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Human Subjects Research
Common Rule Changes
January 21, 2019 is both the effective date and the compliance date for the Revised Common Rule. This means that we cannot implement the revised rule before the effective date. It also means the regulation provides no grace period for which to transition to become compliant with the revised rule. All initial applications submitted under the current rule, must obtain approval prior to January 21, 2019. All initial applications submitted after the effective date must comply with the new elements and regulatory requirements of the revised rule.
The Revised Common Rule broadens the types of research that qualify for exemption. Several exempt categories have been revised, and there are new categories of exemptions. OHRP (Office for Human Research Protections) has broadened the kinds of research that will be eligible for an exempt determination. As a reminder, per institutional policy, the OSU-STW IRB (not the investigator) must make the exemption determination. Studies declared exempt by the IRB do not have an expiration date.
Informed consent forms for complicated studies should include a concise summary of key information about the study at the beginning of the consent so participants do not have to wade through lengthy consent forms to find crucial information to help them determine reasons why one might or might not want to join the study. Many studies at OSU began using the template located on the OSU-STW IRB website in 2018 and are already presenting key information at the top of the informed consent. Templates were updated and posted on the OSU-STW IRB website in January 2018.
“Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.”
Additional information about a study’s results must be included in a statement in the consent about whether clinically relevant research results will be shared with participants. There are also new requirements for additional consent elements related to the use of de-identified information, the use of biospecimens, potential for commercial profit and return of clinically-relevant results. The OSU-STW IRB will be applying the consent form changes to all federally-funded/supported studies and to any study that involves greater than minimal risk.
Certain clinical trial consent forms will be required to be posted on a government website. This requirement applies to studies that are conducted or supported by a federal agency. The posting must occur no more than 60 days after the last study visit by any participant. The specific government website has not yet been named.
The revised Common Rule has new requirements surrounding Continuing Review.
Unless the IRB determines otherwise, continuing review of research is not required in the following circumstances, for new studies submitted in IRBManager on or after January 21, 2019:
- Research eligible for Expedited Review (minimal risk studies)
- Research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study:
- (A) Data analysis, including analysis of identifiable private information or identifiable biospecimens, or
- (B) Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.
For studies meeting the criteria above, a brief IRB “check-in” will be required every 3 years. This “check in” will consist of a brief 1-page summary of events over the last 3 years. Estimated time to complete this summary is about 5-10 minutes and this will be done within the IRBManager system.
At the 3 year check-in, CITI training status will be verified for all key personnel listed on the study.
PLEASE NOTE: All changes to research and personnel must continue to be reported to the IRB via Modification. Investigators must inform the IRB when studies are to be closed and of any adverse events and unanticipated problems.
The requirement for a single IRB to oversee studies that are conducted at multiple sites has been delayed until January 2020.
Updated standard operating procedures and guidance are under development.