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Presentation at an Online Research Program held on Monday, 16 November 2020 at 10:45 AM - 11:30 AM by Professor Omar Hasan Kasule MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Chairman of the Institutional Review Board, King Fahad Medical City
SCOPE OF RESEARCH: IRB Covers The Following Types Of Research:
- Research by clinical observation.
- Controlled clinical comparative research. ́Laboratory research.
- Epidemiological research.
- Genetic research.
- Qualitative research.
- Genetic research.
CORE FUNCTIONS OF IRB:
- Assessing and approving research on patients, volunteers, KFMC staff and human tissues.
- Assessing any research involving access to medical records with a potential to breach confidentiality.
- Monitoring the conduct of research to detect any ethical violations.
CORE FUNCTIONS OF IRB, con’t.
- IRB oversight activities include monitoring full review IRB approved research yearly and monitoring the consent process.
- A continuing review process is integral to the audit and monitoring processes.
- Assuring protection of research subjects’ physical and mental well-being as stipulated in the Helsinki Declaration.
- Protection of the researchers and the institution in which they work by advising them about ethical conduct so that they do not commit.
OTHER IRB FUNCTIONS:
- Issue letters to heads of department to allow researchers.
- Issue letters to security to allow external researchers to enter KFMC.
- Certification of various issues to sponsors and other agencies.
- Approval of manuscripts for publication.
- General advice on research methods for researchers.
EXEMPT REQUEST FORM:
EXEMPT CONSENT FORM:
EXEMPT CONSENT FORM:
EXPEDITED REQUEST REVIEW FORM:
EXPEDITED REQUEST REVIEW FORM 2:
EXPEDITED STUDIES CONSENT FORM:
EXPEDITED STUDIES CONSENT FORM: con’t.
AMENDMENT FORM:
