online irb certification nih drug lit answers

8/9/2019 Online IRB Certification NIH Drug Lit Answers

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Codes and Regulations

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Section Quiz

You got 6correct out of 6.

Please answer all questions below1. 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

2. What are the three ethical principles that constitute the basis for the HHS HumanSubjects 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

3. Which entity has regulatory authority for the protection of human subjects for PHS-funded research?

A. OHRP

B. NIH

C. Institutions that receive Federal fundsD. HHS

4. True or False: All research that involves interaction or intervention with humans orhuman samples/data, whether they are alive or dead, is human subjects research.

A. True

B. False

5. True or False: An institutionally designated authority, other than the investigator,should determine that proposed studies are exempt from regulatory requirements.

A. True

B. False6. Which of the following should be eliminated or minimized in the research design?

A. Coercion

B. Research risks

C. Repeated recruitment of research participants for new protocols

D. All of the above
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Respect for Persons


Section Quiz


Please answer all questions below1. When might human subjects research require investigators to obtain informed

consent?

A. Investigators must obtain informed consent if the study involves interactions withresearch participants.

B. Investigators must obtain informed consent if the study involves interventions withresearch participants.

C. Investigators must obtain informed consent if the study involves collection of privateinformation from or about research participants.

D. All of the above

2. True or False: After informed consent for a research study is given, a researchparticipant must complete the study.

A. True

B. False

3. True or False: In general, informed consent should be a process rather than a one-time event.

A. True

B. False

4. In order to participate in research, children must

A. Provide written informed consent

B. Provide written permissionC. Provide assent, unless the IRB determines that they are too young

D. Sign, or put anXon the assent document

5. For research involving pregnant women, participation requires ...

A. That women have completed the first trimester.

B. That the study be conducted first in men.
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C. Permission of the father.

D. Consideration of risks and potential benefits for the fetus and the pregnant woman.

6. Why might an individual have diminished autonomy?

A. They are a neonate.

B. They are incarcerated or involuntarily confined.C. They are unconscious.

D. All of the above.

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Beneficence


Section Quiz


Please answer all questions below1. True or False: Risks to research participants must be completely eliminated for the

study to be considered ethical.

A. TrueB. False

2. When are researchers specifically required by NIH policy to describe Data and SafetyMonitoring?

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

3. True or False: There must be equipoise in order to justify conducting a clinical trial.

A. True

B. False

4. What is an appropriate method for maintaining confidentiality of private informationobtained from human subjects?

A. Keeping data in a password-protected database

B. Storing images in a secured cabinet


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C. Coding data or specimens and keeping the key to the code in a separate, lockeddrawer

D. All of the above are ways to maintain confidentiality

5. True or False: If a researcher determines that his/her study poses no more thanminimal risk as defined in 45 CFR 46, there is no need for the protocol to have IRB

review and approval.A. True

B. False

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Justice


Section Quiz


Please answer all questions below1. 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 involvechildren in the proposed research

2. True or False: For HIV antiretroviral treatment trials conducted in developingcountries, the NIH expects investigators/contractors to address the provision ofantiretroviral treatment to trial participants after their completion of participation inthe clinical trial.

A. True

B. False

3. Which of the following is TRUE regarding applications for NIH-funded researchoverseas?

A. It is illegal to spend NIH funds in research overseas

B. Research conducted overseas is subject to HHS Human Subjects Regulations (45CFR 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


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4. In localities where community consent is the norm,

A. A family member's consent for another individual may be sufficient, as long ascommunity 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

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online irb certification nih drug lit answers

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