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Feb2017

On January 28, 2017, PRIM&R hosted PRIM&R’s Primer on the Revised Common Rule, a webinar to introduce the human subjects research community to the changes present in the revised Federal Policy for the Protection of Human Subjects. Published on January 19, the revised policy, or “Common Rule,” represents the first significant regulatory changes in human research oversight since 1991. Presented by P. Pearl O’Rourke, MD, and Heather Pierce, JD, MPH, this webinar provided an overview of the noteworthy changes from the current rule, as well as a discussion of various possible fates of the revised Common Rule under the new presidential administration.

After the webinar, Dr. O’Rourke and Ms. Pierce answered some of the attendee questions that time didn’t permit us to answer live. We’re pleased to share those answers with the readers of Ampersand. For more information and resources about the revised Common Rule, including a quick-reference guide, blog posts, and news coverage, please visit PRIM&R’s Common Rule webpage.

Q: Once continuing review is eliminated for some reason (e.g. for research eligible for expedited review), how should an IRB keep track of that research’s progress?
A:
The elimination of continuing review in circumstances that have long been recognized as low risk to research subjects is a welcome change. However, it does raise new questions for the IRB or research administration office about tracking, following, and closing studies. New processes will likely be needed to help an institution know when to revisit a study, when to mark it as completed or terminated, and how to ensure the IRB knows about important changes to the study. Guidance from the Common Rule agencies or community best practice sharing may be necessary.

Q: The final rule requires posting of informed consent forms for clinical trials. Who is responsible for posting the form, and does the posting have to be updated every time the form is revised?
A:
This posting requirement in the final rule only applies to federally conducted or federally supported clinical trials as defined in the final rule. For federally funded clinical trials, the rule requires that the form be posted by the awardee, typically the institution. Although the relevant website hasn’t been created or identified yet, it appears likely from the preamble of the rule that the Department of Health and Human Services is strongly considering ClinicalTrials.gov as the appropriate place to house the forms. Only one form needs to be posted, and there is no requirement to update the posted form if it is revised, as long as the posted form was actually used to enroll subjects.

Q: What does it mean to say that Subpart D isn’t allowed for certain exemptions?
A:
If Subpart D is not allowed, it means that the exemptions do not apply to subjects who are children. While most of the exemptions apply to children as well as adults, the following exemptions do not apply to subjects who are children:

  • (d)(3) benign behavioral interventions
  • (d)(2) interactions including educational tests, surveys, interviews, etc. if:
    • identifiable information is recorded
    • the investigator participates in the observations being observed

Q: When is broad consent required? When can it be waived?
A:
Broad consent, a key new requirement that was included in the proposed rule, is available as an option and is never required under the final rule. Broad consent is a prospective option that investigators could use to store, maintain, and conduct secondary research with identifiable data or biospecimens. The current available options of (1) deidentifying the data or biospecimens, (2) getting study-specific informed consent, or (3) getting an IRB waiver of the informed consent requirement are all still available. Because broad consent is never required, it does not need to be waived, which is why the waiver instructions don’t apply to the broad consent requirements. Note that if you want to be able to use exemptions 104(d)(7) or (8) for secondary research, you must have previously obtained broad consent that includes all the elements in 116(d). Therefore, these two exemptions “require” broad consent, but if you aren’t trying to use those exemptions, you aren’t required to use broad consent.

Q: Does the single IRB requirement only apply to institutions that are “engaged” in research?  What would our obligation be if there was research taking place on our campus with students or faculty but in which we weren’t engaged?
A:
We believe that the existing guidance on when an institution is “engaged” in research is still applicable. The single IRB requirement alone does not change the current rules with respect to whether activities on your campus need to be reviewed by an IRB. 

Q: What types of studies are required to use a single IRB and who decides which IRB will be the single IRB?
A: The requirement to rely upon a single IRB applies to all research covered under the Common Rule “that involve more than one institution.” This requirement is not limited to clinical trials. The lead institution can propose which IRB will be the single IRB on which the other sites will rely, whether that is a central, commercial, or institutional IRB, and the funding agency will need to agree and accept that proposal. 

Q: Can the single IRB requirement be waived by a federal agency? Can this be proposed or suggested by an institution where the context may be very different due to the nature of the subject pool?
A:
Yes, the final rule allows any Common Rule department or agency to make and document a determination that “the use of a single IRB is not appropriate for the particular context.” Presumably that could include a situation where an institution makes a request to an agency about a particular study, but may also allow an agency to make a more sweeping determination that some types of research or studies with certain characteristics don’t ever have to rely on a single IRB.

Q: Will there still be an option to “check the box” through the federalwide assurance (FWA) process?
A:
No, the preamble to the final rule makes it clear that the assurance process will no longer provide a mechanism for institutions to indicate that they apply the requirements of the Common Rule to all research, even that which is not federally supported and thus not under the Common Rule. Of course, nothing prevents institutions from stating in communications to patients and research subjects that all research conducted at the institution is conducted in accordance with the highest ethical standards and that the strength of protections afforded individuals who participate in research do not vary depending on the source of support for the research.

Q: With the effective and compliance dates a year away, what actions should institutions take now to implement the new rule? Should new research activities follow the requirements of the new rule or the existing rule?
A:
The transition provisions of the final rule clarify which research activities must comply with the new requirements. Research studies (1) approved by an IRB, (2) granted a waiver from IRB review by a department or agency, or (3) determined to be exempt prior to January 19, 2018 are by default covered by the pre-2018 rule for the duration of the study. After January 19, 2018, case by case determinations can be made to apply the final rule, and the IRB must document that change.

Research studies (1) approved by an IRB, (2) granted a waiver from IRB review by a department or agency, or (3) determined to be exempt on or after January 19, 2018 must follow the final rule

Note that the single IRB requirement has a three year implementation period, instead of the one year for all other provisions. 

While it is a good idea to familiarize yourself with the new requirements and understand the impact they will have on your institutions and what policies and processes will need to change to comply with the new requirements, it’s important to remember that the rule was issued in the final days of an outgoing administration, and that the implementation details or date could be affected by this transition. We suggest waiting for at least 60 days into the new administration’s term for further clarity on whether this or any other recently issued regulation will be implemented as published or undergo further revision before taking any implementation actions.

PRIM&R would like to thank Dr. O’Rourke and Ms. Pierce for developing this webinar and for taking the time to answer attendee questions after the webinar.

Individual PRIM&R members may view the webinar in the Knowledge Center. Individual nonmembers can purchase access in the online store. Groups who would like access may complete the order form. For more information and resources about the revised Common Rule, please visit PRIM&R’s Common Rule webpage.

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