What are the four common abuses that historically are described as giving rise to vulnerability?
There are four common abuses that historically are described as giving rise to vulnerability 1) physical control, 2) coercion, 3) undue influence, and 4) manipulation.
Which of the following is a general consideration for IRBs reviewing Big Data Research quizlet?
Which of the following is a general consideration for IRBs reviewing big data 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 Subpart S of the 45 CFR 46 is are sometimes referred to as the Common Rule group of answer choices?
The Common Rule is also referred to as “Subpart A” of the DHHS regulations of human research 45 CFR 46, to distinguish it from the other subparts listed below. Institutions assure that they will comply with the regulations regarding human subjects research.
What are the subparts of the 45 CFR?
The HHS regulations, 45 CFR part 46, include four subparts: subpart A, also known as the Federal Policy or the “Common Rule”; subpart B, additional protections for pregnant women, human fetuses, and neonates; subpart C, additional protections for prisoners; and subpart D, additional protections for children.
What is the common rule in bioethics?
The Common Rule is the baseline standard of ethics by which any government-funded research in the US is held; nearly all U.S. academic institutions hold their researchers to these statements of rights regardless of funding.
Why do we need regulations to protect human research subjects?
The decision to conduct a study with human subjects carries both ethical and regulatory responsibilities to protect the welfare and interests of those subjects, to design the study so as to minimize risks to subjects, and to obtain adequate training for protecting the interests and welfare of the research subjects.
Do IRBs effectively protect the rights and welfare of human subjects?
IRBs have a unique role since this is their reason for existence. While there are theoretical and practical controversies, most IRBs are becoming increasingly sophisticated and more able to provide good oversight of human subject protection, even if it is not a perfect system.
Why is it important to protect participants in a study?
One of the key aspects of protecting individuals participating in research is making assurances to those participants regarding how their personal information will be protected. This includes protecting participants’ privacy, keeping information confidential, and/or allowing the participant to remain anonymous.