The Common Rule
Federal Policy for the Protection of Human Subjects is also known as the Common Rule.
Definitions
Research
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. The revised Common Rule adds a provision that identifies four types of activities as not being “research” as defined in the Rule. The following are not considered research:
- Certain scholarly and journalistic activities,
- Certain public health surveillance activities,
- Collection and analysis of information, specimens, or records, by or for a criminal justice agency for certain criminal justice or investigative purposes, and
- Certain authorized operational activities for national security purposes
[Please refer to 45 CFR 46.102(l) of the revised Common Rule for the full description of the excluded categories of activities. Also refer to the January 19, 2017 preamble to the revised Common Rule at 82 FR 7172 for further information regarding which types of activities fall within these four categories, and to the OHRP draft guidance available on the OHRP website.]
Human Subjects
- The regulatory definition of human subject remains substantively unchanged in the revised Common Rule. The definition has not been expanded. However, there have been clarifications to the wording.
- The pre-2018 Common Rule referred to “data” obtained by an investigator through intervention or interaction with the individual, but in the revised Common Rule “data” is replaced with “information or biospecimens” for clarity.
- Language has been added related to “using, studying, or analyzing individuals’ information or biospecimens or generating identifiable private information or identifiable biospecimens” to clarify OHRP’s understanding of the meaning of “obtaining”.
Exemptions
EXEMPT CATEGORY 1: Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
EXEMPT CATEGORY 2: Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
- The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
- Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or
- The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review.
EXEMPT CATEGORY 3: Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
- The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
- Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or
- The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review.
Benign behavioral interventions are 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. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else. If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that they will be unaware of or misled regarding the nature or purposes of the research.
EXEMPT CATEGORY 4: Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
- The identifiable private information or identifiable biospecimens are publicly available;
- Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
- The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or
- The research is conducted by, or on behalf of, a federal department or agency using government-generated or government-collected information obtained for non-research activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with applicable federal privacy standards found in the E-Government Act, Privacy Act, and the Paperwork Reduction Act.
EXEMPT CATEGORY 5: Research and demonstration projects that are conducted or supported by a federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct their search and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs.
Such projects include, but are not limited to, internal studies by federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants.
EXEMPT CATEGORY 6: Taste and food quality evaluation and consumer acceptance studies: if wholesome foods without additives are consumed, or if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the USDA.
EXEMPT CATEGORY 7: Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and determinations as such.
EXEMPT CATEGORY 8: Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use.
Limited IRB Review
- Extent to which identifiable private information can be re-identified.
- Use of information.
- Extent to which the information will be shared or transferred to a third party or otherwise disclosed or released.
- Likely retention period of the information.
- Security controls that are in place to protect the confidentiality and integrity of information.
- Potential risk of harm to individuals should the information be lost, stolen, compromised, or otherwise used in a way contrary to the contours of the research under the exemption.
Continuing Review
Under the revised Common Rule, continuing review is not required for:
- Research that is eligible for expedited review,
- Exempt research conditioned on limited IRB review,
- Research that has completed all interventions and now only includes analyzing data, even if the information or biospecimens are identifiable,
- Research that has completed all interventions and now only includes accessing follow-up clinical data from clinical care procedures.
Importantly, the IRB can override this default and still choose to require continuing review, as long as the IRB documents the decision and the rationale for this decision.
Informed Consent Requirements
- First is introducing the requirement that informed consent must give prospective subjects the information that a reasonable person would want to have in order to make an informed decision about whether to participate. Using this standard, informed consent remains focused on what information a reasonable person would want to have to make an informed choice about participation.
- Second is that the information needs to be presented in sufficient detail and organized and presented in a way that facilitates an understanding of why one might, or might not, want to participate.
- Third is the new requirement that key information about the study must be provided at the beginning. This will likely include information about the purpose, the risks, the benefits, and alternatives, and it will explain to the person how to think about these pieces of information in terms of making a decision. It should be presented in a concise and focused manner.
Key information must include:- A statement that the project is research and participation is voluntary
- A summary of the research including purpose, duration and list of procedures
- Reasonable, foreseeable risks or discomforts
- Reasonable, expected benefits]
- Alternative procedures or course of treatment (if applicable)
New templates can be found on our Forms, Sample and Templates page.
Broad Consent
Broad consent is a new type of informed consent provided under the revised Common Rule pertaining to storage, maintenance, and secondary research with identifiable private information or identifiable biospecimens. Secondary research refers to research use of materials that are collected for either research studies distinct from the current secondary research proposal, or for materials that are collected for non research purposes, such as materials that are left over from routine clinical diagnosis or treatments. Broad consent does not apply to research that collects information or biospecimens from individuals through direct interaction or intervention specifically for the purpose of the research.
Single IRB Review
The single IRB (sIRB) mandate is mix of federal policies and regulations that require certain types of federally-funded studies that involve multiple institutions to use a single IRB to accomplish IRB review and approval for all of the institutions.
