Consent process aids
Informed consent is one of the most important aspects of conducting ethical research with human participants. Respecting the autonomy of research participants, the investigator must provide complete and true information regarding the study. The "informed" in informed consent means the participant has all the information necessary to make a decision. The principle of informed consent applies to ALL types of research including surveys, interviews, and observations in which participants are identified, and other experiments, such as diet, drug and exercise studies. The consent form must be written in language that is easy for the participant to understand. Avoid technical terms and complex sentences, regardless of your intended audience. When there are different groups or types of participants who may take part in a study, different consent documents may be required for different study populations.
Signed informed consent is the gold standard. This involves presentation of a written document to the prospective participant, including all elements of informed consent. The document is read and signed by the participant and kept as a record by the researcher.
Implied consent is the tacit indication that a person has knowingly agreed to participate in research by performing a research activity or task. This type of consent process is most common in internet-based research. Participants must still be presented with the consent information - the information a participant needs to know in order to make an educated decision about whether or not to participate.
Oral consent occurs when the researcher reads a consent script, and the subject verbally indicates that they agree to participate. Subjects should be given the opportunity to ask questions and, in most cases, provided with an information sheet containing key information about the study, including contact information for the PI.
In research with children, a parent or guardian must typically give their permission (called "parental consent") to allow the child to participate. Also, if the child is mature enough, they will need to give their "assent" to participate.
Generally, the IRB requires consent to be documented by a written consent form that includes all the required elements, and all appropriate optional elements, approved by the IRB prior to use. An IRB approved consent document will contain the date of IRB approval. Unless the need for consent is waived by the IRB, the written consent form must be reviewed with the participant (or the participant's representative) and signed and dated by the participant or the participant's representative before any research procedures (including screening) or research data collection can begin. The consent form should also be signed and dated by the individual who obtains the participant’s consent.
DHHS (45 CFR 46.116) and FDA regulations (21 CFR 50.20) required elements:
- A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures that are experimental;
- A description of any reasonably foreseeable risks or discomforts 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, 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 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 subjects' rights, and whom to contact in the event of a research-related injury to the subject;
- 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; and
- One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
i. A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
ii. 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.
If the research is subject to FDA regulation, a there must also be a statement that notes the possibility that the FDA may inspect study records (Research is FDA regulated if it involves the use of any drugs or medical devices other than the use of approved drugs and medical devices in the course of medical practice, or if the data will be submitted to or held for inspection by the FDA.)