Institutional Review Board Manual
Required Informed Consent Information
Perhaps most central in Institutional Review Board (IRB) deliberations is the informed consent, for it is this document which explains to a potential research subject exactly what is being asked of him/her and the inherent risks/benefits of participation in the research.
Unless specifically waived by the IRB, no investigator may involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative.
The IRB may waive the requirement to obtain informed consent provided the IRB finds and documents that:
- The research involves no more than minimal risk to the subjects;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects;
- The research could not practicably be carried out without the waiver or alteration; and
- Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
An investigator shall seek an informed consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and under circumstances that minimize the possibility of coercion or undue influence.
The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. Investigators are encouraged to write informed consents at the 8th grade reading level.
No informed consent may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, sponsor, the institution, or its agents from liability for negligence.
The eight elements that are required for all informed consent forms, unless specifically waived by the Board, include:
- A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subjects' participation, a description of the procedures to be followed, and identification of any procedures which 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 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 and that notes the possibility that the Food and Drug Administration may inspect the records.
- An explanation of whom to contact for answers to pertinent questions about the research and research subject's rights, and whom to contact in the event of research-related injury.
- A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
- For research involving more than minimal risk, an explanation as to whether any compensation and/or any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
In addition, there are five additional elements that should be considered for inclusion depending on the nature of the research project. They include:
- A statement that the treatment/procedure may involve risks to the subject (or to embryo/ fetus, if the subject is or may become pregnant) which are currently unforeseeable.
- Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent.
- Any additional costs to the subject that may result from participation in the research.
- 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.