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 http://www.hsph.harvard.edu/ohra/department-assignments/

Quality Improvement Program (QIP)

Stanley Estime, MSCI, CIP Sr. QA/QI SpecialistQIP 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)

• 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 kserpico@hsph.harvard.edu

• ESTR Help Desk: estrhelp@harvard.edu

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 Email Notice

• Comments can now trigger an out of system email 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 (https://irb.harvard.edu) 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 email 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

• 2015-2016 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?