Transition to email IRB
submissions
INFORMATIONAL SESSION
* T O P L AY T H E P R E S E N TAT I O N , C L I C K O N T H I S I C O N
O N T H E S TAT U S B A R B E L O W
Yale IRBs
HIC I (paper submissions only)
HIC II (Coeus, paper)
HIC III (Coeus, paper)
HIC IV (paper, Coeus)
HSC (email only)
3 administrative assistants for HIC
1 administrative assistant for HSC
Goal – eliminate paper submissions by August 1
Division of Departments
HIC I
(Dawn Pedevillano, Christine Earley)
Comprehensive Cancer Center
including:
Adult Oncology, Bone Marrow
Transplant, Pediatric Oncology,
Hematology/Oncology, Medical
Oncology, Surgical Oncology
Therapeutic Radiology
HIC II
(Jennifer Reese, Stacey Scirocco)
Dermatology
Immunobiology
Ophthalmology & Visual Science
Pathology
Psychiatry
Yale School of Nursing
Diagnostic Radiology
Mechanical/Chemical Engineering
JB Pierce (for PIs with appointments
also in Psychiatry)
Division of Departments
HIC III
(Michele Antisdel, Ellen Bedard)
Anesthesiology
HIC IV
(Amy Blakeslee, Donna Lacivita)
School of Public Health
Emergency Medicine
Child Study Center
Genetics
Internal Medicine
Laboratory Medicine
Obstetrics and Gynecology
Neurology
Orthopedics and Rehabilitation
Pharmacology
Neurobiology
Neurosurgery
Pediatrics
JB Pierce – OB/GYN
Surgery
Comparative Medicine
Haskins
Physiology
Urology, Cell Biology
Transition Dates
HIC III – Monday, April 6
HIC IV - Monday, May 4
HIC I – Monday, June 1
HIC II – Monday, July 6
Process
1. Submission comes into email
hic.submissions@yale.edu
Automatic Receipt Sent
Administrative assistant checks:
PI’s training/COI
Submission Cover Sheet
Appropriate Signatures
Zip file
Admin Actions
Rejection
You will get an email that the submission was rejected and reasons why.
Resubmit the entire submission to hic.submissions@yale.edu
Process and Pass to Regulatory Analyst
You will NOT get an email if the submission is passed to RA for triage.
If it’s a submission of a new protocol (initial protocol submission), you
will get the HIC number via email.
Triage – RA’s actions
Regulatory Analyst checks for completeness of the submission e.g. are
amendment changes described properly in the amendment request
form?
Rejection
You will get an email explaining why the submission is rejected and
what steps to take.
Triage to Review
Submission is placed in queue awaiting review (expedited or full
committee).
Review and Approval
The submission follows a regular review process (expedited or full
board)
 When revisions are needed during/after review, you will receive email
from your regulatory analyst (‘SMR’ or revisions to regulatory review)
 When approved, you will receive an email from your regulatory analyst
with approval letter and approved documents
Submission Instructions
All protocol related documents must be emailed to HIC.submissions@yale.edu
with the subject of the email as follows:
◦ Request for initial review: ‘Initial Protocol Submission for xxxx (name of the PI)’
◦ Request for renewal: ‘Renewal for xxxx (protocol number), xxxx (name of the
PI)’
◦ Request for amendment: ‘Amendment to xxxx (protocol number), xxx (name of
the PI)’
◦ Revisions requested by Committee, chair or vice-chair, or a regulatory analyst:
‘Revisions to xxxx (type of submission - e.g., renewal) for xxxx (protocol
number), xxx (name of PI)’
◦ Other submissions - e.g., deviation reports, SAEs, approval from other
Committees, etc.: FYI for xxx (protocol number), xxxx (name of the PI)
Instructions
All documents should be in a zipped file
Always include a completed Submission Cover Sheet
http://www.yale.edu/hrpp/resources/docs/submissioncoversheet.docx
Protocols, applications and consent documents must be submitted in WORD.
For amendments, amended versions of documents must show tracked changes.
Do not submit both tracked changes and clean versions of the same forms.
Electronic signatures
NO typed signatures in WORD
Acceptable forms:
Electronic signature on PDF documents (Adobe) or WORD documents
Scanned signature page
PI emailing the documents him/herself (not just being copied on the email)
The above referenced methods are acceptable for the Department Chair’s
signature on new submissions and other forms requiring the Department
Chair’s signature.
Adobe Signatures
If you are using electronic signatures or a scanned handwritten
signature, make sure to also send WORD version of the document
without the signature.
Points To Remember
 Do not email submissions the regulatory analyst directly – use
hic.submissions@yale.edu
Finish paper submissions (e.g. if revisions were requested on a paper
amendment) before switching to email
30 days from the transition date before we stop accepting paper
submissions for each team
Questions?