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The NIH Policy on the Dissemination of NIH-Funded Clinical Trial
Information also requires registration for all clinical trials
funded wholly or partly by the NIH - ANSWERS-ClinicalTrials.gov
The sponsor is usually the responsible party for the purposes of
submitting information about the clinical trial, unless the
sponsor designates a qualified PI as the responsible party.
According to 42 CFR 11, the responsible party would need to: -
ANSWERS-1) Register the trial on ClinicalTrials.gov
2) Submit summary results and AE information about the trial
to ClinicalTrials.gov
3) Ensure the information about the registered trial was
accurately submitted to ClinicalTrials.gov
,An autonomous person - ANSWERS-A person capable of
deliberation about personal goals and of acting under the
direction of such deliberation
Beneficence - ANSWERS-Do not harm and maximize possible
benefits and minimize possible harms
Justice - ANSWERS-1) to each person an equal share 2) to each
person according to individual need 3) to each person
according to individual effort 4) to each person according to
societal contributions 5) to each person according to merit
Justice - ANSWERS-· The selection of research subjects needs to
be scrutinized in order to determine whether some classes are
being systematically selected simply because of their easy
availability, their compromised position, or their manipulability,
rather than for reasons directly related to the problem being
studied.
Justice - ANSWERS-· Whenever research supported by public
funds leads to the development of therapeutic devices and
,procedures, justice demands both that these not provide
advantages only to those who can afford them and that such
research should not unduly involve persons from groups
unlikely to be among the beneficiaries of subsequent
applications of the research.
Belmont Report (1979) - ANSWERS-ethical principles and
guidelines for the protection of human subjects of research.
respect for persons - ANSWERS-individuals should be treated as
autonomous agents and persons with diminished autonomy are
entitled to protection
Three elements of the consent process - ANSWERS-information,
comprehension, voluntariness
What is an example of how the principle of beneficence can be
applied to a study employing human subjects - ANSWERS-
Determining the study has a maximization of benefits and a
minimization of risks
, What are the three principles discussed in the Belmont Report?
- ANSWERS-Respect for persons, beneficence, justice
The Belmont Report's principle of respect for persons
incorporates at least 2 ethical convictions: first, that individuals
should be treated as autonomous agents, and second, that: -
ANSWERS-Persons with diminished autonomy are entitled to
protection
Nuremberg Code (1947) - ANSWERS-1) a requirements for
voluntary consent 2) the research must have scientific merit 3)
The benefits of the research must outweigh the risks 4)
Subjects have the ability to terminate participation in the
research at any time
National Research Act (1974) - ANSWERS-1) Authorized the
creation of the National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research, which
was charged with developing an ethical code and guidelines for
researchers 2) Required the establishment of IRBs at
organizations receiving PHS support for human subject's
research
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