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_______ provided a model for many disciplinary guidelines.
Belmont Report
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Three major ethical principles from the Belmont Report.
- Beneficence
- Respect for Human Dignity
- Justice
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______ involves the performance of some good and the protection of participants from physical and psychological harm and exploitation (nonmalificence).
Benificence
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_____________ involves participants' right to self-determination, which means they have the freedome to control their own actions, including voluntary participation.
Respect for Human Dignity
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_________ means that researchers have fully divulged participants' rights and the risks and benefits of the study.
Full disclosure
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When participants' rights and study demands are in direct conflict, this is called?
ethical dilemma
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________ imposes a duty on researchers to minimize harm and maximize benefits.
Benificence
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This means that prospective participants can voluntarily decide whether to take part in a study, without risk of prejudicial treatment.
Self-determination
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A person's right to self-determination includes freedom from _______.
coercion
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______ involves threats of penalty from failing to participate in a study or excessive rewards from agreeing to participate.
coercion
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What is a stipend?
a monetary incentive offered to encourage participation among an economically disadvantaged group
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The collection of data without participants' knowledge and consent.
covert data collection
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Deliberately withholding information about the study or providing participants with false information.
deception
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What is a risk-benefit assessment?
examines whether the benefits of participating in a study are in line with the costs
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Minimal risk is no greater than those ordinarily encountered in ____ _____ or during routine ____ or ______.
- daily life
- tests
- procedures
-
Informed consent means that participants have adequate information about _____, __________, and have ability to consent or decline ________?
- the research
- comprehend the information
- voluntarily
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What must be done if a short form is used?
the oral presentation must be witnessed by a third party, and witness's signature must appear on the short consent form
-
The U.S. formal committee for reviewing proposed research plans.
Institutional Review Board
-
The Canadian formal committee for reviewing proposed research plans.
Research Ethics Board
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Who carries out the expedited review?
a single IRB member (usually the chairperson)
-
For researchers evaluating interentions in clinical trials, NIH also requires review by?
a data and safety monitoring board (DSMB)
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Which of the three major ethical principles from the Belmont Report means that researchers have fully dibuled participants' rights and the risks and benefits of the study?
Full disclosure
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Which of the three major ethical principles from the Belmont Report involves the right to self-determination?
Respect for human dignity
-
_______ means the participants have the freedome to control their own actions.
self-determination
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What do researchers sometimes use when full discosure could yield biased results?
covert data collection or concealment or deception
-
This includes either withholdig info from participants or providing false info.
deception
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Of the three major ethical principles from the Belmont Report, JUSTICE includes what two things?
- the right to fair treatment
- the right to privacy
-
What protects researchers against the forced disclosure of confidential information through a court order or other legal or admin process?
Certificate of Confidentiality
-
What three groups of people may be considered vulnerable?
- children
- prisoners
- pregnant women
-
When can an expedited review be done?
When risks to participants are minimal
-
Forms of research misconduct
- plagiarism
- fabrication of results
- falsification of data
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What type of consent is used in qualitative studies to continually negotiate?
process consent
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What three things must be included in an authorization for a hospital to disclose individually identifiable health info?
- what type of info will be disclosed
- who will receive the info
- what further disclosures the researcher anticipates
-
Privacy Boards are used to review researchrs' compliance with what?
HIPAA, including review of authorization forms & requests for waivers
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For researchers evaluating interventions in clinical trials, NIH also requires review by who?
Data and Safety Monitoring Board
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The US agency responsible for overseeing efforts to improve research integrity and for handling allegations of research misconduct.
Office of Research Integrity w/in DHHS
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Making up data or study results
fabrication
-
Manipulating research materials, equipment, or processes.
falsification
-
Changing or omitting data.
falsification
-
Distorting results such that the research is not accurately represented in reports.
falsification
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To be construed as misconduct, there must be a _______ from _______.
- significant departure
- accepted practices
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To be construed as misconduct, it must have been committed _______.
intentionally, knowingly, or recklessly
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