Exam 14: Ensuring Ethical Research

When submitting a research proposal application to an institutional review board (IRB), the application will typically address some major topics. Which of the following would not likely be included among these?

Research policies required by the Health Insurance Portability and Accountability Act (HIPAA) only pertain to studies where public or private insurance (or other reimbursement sources) are billed for experimental services.

What is the role of the institutional review board (IRB) in protecting human subjects?

Which of the following is not one of the Principles of Belmont?

In both the Tuskegee Experiments and Nazi Doctors Trials, examples of ethical misconduct included the following: informed consent was not being obtained, known harm was inflicted to subjects without regard to pain and suffering, and the potential benefits did not outweigh the associated risks of the studies.

Following multiple instances of unethical research practices, regulations were put into place to protect subjects and ensure ethical research practices. Which of the following is not an example of a regulatory code put into place toward this effort?

The impetus for contemporary ethical standards for the protection of human research subjects is grounded in previous abuses of humans under the guise of research, such as the Nazi Doctors Trials and the Tuskegee Experiments.

The Office of Research Integrity defines misconduct for purposes of research. Which of the following characteristics is not part of their description?

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

Within an institutional review board (IRB), committee members must be:

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

When researchers receiving federal funding are investigated and judged to have engaged in research misconduct, there is the potential for significant penalties and consequences, including imprisonment.

Regarding the training of key personnel as required by typical institutional review board (IRB) guidelines, which of the following statements is correct?

The principal investigator is ultimately responsible for ensuring that human subject protections are followed, reporting any unanticipated problems involving risks to subjects or others, and for abiding by the institutional review board (IRB) approved protocol and consent document/process.

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