Rio Salado Community College Risk Assessment in Clinical Research Discussion
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
