Changes to the Common Rule and Single IRB (sIRB) Shana Stolarczyk Sr. IRB Manager Research Compliance Office

PART 1: Changes to the Common Rule Here are the three broad topics we’ll be covering

Changes to the Common Rule Revised Common Rule to go into effect on July 19, 2018 General Compliance date given an additional 6 month grace period until January 21, 2019. During the delay for General Compliance, institutions may implement certain ‘burden-reducing’ provisions*. Using a revised definition of “Research” (which deems certain activities to not be research) Allowing no annual Continuing Review of certain categories of research Elimination of requirement for IRB to review grant applications *If institutions choose to implement these three burden-reducing provisions for particular studies, such studies will be subject to the 2018 Requirements beginning on January 21, 2019. Here are the three broad topics we’ll be covering

Streamlining Continuing Review No longer required for low risk studies & studies in data analysis Grant Review Eliminates requirement for IRB review of Federal Grants Single IRB Review Mandated for > 1 site in US Screening Exception Exception (no consent required) for: screening, recruitment, determining eligibility

Additional Changes Other important changes: Definition of “Human Subject” now includes identifiable biospecimens Modifies and adds to existing Exempt categories Consent form: must begin with a concise summary, providing key information Additional elements of consent, including a requirement indicating that identifiers might be removed from identifiable private information or identifiable biospecimens and whether this information/biospecimens will or will not be used for future research studies Here are the three broad topics we’ll be covering

Preparation - Consent Updates Stanford consent template will include new required language For studies that collect identifiable private information or identifiable specimens Protocol Director selects the option when preparing the consent form Added to templates by summer 2018

Preparation - Consent Updates Option 1 Identifiers might be removed from identifiable private information or identifiable specimens and, after such removal, the information or specimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from you. Option 2 Your specimens or private information will not be used for future research even if all identifying information is removed.

Preparation – Extended Approvals   Extends IRB approvals through the life of the project  for non-federally funded, minimal risk studies Annually, a notice will be sent asking whether any of the following have occurred: increase in risks; adverse events that have not yet been reported to the IRB; or Addition of federal sponsor(s) If one or more of the above have occurred, a Continuing Review application must be submitted and approved to continue with the study

Preparation – Extended Approvals The IRB reserves the right to make exceptions to this policy. Examples of exclusions from this Policy are: Federally sponsored projects, including federal training and program project grants Student projects when the academic sponsor uses federal funding for the student’s project Federal no-cost extensions Studies that include FDA-regulated components/oversight Studies with contractual obligations or restrictions that preclude eligibility in this policy, i.e. sponsor or funder of the research requires annual review.  

Conclusions- Common Rule Common Rule Changes Include streamlining and other changes which affect IRB procedures, templates, policy, etc. Some changes are being implemented at the SU IRB in preparation for the new rule. Guidance is still needed form implementation of some of the changes. Effective Date: July 19, 2018 Compliance Date: January 21, 2019

PART 2: Single IRB (sIRB) Here are the three broad topics we’ll be covering

Single IRB (sIRB) Summary Effective January 25, 2018 NIH Policy Effective January 25, 2018 Applies to:  All NIH funded multi-site study studies where the same research protocol is being conducted at more than one site. Does not apply to studies that involve more than one site but the sites have different role in carrying out the research. Common Rule Effective January 19, 2020 Applies to:  Federally funded cooperative research – that is, all studies that involve more than one institution.

Reviewing IRB Options Commercial IRB Central IRB Institutional IRB’s Western IRB (WIRB)/Copernicus Quorum Review IRB Central IRB Trial innovation Network (TIN) NCI CIRB Consortium’s Institutional IRB’s Lead site’s IRB, other Academic IRB, Hospital IRB, etc. Can you align the 2 bullets I added.

Stanford as the Prime/Lead Site If Stanford is the prime awardee or the lead site on a multi-site study requiring a sIRB, the following reliance options will need to be considered for their NIH proposal: Commercial IRB Trial Innovation Network Central IRB Another academic IRB (i.e., one of the other participating institutions) Should we keep this ?? Edit??

Stanford as the Prime/Lead Site The proposed sIRB will not be evaluated as part of the peer review process for NIH proposals and will not affect the overall score. Single IRB of record does not have to be the IRB of the parent award.

Establishing Reliance Reliance requires a written formal agreement between the reviewing and relying IRB’s Different types of agreements: Study specific IRB Authorization Agreement (IAA) Master IRB Agreement SMART IRB Agreement Quorum Master Agreement Network/Consortium Agreement Trial Innovation Network Agreement Pediatric Alliance Consortium NCI CIRB Agreement

Considerations for sIRB Only IRB review is ceded Local ancillary reviews still required per institutional policy (e.g., COI, radiation, etc.) Review process is different for every IRB, regulatory requirements are the same Still requires interaction and collaboration with the Stanford IRB Abbreviated Stanford sIRB application required Stanford IRB review fees still apply

Local Context - Consent Stanford specific consent language required for the following sections: Costs HIPAA Authorization Compensation for Research-Related Injury Language Bill of Rights

Conclusions- sIRB implemented by the NIH January 25, 2018 sIRB Requirements implemented by the NIH January 25, 2018 common rule effective January 19, 2020 Stanford investigators need to consider reliance options for sIRB review of multi-site and cooperative research where SU is the lead site/prime awardee. Stanford ancillary reviews still apply when the research is reviewed by an outside IRB.

Thank you! Questions???