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Compliance

Federal Policy for the Protection of Human Subjects (Common Rule)

I. PURPOSE

The Federal Policy for the Protection of Human Subjects (Common Rule) imposes several requirements on institutions engaged in federally funded research “in order to protect the rights of the human subjects of [biomedical and behavioral] research.” These rights generally include the right to consent, the right to not be subjected to undue risk, and the right to fair selection for research participation. The Common Rule also requires applicable institutions to establish an Institutional Review Board (IRB) to ensure that any individual participating as a human research subject is afforded these rights.

II. HISTORY

In 1974, Congress created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which convened and subsequently issued what became known as the Belmont Report. In the report, the Commission established that “respect for persons,” “justice,” and “beneficence” should govern human subjects research. These ethical principles served as the foundation for the Common Rule, which was originally issued by the Department of Health and Human Services (HHS). In January 2017, the Common Rule was amended, providing a revised set of regulations that researchers will be required to follow starting in January 2018 (2018 Regulations). This memo provides an overview of the Common Rule as amended by the 2018 Regulations.

III. APPLICABILITY TO BYU–HAWAII

A. Basic Applicability

The Common Rule applies to institutions that undertake research activities that are funded or regulated by any federal agency that enforces the Common Rule. Generally, BYU–Hawaii does not accept federal research funds and, thus, is not subject to these regulations; however, should the university accept such funding the future, the university would need to comply with the Common Rule. Compliance with these requirements might also be desirable as a best practice.

B. Research Activities

Under the Common Rule, “research” is defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”

Though official guidance on the definition of “generalizable knowledge” is sparse, some universities have offered campus guidance on the matter. For example, Colorado State University (CSU) claims,

"Activities that are disseminated with the intent to influence behavior, practice, theory, future research designs, etc. are contributing to generalizable knowledge. In contrast, internal activities specific to CSU, or work conducted for outside entities which cannot be generalized to any other outside entity (e.g., program or community assessments that provide UNIQUE (non-generalizable) data to a specific business or locale) are NOT ‘research’ by the criterion of generalizable knowledge."

Adding to the official definition of research, the Common Rule identifies certain activities that either (1) do not constitute research or (2) constitute research, but qualify for an exemption to the Common Rule. The following activities do not constitute research:

  1. Journalism and similar scholarly pursuits
  2. Certain government activities, such as criminal investigations, public health monitoring, and national security operations

The following activities constitute research, but qualify for an exemption to the Common Rule:

  1. Secondary research conducted for certain health care or public health reasons;
  2. Harmless educational research regarding teaching strategies and curricula;
  3. Research that uses aptitude tests, ability tests, surveys, interviews, or public observation, provided that the subjects’ identities are not easily identifiable, outside disclosure of the collected information would be harmless, or the IRB carries out a limited review;
  4. Short, harmless “behavioral interventions” involving adults, provided that the research is performed with the subjects’ consent, the subjects’ identities are not easily identifiable, outside disclosure of the collected information would be harmless, or the IRB carries out a limited review;
  5. Research based on public or not-easily-identifiable information that has already been collected;
  6. Federally conducted research based on information that was originally gathered by the government for a purpose other than research, under certain circumstances;
  7. Federally conducted research that studies public programs, under certain circumstances;
  8. Research based on information that has already been collected, so long as researchers previously received the subjects’ broad consent, the research conforms with the terms of the broad consent (according to an IRB), the proposal undergoes a limited review, and the investigators do not return the results to the subjects unless that disclosure is legally necessary;
  9. Taste tests and other food-related quality tests, so long as either (1) the food is wholesome and contains no additives or (2) any ingredients or chemicals are present to a degree allowed by relevant federal agencies.

Thus, any of BYU–Hawaii’s federally funded research activities that either (1) do not constitute research or (2) constitute research, but qualify for an exemption to the Common Rule under one of the previously listed categories, do not need to follow the Common Rule.

IV. REQUIREMENTS

A. Institutional Review Board: Administrative Procedures

1. Federal-wide Assurance

Applicable institutions must maintain a Federal-wide Assurance (FWA), a document to be submitted to the Office for Human Research Protections (OHRP). The 2018 Regulations streamline the information that must be included in this assurance, requiring a fairly simple statement declaring the institution’s intention to follow the federal regulations.

