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

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
• 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/
Keisha Turner, BA
IRB Review Specialist
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, selfassessments, 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?