In almost all cases, researchers must obtain the informed consent of each subject participating in their projects.
If the subject is not legally competent to give consent, consent must be obtained from the subject's legally authorized representative: a parent, guardian or conservator.
The researcher should seek such consent only under circumstances that give the prospective subject or the representative sufficient opportunity to consider the matter carefully and that minimize the possibility of coercion or undue influence.
The information that is given should be in language that is understandable to the subject or the representative. It should be a full, clear, but succinct explanation, without jargon or technical terms -- in general, aimed toward a person with an eighth-grade reading comprehension level.
No informed consent, whether oral or written, may include any language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, including release of the researcher, the sponsor, the university or its agents from liability for negligence.
Basic and Additional Elements (45 CFR 46.116)
Eight Basic Elements to Include:
- A statement that the study involves research, an explanation of the purposes of the research, the expected duration of the subjectʼs participation, a description of the procedures to be followed and identification (if any) of any procedures that are experimental.
- A description of any reasonably foreseeable risks or discomforts to the subject. Risks and discomforts include but are not limited to physical, psychological, social and economic harm.
- A description of any benefits to the subject or to others that may reasonably be expected from the research. The description of benefits should be clear and not overstated. If no direct benefit is anticipated, that should be stated. Potential societal benefits should also be included.
- A description of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. To enable a rational choice, potential subjects should be made aware of the full range of options available to them. Consent documents should briefly explain any pertinent alternatives to entering the study. This element of consent might not be applicable to some studies.
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. In addition, subjects should be informed that external regulatory agencies, such as FDA, can inspect study records. If any other entity, such as sponsor of the study, may gain access to the study records, the subjects should be so informed.
- 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 subjectʼs rights, and whom to contact in the event of a research related injury to the subject, including the names of specific offices or persons and the telephone numbers/addresses to contact for answers to questions about the research subject's rights and the research study itself.
- 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
Additional Elements (when appropriate)
- A statement that the particular treatment or procedure may involve unforeseeable risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant). A statement that there may be unforeseen risks to the embryo or fetus might not be sufficient if animal data are not available to help predict the risk to a human fetus. Investigators should ensure that subjects who agree to enter studies fully understand the potential risks. If measures (e.g., use of contraception) to prevent pregnancy should be taken while in the study, that should also be explained.
- Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent. An unexplained statement that the investigator and/or sponsor may withdraw subjects at any time does not adequately inform the subjects of anticipated circumstances for such withdrawal. A statement that the investigator may withdraw subjects if they do not "follow study procedures" is not appropriate. Subjects are not in a position to know all the study procedures. Subjects should be informed, however, that they can be withdrawn if they do not follow the instructions given to them by the investigator.
- Any additional costs to the subject that could result from participation in the research. If the subjects may incur expenses because they are participating in the research, the costs must be explained in sufficient detail as to prepare the potential subject for such a possibility.
- The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject
- A statement that significant new findings developed during the course of the research, which may relate to the subject's willingness to continue participation, will be provided to the subject. When it is anticipated that significant new findings that would be pertinent to subject's continued participation are likely, the IRB should determine that a system, or a reasonable plan, exists to make such notification to subjects.
- The approximate number of subjects involved in the study.