2. IRB Registration

A relevant institution must also register its IRB with HHS. The registration materials must include contact information for the head IRB official of the institution, contact information for the institution, contact information for the IRB, contact information for the IRB chairperson, contact information for the person registering the IRB, and the number of active research proposals under initial or continuing review. If there are any changes with respect to either “the contact person who provided the IRB registration information or the IRB chairperson,” the institution must submit an updated registration within ninety days of the change. Additionally, each registration must be renewed within three years of its last update or renewal.

3. IRB Membership

IRB membership is subject to a number of diversity and background requirements. For example, the board must consist of “at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution.” Further, the Common Rule states that “[t]he IRB shall be sufficiently qualified through . . . the diversity of its members, including race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.”

The Common Rule further requires that there be “at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.” The regulations also require that there be “at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.” Further, the Common Rule establishes that the IRB as a whole (but not necessarily each individual member) must be familiar with the laws, standards, and regulations, as well as the institutional resources and policies, which will affect the IRB’s acceptance or rejection of research proposals.

4. Proposal Review

The IRB must adhere to specific procedures to officially approve the proposal. For example, over half of the board members must be present to review a proposal, and the meeting must include one or more non-scientists. The IRB may then do one of three things: (1) approve the proposal, (2) reject the proposal, or (3) call for amendments to the proposal. A majority vote of the assembled members is required to approve the research proposal.

The IRB must share (in writing) its determination and any required alterations with both the researchers and the institution. The IRB may “suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects.”

5. Expedited and Limited Reviews

The Common Rule provides “an expedited review procedure” for certain research that either (1) presents “minimal risk” or (2) is under active approval and has undergone minor changes. For the expedited procedure, the chairperson may choose to review the proposal or may choose at least one IRB member to review the proposal. If the IRB opts to use the expedited procedure, it must inform everyone on the IRB about proposals accepted through expedited review. The expedited review process may not be used to disapprove a proposal.

The Common Rule also provides various types of limited review procedures, in which a certain type of research activity is partially exempt from the Common Rule, but is still subject to one or more Common Rule requirements. For example, the limited review might allow researchers an exemption from most Common Rule requirements for a certain type of research, provided that the IRB determines that the researchers will enact effective confidentiality procedures. (Limited reviews are also used for proposals in which the Common Rule’s “broad consent” provisions will be followed.) When limited reviews are performed, the IRB may use the expedited review procedures, along with any alterations allowed by the Common Rule for that particular type of limited review.

6. Joint Review

If the research is part of a joint proposal with another institution, the cooperating institutions will be required to use one IRB starting on January 20, 2020. However, during such joint proposals, all institutions involved must maintain appropriate oversight over the research and the human subjects therein.

7. Continuing Review

The IRB must generally review ongoing research at least once annually. However, there are a few types of research for which the IRB does not need to conduct continuing reviews—namely,

  1. research proposals that can be reviewed through an expedited review, such as (1) proposals posing only “minimal risk” and (2) proposals that were partially exempted from the Common Rule through a limited review procedure64
  2. research for which the only current activities are analyzing data or viewing post-study clinical data

8. Mandating Researcher Compliance

The IRB must require researchers to comply with the original proposal unless the IRB officially approves a modification; however, researchers are authorized to make necessary alterations to the research when emergency situations threaten the human subjects.

If research leads to unexpected danger or noncompliance, the IRB may revoke or suspend its approval. If IRB approval is revoked or suspended, the IRB must follow a policy for notifying (1) the researchers, (2) the IRB, (3) the institution, (4) “the department or agency head,” and (5) the Office for Human Research Protections.

