On January 19, the U.S. Department of Health and Human Services (HHS) and 15 other government agencies published a final rule updating regulations governing the protection of human research subjects, which is commonly referred to as the “Common Rule.” As described in our September 4 post, these revisions are intended to enhance the current system of oversight for research involving human subjects by modernizing the rules and improving efficiency. Significant changes to the Common Rule are highlighted below.

Establishes New Exempt Categories of Research

The final rule establishes new categories of research exempt from compliance with the Common Rule. One of the new exempt categories of research includes research involving benign behavioral interventions in conjunction with the collection of verbal, written, or audiovisual information from an adult subject. This exemption is applicable if the subject agrees to the intervention and at least one of three specified criteria are met. The final rule also establishes an exemption for secondary research use of identifiable private information or identifiable biospecimens and an exemption for the storage and maintenance of identifiable private information or identifiable biospecimens for secondary research use. Like the previous exemptions to the Common Role, an exemption applies only if an activity fits the description of an exempt category and does not include nonexempt research activities.

Permits Broad Consent Option for Secondary Research

The final rule permits investigators to obtain broad consent to use identifiable private information or identifiable biospecimens for secondary research use. Unlike informed consent where a research subject consents to specific research being conducted by an investigator, broad consent allows research subjects to prospectively consent to unspecified future research using the subjects’ identifiable private information or identifiable biospecimens. The agencies clarified in the final rule that the broad consent option for secondary research does not prohibit investigators from using pre-2018 alternatives for conducting such research by obtaining an IRB waiver or obtaining study-specific consent.

Revises General and Documentation Requirements for Informed Consents

Informed consents must now begin with a concise and focused presentation of key information most likely to assist prospective subjects (or their legal representatives) with understanding the reasons for choosing whether to participate in the research. The agencies expect such information to be relatively short and no more than a few pages for more complex clinical trials. The final rule also requires an informed consent to contain a statement regarding the investigator’s plans to de-identify collected private information or biospecimens for secondary research use. To comply with this new requirement, an informed consent must either inform research subjects that identifiers might be removed from the data and used for future research studies or distributed to another investigator for future research studies without additional informed consent or that data collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

Requires Single IRB for Cooperative Research

The final rule requires institutions based in the United States that are working on research conducted in the United States and involving more than one institution, otherwise known as “cooperative research,” to use a single IRB for that specific portion of the research. Before the final rule, single IRB review of cooperative research was voluntary and most institutions were reluctant to have IRB review from another institution. The agencies clarified that the goal behind this requirement was to minimize the delays, administrative burdens, and costs involved with having multiple IRBs for a single research project, often leading to no additional benefits for the well-being of the research subjects.

The federal agency conducting or supporting the cooperative research will identify the reviewing IRB or the IRB of record. While lead institutions involved with the cooperative research have the ability to propose the reviewing IRB, the final IRB acceptance decision is given to the federal agency or department.

Institutions may still conduct their own internal IRB reviews; however, these reviews would not have any regulatory or compliance status under the Common Rule. Further, the rule provides for exceptions to the single IRB review requirement in the following instances:

  1. If an official governing tribal body passes a tribal law that requires multiple IRB review for cooperative research,
  2. Multiple IRB review is required by law, or
  3. A federal department or agency that is supporting or conducting the research determines that the use of a multiple IRB review is necessary.

This requirement has an effective date of January 19, 2020. The requirement has received backlash from industry groups who believe that single IRB review should be voluntary and that it is the right of the institution to determine what type of IRB review is best for its studies and patients.

Removes Continuing Review Requirement for Ongoing Research

The final rule removes the continuing review requirement for all studies that have completed expedited review, unless the reviewer provides reasons as to why continuing review would increase the protection of research subjects. Further, continuing review is also not required for research that is reviewed under the limited IRB review procedure. Also, studies that were initially reviewed by a convened IRB, unless later mandated by the IRB, are not subject to continuing review after the study reaches the point where only one or both of the following is occurring:

  1. Analysis of data, including identifiable private information or identifiable biospecimens, or
  2. Access to follow-up clinical data from procedures that subjects would complete as part of standard clinical care for their disease or condition.

Moreover, the final rule does not require annual IRB confirmations from investigators that involve information such as the ongoing status of the research and stating that no changes have been made that would require continuing review by the IRB. Investigators would still be subject to current obligations to provide information to the IRB when certain developments occur, such as proposed changes to the study.

Changes Expedited Review Procedures

The final rule establishes that a study will be deemed minimal risk, and therefore appropriate for expedited review, if the study involves only activities on a list prepared by the Secretary of HHS of expedited review activities.[1] This is true except for instances where a reviewer finds and documents that the study involves greater than minimal risk. The goal of this change in the final rule is to reduce burdens on the IRB by ensuring that studies with no more than minimal risk will undergo expedited review instead of full review processes.

The Secretary’s list of expedited review categories will be evaluated every 8 years and will subsequently be published in the Federal Register and subject to public comment.

Effective Dates and Industry Impact

The final rule was published in the Federal Register on January 19, 2017 and will become effective on January 19, 2018. As noted above, the single IRB requirement for cooperative research has an effective date of January 19, 2020. Research initially approved by an IRB, waived, or determined to be exempt before January 19, 2018 is subject to the pre-2018 rule but institutions may elect on a study-by-study basis to be subject to the final rule. Any research initially approved by an IRB, waived, or determined to be exempt on or after January 19, 2018 is subject to the final rule.

The final rule will require industry that is involved in human subject research to conduct an extensive review and modification of their research policies and procedures in order to ensure compliance by January 19, 2018.

[1] U.S. Department of Health and Human Services, Office for Human Research Protections Expedited Review Categories (Mar. 2016), available at https://www.hhs.gov/ohrp/regulations-and-policy/guidance/categories-of-research-expedited-review-procedure-1998/index.html.