Human Subjects Flashcards
A purpose of monitoring clinical trials is to verify that
The rights, safety, and well-being of human subjects are protected
Any subject enrolled to a non-treatment arm
should still undergo all study procedures outlined in the protocol
Clinical Investigation vs. Clinical trial
Investigation: experiment that must be submitted to the FDA prior to completing or the results must be submitted to the FDA
Trial: study subjects are prospectively assigned to interventions
Generalizability as it helps define research
Whether it is meant to contribue to a body of knowledge or whethere the results are replicable
-If goal is program improvement not research in some cases
Intent of project helps define it it is research
If information or specimes are not readily identifable to the researcher
not human subjects research
Interaction
includes communication or interpersonal contact between an investigator and a subject
Intervention
Both physical procedures by which information or biospeciments are gathered (for example venipuncture) & manipulations of the subject or the subject’s environment that are performed for research purposes
Prospective vs. Retrospective Research
-obtain samples to create new collections
-use pre-existing collections
Research
a systematic investigation including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge
Research about deceased people
Not human subjects research
Research Excludes
- scholarly & journalistic activities (oral hisotry)
- public health surveillance activities
- collection & analysis of information, biospecimens, or records by or for a criminal justic agency authorized by law or court order for justice/investigative prupsoes
- authroized operation activities for national security
Research Question
About whom-human subjects research
About what-not human subjects research
45 CFR Definition
What is a Human Subject?
A living individual about whom an investigator conducting research obtains 1) information or biospecimens through intervention or interaction with the individual and uses, studies, or analyzes the information or biospecimens.
Or
2) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
What is an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participating in the procedures involved in the research called?
Legally Authorized Representative (per FDA regs) or legally acceptable representative (per ICH E6 R2)
What is an individual who is or becomes a participant in research, either as a recipient of the test article or as a control?
Human Subject
What is any food or drug, medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act called?
Test Article
What is any public or private entity or agency (including Federal, State or other agencies)?
Institution
What is the difference between a Phase I, Phase II and Phase III study?
- Phase III: 300-3,000 volunteers who have the disease or condition, 1-4 years in length, IP efficacy and monitoring of AEs.
- Phase II: Up to several hundred people with the disease/condition, months -2 years in length, IP efficacy and side effects.
- Phase I: 20-100 healthy volunteers or people with the disease/condition, several months in length, IP safety and dosage
What is the use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is no sufficient time to obtain IRB approval?
Emergency Use
What means that the probability and magnitude of harm or discomfort anticipated in the research are no greater in an of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examationation or tests?
Minimal Risk
