The concept of “do you want to participate in this study?” can be one of the most difficult and involved questions a person will ever answer. The process of informed consent must include: information, comprehension, and voluntariness. All studies should consult the IRB/Office of Research Integrity for guidance.
- All information must be provided to the participant without any bias to ensure that patients fully understand the goals and mission of the trial, and the rules agreed upon.
- Comprehension ensures that patients are know all of the implications and possibilities that could result from the trial. Voluntariness gives participants 100% control and freedom from threat or pressure to accept or deny participation at their leisure.
- Consent and assent documents are dependent upon the study and content of the protocol. The development of these documents will begin almost simultaneously when the initial protocol procedures are discussed and the associated risks for study participants are well outlined.
- Generally, the principal investigator’s organization will have specific guidelines on creating consent and assent documents for clinical trials, in addition to IRB requirements. The principal investigator may choose to appoint a consent documents team that is specifically responsible for the review and preparation of these documents. In multi-center studies, there could be one consent form that is distributed to many different sites, or several different site-specific versions.
- The consent and assent forms should be written in simple lay language that all participants would understand, an explanation of the research purposes, and the expected participant duration of each subject.
- The consent form should also include a description of the procedures and if any are experimental, as well as any foreseeable discomforts or risks to the participants. The risks should be balanced with the potential benefits to the study participants and to others if the study is successful.
- The consent should include a description on the confidentiality measures of patient information and information on who to contact regarding the study.
- The informed consent document should also include appropriate disclosure of alternative treatment plans applicable to study participants, and any anticipated circumstances where a participant would be asked to withdraw from the study.
- A consent form may include “a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled”.