The Belmont Report:
Practical Application to IRB Protocol Submission Requirements
The UHCMC HRPP is guided by the ethical principles described in the Belmont Report, which underlies the conduct for both biomedical and behavioral research involving human participants.
a. Respect For Persons: requires that subjects, to the degree that they are capable, are given the opportunity to choose what shall or shall not happen to them. This opportunity is provided through the informed consent process and is based on presented information, comprehension and voluntariness.
• Information. Subjects are provided with sufficient information about the research, such as study procedures and their purposes; risks and anticipated benefits; alternative procedures (where therapy is involved); and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the research. For certain subjects, such as illiterate subjects, this information is better presented verbally rather than in a written document (see guidance below).
• Comprehension. Subjects understand the information presented to them, based on their intelligence; rationale; maturity; and language. For example presenting information in a disorganized and rapid fashion; allowing too little time for questions; or presenting information in a language that is not understandable to them, may adversely affect a subject's ability to make an informed choice. In addition, special provisions must be given to subjects whose comprehension is severely limited due to e.g. immaturity or mental disability (e.g., infants and young children, mentally disable patients, the terminally ill and the comatose).These subjects must still be given the opportunity to choose to the extent they are capable, whether or not to participate in research. All objections should be honored, unless the research entails providing them a therapy unavailable elsewhere. Respect for persons also requires seeking the permission of other parties (e.g., parents/guardians or legally authorized representatives) in order to protect the subjects from harm.
• Voluntariness. An agreement to participate in research constitutes a valid consent only if voluntarily given. This element of informed consent requires conditions free of coercion and undue influence. Coercion occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance. Undue influence, by contrast, occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance. Also, inducements that would ordinarily be acceptable may become undue influences if the subject is especially vulnerable.
b. Justice: refers to the fair and equitable selection of subjects. Part of subject selection includes ensuring that no person is unduly denied access to research from which they could potentially benefit, without good reason. For example: to exclude non-English speaking individuals purely because it is inconvenient to have the consent form translated into a language that would be understandable to individuals; or because the research staff do not speak the language, is not an acceptable reason. This would be deemed by the IRB to be unfair and an injustice to those individuals.
c. Beneficence: requires that the risks to subjects are outweighed by the sum of both the anticipated benefit to the subject, if any, and the anticipated benefit to society in the form of knowledge to be gained from the research. The IRB are required to determine whether the presented risks to the subject are justified; and when vulnerable populations are involved, the appropriateness of their inclusion has been demonstrated. For example, if data is to be collected from/about pregnant women, their inclusion must be fully justified; and the nature and degree of risk; and the nature and level of anticipated benefits must be fully described (see guidance below and 45 CFR 46 subpart B).