Chapter 3 Flashcards
Conceived or formulated before an investigation.
A priori
A basic principle of ethics that states that persons should have their decisions respected, be protected from harm, and have steps taken to ensure their well-being.
Beneficence
A type of philosophy that studies right and wrong.
Ethics
A review of study proposals that pose no risk to subjects; the full IRB is not required to participate.
Exempt review
A review of study proposals that pose minimal risk to subjects; one or two IRB members participate.
Expedited review
Reporting as much information about the research as is known at the time without threatening the validity of the study. This practice allows the subject to make an informed decision as to whether to participate.
Full disclosure
A review of study proposals that pose more than minimal risk to subjects, that do not qualify for exempt status, and in which the full IRB committee participates.
Full review
Health Insurance Portability and Accountability Act passed by Congress in 1996 that protects the privacy of personal health information.
HIPAA
A process of information exchange that begins with subject recruitment and includes full disclosure of risks and benefits and the provision of understandable information needed to make a participation decision.
Informed consent
The board required in research institutions that reviews and oversees all research involving human subjects and ensures studies meet all federal regulation criteria, including ethical standards.
Institutional review board (IRB)
A basic principle of ethics that incorporates a participant’s right to fair treatment and fairness in distribution of benefit and burden.
Justice
Studies that are carried out for the purpose of generating knowledge. They are not expected to benefit the research subject, but may lead to improved treatment in the future.
Nontherapeutic research
A basic principle of ethics stating that individuals should be treated as autonomous beings, who are capable of making their own decisions. Persons who have limited autonomy or who are not capable of making their own decisions should be protected.
Respect for persons
A person’s right to have his or her health information kept confidential and released only to authorized individuals and to have his or her body shielded from public view.
Right of privacy
Studies in which the subject can be expected to receive a potentially beneficial treatment.
Therapeutic research
