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).

Description

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. Importantly, minimal risk for prisoners is defined in comparison to daily life and routine examinations for healthy persons specifically.

Subpart D outlines protections for children. Note that the children are defined by the local age of majority, which is 18 in most states. (19 in AL and NE; 21 in MS.)

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.

There are 8 categories of exemptions:

1. Research conducted in established or commonly accepted educational settings involving normal educational practices
2. Research only involving educational tests, survey procedures, interview procedures, or observation of public behavior if...

   1. information is not personally identifiable

   2. disclosure of the information would not be risky or damaging to the human subjects

   3. information for which "the identity of the human subjects can readily be ascertained" and an IRB conducts a limited review to make that determination

3. Research involving benign behavioral interventions anbd collection or response information if the research does not involve deceiving the subjects and if...
   1. information is not personally identifiable
   2. disclosure of the information would not be risky or damaging to the human subjects
   3. information for which "the identity of the human subjects can readily be ascertained" and an IRB conducts a limited review to make that determination
4. Secondary research not requiring consent, i.e. if...
   1. information is public
   2. information is not personally identifiable and the investigators will not re-contact or re-identify the subjects
   3. research is for health care operations
   4. research is conducted by or for a federal department or agency using government-generated or government-collected information that was collected for non-research activities and personally identifiable is handled appropriately
5. Policy evaluation research conducted by or for a federal department or agency and the relevant federal department or agency publishes a list of all research conducted under this exemption
6. Taste and food quality evaluation and consumer acceptance research

7. Storage or maintenance for secondary research requiring broad consent if an IRB conducts a limited review to make a determination that an exemption is applicable

8. Secondary research requiring broad consent if that broad consent was obtained and documented, and an IRB conducts a limited review to make a determination that an exemption is applicable

Note that 'benign' is separately defined to mean "brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing".

The third category of exemption #2 is not applicable to children as subjects. Exemption #3 is entirely not applicable to children as subjects.

See also expedited review.

Implementation

Federal departments and agencies can adopt the Common Rule and any of the supplemental subparts. They can also introduce further processes and requirements.

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.

Department of Justice

The Department of Justice (DoJ), which importantly includes the Bureau of Prisons, has implemented the pre-2018 Common Rule but has not signed the 2018 amendments.

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