Informed consent is understood as an on-going process which starts with the initial presentation of a research activity to a prospective subject by the investigator and continues through the research activities until the subject ends his/her participation or the study closes. The initial phase of the consenting process commonly begins with the first contact between the subject and the investigator when the potential subject is first informed about the study. Many subjects make their decision regarding whether to participate in research during this initial contact. As a result, the greatest potential for misunderstanding exists in the initial consent process. Researchers must provide sufficient time for a potential subject to reflect on the nature of participation during the important initial presentation of a research activity. When subjects are presented with numerous research and clinical options, the consent process must include a clear description of the possible known ramifications resulting from each option presented. Subjects must also be made aware of the possibility of unforeseen risks resulting from participation in the research project. The presentation must not include specific “leading” information about whether to participate in any particular project.
By providing a potential subject with information, understandable to the subject in an initial session regarding complex research issues, potential subjects should have an improved comprehension of the elements within the consent form and provide a more informed consent for participation in the research.
The second step in the consent process is the presentation of the consent form(s) to the subject.
- Consent forms should be presented with consideration to environment. Distractions and noise should be limited. Privacy should be protected when possible.
- In biomedical research the investigator should separate the research consent form from any other clinical information or hospital admission forms. Subjects should not be asked to sign hospital admission paperwork or hospital consent documents for clinically indicated procedures at the same time as the presentation of the research consent form. If this must occur, the study team should make it very clear what is being done for research and what is being done as part of medical care.
- Individuals who have already received pre-op medication or anesthesia should not be asked to sign a consent to participate in a research study. The presentation of the research consent form should be a separate process. The principal investigator or a member of the research team should ensure that the subject or their legally authorized representative (LAR) reads the consent form or has it read to them. After the subject or LAR reads the consent form or has it read to them, the principal investigator or member of the research team should use open ended questions to determine if the subject or their LAR understands the information presented to them. Please note that the IRB must approve the use of an LAR or surrogate prior to obtaining their consent.
The IRB ensures that informed consent will be sought from each prospective subject or the subjects legally authorized representative, in accordance with, and to the extent required by 45 CFR 46.116 and 21 CFR 50.20. In addition, the IRB ensures that informed consent will be appropriately documented, in accordance with, and to the extent required by 45 CFR 46.117 and 21 CFR 50.27. The IRB ensures, as part of its review, that the information in the consent document and process is consistent with the research.