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.)
Which of the following was the result of the Beecher articles?
Which of the following was the result of the Beecher article? Issued in 1974, 45 CFR 46 raised to regulatory status:
US Public Health Service Policy
(45 CFR 46 raised to regulatory status the US Public Health Service policy of 1966 “Clinical research and investigation involving human beings”.)
Which of the following is the most appropriate action to take for the investigator Citi?
Which of the following is the most appropriate action to take for the investigator?
Send a copy of the informed consent via facsimile to the subject’s wife
. After she has had the opportunity to speak to the investigator, she can sign the informed consent and fax it back.
Which of the following considerations was relevant to the IRB’s determination that this activity does not constitute research with human subjects quizlet?
Which of the following considerations was relevant to the IRB’s determination that this activity does not constitute research with human subjects?
The researcher will not be interacting/intervening with subjects and the data has no identifiers.
When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable?
It is such an administrative body that is founded to ensure the protection of human beings which take part in research projects. So, when an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable,
they will ensure the safety of human subjects involved
.
What is the most important aspect of the Nuremberg Code quizlet?
The Nuremberg Code states that once the human subject is enrolled in the experiment, he or she must stay enrolled until the experiment has come to an end. The Nuremberg code, which was developed after the second world war,
points out that voluntary consent can ruin an experiment an is not desirable
.
What was the Belmont Report in response to?
The Belmont Report was written in response to
the infamous Tuskegee Syphilis Study
, in which African Americans with syphilis were lied to and denied treatment for more than 40 years.
What is the primary purpose of a certificate of Confidentiality?
Certificates of Confidentiality are issued by the National Institutes of Health (NIH) and other HHS agencies
to protect identifiable research information from forced or compelled disclosure
.
What action can he expect by the IRB?
The researcher submits the research proposal to the institution’s IRB. What action can he expect by the IRB?
The IRB will not review this study because
it is not research as defined by the federal regulations.
Which of the following studies would need IRB approval?
Which of the following studies need IRB approval?
Studies collecting data about living individuals
. If a study intends to collect data or information about the living individual, an IRB review and approval must be obtained.
What is an example of a situation where deferential vulnerability might be a factor?
Deferential vulnerability is when
a person feels subordinate to another person due to social class, knowledge, or gender
. Many people feel this way when they compare themselves to medical doctors due to the physicians having more knowledge and being considered to be of a high social class.
What statement about risks in social and behavioral sciences research is most accurate:
Risks are specific to time, situation, and culture
. The primary purpose of a Certificate of Confidentiality is to: Protect identifiable research information from compelled disclosure.
Which choice best describes the purpose of most pharmacogenomic research quizlet?
Which choice best describes the purpose of most pharmacogenomic research?
Investigator A has biological specimens that are coded and linked to identifiers of the source individuals
.
Which of the following is considered a requirement of informed consent?
Valid informed consent for research must include three major elements:
(1) disclosure of information
, (2) competency of the patient (or surrogate) to make a decision, and (3) voluntary nature of the decision. US federal regulations require a full, detailed explanation of the study and its potential risks.
Which of the following is a reason that prisoners need special protection?
Which of the following is a reason that prisoners need special protection?
Prisoners have limited free choice because their autonomy is restricted
.
Which of the following is the best reason to explain why these data collections may not require prior IRB approval?
Which of the following is the best reason to explain why these data collections may not require prior IRB approval?
The hospitals are collecting these data with the intent to maintain or better their individual services and facilities programs
, with no intent to share or report the results with any other entity.
