chapter 14

Lack of informed consent and infliction of harm without consideration of well-being are two forms of ethical misconduct that occurred in both the Tuskegee Experiments and Nazi Doctors Trials.

• True

• False

• Not mentioned

• Partially true

Research policies required by the Health Insurance Portability and Accountability Act (HIPAA) only pertain to studies where insurance is billed for services deemed experimental.

• True

• False

• Only for clinical trials

• Only for non-experimental studies

Once informed consent has been obtained, an investigator should never revisit or review the document with participants for the duration of a study.

• True

• False

• Only if necessary

• Only at the end of the study

The World Medical Association adopted principles set forth in the Declaration of Helsinki regarding the ethical conduct of human research.

• True

• False

• Only for clinical trials

• Only for non-human research

Ownership rights of data collected during a study belong to the principal investigator, regardless of who collected the data or funded the study.

• True

• False

When researchers receiving federal funding are judged to have engaged in research misconduct, the potential exists for significant penalties, including imprisonment.

• True

• False

Once research is initiated, the institutional review board (IRB) is responsible for a substantive re-review of the research that occurs no less often than once every 365 days.

• True

• False

The principal investigator is responsible for ensuring that human subject protections are followed, and for abiding by the IRB approved protocol.

• True

• False

Which of the following is not an example of a regulatory code put into place to prevent unethical research practices?

• The Nuremberg Code

• The Declaration of Helsinki

• The Treaty of Versailles

• The Principles of Belmont

What is the role of the IRB in protecting human subjects?

• An IRB exists to evaluate the financial risks associated with research for the institution.

• An IRB exists to review research proposals and ensure that studies are safe and ethical for all participants.

• An IRB exists to ensure all documentation related to research is adequate and correct.

• An IRB exists to exclusively protect human research subjects.