Beecher. An article by Beecher’s in 1966 on
unethical medical experimentation
in the New England Journal of Medicine — “Ethics and Clinical Research” — was instrumental in the implementation of federal rules on human experimentation and informed consent. …
Which of the following was the result of the Beecher article the National research Act 1974?
Which of the following was the result of the Beecher article? Issued in 1974, 45 CFR 46 raised to regulatory status: …
The study involves no more than minimal risk & meets one of the allowable categories of expedited review specified in federal regulations
.
Which of the following was a result of the Beecher article?
Beecher. An article by Beecher’s in 1966 on
unethical medical experimentation
in the New England Journal of Medicine — “Ethics and Clinical Research” — was instrumental in the implementation of federal rules on human experimentation and informed consent. …
In what way did the Beecher article Impact research in the United States?
In what way did the Beecher article impact research in the United States? …
It prompted congress to create an ad hoc panel to provide oversight for human research
.
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. You just studied 35 terms!
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.
Why is Ethics important in clinical research?
Importance of Ethics in Clinical Research
Not only do
ethical strategies ensure the integrity of the research results
, they also protect the safety of patients who volunteer to participate in the trials. And ethical parameters help prevent participants from being exploited or treated unfairly by the research team.
Why was the Nuremberg Code developed quizlet?
The Nuremberg Code is
a set of research ethics principles for human experimentation set in 1947 as a result of the Nuremberg Trials of Nazi war criminals at the end of WWII
. … Before the code, there was no generally accepted code of conduct governing ethics of human research.
What is the purpose of informed consent quizlet?
The purpose of informed consent is:
To provide a potential subject with appropriate information in an appropriate manner and allow that person to make an informed decision about participation in research
. A general requirement for the informed consent is that no informed consent may include any exculpatory language.
Which 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.
What are the three 3 main components of respect for individuals?
The Belmont Report summarizes ethical principles and guidelines for research involving human subjects. Three core principles are identified:
respect for persons, beneficence, and justice
.
What is the 45 CFR 46?
Laws set by the U.S. Department of Health and Human Services (DHHS) to protect a person from risks in research studies that any federal agency or department has a part in. Also called 45 Code of Federal Regulations Part 46,
human participant protection regulations, and Protection of Human Subjects
.
Which choice best describes the purpose of most 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 are the three types of IRB review?
IRB must review all projects that meet the definition of research and that involve human subjects prior to any data collection to determine the appropriate level of review, and, as appropriate, approve them. There are three major types of review:
Exempt, Expedited, and Full
.
What is IRB and its process?
Under FDA regulations, an IRB is an appropriately constituted group that has
been formally designated to review and monitor biomedical research involving human subjects
. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research.
What needs IRB approval?
FDA regulations generally require IRB review and approval of
research involving FDA-regulated products
(e.g., investigational drugs, biological products, medical devices and dietary supplements) (21 CFR Part 56).
