assessing risks and benefits in CT

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LET US NOW SEE HOW THE RISKS ARE MINIMIZEDHow to minimize risks

o

By involving Qualified personnel

o

By Substitution of procedures

o

By Monitoring

o

By excluding

especially susceptible subjects

We have

concentrated our attention more on the risks involved. So now let us also

discuss about the benefits of a research trial.

Types of benefits

o

Direct

benefits- Arising from receiving the intervention being studied

o

Collateral

also called “indirect†benefit- Arising from being a subject, even if one does

not receive the experimental intervention he receives such as

Medical

care

Gratification

Compensation

o

Aspirational

Benefit - Arising from the results of the study to society and to future

patients.

Minimizing risks also

go hand in hand with maximizing benefits

Maximizing

benefits o

By applying Principle

of beneficence

o

Implications

for informed consent

Avoid ambiguity

Avoid the therapeutic misconception

o

Considerations with respect to justice

There are certain situations where it is not possible to

compare the direct risks /benefit ratios.eg:

o

Risks

and benefits may affect different domains of health status

o

Risks

and benefits may affect different parties

o

Risks

may be borne by one individual to benefit another

o

Risks

may be borne by individuals to benefit society

o

Risks

may be borne by society to benefit individuals

The

following examples may be studied in depth to understand how an IRB should go

about the judgement and sanction procedure.

Example

1: Analysis of Existing Data

Investigators studied gender differences in industry wages by

analyzing data from the 1988 Current Population Survey. Variables in the

analysis include hourly wage, level of education, years of work experience,

size of the metropolitan area in which workplace is located, whether the

workplace is in an urban or rural area, geographical region of the United

States, marital status, race, type of occupation, and type of industry.

In this case, risks are associated with breaches in

confidentiality, and the IRB should determine whether confidentiality

protections are appropriate. The risk/potential benefit analysis involves

judging whether the risks are reasonable in relation to the potential gains in

knowledge for society.

Based on this analysis,

this study should be eligible for review using procedures other than the full

board because it involves no more than minimal risk.

Example

2: Face-to-Face Interviews Involving Sensitive Issues and a Small Sample

Investigators studied the effect of traumatic experiences on

memory. Five individuals who were incarcerated between 1942 and 1945 in Auschwitz were the participants. A detailed questionnaire

was given concerning personal characteristics (e.g., age, education, and place

of work), concentration camp characteristics, daily routine at the camp, and

events that occurred while there. They were also shown ten photos of famous

Nazis who were either known nationally or active at Auschwitz.

Interviewers administered the questionnaires in the participants homes and

conducted interviews in Hebrew or German. Investigators analyzed responses for

accuracy based on historical accounts.

Concerns of the IRB should be threats to privacy, breaches in

confidentiality, and psychological risks, such as distress. The risk/potential

benefit analysis involves judging whether the risks are reasonable in relation

to the potential gains in knowledge for society.

Based on the analysis of

the components of this study, it should receive full IRB review because some

components pose more than minimal risk.More examples follow in next post.kunda.KUNDA

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