What must the investigator obtain before consenting trial participants?

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Multiple Choice

What must the investigator obtain before consenting trial participants?

Before inviting someone to participate, the consent information and the way consent will be obtained must be reviewed and approved by an ethics review body (the IRB or IEC). Their written approval or a favorable opinion ensures the informed consent materials clearly describe the study, risks, benefits, and rights, and that the process respects voluntariness and comprehension. This approval documents that participants will be approached and asked to consent in a way that protects their safety and autonomy. Sponsor approvals or collecting participants’ bank or household details aren’t substitutes for this ethical review, and consent cannot be obtained until the IRB/IEC has given its documented approval of both the consent form and the consent process.

Before inviting someone to participate, the consent information and the way consent will be obtained must be reviewed and approved by an ethics review body (the IRB or IEC). Their written approval or a favorable opinion ensures the informed consent materials clearly describe the study, risks, benefits, and rights, and that the process respects voluntariness and comprehension. This approval documents that participants will be approached and asked to consent in a way that protects their safety and autonomy. Sponsor approvals or collecting participants’ bank or household details aren’t substitutes for this ethical review, and consent cannot be obtained until the IRB/IEC has given its documented approval of both the consent form and the consent process.

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