Informed consent is an ongoing process. It is a means of communication between the subject, the investigator(s), and the research team. Informed consent is not merely a written documentation of the subject's willingness to participate. Informed consent means open communication of any information that may influence the subject's decision to initiate or continue participation in the study. This information must be available to the subject and the discussion regarding the information should be documented. When the subject's participation spans several months or even years, the investigator and the research team need to take steps to regularly review with the participant the elements of consent described at the time the subject originally signed consent.
Informed consent presumes two simultaneous concepts: informed decision-making and voluntary participation. Prospective subjects must be given sufficient information about the research and its risks and benefits in order to reach an informed decision as to whether they will voluntarily participate.
To obtain informed consent from a subject, the investigator must fully explain the study to the subject. The subject must be given the opportunity and encouraged to ask questions. Before any research procedures/tests are done, the subject must sign and date the informed consent document in the presence of the investigator and/or a member of the research team. The investigator must also sign and date the informed consent document.
A witness may be required during the entire consent presentation to attest to the accuracy of the presentation and the apparent understanding of the subject. This person verifies that he/she witnessed the informed consent process, not simply the signature of the subject and/or the authorized representative. The informed consent process should take place at each protocol visit to ensure that the subject is aware of the research and wants to continue.
All studies must include a statement in the case history (or medical record) that informed consent was obtained prior to participation in the study. The investigator must sign and date the statement. No screening procedures or answers to study specific questions may be obtained prior to the subject signing the informed consent document.
The following statement must be included in all consents for research in which women will be included in the subject population and the use of contraceptives is addressed: "Mount Carmel, a Catholic affiliated institution, wishes to remind Catholic women and/or men of the official teachings of the Roman Catholic Church regarding contraception." The statement is present to allow Catholic women/men with the potential for child bearing the opportunity to decide whether they would like to participate in the study, based on the religious teachings of the church.
There are limited circumstances for which a written consent form is not required. When the IRB does not require written consent, the IRB will ask the researcher to prepare a script to obtain verbal consent.
The language and sentence structure of the informed consent should be written at the sixth grade reading level. Scientific and medical terminology should be avoided whenever possible, and defined if used. Remember that those who use medical terms in conversation may not realize that their subjects don't understand what they mean.
The Mount Carmel IRB requests that consent forms adhere to a standard format, as shown in the sample below. The sample informed consent form contains all of the required elements of a consent as outlined by Federal regulations. Use this form as a template, adding the information specific to your research study.
Tips for preparing the informed consent for your project:
- Use short sentences
- Use simple language whenever possible and define medical or scientific terms
- Use an active voice
- Use large fonts for ease of reading
- Use tables, diagrams, and pictures whenever appropriate
- Use sufficient space between paragraphs and in the margins
Click here to review the Informed Consent template.