GU Research Module 2
Card Set Information
GU Research Module 2
_______ provided a model for many disciplinary guidelines.
Three major ethical principles from the Belmont Report.
Respect for Human Dignity
______ involves the performance of some good and the protection of participants from physical and psychological harm and exploitation (
_____________ involves participants' right to self-determination, which means they have the freedome to control their own actions, including voluntary participation.
Respect for Human Dignity
_________ means that researchers have fully divulged participants' rights and the risks and benefits of the study.
When participants' rights and study demands are in direct conflict, this is called?
________ imposes a duty on researchers to minimize harm and maximize benefits.
This means that prospective participants can voluntarily decide whether to take part in a study, without risk of prejudicial treatment.
A person's right to self-determination includes freedom from _______.
______ involves threats of penalty from failing to participate in a study or excessive rewards from agreeing to participate.
What is a stipend?
a monetary incentive offered to encourage participation among an economically disadvantaged group
The collection of data without participants' knowledge and consent.
covert data collection
Deliberately withholding information about the study or providing participants with false information.
What is a risk-benefit assessment?
examines whether the benefits of participating in a study are in line with the costs
Minimal risk is no greater than those ordinarily encountered in ____ _____ or during routine ____ or ______.
Informed consent means that participants have adequate information about _____, __________, and have ability to consent or decline ________?
comprehend the information
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
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)
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?
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.
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.
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?
When can an expedited review be done?
When risks to participants are minimal
Forms of research misconduct
fabrication of results
falsification of data
What type of consent is used in qualitative studies to continually negotiate?
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
For researchers evaluating interventions in clinical trials, NIH also requires review by who?
Data and Safety Monitoring Board
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
Making up data or study results
Manipulating research materials, equipment, or processes.
Changing or omitting data.
Distorting results such that the research is not accurately represented in reports.
To be construed as misconduct, there must be a _______ from _______.
To be construed as misconduct, it must have been committed _______.
intentionally, knowingly, or recklessly