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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.