IRB Flashcards
What is the definition of practice as defined by the Belmont Report (1976)
interventions designed to enhance the well-being of an individual pt and that have a reasonable expectation of success.
Goal: provide dx, preventative tx/therapy
What is the definition of research as defined by the Belmont Report
activity designed to test a hypothesis, draw conclusions, to increase generalizable knowledge
experimental procedures are NOT always considered research (ex: new, untested, different technology)
if there is ANY element of research in an activity, that activity should undergo review for the protection of human subjects
Describe the following basic ethical principle as outlined by the Belmont report: respect for persons
individuals should be tx as autonomous agents AND persons w diminished autonomy are entitled to protection
subjects enter into research voluntarily and with adequate info
not everyone is capable of self-determination
What are the basic ethical principles outlined in the Belmont report
respect for persons, beneficence, justice
Describe the following basic ethical principle as outlined by the Belmont report: beneficence
do not harm AND maximize possible benefits and minimize possible harms
decide when it is justifiable to seek certain benefits despite the risks involved and when the benefits should be foregone bc of the risks
Describe the following basic ethical principle as outlined by the Belmont report: justice
selection of the research participants needs to be scrutinized to determine whether some classes are being systematically selected
What is the importance of information giving in terms of the Belmont report
ppl knowing the procedure is neither necessary for their care nor perhaps fully understood, can decide whether they wish to participate in furthering of knowledge
information about risks should NEVER be withheld for the purpose of eliciting the cooperation of subjects and truthful answers should always be given to direct questions about the research (take care to distinguish cases in which disclosure would destroy/invalidate the ongoing research)
What is the importance of comprehension in terms of the Belmont report
When comprehension is severely limited respect requires giving the individual the opportunity to choose to the extent that they are able
objections should be honored unless the research provides a therapy unavailable elsewhere
3rd parties may be utilized- they should be those who are most likely to understand the incompetent subject’s situation and to act in that person’s best interest
What is the importance of voluntariness in terms of the Belmont report
must be free of coercion/undue influence
Define coercion in terms of research
overt threat of harm is intentionally presented by one person to another to obtain compliance
Define undue influence in terms of research
an offer of an excessive, unwarranted inappropriate or improper reward or other overture to obtain compliance
What is the Common rule
protects 3 distinct groups of vulnerable populations
Part B: pregnant women, human fetuses, and neonates- protected bc research may pose additional and/or unknown risks
Part C: children- defined as an individual under the age of 18; research w children requires assent from the child AND permission from parents; when children are wards of the state or other entity, an advocate is required AND an individual acting on behalf of the child as a guardian
Part D: prisoners; protected bc prisoners may not be free to make a truly voluntary and uncoerced decision regarding whether or not to participate in research
Part E: registration of IRBs; establishes IRBs, informed consent, and scope of human research subject protections
What is a protocol deviation?
Occurs when an investigator does not implement or follow some aspect of a research study as approved by the IRB. An example of a protocol deviation would be enrolling a participant who did not meet all the inclusion criteria for study.
What is research misconduct?
Refers to the fabrication, falsification or plagiarism and proposing performing or reviewing research or in reporting research results
What are privacy violations in terms of research?
Involves the unauthorized access use or disclosure of a research subjects personal information
