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Understanding Risk in a Research Study

Assessing risk in a research study is one of the primary responsibilities of an IRB and one of its most controversial tasks.  By nature, studying human beings is a complicated process because the subject matter itself is complicated.  The level of risk can vary because of many factors including: the population included in the study, the situations encountered by the participants, and/ or the experience of the researcher or team. Two studies may appear similar but a few factors could make one inherently more risky than the other. 

This section describes what a researcher needs to consider when developing a protocol as well as the risk analysis conducted by an IRB board member. This section does not cover ever scenario nor is it meant to be all inclusive; if you have a specific question about the risks in your study, please contact our office for further guidance.

Section Topics

Defining Risk
>>Types of Harm
>>Minimal Risk
Reducing Risk in a Research Study
Reviewing Risk by an IRB Board Member
>>Foundation for IRB Review
>>Explaining Risk in a Protocol
Benefits of Participating in a Study

Additional Topics

Undesireable Events

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