Identify the most influential event that led to the HHS Policy for Protection of Human Research Subjects:
a. Nuremberg trials
b. Syphilis Study at Tuskegee
c. Jewish Chronic Disease Hospital Study
d. Willowbrook Study
What are the three ethical principles that constitute the basis for the HHS Human Subjects Regulations (45 CFR 46)?
A. Honesty, Trust, Respect
B. Informed consent, IRB review, Research Integrity
C. Respect for Persons, Beneficence, Justice
D. Protections for Pregnant Women, Prisoners, Children
Which entity has regulatory authority for the protection of human subjects for PHS-funded research?
C. Institutions that receive Federal funds
True or False: All research that involves interaction or intervention with humans or human samples/data, whether they are alive or dead, is human subjects research.
True or False: An institutionally designated authority, other than the investigator, should determine that proposed studies are exempt from regulatory requirements.
Which of the following should be eliminated or minimized in the research design?
B. Research risks
C. Repeated recruitment of research participants for new protocols
D. All of the above
When might human subjects research require investigators to obtain informed consent?
A. Investigators must obtain informed consent if the study involves interactions with research participants.
B. Investigators must obtain informed consent if the study involves interventions with research participants.
C. Investigators must obtain informed consent if the study involves collection of private information from or about research participants.
D. All of the above
True or False: After informed consent for a research study is given, a research participant must complete the study.
True or False: In general, informed consent should be a process rather than a one-time event.
In order to participate in research, children must ...
A. Provide written informed consent
B. Provide written permission
C. Provide assent, unless the IRB determines that they are too young
D. Sign, or put an "X" on the assent document
For research involving pregnant women, participation requires ...
A. That women have completed the first trimester.
B. That the study be conducted first in men.
C. Permission of the father.
D. Consideration of risks and potential benefits for the fetus and the pregnant woman.
Why might an individual have diminished autonomy?
A. They are a neonate.
B. They are incarcerated or
C. They are unconscious.
D. All of the above.
True or False: Risks to research participants must be completely eliminated for the study to be considered ethical.
When are researchers specifically required by NIH policy to describe Data and Safety Monitoring?
A. For all research involving human subjects
B. For all research involving children as subjects in research
C. For all clinical trials
D. For all research with prisoners
True or False: There must be equipoise in order to justify conducting a clinical trial.
What is an appropriate method for maintaining confidentiality of private information obtained from human subjects?
A. Keeping data in a password-protected database
B. Storing images in a secured cabinet
C. Coding data or specimens and keeping the key to the code in a separate, locked drawer
D. All of the above are ways to maintain confidentiality
True or False: If a researcher determines that his/her study poses no more than minimal risk as defined in 45 CFR 46, there is no need for the protocol to have IRB review and approval.
Children must be included in all NIH-supported human subjects research unless:
A. The researcher is not a pediatrician
B. Past experience has shown it is time-consuming and expensive to recruit children
C. There are scientific and ethical reasons to exclude them
D. The researcher does not possess the pediatric equipment necessary to involve children in the proposed research
True or False: For HIV antiretroviral treatment trials conducted in developing countries, the NIH expects investigators/contractors to address the provision of antiretroviral treatment to trial participants after their completion of participation in the clinical trial.
Which of the following is TRUE regarding applications for NIH-funded research overseas?
A. It is illegal to spend NIH funds in research overseas
B. Research conducted overseas is subject to HHS Human Subjects Regulations (45 CFR 46) and local regulations and policies
C. Research conducted overseas is only subject to local regulations and policies
D. Research conducted overseas need not address human subjects protections
In localities where community consent is the norm,
A. A family member's consent for another individual may be sufficient, as long as community consent is given
B. Federal regulations preclude the conduct of PHS-funded research
C. Community consent to participate in the research study is sufficient and no IRB approval is required
D. In addition to the cultural norm, individual informed consent is required