Updates to the Common Rule, the principal rule which regulates human subjects research, are scheduled to go into effect this month on January 21, 2019 (after several delays). Studies approved or altered after January 21 will be governed by the new rule. If necessary, existing studies will need to be amended in ordfer to transition to the new rule. Research reviewed before January 21 will be reviewed under the current rule.
This is not an exhaustive list, but below are five of the largest areas of change for which researchers should prepare. Read our experts’ answers to some FAQs about the 2019 Revised Common Rule and changes to Pearl IRB policies in our comprehensive guide.
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.
Stay tuned to the Pearl IRB blog or our Twitter handle for more information (i.e. the Revised Common Rule is delayed once again).