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IRB Question and Answer

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on 21 July 2014

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Transcript of IRB Question and Answer

Which entity has regulatory authority for the protection of human subjects for Public Health Service-funded research and when did they take on that role?

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1974
When might human subjects require investigators to obtain informed consent?

- If the study involves interatcions with research participants.
- If the study involves interventions with research.
- If the study involves collection of private information from or about research participants.

In localities where community consent is the norm...

D. In addition to the cultural norm, individual informed consent is required
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.

What was the most influential event that led to the HHS Policy for Protection of Human Research Subjects and why?

The Tuskegee Syphilis Study

When are researchers specifically required by NIH policy to describe Data and Safety Monitoring?

C. For all clinical trials
For research involving pregnant women, participation requires...
True or False: Risks to Research participants must be completely eliminated for the study to be considered ethical.

What is "data and safety monitoring"?

The process for reviewing data collected as research progresses to ensure the continued safety of current and future participants as well as the scientific validity and integrity of the research.
What is the law that protects and provides for portability in health data? Describe it's main protections and responsibilities.
45 CFR 46, its main protections and responsibilities include:
Requirements for assuring compliance by research institutions
Requirements for researchers obtaining and documenting informed consent
Requirements for IRB membership, function, operations, review of research, and record keeping
Additional protections for certain vulnerable research subjects - pregnant women, prisoners, and children
True or False: In general, informed consent should be a process
rather than a one-time event.

Respect for persons, beneficence, and justice
What are the three ethical principles that constitute the basis for the HHS Human Subjects Regulations
(45 CFR 46)?
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.
D. All the above
Which of the following should be eliminated or minimized in the research design, and why?
A. Coercion
B. Research Risks
C. Repeated recruitment of research participants for new protocols
D. All the above

True or False: After informed consent for a research study is given, a research participant must complete the study
IRB Question and Answer
In order to participate, children must...
Provide assent unless the IRB determines them to be too young
Explain Consent vs. Assent

Consent means to give permission
Assent means to agree and understand (usually for children who aren't old enough to consent)
Consideration of risks and potential benefits for the fetus.
Why might an individual have diminished autonomy?
They are neonate, they are incarcerated of involuntarily confined or they are unconscious
What is an appropriate method for maintaining confidentiality of private information obtained from human specimens?
D. All of the above are ways to maintain confidentiality
Which of the following is TRUE regarding applications for NIH funded research overseas?
B. Research conducted overseas is subject to HHS human Subjects Regulations (45 CFR 46) and local regulations and policies
By Suzanne Rutter, Sara Richards and Clare Powell
Full transcript