Protecting Human Research Participants Certificate – Computer Apps in Public Health

A study proposing to involve pregnant adolescents who are detained in a juvenile detention center would only be allowed if:
The requirements of Subparts A, B, C, and D are met.
A “systematic investigation designed to develop or contribute to generalizable knowledge” may include:
Research Development
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.
What are the three ethical principles that constitute the basis for the HHS Human Subjects Regulations (45 CFR 46)?
Respect for Persons, Beneficence, Justice
Which entity has regulatory authority for the protection of human subjects for PHS-funded research?
All research that involves interaction or intervention with humans or human samples/data, whether they are alive or dead, is human subjects research.
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.
Research involving prisoners requires both specific IRB membership and approval by OHRP to signify that the proposed research falls within the permissible research categories.
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.
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.
In general, informed consent should be a process rather than a one-time event.
In order to participate in research, children must:
Provide assent, unless the IRB determines that they are too young
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.
Therapeutic misconception is the tendency for investigators to overemphasize the benefits of research to society while incorrectly minimizing the risks to a particular patient.
According to the regulations, to be approvable, research participation must provide a tangible benefit to the individual research subjects.
There must be equipoise in order to justify conducting a clinical trial.
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.
IRBs reviewing research in a different geographical location and/or cultural context have a responsibility to:
Defer to an IRB that is in the situated within the local research context and ask specialists with direct knowledge of the local research context to participate in IRB discussions
Children must be included in all NIH-supported human subjects research unless:
There are scientific and ethical reasons to exclude them
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.
The regulations strongly suggest but do not require that the informed consent process be delivered in a language that is understandable to the subject. T or F
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

D. All of the above.
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. T or F
No less stringent and is not necessarily shorter.
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

a) Scientific uncertainty that one study intervention is superior to another.
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. T or F
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

d) All of the above are ways to maintain confidentiality
When appropriate, research data should be ___________ to prevent accidental disclosure of private information.

a) De-identified
b) Maintained in multiple secure places
c) Published only in scientific journals

a) De-identified
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. T or F
The use of placebo in a clinical trial may be justified:

a) When there is agreement about whether the standard treatment is more effective than a placebo
b) For conditions where there is no approved, effective treatment
c) When the risks posed by placebo are significant and withholding the current standard therapy could lead to serious or permanent harm
d) All of the above

b) For conditions where there is no approved, effective treatment
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

d) All of the above
Social justice and individual justice are different and distinct, yet compatible, concepts. T or F
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