210603P - RISK MANAGEMENT

Presentation prepared and written by Professor Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Chairman of the Institutional Review Board

 

CRADES OF RESEARCH RISKS:

· Risk: A potential harm or the potential of an action or event to cause harm.

· Minimal risk:  The Common Rules define minimal risk as a risk of harm to the subject from participation in the research that is no greater than the risk encountered in normal day-to-day activities or during routine physical or psychological examinations.

· Low Risk: Involves a minor increase over a minimal risk- the intervention or procedure presents experiences that are reasonably commensurate with those inherent in actual or expected medical, dental, physiological, social, or educational situations.

· Moderate Risk: Risks are reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge that may reasonably be expected to result.

· High Risk: Involves greater than moderate risk with no prospect of direct benefit to individual subjects, but is likely to yield generalized knowledge about the subject’s disorder or condition. Studies that are of high levels of risk may result in permanent physical and/or mental changes, hospitalization, and/or death.

 

TYPES OF RISKS:

· Physical  risks

· Psychological risks

· Risks to privacy and confidentiality

· Social. Risks

· Economic Risks

 

CLASSIFICATION OF RESEARCH ACCORDING TO RISK:

· Exempt (no human risk): educational tests, interviews, observation of public behavior, use existing data and pathological specimens provided no personally identifying information is recorded

· Expedited (minimal risk): Research activities that present no more than minimal risk to human subjects and are either activities of daily living or outpatient medical procedures

· Full review (more than minimal risk): intervention with drugs or devices

 

CLINICAL RESEARCH BENEFITS:

· New more effective treatments

· Cheaper treatments

· Treatments with easier routes and doses

· Stopping ineffective/less effective treatments

· Participants get enhanced care and screening

 

ASSESSING THE RISK-BENEFIT RATIO:

· Identify the additional risks to the participant due to research intervention

· Determine what you can do to minimize the risks

· Identify benefits from the research (participant vs society/knowledge)

· Make a determination that the risks are reasonable in relation to the benefits

 

DECISION RULES ABOUT RISKS AND BENEFITS:

· If risks outweigh the benefits

· If the benefits outweigh the risks

· If the risks = benefits (equipoise). Prevention of harm takes precedence درء المفاسد مقدم علي جلب المصالح.  

 

METHODS OF DETECTING RESEARCH RISKS:

· Reporting of adverse events to IRB followed by investigation and resolution

· Monitoring by IRB and the Sponsor

· Auditing by IRB

· Independent Data monitoring and safety committee

· Participant complaint process