Changes Afloat at the Harvard LMA IRB: what you need to know for smooth sailing

Outline Who we are What’s new with ESTR Recent federal guidance/NIH policy & IRB review Quality Improvement Program initiatives Questions

Office of Human Research Administration

IRB Operations Grace Bullock, BA IRB Coordinator Jada Dixon, MJ, MPH, CIP IRB Review Specialist Paul Hryvniak, MS, CIP IRB Review Specialist Keren-Nicole Insalaco, MS, CIP, CIM Sr. IRB Review Specialist Kimberley Serpico, MEd, CIP Sr. IRB Review Specialist Keisha Turner, BA IRB Review Specialist Employs “one-stop-shop” model Regardless of type of submission, mode of review Department-assignments available at

Quality Improvement Program (QIP) Stanley Estime, MSCI, CIP Sr. QA/QI Specialist QIP Team Lead Lisa Gabel, BA, CIP Sr. QA/QI Specialist Alyssa Speier, MS, CIP Assistant Director, Regulatory Affairs & Research Compliance Ensures compliance of IRB and investigators through for cause and not for cause audits, self- assessments, etc. Education and training (schedule available here)here Human research support services, e.g., IRB submission/grant writing assistance; study management tools; routine onsite monitoring, and external audit preparation

What’s New with ESTR In mid-October, ESTR will be upgraded (expect more updates) Users expected to experience minimal change Changes will not alter any IRB policies or application requirements During the upgrade, users with an active submission pending review may be asked to supply additional information Questions LMA IRB ESTR representative: Kim Serpico at ESTR Help Desk:

ESTR Changes: Submitting Parallel Ancillary Review(s) Required reviews by Faculty Sponsors and/or Department Chairs will occur in parallel with the IRB review PI Proxy A PI with an approved study may designate one or more proxy to submit modifications and continuing reviews

ESTR Changes: Communicating Comment with Notice Comments can now trigger an out of system to a member of the study staff or IRB reviewer, e.g., a coordinate can use a comment to notify the PI that an application is ready to submit Withdraw to an Editable State Study staff members can transition the submission back to an editable state after submission (helpful when changes are necessary)

ESTR Changes: Streamlining/Clarification Automated Conversion to Clean Copies Upon approval, ESTR will automatically convert all track-changed Word documents to clean PDF versions Redundancies Removed Unnecessary questions have been removed from the SmartForm Question and attachment prompts have been reworded and rearranged

Recent federal guidance/NIH policy 1.OHRP Engagement Guidance E.g., Harvard LMA School is considered engaged if the prime awardee of HHS-funding regardless of where human research activities occur (even off site) 2.PHS Newborn Dried Blood Spots All research funded pursuant to the PHS Act using newborn dried blood spots is considered human subjects regardless of whether specimens are de-identified An IRB cannot waive informed consent 3.NIH Genomic Data Sharing All NIH-funded research generating or using large-scale human or non-human genomic data requires data sharing plans and Institutional Certification

Obtaining Institutional Certification (no prior Harvard LMA IRB review) Log into ESTR ( and “Create New Study” Add a “comment” in ESTR to denote request for Institutional Certification Under “Study Scope,” upload applicable application, which includes: A description of all data fields (genotype and phenotype) to be submitted to repository A plan for de-identifying datasets and how the key will be maintained Written confirmation that the coding system or “key” will never be shared with NIH Upload a copy of the consent form(s) Under “Consent, Assent…” page, if collecting data/specimens prospectively Under “Supplemental Documents” page, if collecting existing data/specimens

Obtaining Institutional Certification (prior Harvard LMA IRB review secured) PI to department-assigned Review Specialist Use subject heading “GDS Institutional Certification Requested” to facilitate prioritization Reference Harvard LMA IRB protocol # outlining underlying data/specimen collection/analyses If not available in ESTR, “Create a Modification” that includes: IRB approval notification (if Harvard LMA IRB didn’t review/approve) A description of all data fields (genotype and phenotype) to be submitted to repository A plan for de-identifying datasets and how the key will be maintained Written confirmation that the coding system or “key” will never be shared with NIH A copy of the underlying consent form(s)

Some “life vests” for Investigators and Study Staff New Resources Investigator Portal featuring Self-Assessment and Onsite Review FAQ pages Electronic Regulatory Binders, e.g., REDCap and SharePoint Education Series Offers a variety of topics, featuring guest speakers Revamped Auditing Program Required for new/transfer/“exception” PIs Revitalizing QIP’s Onsite Review and Support Service offered at the department level Human research training refresher credit earned for participants

Questions?