HOW TO BEGIN
Human Subject Training
Anyone planning on participating on a research study involving human subjects and who will work either directly with the subject, or with data or biological specimens derived from subjects MUST be trained in human subject protections.
There are two (2) training requirements for certification to conduct research involving human subjects.
https://www.stonybrook.edu/commcms/research-compliance/Human-Subjects/Training.
For Sponsor Funded Studies
1) If a Site Questionnaire is received and you require assistance completing it, please contact our office.
2) If the sponsor accepts us as a study site and they send a Confidentiality Disclosure Agreement (CDA), it must be sent for review to: sbu_nda@stonybrook.edu with a copy to the OCT.
3) After CDA execution, the sponsor will send the protocol, Clinical Trial Agreement (CTA) and proposed budget. These should go to the Office of Sponsored Programs and the OCT. A Site Implementation Plan (SIP) must be completed by the PI and sent to the OCT. See Forms below. Proposed budgets will be reviewed to ensure that ALL costs are covered.
4) After budget approval, a myResearch Grants proposal should be submitted for approval before IRB submission.
5) The next steps can occur concurrently: contract negotiation by OSP and IRB review/approval.
OBTAINING IRB APPROVAL
Investigators wishing to conduct industry sponsored biomedical research studies must use Advarra IRB provided that the sponsor is able to pay Advarra IRB directly. Please note that investigator-initiated studies must be reviewed by SBU's IRB and are not eligible for review by Advarra IRB.
To apply for CORIHS, review section 3 of the Standard Operating Procedures https://www.stonybrook.edu/commcms/research-compliance/Human-Subjects/sops
To apply for External IRB services: https://www.stonybrook.edu/commcms/research-compliance/External-IRBs/Which_IRB.php
Complete your External IRB application materials by visiting their website: Advarra Login. Note: Advarra IRB will take the sponsor's consent template and revise it according to the acceptable format.
Any questions regarding the IRB process, please call the Office of Research Compliance at (631) 632-9036. They are located at W5530 Frank Melville Jr. Memorial Library (5th floor), Stony Brook, NY 11794-3368.
UNIVERSITY HOSPITAL APPLICATION
The Application for Approval to Conduct Research Activities at Stony Brook University Hospital must be completed and uploaded into myResearch. Applicable ancillary hospital departments/directors must be given access to your project. Please see application for a list of departments /directors that need access.
For questions pertaining to hospital cost and discounts, please call Ms. Chernoff at 444-4772, E-mail: Rhona.Chernoff@stonybrookmedicine.edu the Finance Dept. at 444-4100, or contact our office.
THE STUDY MUST NOT BEGIN AT STONY BROOK MEDICINE UNTIL ALL APPROVALS HAVE BEEN GRANTED (IRB APPROVAL, UH APPROVAL) AND THE CORRESPONDING CONTRACT WITH THE SPONSOR HAS BEEN EXECUTED.
FORMS
Site Implementation Plan (SIP), Device Trials Worksheet
Should be completed by PI or SC for each protocol and faxed or emailed to OCT.
Forms for Human Subjects Research - The forms for IRB submission can be found on myResearch or Advarra IRB websites. Other Forms (https://research.stonybrook.edu/forms)
Approval, Continued Approval, reporting Unanticipated Problems, Serious Adverse Events and HIPAA Compliance.