When an activity does not involve therapy, diagnosis, or treatment and there is a professional-subject relationship, such as in a research study, the subject must be provided with key information. This includes a clear and honest disclosure of all facts, probabilities, options, and opinions that a reasonable person would consider before consenting. A signed consent form should be given to the person signing and a copy retained by the investigator or institution as required.
Subjects' informed consent must be obtained in a suitable and proper manner. Consent should be obtained directly from the subjects unless they are legally unable to give it due to age, mental incapacity, or communication difficulties. For minors, the IRB may accept a parent's or guardian's permission along with the minor's assent, in line with federal rules. For other subjects unable to consent, the IRB may accept consent from a legally authorized representative (LAR), who must be authorized via a power of attorney or court order.
Informed consent entails ensuring potential subjects or their legal representatives are fully informed about all aspects of their participation in a study, allowing them to make a free choice without coercion, fraud, or force. Details on necessary elements of consent are provided at a specific site. The IRB may allow a consent procedure via phone/email with a document sent by fax or courier, signed and returned before a subject is enrolled in the study, with a neutral witness overseeing the process.
The IRB evaluates whether the consent is appropriate given the risks to subjects and research context. It ensures that verbal or written information to subjects or third parties is a clear explanation of procedures, benefits, and risks. Where debriefing is part of the study, the IRB ensures it will be thorough and timely, using plain language suitable for the audience.
If there is more than minimal risk determined during review, the consent form must include a compensation for injury statement, clarifying who covers treatment costs or compensation related to participation injuries.
Some research may not require informed consent. The IRB may waive the need for a signed consent form if
For any waiver, the IRB needs clear reasons, similarly from investigators.
The IRB may also approve a consent process that changes or skips some consent elements if
Informed consent does not need to be based on complete pre-study information. The IRB must decide on acceptable limits for incomplete information. If deception is proposed in data collection, the IRB assesses any violation of subjects' rights to define acceptable boundaries for these methods.