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200722P - IRB SERVICES OVERVIEW

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Presented in the Rehabilitation Hospital Research Day held on Monday, 20 July 2020 at 06:10 - 06:20 by Professor Omar Hasan Kasule MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Professor of Epidemiology and Bioethics 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.

o 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.