Informed consent is the principle that requires participants to be informed fully about a study's benefits, purpose and risks before voluntarily agreeing to participate. It ensures that individuals have the autonomy to make a decision regarding their involvement.
Employ the list below when constructing your informed consent for adult participants. Note that some items may not apply to your study.
- A statement that the study involves research.
- An explanation of the purposes of the research.
- The expected duration of the subject's participation.
- Identification of any procedures which are experimental.
- A description of any reasonably foreseeable risks of discomforts to the subject.
- A description of any benefits to the subject or to others which may reasonably be expected from the research.
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
- For research involving more than minimal risk, an explanation as to whether any compensation is due, and an explanation as to whether any medical treatments are available if injury occurs, and, if so, what they consist of, or where further information may be obtained.
- An explanation of whom to contact for answers to pertinent questions about the research and research subject's rights, including the faculty sponsor's name and contact information if the investigator is a student.
- A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits, to which the subject is otherwise entitled.
- A statement that the subject or the subject's legally authorized representative will receive a copy of the information consent statement.
Our office provides templates to help you as a Principal Investigator create informed consent forms relevant to your research. They include guidance and explanations, and each section has sample questions to help you gauge your participant's understanding. Refer also to sample forms commonly used in your field of study.