IPP3 - Exam 2 - Ethics, Guidelines, Cases Johnson

Match the following

• Tuskegee Syphilis

• ethical principles and guidelines for the protection of human subjects of research

• Ethical Principles of the Belmont Report

• federally funded research need to set up an institutional review board

• Nuremburg code

• respect for persons, beneficence, justice

• National Research Act (1974)

• this study led to establish the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research

• Belmont Report

• participation in research must be voluntary and should never cause deliberate harm

Answer explanation

Tuskegee Syphilis study led to the creation of the National Commission for Protection of Human Subjects of Biomedical a Behavioral Research and required institutions that are federally funded to set up an Institutional Review Board (IRB)

World War II triggered the creation of

• the Nuremburg code

• the National Research Act

• the National Commission for Protection of Human Subjects of Biomedical and Behavioral Reserach

• the Protection of Human Subjects of Research

• the Belmont Report

Answer explanation

Nuremberg Code: participation in research must be voluntary and should never cause deliberate harm

The Tuskegee Syphilis study triggered the creation of

• the Nuremburg code

• the National Research Act

• the National Commission for Protection of Human Subjects of Biomedical and Behavioral Reserach

• the Protection of Human Subjects of Research

• the Belmont Report

Answer explanation

The National Research Act (1974) also required that institutions engaging in federally funded research need to set up an Institutional Review Board (IRB)

What discusses the 3 fundamental ethical principles that must be the basis of all research with human subjects

• the Nuremburg code

• the National Research Act

• the National Commission for Protection of Human Subjects of Biomedical and Behavioral Reserach

• the Protection of Human Subjects of Research

• the Belmont Report

Answer explanation

1. Respect for persons

2. Beneficence

3. Justice

Established in 1979

Informed consent is:

• process by which a potential study subject is presented with information about the study and willingly volunteers to participate

• ongoing dialogue b/w study personnel and participants

• must be presented in an understandable manner, understanding must be verified

• may be influenced under coercion and duress as long as it is what is medically best for the patient

• persons with diminished autonomy require special safeguards to prevent their exploitation in research

Answer explanation

Informed consent may not be performed under coercion, undue influence, or duress

Consent is ___ to be included in the research protocol for IRB approval

• required

• suggested

• not

An IRB exemption means that your research is exempt from HIPAA laws

• true

• false

Answer explanation

Even if human subject protection rules do not apply, HIPAA still applies

An Institutional Review Board (IRB) is a committee that is formally designated to ___ research

• approve

• monitor

• review biomedical and behavioral

• perform

• pass laws on

The mission of the IRB is to protect human subjects from physical or psychological harm caused by experimental research

• true

• false

A "human subject" is a living individual whom an investigator can obtain

• data through interaction

• data through intervention

• identifiable private information

• identifiable biospecimens

• data through existing published literature

Answer explanation

Reviews or meta-analyses of existing published literature is NOT considered a "human subject"