Obtaining Informed Consent
This guidance is provided to assist investigators in understanding: 1) what is legally-effective informed consent; 2) who may be authorized to obtain consent from prospective research subjects; 3) how to obtain informed consent; and 4) how to document informed consent.
The Code of Federal regulations, 45 CFR 46.116 states that "the investigator" must obtain "the legally effective informed consent of the subject or the subject’s legally authorized representative" unless the requirement has been waived by the IRB in accordance with 45 CFR 46.116(c) and (d) or 21 CFR 50.24 or the research is exempt from IRB review in accordance with 45 CFR 46.101(b).
“Legally effective” means that the individual providing consent (or permission for participation of minors) has enough information to make a decision, can understand the consequences of a decision, and is able to communicate their decision. The informed consent process should be conducted in a language understandable to the subject or their legal representative, and the timing and setting of consent should be arranged to minimize even the appearance of pressure or undue influence. State laws and federal regulations provide specific requirements that must be followed. [Click here to read the state regulations]
Both the DHHS and FDA regulations require that each subject in research provide consent in a process that provides an understanding of the following eight elements of consent:
1. The purpose of the research and expected duration of the subject’s participation, the procedures that will be followed and identification of any procedures which are experimental;
2. Any reasonably foreseeable risks or discomforts;
3. Benefits to subjects or others which may reasonably be expected;
4. Appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
5. The extent, if any, to which confidentiality of records identifying the subject will be maintained;
6. 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 (for research greater than minimal risk);
7. Whom to contact for questions regarding the research, research-related injuries, and rights as a research subject;
8. That participation is voluntary, refusal to participate will not involve any penalty or loss of benefits to which the subject is otherwise entitled and participation may be discontinued at any time without any such penalty or loss.
The federal regulations provide additional elements of informed consent that also should be considered. When appropriate, one or more of the following elements of information should also be provided to each subject:
1. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
3. Any additional costs to the subject that may result from participation in the research;
4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
5. 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;
6. The approximate number of subjects involved in the study.
III. Authorized Individuals
It is not always possible for an investigator to personally obtain informed consent in an academic medical center setting. Residents, nurses, research coordinators, technicians, and other individuals play an integral part in the care of patients who are eligible to participate in research protocols, and these individuals participate in conducting the research. Although the Principal Investigator (PI) bears the ultimate responsibility for the informed consent process and for establishing the necessary content of the informed consent discussion; designated qualified individuals other than the PI may obtain informed consent.
The PI is responsible for stating in the IRB submission materials who will obtain consent, and for outlining the consent procedures. The IRB determines whether the proposed consent procedure, as outlined in the IRB submission materials, is appropriate.
The responsibility to obtain legally effective consent extends to the PI’s selection of designees who are authorized to obtain consent. In selecting an appropriate designee to obtain informed consent, the PI should consider the nature of the research study and the expertise of the designee.
Issues influencing who may obtain consent for subject participation in research activities
- The risk level of the research as determined by the reviewing committee
- The competence and/or vulnerabilities of the subject population
An appropriate designee should be:
- Well-versed in all aspects of the research; with appropriate experience and understanding to discuss the risks and potential benefits
- Familiar with the principles for obtaining informed consent
- Able to answer questions regarding the research
- Have adequate time to spend with the potential subject to ensure a comprehensive discussion of the research can take place.
If the prospective subject has questions that he or she would like to discuss with the PI, a physician co-investigator, their treating physician, or others, such arrangements for further discussion should be made before the subject signs the consent document.
The Institutional Review Board (IRB) may, in research that involves more risk, require that a physician be responsible for obtaining written consent. However, even in these circumstances, a well-instructed and qualified designee may provide much of the study information to the potential subject. A physician would then personally talk with the potential subject regarding the research study – particularly regarding potential risks – and give them an opportunity to ask questions before the consent document is signed.
IV. Consent Process
The process of obtaining legally effective informed consent from a prospective participant must be free from coercion or undue influence, be provided in language understandable to the individual, and the individual must have both the capacity to make decisions, and adequate time to consider all information related to participation in the research study. The PI is responsible for ensuring that legally effective consent is obtained from each participant prior to the enrollment of the individual in the study. Furthermore, legally effective consent must be obtained prior to procedures and assessments (e.g., screening or diagnostic tests, surveys, etc., required by the study) that are conducted to determine eligibility for enrollment in the study.
The consent process must be documented by: 1) obtaining the signature of the prospective participant on the IRB-approved informed consent form(s), unless this requirement has been waived by the IRB; and 2) documenting the process itself in the research records. The name of the person obtaining consent and the date that consent was obtained should be documented on the consent form.
For minimal risk research, the signed IRB-approved informed consent form(s) generally serves as adequate documentation of the consent process unless otherwise stipulated by the IRB for a specific research activity. For research activities approved by the IRB with the requirement of only obtaining verbal consent (i.e., waiver of the documentation of informed consent, that is, waiver of a signed consent form), the research records should document that verbal consent was obtained in accordance with IRB requirements.
For clinical research studies conducted at our affiliated hospitals, a copy of the signed consent form(s) (other than DNA consent forms) must also be included in the medical record. Clinical research in this context refers to research in which the research protocol determines the treatment or management of the subject, regardless of whether the treatment, drug, or device is investigational in status.