, 1978) identifies Additional DHHS Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects. Subpart D (last revised March 8, 1983) identifies Additional DHHS Protections for Children Involved as Subjects in Research. The local Institutional Review Board (IRB) at the research site is the cornerstone of this system of protection of human subjects. No human subjects research may be initiated, and no ongoing research may continue, in the absence of IRB approval. HHS cannot provide funds for, or conduct, human subjects research unless one or more IRB’s approves the protocol for such studies. An IRB is established at the local level and, by regulation, has a minimum of five people, including at least one scientist, one nonscientist, and one person not otherwise a;liated with that institution. Description of Department of Health and Human Services Regulations for the Protection of Human Subjects appendix c IRB review is a prospective as well as continuing review of research by a group of individuals. In reviewing research, IRB’s must be knowledgeable about the research site; the resources of the institution; the capabilities and reputations of the investigators and sta=; and the prevailing values and ethics of the community and, most important, the likely subject population. In order to approve research, the IRB must determine that all of the following requirements are satisfied: 1. Risks to human subjects are minimized. 2. Risks to human subjects are reasonable in relation to anticipated benefits, if any, to human subjects, and the importance of the knowledge that may reasonably be expected to result. 3. Selection of human subjects is equitable. 4. Informed consent will be sought from each prospective human subject or the human subject’s legally authorized representative, in accordance with, and to the extent required by 45 CFR Part 46. 5. Informed consent will be appropriately documented in accordance with and to the extent required by 45 CFR Part 46. 6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of human subjects. 7. When appropriate, there are adequate, provisions to protect the privacy of human subjects and to maintain the confidentiality of data. In addition, when some or all of the human subjects are likely to be vulnerable to coercion or undue influence, additional safeguards have been included in the study to protect the rights and welfare of these human subjects. Once research is underway, the IRB must conduct continuing review of the research, at intervals appropriate to the degree of risk—in any event, at least once per year. Continuing review is substantive and meaningful. In approving the continuation of ongoing research, an IRB attests to its satisfaction that the research continues to be conducted in accord with all relevant provisions of the regulations. IRB’s also oversee the informed consent process. The regulations specify eight required elements of informed consent: 1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation , a description of the procedures to be followed, and identification of any procedures which are experimental. 128 APPENDIX C 2. A description of any reasonably foreseeable risks or discomforts to the subject. 3. A description of any benefits to the subject or to others which may reasonably be expected from the research. 4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. 5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. 6. For research involving more than minimal risk, an explanation as to whether any compensation and an...