Medical Informatics IRB Quiz

Issued in 1974, 45 CFR 46 raised to regulatory status:

US Public Health Service Policy

Which of the following is included in the Nuremberg Code:

Voluntary consent

PI IRB Responsibilities

All aspects of IRB approval (initial, renewal, modifications) Tracking and reporting noncompliance and adverse events Inactivation of IRB

Which of the following brought increased public attention to the problems with the IRB system?

Death of Jesse Gelsinger

Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects?

Determining that the study has a maximization of benefits and a minimization of risks.

Declaration of Helsinki

Divides these activities into two basic categories: Standard medical care or treatment Research, which is further divided into Medical/Clinical research Nonclinical biomedical research

The National Research Act of 1974

Established the National Commission.

How long is an investigator required to keep consent documents, IRB correspondence, and research records?

For a minimum of three years after completion of the study

Belmont Report

Identifies three basic ethical principles, the "Belmont Principles" Respect for persons Beneficence Justice

FDA Definition of Human Research

Is the activity a clinical investigation? Does the research involve human subjects? Research involving a test article cannot be "exempt" under FDA regulations

DHHS Definition of Human Research

Is the activity research? Does the research involve human subjects? Is this human research exempt from IRB approval?

Respect for Persons (Pillar of Belmont Report)

Mental capacity (and providing extra protection for those who can't) Voluntariness Obtain informed consent Respect Privacy

Four Types of Review

Not research or nonhuman research Exempt from review Expedited IRB review (minimal risk, must fit into one of seven categories) Full IRB review (greater than minimal risk)

IRB continuing review of an approved protocol must:

Occur at least annually.

Which of the following studies has the LEAST potential to create group harm?

Phase 3 clinical trial of a new anticancer agent in middle-aged women diagnosed with breast cancer.

The use of prisoners in research is a concern under the Belmont principle of Justice because:

Prisoners may be used to conduct research that only benefits the larger society

Which of the following was the result of the Beecher article?

Realization that ethical abuses are not limited to the Nazi regime

A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?

Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB.

Informed consent is considered an application of which Belmont principle?

Respect for Persons

Which of the following are the three principles discussed in the Belmont Report?

Respect for Persons, Beneficence, Justice.

All of the following are true regarding the Belmont Report, EXCEPT:

The Belmont Report indicates that it is necessary to rigorously avoid conflicts of interest.

Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if:

The changes must be immediately implemented for the health and well being of the subject.

According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?

The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations

Justice (Pillar of Belmont Report)

Treat people fairly Design research so its burdens and benefits are shared equally Select subjects equitably Avoid exploitation of vulnerable populations