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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 [email protected]
• ESTR Help Desk: [email protected]
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?