Informed Consent
Informed consent is a voluntary agreement to participate in research. It is a process that includes an informed consent document. The goal of the informed consent process is to provide sufficient information so that a participant can make an informed decision about whether or not to enroll in a study or to continue participation. The informed consent document must be written in language easily understood by the participant, it must minimize the possibility of coercion or undue influence, and the subject must be given sufficient time to consider participation and ask questions.
The informed consent process must:
- Be presented in language easily understood by the subject,
- Minimize the possibility of coercion or undue influence,
- Allow subject sufficient time to consider participation,
- Allow subject to refuse or discontinue participation at any time,
- Distinguish between research and standard medical care,
- Not include exculpatory language,
- Be appropriately presented for the subject’s physical, emotional and psychological capacity, and vulnerable status, and
- Assure that subject understands what participation entails.
These are the elements of informed consent required by the Federal Regulations:
- A concise and focused presentation at the top of the first page of key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might want or not want to participate in the research.
- A statement that the study involves research and an explanation of the purpose of the research, the duration of the research/subject’s participation, the procedures to be followed, and the identification of any procedures that are experimental.
- A description of any reasonably forseeable risks or discomfort to the subject.
- A description of any benefits to the subject or to others that may reasonably be expected from the research.
- A disclosure of appropriate alternative procedures or courses of treatment that might be available to the subject.
- An explanation 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 describing the extent if any, to which confidentiality of records identifying the subject will be maintained.
- Person to contact for answers to questions about the study or in the event of a research-related injury or emergency.
- One of the following statements about any research that involves collection of identifiable private information or identifiable biospecimens:
- A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after removal, the information or biospecimens could be used for future research studies or distributed to another researcher for future studies without additional informed consent, if this might be a possibility; or
- A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies. For research that is greater than minimal risk, an explanation as to whether any compensation or medical treatments are available if injury occurs, and if so, what they consist of or where further information may be obtained.
- For research that is greater than minimal risk, an explanation as to whether any compensation or medical treatments are available if injury occurs, and if so, what they consist of or where further information may be obtained.
There are additional elements of informed consent that may be required (see section 10 CFR Part 745.116 (c)).
The IRB may allow the method of consent to vary depending on the level of risk and the nature of the research.