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Human Subjects of Research (the "Common Rule")

The Common Rule, which governs research with human subjects conducted or supported by 15 federal departments and agencies including EPA, establishes a comprehensive framework for the review and conduct of proposed human research to ensure that it will be performed ethically. EPA's codification of the Common Rule is at 40 CFR part 26 . The central requirements of the Common Rule are:
  1. That people who participate as subjects in covered research are selected equitably and give their fully informed, fully voluntary written consent; and
  2. That proposed research be reviewed by an independent oversight group referred to as an Institutional Review Board (IRB), and approved only if risks to subjects have been minimized and are reasonable in relation to anticipated benefits, if any, to the subjects, and the importance of the knowledge that may reasonably be expected to result.

The Department of Health and Human Services (HHS) has historically taken the lead in the development of U.S. regulations for the protection of human research subjects, and has promulgated the Common Rule as Subpart A of their regulations in 45 CFR part 46. HHS has also promulgated regulations providing additional protections to research subjects drawn from certain vulnerable populations. These are codified as Subparts B, C, and D in the HHS rules.

Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research

This subpart requires IRBs to apply additional criteria to proposals for research with pregnant women, fetuses, or certain newborns, to ensure that risks have been minimized and that any such research provides benefits to the subjects that outweigh the risks.

EPA has long followed these procedures in research it conducts or supports; we're proposing now to adopt appropriate provisions of subpart B formally.

Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects

This subpart requires that a majority of the members of IRBs reviewing proposed research with prisoners must not be associated in any way with the prison, and must include at least one member who is a prisoner or prisoner representative. It prohibits research with prisoners except when it directly investigates criminal behavior or prisons, or directly benefits the subject prisoners. It sets additional requirements for the informed consent process to ensure that subject selection and consent is free from any duress or undue influence.

EPA has not proposed to adopt subpart C at this time. An HHS advisory committee is reviewing it now, and is expected to recommend significant changes. Since EPA neither conducts nor supports research with prisoners, and has not received any third-party research with prisoners for many years, the Agency has decided to defer a decision until the possible HHS revisions are settled.

Subpart D: Additional Protections for Children Involved as Subjects in Research

This subpart spells out how informed consent should be carried out when children are research subjects, and generally requires both parental (or guardian) permission and assent by the child. It also provides that research involving greater than minimal risk to the subjects can be approved by IRBs only when justified by direct benefits to the subjects.

EPA has long followed these procedures in research it conducts or supports; we're proposing now to adopt appropriate provisions of subpart D formally.

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