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Ethical Research Practice
Institutional Review Board
IRB Review Criteria

Informed Consent
--Capacity to Consent
--Freedom from Coercion
--Risks & Benefits
--Informed Consent Document
--Informed Consent Delivery
--Waiver of Informed Consent
--Quiz

Genetic Testing
Types of Review
Continuation & Final Reports
Serious Adverse Events
Frequently Asked Questions
Conclusion

Freedom from Coercion

The most obvious patient population that is at risk for being influenced to participate in research is the terminally ill patient or a patient with a life threatening disease. These patients will often take greater risks with a lesser chance for success of the intervention, but they need to be completely and thoroughly informed of the chances of success and of side effects. There is a fine line between persuasive motivation to participate in clinical studies and coercion.

Another population at risk for coercion is the financially underprivileged (including students and minors) who may take greater risks for a financial reward. It is for this reason that IRB applications are required to disclose incentives and also to include advertisements for subjects in the application. There have been toxic chemical and pesticide studies that have advertised in college newspapers offering large monetary amounts for ingestion of the substances contained in the poisonous chemicals to establish potential effects on humans (see the Historic Research page). There are no known benefits beside the monetary gain, making this type of research ethically questionable.

Investigators need to realize that certain relationships will produce an unfair influence on patients and therefore the avoidance of coercion or excessive persuasion to participate in the study is vital. This is particularly important for physicians who are actively treating the potential subjects, for leaders in a position of power who are recruiting subjects from colleagues or employees and for instructors recruiting participants from their student populations. Studies using members of the Armed Forces, government institutions or companies where the subjects are influenced by expectations for social compliance also fit into the at risk for coercion category. Prisoners are another subject population that may be under stress to gain added freedoms by participating in a research study. All of these situations may lead to subjects feeling there is a need to participate for reasons other than their desire to contribute to science or their personal benefit.

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