The Belmont Report

Attempts to summarize the basic ethical principles of human subject research.  February 1976.

Objective: To provide an analytical framework that will guide the resolution of ethical problems arising from research involving human subjects.

Practice: Designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success.  Behavioral practice: To provide diagnosis, preventive treatment or therapy to particular individuals. 

Research: designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge.  Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.

When a clinician departs in a significant way from standard oar accepted practice, the innovation does not , in and of itself, constitute research.  The fact that a procedure is “experimental,” in the sense of new, untested or different, does not automatically place it in the category fo research.  Research and practice may be carried on together when research is designed to evaluate the safety and efficacy of a therapy.

Basic Ethical Principles:

1.      Respect for Persons.

a.       Individuals should be treated as autonomous agents

b.      Persons with diminished autonomy are entitled to protections.

2.      Beneficence.

a.       Do not harm: one should not injure one person regardless of the benefits that might come to others.

b.      Maximize possible benefits and minimize possible harms

                                                              i.      Physicians are required to benefit their patients “according to their best judgment.”

3.      Justice.

a.       To each person an equal share

b.      To each according to individual need

c.       To each according to individual effort

d.      To each according to societal contribution

e.       To each according to merit

Applications:

1.      Informed Consent. Respect for person requires that subjects be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied.

a.       Information

                                                              i.      Disclosure; sufficient information

1.      Research procedure

2.      Purposes

3.      Risks

4.      Anticipated benefits

5.      Alternative procedures (where therapy is involved)

6.      Statement offering the subject the opportunity to ask questions and to withdraw at any time.

7.      The subject should understand clearly the range of risk and the voluntary nature of participation.

                                                            ii.      When informing subjects of some pertinent information of the research is  likely to impair the validity of:

1.      Incomplete disclosure is truly necessary to accomplish the goals of the research,

2.      There are no undisclosed risks to subjects that are more than minimal

3.      There is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them.

b.      Comprehension

                                                              i.      Necessary to adapt the presentation of the information to the subject’s capacities. (on occasion, it may be suitable to give some oral or written tests of comprehension.)

                                                            ii.      Special provisions may need to be made when comprehension is severely limited (e.g. immaturity or mental disability)

1.      Respect for persons also requires seeking the permission of other parties in order to protect the subjects from harm. Such persons are thus respected both by acknowledging their own wishes and by the use of third parties to protect them from harm.

c.       Voluntariness:

                                                              i.      Free of coercion

1.      Coercion occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance.

                                                            ii.      Free of undue influence

1.      Under influence occurs through as offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance. 

2.      Also, Inducements that would ordinarily be acceptable may become undue influences if the subject is especially vulnerable.

2.      Assessment of Risks and Benefits:

a.       For the investigator, it is a means to examine whether the proposed research is properly designed.

b.      For a review committee, it is a method for determining whether the risks that will be presented to subjects are justified.

c.       For prospective subjects, the assessment will assist the determination whether or not to participate.

d.      Previous codes and Federal regulations have required that risks to subjects be 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.  In balancing these different elements, the risks and benefits affecting the immediate research subject will normally carry special weight.  On the other hand, interests other than those of the subject may on some occasions be sufficient by themselves to justify the risks involved in the research, so long as the subjects’ rights have been protected.  Beneficence thus requires that we protect against risk of harm to subjects and also that we be concerned about the loss of substantial benefits that might be gained from research.

e.       Procedure of assessment:

                                                              i.      Determination of the validity of the presuppositions of the research

                                                            ii.      The nature, probability and magnitude of risk should be distinguished with as much clarity as possible.

                                                          iii.      The method of ascertaining risks should be explicit, especially where there is no alternative to the use of such vague categories as small or slight risk.

                                                          iv.      It should also be determined whether an investigator’s estimates of the probability of harm or benefits are reasonable, as judged by known facts or other available studies.

f.       Justifiability:

                                                              i.      Brutal or inhumane treatment of human subjects is never morally justified

                                                            ii.      Risks should be reduced to those necessary to achieve the research objective.  It should be determined whether it is in fact necessary to use human subjects at all.  Risk can perhaps never be entirely eliminated, but it can often be reduced by careful attention to alternative procedures.

                                                          iii.      When research involves significant risk of serious impairment, review committees should be extraordinarily insistent on the justification of the risk (looking usually to the likelihood of benefit to the subject – or, in some rare cases, to the manifest voluntariness of the participating.

                                                          iv.      When vulnerable populations are involved in research, the appropriateness of involving them should itself be demonstrated. A number of variables go into such judgments, including the nature and degree of risk, the condition of the particular population involved, and the nature and level of the anticipated benefits. 

                                                            v.      Relevant risks and benefits must be thoroughly arrayed in documents and procedures used in the informed consent process.

3.      Selection of subjects:

a.       Individual justice: selection must exhibit fairness: They should not offer potentially beneficial research only to some patients who are in their favor or select only “undesirable” persons for risky research.

b.      Social justice: requires that distinction be drawn between classes of subjects that ought, and ought not, to participate in any particular kind of research, based on the ability of members of that class to bear burdens and on the appropriateness of placing further burdens on already burdened persons. 

c.       Thus, it can be considered a matter of social justice that there is an order of preference in the selection of classes of subjects (e.g., adults before children) and that some clases of potential subjects (e.g., the institutionalized mentally infirm or prisoners) may be involved as research subjects, if at all, only on certain conditions.