assessing risks and benefits in CT

[Guest guest]

hello,In continuation of my earlier post and the examples given , We will see how those examples should be ideally treated. Treatment of different types of procedures, by IRB

When a study involves therapeutic

procedures, the REB must ascertain that a state of clinical equipoise

exists. We have already had discussion on clinical equipoise. The ethical

analysis of therapeutic procedures involves a risk-benefit calculus.

Non-therapeutic

procedures, by definition, do not offer any prospect of benefit to the research

subject and, thus a risk-benefit calculus is inappropriate., the ethical

analysis of nontherapeutic procedures does not involve a risk-benefit calculus,

rather a risk-knowledge

calculus.

Let us consider

what procedures might be considered therapeutic in the examples quoted in the

earlier post

_ In study A, a novel

antipsychotic drug is compared with placebo. Both of these procedures are therapeutic interventions. The use of

psychometric scales may be therapeutic if they are used routinely in clinical

practice to guide treatmen. We do not have enough information to make this judgement,

so we will assume that they are non therapeutic.

_ In study B, a

questionnaire related to sexual activity is administered to high school

students. Obviously, this is not a therapeutic intervention.

_ IHaving determined

which procedures are administered with therapeutic warrant, how do we determine

whether they are morally acceptable?

Only Study A involves the use of therapeutic

procedures. The question the IRB must ask itself is -Does a state of clinical

equipoise exist among the new antipsychotic, placebo, and alternatives

available in clinical practice? Effective treatment exists for the treatment of

schizophrenia, and, hence, the use of placebo in this case is impermissible. The IRB must not approve

the study unless either an active control is used or the patient population is

restricted to those who have no response to standard therapy

Non therapeutic

procedures and risks associated with them.

Study A (trial of new medication in

schizophrenia) proposes to test subjects regularly with psychometric scales.

Filling out such forms is time consuming, potentially upsetting, and may expose

subjects to the risk of discrimination.

_ Study B (adolescent

sexual practices) again involves only non therapeutic procedures. The

questionnaire addresses a number of sensitive areas of inquiry, including

sexuality and practices that predispose to HIV transmission. Subjects may find

the questions anxiety provoking, and others may learn of deeply private

matters, leading to stigmatization.

By

definition, risks associated with non therapeutic procedures cannot be

justified by the prospect of benefits to individual research . The IRB must first

ensure that the risks associated with non therapeutic procedures are minimized

by using procedures consistent with sound research design.

We

will next see how to minimize risks.

kunda

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