Transition to email IRB submissions INFORMATIONAL SESSION * TO PLAY THE PRESENTATION, CLICK ON THIS ICON ON THE STATUS BAR BELOW
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 Child Study Center Internal Medicine Obstetrics and Gynecology Orthopedics and Rehabilitation Pharmacology JB Pierce – OB/GYN Comparative Medicine Physiology HIC IV (Amy Blakeslee, Donna Lacivita) School of Public Health Emergency Medicine Genetics Laboratory Medicine Neurology Neurobiology Neurosurgery Pediatrics Surgery Haskins 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 email@example.com Administrative assistant checks: PI’s training/COI Submission Cover Sheet Appropriate Signatures Zip file Automatic Receipt Sent
Admin Actions Rejection You will get an email that the submission was rejected and reasons why. Resubmit the entire submission to firstname.lastname@example.org@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.email@example.com with the subject of the email as follows:HIC.firstname.lastname@example.org ◦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 email@example.com firstname.lastname@example.org 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