9. IRB Records

Either the research institution or its IRB must preserve the following documents :

  1. “[c]opies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent forms, progress reports submitted by investigators, and reports of injuries to subjects”
  2. “[m]inutes of IRB meetings, which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution”
  3. “[r]ecords of continuing review activities, including the rationale for conducting continuing review of research that otherwise would not require continuing review as described in §46.109(f)(1)”
  4. “[c]opies of all correspondence between the IRB and the investigators”
  5. detailed documentation of the IRB’s members
  6. detailed documentation of the IRB’s procedures
  7. “[s]tatements of significant new findings provided to subjects,” which statements must be provided when there are “significant new findings developed during the course of the research that may relate to the subject’s willingness to continue participation”

The institution or its IRB must preserve these documents “for at least 3 years,” and “records relating to research that is conducted shall be retained for at least three years after completion of the research.” Further, “[a]ll records shall be accessible for inspection and copying by authorized representatives of the Federal department or agency [HHS] at reasonable times and in a reasonable manner.”

10. Storing Information for Future Research

The 2018 Regulations also include provisions for storing research information in anticipation of future research. To do this, the researchers would need to (1) gather “broad consent” from the subjects; (2) provide for limited reviews to approve the data storage and determine whether subsequent studies are consistent with the broad consent that was obtained; and (3) refrain from contacting the original research subjects to report the research results, unless required to do so by law.

B. Institutional Review Board: Researcher Requirements

The following policies must be followed by institutional researchers and enforced by the IRB.

1. Informed Consent

Consistent with the first ethical principle identified in the Belmont Report, “respect for persons,” the institution generally must garner informed consent “from each prospective subject or the subject's legally authorized representative.” The informed consent document must “be in language understandable to the subject or the legally authorized representative,” without any language that would be interpreted to waive subject rights or eliminate researcher liability. The 2018 Regulations provide that the informed consent document must also “begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research,” with this information also written in a comprehensible manner.

Further, the researcher “shall seek informed consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence.” When seeking informed consent, researchers must generally gain the signature of the subject or his or her official representative after providing each of the required elements of informed consent. However, there are circumstances in which an IRB may determine that the subject’s signature is not necessary. The requirements for informed consent, along with the available exemptions fro the provision, are listed in Appendix A of this memo.

2. Risk and Benefit Assessment

Beneficence, another ethical principle identified by the Belmont Report, requires researchers to optimize the balance of risks and benefits that the subject may foreseeably experience. The IRB must determine that any “[r]isks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.” Additionally, the proposed research must be based on sound procedures “that do not unnecessarily expose subjects to risk.”

3. General Selection of Subjects

The selection of subjects for research proposals should be set up in accordance with another ethical principle set forth by the Belmont Report: justice. In particular, the IRB must evaluate (and the researchers must address) any issues that might arise when performing research on groups that are especially vulnerable to persuasion.

Beyond the essential protections provided in the Common Rule, there are additional safeguards required for groups that are especially vulnerable to persuasion, such as children, pregnant women, and prisoners. These protections build upon the foundation established above, but impose more regulations regarding risk, consent, etc. These requirements are presented in Appendix B of this memo.

4. International Research

Research that is subject to the Common Rule must generally follow the Common Rule, even if the research takes place internationally. However, a federal administrator can allow researchers to use the research protections established for the studied country if the protections are determined to be “at least equivalent to” U.S. regulations. If the country in question provides research protections or requirements beyond those of the United States, the Common Rule does not negate these requirements.

V. PENALTIES

If a research institution does not comply with the Common Rule, the relevant federal agency may withdraw further funding for human subjects research from the institution.

Additionally, if the IRB finds that any research is out of compliance or unexpectedly dangerous, the IRB can end or suspend the study.

VI. COMPLIANCE CALENDAR

Most of the revised regulations in the Common Rule will go into effect on January 19, 2018. However, studies that were approved or exempted before that date may continue to follow the old requirements under which they were originally approved or exempted, with the option to start following the 2018 Regulations on January 19, 2018. If the researchers at that point decide to follow the 2018 Regulations for an older study, they must officially file that change with the IRB.

The Common Rule also provides that “[e]ach IRB must renew its registration every three years.”

Additionally, the IRB generally must “conduct continuing review of research” one or more times each year (except for research proposals that are exempt as described in section (IV)(A)(7) of this memo, Continuing Review), with the exact frequency depending on the magnitude of risk involved.