Informed Consent Checklist
Informed consent is one of the primary ethical considerations in research involving human participants. The process of consent is to ensure that participants understand the research study and voluntarily agree to participate.
All researchers, faculty and students, should consider that consent is a process, and not just a form that potential study participants must sign.
There are federal requirements that mandate the type of consent that may be obtained, the elements that should be present in a written or oral consent explanation, and who may obtain and give consent for research purposes.
The Informed Consent Checklist contains all the elements of the federal requirements.
Deception and incomplete disclosure can be useful in research, but raises special issues for the IRB review and informed consent. Deception occurs when participants are deliberately given false information about some aspect of the research. Incomplete disclosure occurs when participants are not given information about the real purpose or the nature of the research.
Justifying the Use of Deception
Federal regulations prohibit the use of deceptive techniques that place participants at greater than minimal risk. An investigator proposing to use deception or incomplete disclosure should justify the use of deception and explain why deception is necessary to achieve the goals of the study.
Informed Consent in Cases of Research Deception or Incomplete Disclosure
Potential participants should be advised in the consent form that the information they are given is not complete and that they will be debriefed after the research procedures are completed.
In the consent form, provide a truthful and accurate explanation of the purpose of the study to the extent possible, without priming participants or by giving too much of the study away.
Examples: “Some research requires that the full purpose of the study not be explained before you participate. We will give you a full explanation at the end of the study.” OR “We will give you a full explanation as soon as you complete the study.”