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
An “autonomous person” is someone who:
A. Has reached the legal age to provide informed consent in the State.
B. Is willing to accept certain risks if the research will benefit others in the future.
C. Understands the risks and benefits of his or her participation and is able to make a voluntary decision if adequate information is provided.
D. Meets all eligibility criteria for a study and asks the investigator if she or he may participate.
The Belmont Report is significant because:
A. It was written by the National Commission for the Protection of Human Subjects.
B. It articulated ethical principles that formed the basis for the HHS Human Subjects Regulations.
C. Belmont is another word for individual autonomy and respect.
D. It was a seminal document about the concept of informed consent.
A “systematic investigation designed to develop or contribute to generalizable knowledge” may include:
B. Research Development
D. All of the above
True or False: Communities may grant emergency waivers of informed consent for research involving pregnant women in the community who are in active labor and call Emergency Medical Services.
True or False: Requirements specific to informed consent for prisoners include adequate assurance that parole boards do not consider a prisoner?s participation in making decisions regarding parole.
True or False: The regulations strongly suggest but do not require that the informed consent process be delivered in a language that is understandable to the subject
True or False: According to the regulations, to be approvable, research participation must provide a tangible benefit to the individual research subjects.
Risk to research subjects includes:
A. Physical, psychological, social, legal or economic harm that may reasonably be anticipated as a result of participation in research
B. The probability that a certain harm will occur from disclosure of findings
C. Unforeseen physical harm that is possible from participation in therapeutic research
D. All of the above
True or False: Financial compensation of individual research participants is one way to achieve a favorable ratio of benefit to risk, provided that the amount does not constitute undue inducement.
True or False: Social justice and individual justice are different and distinct, yet compatible, concepts.
True or False: It is ethical to use deceptive methods in research when the scientific goals of the project can be achieved by non-deceptive methods.
Which subpart(s) of the 45 CFR 46 is/are sometimes referred to as The Common Rule
A. Subpart A which describes the required protections for all human subjects
B. Subparts B, C , and D which deal with protections for certain vulnerable subjects
C. Subpart E which addresses the registration of IRBs
D. All of the above
Waivers of informed consent can be granted by which of the following:
A. The NIH or other funding agency
B. The Department of Justice
C. The IRB
D. Any of the above.
True or False: One of the requirements of informed consent is that subjects must be told whether they are eligible to receive compensation if they are injured as a result of their participation in the research.
Which of the following most accurately describes clinical equipoise:
A. Scientific uncertainty that one study intervention is superior to another.
B. A reasonable balance of risks and benefits to research subjects
C. When the probability and magnitude of harm or discomfort is not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological exams
D. A double blind controlled trial
When appropriate, research data should be ___________ to prevent accidental disclosure of private information.
B. Maintained in multiple secure places
C. Published only in scientific journals
True or False: 1. Because the expedited IRB review process is generally used for certain types of minimal risk research, it is less stringent than review by the full IRB.
True or False: 2. Therapeutic misconception is the tendency for investigators to overemphasize the benefits of research to society while incorrectly minimizing the risks to a particular patient.
True or False: 3. An example of a potential economic risk to a research subject is the potential negative impact research may have on the employment or promotion potential of a research subject.
NIH has specific policies addressing:
A. Inclusion of children in research
B. Inclusion of women and minorities in research
C. Treatment for research subjects in HIV/AIDS antiretroviral studies following completing of trials in developing countries
D. All of the above
True or False: Excluding children from participation in research, while well intentioned, may deny children the benefits of participation and prevent the collection of sufficient data about the possible effects of potentially therapeutic agents in children.
IRBs reviewing research in a different geographical location and/or cultural context have a responsibility to:
A. Obtain knowledge of the local context by talking to those who have traveled to the region
B. Defer to an IRB that is in the situated within the local research context
C. Ask specialists with direct knowledge of the local research context to participate in IRB discussions
D. B or C
E. A or C
1. A study proposing to involve pregnant adolescents who are detained in a juvenile detention center would only be allowed if:
A. The requirements for Subpart B, Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research are met, because Subpart B takes precedence over Subpart D.
B. The requirements of Subparts A, B, C, and D are met.
C. Such research would never be allowed because it involves an extremely vulnerable population.
D. The research is noninvasive and the adolescent detention periods are temporary and will end at about the same time the study is completed.
The three fundamental principle of Informed consent are
A. Voluntariness, Equipoise, Respect
B. Voluntariness, Comprehension, Disclosure
C. Benefits, Comprehension, Privacy
D. Disclosure, Equipoise, Privacy
True or False: 45 CFR 46 requires Federal Departments and Agencies to rely solely on IRBs to evaluate risks to subjects, protection against these risks, potential benefits of the research and the importance of the knowledge to be gained.
True or False: Research involving prisoners requires both specific IRB membership and approval by OHRP to signify that the proposed research falls within the permissible research categories.