Rio Salado Community College Risk Assessment in Clinical Research Discussion
Description
There are many types of risk related to human subjects research.
Physical
Psychological
Social
Legal
Economic
Attached are some hypothetical studies. Choose one study and provide an analysis on the potential risks. Your analysis should include the following:
Identify which study you are reviewing
Identify the study population/participants
Include if they are a vulnerable population and any special safe guards they may need per 45 CFR 46 and/or Title 21.
What types of risk could be involved with the study and explain why
Identify study procedures and their related risks
Identify potential risks not related to direct study procedures (psychological risks, data risks)
Use the 5 categories of risk to help identify risks
What kind of questions might a study participant ask
Think about if you were being asked to participate what would you want to know?
How would you communicate risk and benefits with a the potential participant. Address the questions posed above.
Use the materials on communicating risk and benefits to help formulate your response
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