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Minimizing the possibility of coercion or undue influence in the consent process

For studies that involve an informed consent process, the new submission form requires a response to the query, “Explain how the possibility of coercion or undue influence will be minimized in the consent process.” We see a lot of variety in the responses to this query. However, what we don’t see a lot of are specifics regarding how coercion or undue influence will be minimized. In responding, please specifically address issues such as explaining the voluntary nature of participation, any alternatives to participating, the ability to withdraw at any time, and the fact that the decision whether or not to participate will have no impact on the availability of care. This information will help the IRB as it considers the appropriateness of the proposed informed consent process.