FAQs on Common Rule Changes – What to know for the 2018 Final Rule

FAQs on 2019 Common Rule changes

Changes to the Common Rule, the principal rule regulating human subjects research, go into effect on January 21, 2019. A number of Pearl IRB policies and procedures will be updated as a result of changes to the rule. Please note that only studies approved or altered AFTER January 21, 2019 will be governed by the new rule; if necessary, existing studies will need to be amended in order to transition to the new rule. Projects reviewed BEFORE January 21 will be reviewed and approved under current rule.

 

HHS new common rule changes FAQThere will be a number of changes required under the new rule. Highlights include:

  • Consent forms will now require a concise summary of study activities, risks, and benefits presented to research participants in advance of the body of the consent document. The IRB will not require re-consent, except when other significant changes are made. Consent forms will need to be updated at the time of continuing review. Example language may be found on the Pearl IRB consent template documents available to clients.
  • Additional elements of informed consent are required to be included in consent forms – these are included in the Pearl IRB consent template documents available to clients.
  • In requests for waivers to use identifiable data and specimens, the IRB must now find that it would be impracticable to use de-identified data. The waiver request form (new form) may be found on the Pearl IRB website at a later date.
  • Minimal Risk studies reviewed via the expedited procedure after the new rule goes into effect will no longer require annual continuing review under the new rule, but will require that an annual update be submitted to the IRB. Remember that the requirement to submit amendments and reportable safety events to the IRB has not changed. An updated annual update form will be added to the Pearl IRB website at a later date.
  • The Common Rule regulations are separate from FDA regulations. FDA regulations have NOT changed, so FDA still requires annual continuing review for FDA-regulated studies, even uncommon Minimal Risk FDA-regulated studies.

 

How will the Common Rule changes affect NEW submissions to the IRB?

After January 21, 2019, new protocol submissions to Pearl IRB will be required to contain updated consent language that can be found on the IRB website. If a study is approved prior to the January 21, 2019 effective date of the new rule, it will remain on the old rule until its next Continuing Review. At that point, it will transition to the new rule. If a study is approved on or after January 21, 2019, it will automatically be governed by the new rule. Some studies under the new rule may no longer require annual review.

 

How will the changes to the Common Rule affect my studies? 

 Existing Full Board Protocols

  • Protocols that were reviewed by a full board and are open to enrollment or still in an intervention phase will see the fewest changes under the new Common Rule. At the time of the next renewal or significant amendment affecting the informed consent form that occurs after January 21, 2019, you will be requested to update the study documents to meet the new requirements.

Existing Expedited Protocols

  • Most studies that were originally expedited by the IRB under the old rule will be eligible for less frequent review, beginning on January 21, 2019. At the time of the next renewal or significant amendment affecting the informed consent form that occurs after January 21, 2019, you will be requested to update consent form to meet the new requirements. Pearl IRB will require an annual abbreviated renewal (update) in order to keep the study active.

Existing Exempt Protocols

  • There will be no changes to these protocols.

Additional requirements for federally funded studies

  • There is an added requirement for posting clinical trial consent forms on a publicly available Federal website. This website has not yet established. For each clinical trial conducted or supported by a Federal department or agency, one (1) IRB-approved informed consent form must be posted to the repository after the trial is closed to recruitment and no later than 60 days after the last study visit by any subject.

What are the largest areas of change? (not an exhaustive list)

1. Certain activities are now deemed to NOT be research, thus requiring no IRB review:

Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).

Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.

Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.

Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

Note: Pearl IRB already considered these activities as not meeting the definition of human subjects research. These are now specifically defined as such in the Common Rule changes.

2. New exempt categories:

Exempt categories were added for secondary research on identifiable private information and identifiable biospecimens collected prior to and after the time of IRB review and approval.

Exempt categories 2c, 3c, 7, & 8 will require limited review. If limited review is necessary, you will be prompted to include additional information on the Exemption Determination form.

 3. Continuing review:

Unless Pearl IRB determines otherwise, continuing review will no longer be required for projects under specific expedited category or those that have progressed to data analysis only. Instead, Pearl IRB will implement a short “annual check-in,” primarily to capture data corresponding with IRB metrics and AAHRPP accreditation tracking. Annual update forms will be added to the Pearl IRB website at a later date.

4. Informed consent:

 The informed consent process, for non-exempt studies, must now begin with a concise and focused presentation of the “key information” that is most likely to assist a prospective subject in understanding the reasons why one might or might not want to participate in the research. The informed consent must also be “organized and presented in a way that facilitates comprehension.”

Current thinking on this equates to providing a brief summary paragraph or bulleted listing at the beginning of each consent form. This may introduce redundancies in the consent itself. Information within the opening paragraph is not required to be repeated in the body of the consent form, but no further Federal guidance has been presented.

Added requirements to include one of two statements about collection of private information or identifiable biospecimens for future research (either that identifiers might be removed and the de-identified information or biospecimens used for future research without additional informed consent from the subject; or, that the subject’s information or biospecimens will not be used or distributed for future research studies even if identifiers are removed).

Three (3) new requirements requiring 1) biospecimens, even if identifiers are removed, may be used for commercial profit and whether the subject will share in the profit 2) whether clinically relevant research results will be disclosed to subjects and 3) whether the research project might include whole genome sequencing.

A new option for “broad consent,” that may be used in lieu of informed consent only with respect to the storage, maintenance and use of private information and identifiable biospecimens.  Broad consent is not required for storage and secondary research use of de-identified data or specimens or for uses consistent with the original informed consent. 

5. Clinical trials are now specifically defined:

Clinical trial means “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.”

This new definition means that behavioral research studies (i.e., students lie in an MRI machine that records their brain activity while they do a task) are now considered clinical trials. While these studies have always needed IRB review, they must now follow different standards with regards to funding applications and report results to clinicaltrials.gov, etc. 

Multi-site research:

Beginning January 25, 2018, all NIH-funded multi-site studies involving non-exempt human subjects research were required to utilize a single IRB-of-Record (sIRB) for the review of human subject protections. Pearl IRB is a member of SMART IRB for online reliance agreements. This furthers our efforts to comply with these requirements. The Common Rule gives the research community until 2020 to start relying on one (1) IRB for all of the investigative sites in most multisite, federally funded research.

 

What do I need to do now to prepare for the new Common Rule changes?

 Look for news and announcements from Pearl IRB. Beginning January 21, 2019, new submissions must comply with the new consent requirements. Exemption determination submissions will also change. Contact info@pearlirb.com with any questions or concerns.

 

The Final Rule published in the Federal Register