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| The '''Common Rule''', established by '''The Federal Policy for the Protection of Human Subjects''' in 1991, is a set of rules and guidelines for human subject research (biomedical or behavioral). | The '''Common Rule''', established by '''The Federal Policy for the Protection of Human Subjects''' in 1991, is a set of rules and guidelines for [[UnitedStates/EthicsLaw/HumanSubjectResearch|human subject research]] (biomedical or behavioral). |
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| At a high level, the Common Rule is a set of requirements for human subject research. The requirement for [[UnitedStates/EthicsLaw/InstitutionalReviewBoards|IRBs]] (as well as requirements for how IRBs operate) is established. Requirements for informed consent are also outlined. |
At a high level, the Common Rule is a set of requirements for [[UnitedStates/EthicsLaw/HumanSubjectResearch|human subject research]]. The requirement for [[UnitedStates/EthicsLaw/InstitutionalReviewBoards|IRBs]] (as well as requirements for how IRBs operate) is established. Requirements for informed consent are also outlined. |
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| All investigators conducting human subject research that is supported by a department that has implemented the Common Rule, unless it is exempt, must be covered by a '''Federal Assurance''' or establish a contractual '''Investigator Agreement''' with another institution that is covered. | All investigators conducting [[UnitedStates/EthicsLaw/HumanSubjectResearch|human subject research]] that is supported by a department that has implemented the Common Rule, unless it is exempt, must be covered by a '''Federal Assurance''' or establish a contractual '''Investigator Agreement''' with another institution that is covered. |
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| The DoD implementation of the Common Rule is applied to any human subject research for which the department provides e.g. funding, facilities, data, etc. DoD does not waive their Common Rule requirements for departments or agencies already operating under another department's Common Rule implementations, or some other institution's policies.Investigators conducting only exempt human subject research must still have a Human Research Protection Program (HRPP) approved by the DoD. | The DoD implementation of the Common Rule is applied to any [[UnitedStates/EthicsLaw/HumanSubjectResearch|human subject research]] for which the department provides e.g. funding, facilities, data, etc. DoD does not waive their Common Rule requirements for departments or agencies already operating under another department's Common Rule implementations, or some other institution's policies. Investigators conducting only exempt human subject research must still have a Human Research Protection Program (HRPP) approved by the DoD. |
Common Rule
The Common Rule, established by The Federal Policy for the Protection of Human Subjects in 1991, is a set of rules and guidelines for human subject research (biomedical or behavioral).
Definition
At a high level, the Common Rule is a set of requirements for human subject research. The requirement for IRBs (as well as requirements for how IRBs operate) is established. Requirements for informed consent are also outlined.
Subpart B outlines protections for pregnant women and fetuses.
Subpart C outlines protections for prisoners, including subjects who become prisoners during a study.
Subpart D outlines protections for children.
History
The Belmont Report is the ethical basis for regulations encapsulated by the Common Rule.
The U.S. Department of Health, Education, and Welfare (HEW) produced 45 CFR 46.110 ("The Federal Policy for the Protection of Human Subjects") in 1974. The Office for Human Research Protections (OHRP) was established within HEW to oversee the implementation of it. These regulatory laws are collectively known as the Common Rule.
The Common Rule was amended in 1991 and again in 2018.
Applicability
All investigators conducting human subject research that is supported by a department that has implemented the Common Rule, unless it is exempt, must be covered by a Federal Assurance or establish a contractual Investigator Agreement with another institution that is covered.
Implementation
45 CFR 46.110 ("The Federal Policy for the Protection of Human Subjects", 1991) outlines the process and requirements for a Common Rule implementation.
See also expedited review.
Department of Defense
The Department of Defense (DoD) has delegated Common Rule responsibilities to the Under Secretary of Defense for Acquisition, Technology, and Logistics., then to the Assistant Secretary of Defense for Research and Engineering.
The DoD implementation of the Common Rule is applied to any human subject research for which the department provides e.g. funding, facilities, data, etc. DoD does not waive their Common Rule requirements for departments or agencies already operating under another department's Common Rule implementations, or some other institution's policies. Investigators conducting only exempt human subject research must still have a Human Research Protection Program (HRPP) approved by the DoD.
For defense contracts, the contract will contain a Defense Federal Acquisition Regulation Supplement (DFARS) clause. If work is determined to be exempt, a written determination evidencing this should be submitted to the DoD's relevant Human Research Protection Officer (HRPO). Their approval is required. If work is non-exempt, the IRB approval must be submitted to the relevant HRPO for review, especially to ensure that DoD-unique requirements are met.
For recruitment of military or DoD personnel as subjects specifically, there are restrictions on the actions of superior officers. Letters of support cannot contain language that could influence participation. Recruitment cannot occur in official business. Superiors cannot be present at recruitment of their juniors.
Compensation to military or DoD personnel recruited as subjects for research conducted on-duty is restricted to $50.
For purposes of DoD-supported research, all active duty service and reserve members are legal adults. The necessity of recruiting members under 18, academy students, and trainees must still be considered.