Institutional Review Board (IRB)

The SSMC Institutional Review Board (IRB) is an administrative body responsible for safeguarding the rights and welfare of human research participants. Through continuous monitoring and review of research activities, the IRB protects the health and safety of all participants.

The IRB has the authority to review, approve, modify, or disapprove of any research protocols submitted by SSMC faculty and staff.

The clinical trial submission process

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Step Description Person Responsible

1Research Proposal Submission
  • The Principal Investigator (PI) submits the study proposal to the IRB
  • The PI reviews the application for completeness of the requirements
  • IRB research coordinator

2IRB Initial Review / Interview
  • Assigned to a primary reviewer for an initial review
  • The PI may be requested to present a brief presentation
  • Review process may be expedited without requiring an IRB interview
  • IRB research coordinator
  • Primary reviewer

3Researcher Modifications
  • Feedback letter will be shared with the PI
  • (Addressing IRB’s concerns, making any necessary modifications)
  • PI
  • IRB research coordinator
  • Primary reviewer and members of IRB

4IRB Full Review
  • IRB conducts a thorough review of the revised proposal
  • Primary reviewer and members of IRB

5IRB Approval
  • If the proposal meets requirements, IRB grants approval letter
  • IRB Chair

6Ongoing Compliance
  • The PI should report to the IRB the following:
    • Any adverse events
    • Protocol amendments
    • Informed consent form amendments
    • Annual progress reports
    • End of study reports
  • PI
  • IRB research coordinator

7Study Completion
  • PI informs IRB of study completion and submits final reports.
  • PI
  • IRB research coordinator

About
SSMC’s Research

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Clinical Trials
Unit (CTU)

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Research Highlights and News

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Frequently Asked Questions (FAQ’s)

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Contact us

For consenting patients or subjects already enrolled in clinical trials at SSMC:

If you have questions about the ethics (REC/IRB) of the research studies you are involved in, please contact [email protected]

If you have inquiries regarding your research team or study, you can contact an Independent Research Subject Advocate (RSA) at [email protected]

For inquiries regarding clinical trials at SSMC, please contact [email protected]. This includes queries on whether you are eligible to enroll in clinical trials at SSMC.

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