Informed consent is a fundamental and thoughtful process to ensure respect for human subjects and to ensure that their initial and continuing participation in studies is an informed, voluntary act. With few exceptions, no study may involve a human participant unless the human participant is fully informed of the basic elements of the study and the Principal Investigator has obtained the legally effective, informed voluntary consent of the subject or the subject's legally authorized representative PRIOR to the subject's participation. Appropriate documentation of the informed consent process is required unless that documentation has been waived by the IRB. The informed consent document should be signed and dated by the subject or his/her legally authorized representative and by the person obtaining consent and/or a witness who attests with his/her signature to the appropriateness of the consent process. The Principal Investigator is responsible to ensure that the requirements of informed consent are fulfilled.
The person who obtains consent from the subject must be the Principal Investigator or an individual designed by the PI to perform this function. The IRB shall require that the Principal Investigator submit to the IRB, on application and/or amendment forms, the names of all individuals who, in addition to the Principal Investigator, will be authorized to obtain informed consent from the subjects in the study. All of these individuals must have adequate knowledge about the study to be able to answer questions posed by the subject. These individuals must also have completed training including CITI certification. The Principal Investigator must obtain IRB approval prior to adding additional individuals to the authorized list. All consent forms must include a line on which the individual(s) who obtained informed consent is (are) identified by name(s), signature(s), and date(s).
For most research, no separate (i.e. third party) witness signature on the consent documents is required. Rather, the role of the witness may be satisfied by the person obtaining consent. However, there are circumstances where federal regulations, study sponsors and/or the IRB may require that a third party (a witness) be part of the informed consent process and sign the consent form. Examples of such instances include when the risks of the research are greater than minimal, where there is a potential for coercion or where the subject has limited mental capacity.
Should a subject be incapable of reading and understanding the consent process, there must be a witness present during the entire consent process who must attest to the accuracy of the presentation and the apparent understanding of the subject. This witness should sign and date the consent documents in addition to the person obtaining consent and the procedures pursuant to the utilization of a short-form written consent (c.f. Policy 21.5) should be followed.
Other key principles of informed consent include:
1) Use Understandable Terms: Procedures used to obtain informed consent should be designed to educate subjects and/or their representatives in understandable terms. Except as provided below, the procedures used to obtain informed consent should describe the study's purpose, the duration of the subject's participation, a description of the procedures, reasonably foreseeable risks, and benefits that may reasonably be expected from participation.
Informed consent documents should explain that participation in the research study is voluntary and will not result in any penalty if the participation is withdrawn or not given. This information should be written and communicated in a manner that is understandable to the people being asked to participate. Every effort should be made to express a scientific concept/idea in lay terms at an approximate 6th grade reading and comprehension level. A copy of the signed consent form shall be given to the subject.
2) Sufficient Time for Careful Decision-Making: Investigators should seek consent from potential or current subjects only under circumstances that provide the subjects and/or their representatives with sufficient time to read the consent form, to question and discuss the information and to carefully decide whether or not to volunteer for the study. Language in the informed consent documents and process should not be coercive.
3) Thorough Information: During the informed consent process, subjects should be sufficiently informed about the research study including its procedure, risks and anticipated benefits, and alternative procedures (where therapy is involved). Federal regulations define eight required elements of informed consent that must be included in this documentation in compliance with 45 CFR 46.116 and 21 CFR 50 SubPart B. These are defined more completely in Policy 21.3 on "Required Elements of Informed Consent".
In addition to the eight "required elements of consent", federal regulations at 45 CFR 46.116(b) and 21 CFR 50.25 define six additional elements of informed consent which, based on their individual appropriateness, shall be provided to each subject. These are also included in Policy 21.3 (below).
NOTE – Guidance on writing informed consent documents with UM-required language that applies to certain situations is included on the HSRO web-site at www.hsro.miami.edu.
4) Questions and Comments: Subjects should be offered the opportunity to ask questions and to withdraw at any time from the research. They should also be informed about how subjects are selected, the person(s) responsible for the research and the mechanism(s) by which their comments and/or complains will be received and acted upon. To ensure that this principle is met, an appropriate (IRB approved) individual should be present or available when the consent form is reviewed by a prospective subject and/or his/her representative, to be certain that the consent form is fully understood and that any questions are answered.
5) No Exculpatory Language: Informed consents, no matter whether oral or written, should not include any exculpatory language through which subjects or their representatives are made to waive or appear to waive any of the subject's legal rights, or that releases or appears to release the Principal Investigator, the sponsor, the institution or its agents from liability for negligence.
6) Minimize Coercion or Undue Influence: Informed consents, no matter whether oral or written, should be communicated in a manner that minimizes the possibility of coercion or undue influence directed toward subjects and/or their representatives.
7) Voluntary Participation: Informed consents should define that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subjects is otherwise entitled, and that the subjects may discontinue participation at any time without penalty or loss of benefits to which the subjects is otherwise entitled.
Principal Investigators shall submit to the HSRO for IRB review revisions of consent documents when changes are appropriate due, for example, to new information or to improve the consent process. If significant revisions are approved by the IRB, the PI and/or the IRB shall require that currently enrolled subjects sign the new consent form.
Principal Investigators should make provisions so that an IRB-approved individual is available who can communicate with the research subject during the consent process and over the course of the study (during both working and non-working hours).