assessing risks and benefits in CT

[Guest guest]

hello, how different projects are/ should be screened by IRB

Example

3: Observational Study Using Mail Questionnaires to Evaluate the Effects of

State Law on Behavior

Investigators studied the effects of two divorce laws on the

functioning of parents and children immediately after separation and two years

later. In this state, until 1987 the divorce law was no-fault and permissive of

joint custody. In 1988, a new law went into effect that focused on parental

functions and responsibilities rather than custody. Investigators identified

divorcing couples through their divorce petitions. One hundred couples were

identified in 1987 and 100 in 1988 and were sent a questionnaire at the time of

separation. If they responded to the questionnaire, they were sent another

questionnaire two years later. Individuals were asked to respond to questions

about themselves regarding depression, social withdrawal, irritability, work

problems, and childrearing problems. They were asked to answer questions about

their children regarding depression, anxiety, eating behavior, sleeping

patterns, nighttime fears, and withdrawal. They also responded to questions

regarding the circumstances of the separation, including parental substance

abuse and child abuse.

Privacy and

confidentiality risks related to psychological,

social, and legal harms are heightened, because divorcing spouses might

attempt to obtain through legal mechanisms information about the other or

physically harm the other based on information disclosed in the survey. Other

issues would include whether cases of child abuse must be reported. None of the

research procedures offer the prospect of direct benefit.

Thus, the

study should receive full IRB review.

Example

4: Clinical Trial to Determine Safety and Immunogenicity of a Vaccine

Investigators conducted a Phase I, dose-escalating trial of a prophylactic

recombinant human papillomavirus vaccine candidate in healthy participants. The

study was designed to evaluate the safety and immunogenicity of two dose levels

of the vaccine in a double-blind, randomized, placebo-controlled trial. To

determine whether the dose of the vaccine or the addition of alum or MF59

adjuvant would influence the reactogenicity or immune response, a

dose-escalation design was used, starting with the lower dose of the vaccine

alone, then with alum added to the vaccine, then with MF59 added to the

vaccine, and the design repeated with the higher dose of the vaccine.

Assessments included a physical examination and laboratory tests prior to

enrollment and clinical evaluations and clinical and immunologic tests before

each injection at 0, 1, and 4 months and 1 month after each injection.

The trial was not designed to offer a potential direct benefit

(protection from human papillomavirus) to participants. The vaccine, the design

of the trial, and all of the assessments were administered solely to answer the

research question(s) related to safety and immunogenicity. None of the research

procedures offer the prospect of direct benefit.

Thus, the study should receive full IRB review.

Example

5: Clinical Trial to Test Efficacy of a Drug

Investigators conducted a trial to determine whether paroxetine,

an antidepressant, would reduce depressive symptoms in patients with malignant

melanoma who were treated with a high dose of interferon therapy. The

investigators used a double-blind, placebo-controlled trial design.

Participants were randomly assigned to either the experimental arm or the

control arm of the trial. Paroxetine or placebo was administered for two weeks

before initiation of the inter-feron therapy as well as during the treatment

period. Participants were evaluated at regularly scheduled intervals for

depressive symptoms. Assessments included depression and anxiety rating scales,

a neurotoxicity rating scale used in the measurement of psychiatric and

physical symptoms related to cytokine therapy, and a psychiatric evaluation.

This

trial was designed to offer the prospect of direct benefit to participants in

addition to answering the research question(s). In this study, the research takes place in the

context of providing standard medical care (interferon therapy). The use of

standard medical care should not be factored into the risk/potential benefit

analysis of the IRB. In addition to

determining that these procedures will yield potentially useful societal

knowledge, they are evaluated in terms of whether they meet the test of

research equipoise.Can you give your opinion on how the IRB should review this proposal?kunda

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