assessing risks and benefits in CT

[Guest guest]

hello, finally in a nutshell, For assessment of

risks and benefits in CT, Important points to consider

1. Are both risks and

anticipated benefits accurately identified, evaluated, and described?

2. Are the risks greater

than minimal risk? Has the IRB taken into account any special vulnerabilities

among prospective subjects that might be relevant to evaluating the risk of

participation?

3. If the research involves

the evaluation of a therapeutic procedure, have the risks and benefits of the

research interventions been evaluated separately from those of the therapeutic

interventions?

4. Has due care been used

to minimize risks and maximize the likelihood of benefits?

5. Are there adequate

provisions for a continuing reassessment of the balance between risks and

benefits? Should there be a data and safety monitoring committee?

Evaluation of the risk/benefit ratio is the major

ethical judgment that IRBs must make in reviewing research proposals. The

risk/benefit assessment is not a technical one valid under all circumstances;

rather, it is a judgment that often depends upon prevailing community standards

and subjective determinations of risk and benefit. Consequently, different IRBs

may arrive at different assessments of a particular risk/benefit ratio.

Concluding comments

o Although balancing

risks and benefits can be difficult, or impossible, there is an obligation to

minimize risks and maximize potential benefits in research

o To do this task well

requires a well studied evaluation of risks and benefits

o Such an evaluation not

only promotes the welfare of subjects but also enhances consent and the

accuracy of claims about justice.

This was a wee bit lengthy discussion and time

did not allow for more examples or even more exercises. However if you have

learnt the importance and methods of

assessing risks in a CT, it was well worth the time and energy spent on this

discussion.

kunda

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