IRB Member Newsletter -- Volume 12 (Summer 2019)When to apply the Revised Common Rule Criteria
The staff reviewer will select the following in section E of the staff reviewer checklist, indicating which set(s) of regulations should be applied to the study under review:
Section E. Human Subjects Regulations to be Applied (completed by IRB staff; check all that apply)
|☒ Common Rule (effective date January 21, 2019)
☐ FDA regulations and the Common Rule to the extent compatible with FDA regulations
☐ Department of Justice (which did not adopt the revised Common Rule)
☐ Other (e.g., Department of Defense), please specify: Click or tap here to enter text.
Because the FDA did not adopt the Revised Common Rule, in FDA-regulated studies, we will apply the new Rule up to the point that it doesn’t conflict with the FDA’s human subjects regulations. For example, we can apply the consent-related changes below to FDA-regulated studies.
Most studies that were approved prior to January 21, 2019 will remain under the prior version of the Common Rule. Staff reviewers will guide IRB members regarding which version of the Common Rule to apply for changes of protocol and continuing reviews.
New Flexibilities for Screening, Recruiting, or Determining Eligibility
➢ Consent is not required for most screening, recruitment, and eligibility determination procedures.
- A waiver of signed consent and/or an alteration of the required elements of consent is not needed for phone screening procedures.
- A waiver of informed consent is not needed to identify potential subjects from medical records or clinic schedules.
- Researchers will still be expected to show that they have valid access to records, explain processes by which they will determine eligibility, and provide scripts for oral screening that include a portion to inform subjects about the study, the voluntary nature of the eligibility screening, etc.
New Criterion for Waiver of Informed Consent
➢ To grant a waiver of consent for the use of identifiable private information or identifiable biospecimens, the IRB must determine that the research could not be carried out without using the information or biospecimens in an identifiable form (in addition to the previous waiver criteria).
New Required Elements of Consent and Consent Form Requirements
➢ A new required element of consent regarding future use of data/specimens has been added.
If a study collects identifiable private information or identifiable biospecimens, the consent form must specifically indicate that a.) subjects’ information or biospecimens might be stripped of identifiers and used for other research in the future or b.) that subjects’ information or biospecimens will not be used for other research in the future, even if identifiers are removed.
- HS IRBs informed consent templates include default language assuming that future use may occur.
➢ Three additional elements of consent have been added. When appropriate to the study, subjects should be told:
- if the subject’s biospecimens might be used for commercial profit, and whether the subject will share in the profit.
- whether or not clinically relevant research results will be released to them.
- if whole genome sequencing will or may be performed.
➢ Consent forms must begin with a concise and focused presentation of key information
(This was also discussed in the Spring 2018 newsletter
, but now the summary will be built in to the informed consent document, rather than being a separate document)
- If the informed consent form uses our template and is less than 10 pages long, we consider this requirement met.
- Longer consent forms will need to include a study summary, which will be displayed in two-column format for easier reading.
The informed consent templates have been updated to address the requirements above. A “receiving results” section includes incidental imaging findings, plans for handling results indicative of depression or suicidality, the performance of tests for communicable diseases, and the results of other tests performed on biospecimens.
Of note – while there is a new requirement that consent forms associated with clinical trials be posted online, this will NOT be addressed or monitored by the IRB.
You will likely see fewer initial review items come to the board, as the revised Common Rule broadened the criteria for studies to be exempt from review or eligible for review via expedited procedures. In addition, more studies will be reviewed by IRBs outside the UW due to the National Institutes of Health single IRB policy and the requirement in the revised Common Rule, which will be implemented in 2020, for non-exempt, multi-site studies, that requires a single IRB for any studies that fall under the Common Rule.
Similarly, it is expected that the volume of continuing reviews will continue to decrease, as more studies are eligible to be excused from continuing review. One notable change in process resulting from this is that the Preliminary Review Session (PRS) approach has been discontinued for the MR-IRB.