What is the term for management controls that are built in to a research study?
What is the term for management controls that are built in to a research study (for example, independent data analysis)? Inherent controls.
Can investigator B use the specimens for cancer research?
Can Investigator B use the specimens for cancer research without re-consent if the specimens are de-identified? Yes, if the biospecimens are de-identified then the research is no longer considered human subjects research.
Which choice best describes the purpose of pharmacogenomic research?
1 Answer. To evaluate the association between individual genotypes and the safety and efficacy of a particular drug or class of drugs.
What is the main risk of harm in big data research characterized as?
The main risk to human subjects in these contexts, as identified by IRBs, has been breach of confidentiality and any resulting psychological, social, legal, or financial harm.
What is true of inducements in research?
Which is true of inducements in research? Inducements constitute an “undue influence” if they alter a potential subject’s decision-making processes, such that they do not appropriately weigh the risk-benefit relationship of the research.
Which of the following issues is the most important for the IRB to consider?
Answer: the most important issue for IRB (Institutional Review Board) to consider is the effect of the findings on family members.
What is an example of a situation where deferential vulnerability might be a factor?
An example of a situation where deferential Vulnerability might be a factor is a physician recruiting his patients.
Which of the following brought increased public attention to the problems?
Which of the following brought increased public attention to the problems with the IRB system? Death of Jesse Gelsinger (Although all of these are related to the problems with the IRB system, the death of Jesse Gelsinger was what received public attention.)
Examining age at the first arrest is the example of research in which prisoners would be allowable under the regulations. Further Explanation: The age of the criminal is examined because to check the history of the criminal of adult crime. Research on criminals is governed by federal laws.
Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB. The reviewer(s) may exercise all the authorities of the IRB, except disapproval.
What is a full board review?
Full board review usually involves research that is greater than minimal risk but also includes minimal risk research that does not meet one or more of the Expedited Review Categories. If the full board determines that the research is indeed minimal risk, then all subsequent reviews may use Expedited Review procedures.
What is a convened review?
All research involving human subjects that does not qualify for Exempt or Expedited review is reviewed by the convened IRB. For example, convened review is required for all research that involves. greater than minimal risk. investigational drugs.
What are the 13 principles of ICH GCP?
What is the role of IRB IEC?
1 An IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects. Special attention should be paid to trials that may include vulnerable subjects.
How many principles of GCP are there?
13
How long is IRB training?
How long will it take to complete the course? Each CITI module has text to read and a quiz to complete. The average learner spends approximately 4.5 hrs in the Basic Course site and approximately 1.5 hours if your site requires additional modules. The Refresher Training will take approximately 2 hours.
Who is responsible for protecting human subjects?
‘ (Code of Federal Regulations for Department of Health and Human Services 45CFR46. 102(d)). Human subject protections are a shared responsibility of principal investigators, other personnel involved in studies with human subjects, and the Institutional Review Board (IRB).
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