Informed Consent
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Informed Consent and Ethics :::curator: ....
Regulations and policies have been developed to ensure that people are told about the benefits, risks, and purpose of research for which they volunteer. In 1976, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research developed three basic principles governing research involving human subjects that were published in the Belmont Report. These principles, which today form the basis for human subject protection regulations in the United States are:
- Respect for persons—recognition of personal dignity and autonomy of individuals, and special protection of persons with diminished autonomy
- Beneficence—obligation to protect persons from harm by maximizing unanticipated benefits and minimizing possible risk of harm
- Justice—fairness in the distribution of research benefits and burdens
The Informed Consent Process Informed consent is a critical part of ensuring participant safety in research. Informed consent is an ongoing process during which potential participants learn important information about a clinical trial. This information helps them decide whether to participate. The research team first explains the trial to potential participants in understandable language. This explanation entails the trial’s:
- Purpose
- Procedures
- Risks and benefits
- Participant rights, including the rights to: – Make an independent decision about participating – Leave the study at any time without jeopardizing future treatment
Before agreeing to take part in a trial, people have the right to:
- Learn about all their treatment options
- Learn all that is involved in the trial—including all details about treatment, tests, and possible risks and benefits
- Discuss the trial with the principal investigator and other members of the research team
- Learn if the investigators have any vested interest in the outcome of the study
The participant should hear and read the information in language they can understand (the consent should usually be written so that it can be read at an eighth grade reading level)
- If the imaging part of the trial is not the 'Primary Endpoint' (but is rather, 'correlative data' or a 'secondary endpoint') and the imaging entails possible discomfort, risk or extra cost, it is common to have a separate paragraph with a space for a separate patient initial or signature that allows the patient to opt-in or opt-out of the imaging component of the trial.
Informed Consent Form After discussing all aspects of the study with a potential participant, the team gives the person an informed consent form to read. The form includes written details about the information that was discussed and also describes the confidentiality of the participant’s records. If a person agrees to take part in the study, he or she signs the form. Although informed consent documents can vary in their length and complexity, they should all contain information on
- The clinical trial’s nature, purpose, and duration; the procedures to be followed; and which procedures are experimental
- Reasonable, foreseeable risks and discomforts
- Benefits to the participants and to others
- Alternative procedures or treatments
- Confidentiality of records
- Procedures if the trial involves more than minimal risk (e.g., compensation, availability of medical treatment)
- Person to contact for questions
- Voluntary participation — that there will be no loss of benefits on withdrawal and that participants may stop participating at any time All Government-funded trials must contain this information by law.
– These informed consent requirements are listed in Title 45 CFR Part 46, Sub part A.
Consent Forms Make them easy to understand: The informed consent process can be effective only if potential participants understand the information given to them. In recent years, both participants and investigators have voiced concerns that informed consent documents for clinical trials were becoming too long, complicated, and difficult to understand. NCI has issued recommendations designed to help research institutions and clinical centers write user-friendly informed consent documents. Sample templates can be found online in both English and Spanish at http://www.cancer.gov/clinicaltrials/understanding/simplification-of-informed-consent-docs/page3