assessing risks and benefits in CT

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Let us now discuss the different levels of risks that are considered before the IRB

approves a project.

Levels

of risks

1. Minimal Risk

means that the probability and magnitude of harm or discomfort anticipated in

the research are not greater than those ordinarily encountered in daily life or

during the performance of routine physical and psychological examinations or

tests and where confidentiality is adequately protected. This category includes

protocols that pose “no greater than minimal risk†according to federal

regulations.

Requires Minimal Intensity Monitoring.

Examples of risk level 1:

Study poses no more risk than

expected in daily life (blood draw, physical exam, routine psychological

testing).Non-interventional studies

(e.g., observational studies of behavior or nutrition).Survey/Questionnaire studies

of a non-sensitive nature.

2. Minor Increase

over Minimal Risk– Research involves a minor increase over minimal

risk. There is medium to high probability of the occurrence of a low-severity

event that is completely reversible (e.g., headache from lumbar puncture) or

the likelihood of serious harm occurring is low (e.g., fatal anaphylaxis from

allergy skin testing).

Requires Low Intensity Monitoring.

Examples of risk level 2:

Studies of normal volunteers

using well-described research procedures and/or single dose of

experimental agent.Post-marketing study - phase

IV drug study or device (as defined by FDA) with minor safety concernsInterventions or invasive procedures

present low risks, reasonably commensurate with those expected in medical

or dental practice.Studies that involve

sensitive information or a potential risk of breach of confidentiality

3. Moderate Risk - Risks

are recognized as being greater than minimal, but are not considered high.

There is a medium to high probability of a moderate-severity event occurring as

a result of study participation (e.g., reversible worsening of a non-fatal

disease such as seasonal allergy while receiving placebo or pneumonia from a

bronchoscopy), but there is adequate surveillance and protections to identify

adverse events promptly and to minimize their effects.

Requires Moderate Intensity Monitoring.

Examples of risk level 3:

Subjects treated with placebo

for a recognized diseaseSubstantial risk of a serious

adverse event originating from the underlying condition of the enrolled

subject Involves subjects with

serious viral, autoimmune, and malignant illness in a treatment study in a

treatment studyPhase I or II, clinical trial

with available safety data in humans Minimal risk studies

involving vulnerable populations (i.e. Subjects with impaired capacity to

give informed consent)

4. High Risk - The study risk is greater than a moderate risk study

due to increased probability for generating serious adverse events. There is a

high probability of an event that is serious and prolonged or permanent

occurring as a result of study participation or there is significant

uncertainty about the nature or likelihood of adverse events.

Requires High Intensity Monitoring.

Examples of risk level 4:

Clinical trials of

interventions to prevent or treat diseases that lead to death or

irreversible morbidityInvolves an intervention or

invasive procedure with substantial risk or potential for severe toxicityAn investigator initiated IND

trialImplantation of a device with

an IDEInvolves the use of a new

chemical or drug for which there is limited or no available safety data in

humansA gene transfer study or

research involving recombinant DNA

moleculesAn investigator initiated

phase III clinical trial

As you can realize from the above post, it depends upon the level of risk involved in a project that decides how the IRB takes a decision for approval.kunda

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