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Page 305

identified in connection with the sick role--is the concept of the fragility

of the individual who is either highly dependent or highly vulnerable (by

virtue of having assumed the sick role). The notion of fragility suggests

the relative lack of power such persons have in negotiating with investi-


General considerations for the development of guidelines: In general,

it is appropriate to draw upon the administratively available to assume in-

convenience. However, in research presenting risk of physical or psycholo-

gical harm, as the degree of risk increases, there should be a decreasing

assumption of-the validity of drawing upon the administratively available.

In situations in which known risk is presented in order to develop basic

information that will be
presumed benefit to the class, there will be a de-

creasing assumption of the appropriateness of drawing upon the administratively

available without consulting them as a group. Thus, in some cases it will be

necessary to seek community consultation and in others, community consent.

In general, it is not appropriate to threaten individuals with loss

of dependent status owing to unwillingness to assume known and/or unknown

risk of physical or psychological harm; rare exceptions are specified sub-

sequently ( infra ).

In general, it should be assumed that most persons can choose to receive

an innovative therapy. However, the choice to receive an innovative therapy

imposes upon the individual the reciprocal obligation of assuming the in-

convenience of tests necessary to prove its safety and/or efficacy. In cases

in which the innovative therapy is scarce, refusal to assume this reciprocal

obligation may justify exclusion of that individual. However, a distinction

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must be made between depriving a person of a single modality on the one

hand and, on the other, of an entire dependent relationship. It is not

appropriate to terminate a professional-client relationship because the

client refuses to be the subject of research--including innovative therapy.

The issue of developing a system for compensation of harmed research

subjects is reviewed in some detail. Development of a suitable system

would yield several salutary effects to the entire research process. It

will be most difficult to develop appropriate guidelines for the selection

of subjects for research presenting known and/or unknown risk without having

first developed suitable systems for compensation. The proposals for guide-

lines for selection of subjects contained in this paper are based on the

assumption that appropriate mechanisms for compensation of harmed subjects

will be developed.

A proposal for the development of lottery systems to distribute some

sorts of known and unknown research risks is presented. The proposal has

the following features. Built into it is a device for securing community

consultation to determine whether the group as a group perceives the

potential benefits of the research as being sufficient to merit the presen-

tation of the risks to even a small number of them. It is suggested that

an assembly of prospective subjects would tend to reduce the fragility of

the individual negotiating as an individual with the more powerful pro-

fessional. This system might also be used to minimize the possibility of

exploitation of the administratively available. Entry into the lottery

would be validated only by the informed consent of the individual.

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