210407P - RESEARCH: CHALLENGES AND OPPORTUNITIES

Presentation to the ATA team at Qaseem by Professor Omar Hasan Kasule MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Professor of Epidemiology and Bioethics, King Fahad Medical City

WHY RESEARCH?

• Research leads to better diagnosis, treatment, and prevention by providing locally relevant data on disease epidemiology
• Health care workers who research are intellectually active and read and are therefore more up to date in diagnosis, treatment, and prevention of disease
• Research data and findings can direct policy making at the local level
• Research publications bring reputation to the hospital and cluster
• Research publications lead to career growth and promotion for the researcher

TYPES OF RESEARCH

• EXEMPT REVIEW research has no risk to the research subject it can be a case report/series, interview, questionnaire, analysis of records, or analysis of stored tissues like blood
• EXPEDITED REVIEW research has minimal risk and its procedures are the same as those in a normal outpatient clinic
• FULL REVIEW research involves high risk intervention either drugs or devices

RESEARCH ADMINISTRATION: Director of research and/or research committee

• Encourage submission of research proposals by providing training and technical support in proposal writing, data collection, data analysis, and report writing
• Make sure that financial, human and logistic facilities are provided to the researcher
• Follows up and monitors the research till the end.
• Helps the researcher to submit and publish the research
• A research library or electronic data bases

RESEARCH ADMINISTRATION: Institutional Review Board (IRB)

• The main function of IRB is to protect participant rights and welfare by approving and monitoring the research to make sure it follows international and national guidelines
• The committee must have a minimum of 5 members of both genders and representing medical and surgical disciplines. One member must be non-medical and from outside the hospital to represent the community
• Each institution must strive to have its own local committee that must be registered with NCBE by submitting member CVs, a registration form, and ethics certificate.
• The IRB committee meets at least once a month. Exempt and expedited studies are approved within 5 working days. Full review studies are approved within one month.
• IRB approves paper manuscripts before submission to journals

PROCESS OF IRB: FORMS

• Exempt request
• Exempt consent
• Expedited request
• Amendment form