21 CFR Part 50 Flashcards
what does 21 CFR part 50 cover?
protection of human subjects
what 3 applications are included in this chapter?
1) investigational new drug application, part 312
2) a new drug application, part 314
3) application for an investigational new device exemption
what is a clinical investigation?
any experiment that involves a test article and one+ human subjects, and that either is subject to requirements for prior submission to the FDA or is not subject to requirements for prior submission tot he FDA but the results of which are intended to be submitted later to or held for inspection by the FDA as part of an application for a research or marketing permit
who is an investigator
person conducting the clinical investigation
who is the sponsor
person who initiates a clinical investigation, but who does not actually conduct it
who is the sponsor-investigator
person who initiates and conducts, alone or with others, a clinical investigation
who is a human subject
person who participates in research, either as a recipient of the test article or as a control
what are exceptions from informed consent for emergency research? (7)
1) subject is in a life-threatening situation and collection of valid scientific evidence is necessary to determine safety and effectiveness of interventions
2) obtaining consent isn’t feasible
3) participation in the research holds out the prospect of direct benefit
4) investigation could not practicably be carried out without the waiver
5) treatment plan makes sense and the investigator is is doing what they can to contact an LAR
6) IRB has approved
7) additional protections of rights and welfare of subjects will be provided
elements of informed consent (8)
1) statement that the study involved research. 2) description of any reasonably foreseeable risks or discomforts to the subject. 3) description of any benefits to the subject or others. 4) disclosure of alternative procedures. 5) statement describing the extent to which confidentiality of records will be maintained 6) statement regarding compensation and medical tx if any injury. 7) who to contact for answers to pertinent questions about research and subjects rights. 8) participation is voluntary.
additional elements of informed consent (6)
1) statement that the particular tx may involve additional risk to the subject.
2) anticipated circumstances under which participation may be terminated.
3) any additional costs.
4) consequences of a subjects decision to withdraw.
5) statement that significant findings during the research will be provided.
6) approximate number of subjects involved in the study.
IRB must require appointment of WHO for each child who is a ward?
advocate
what attributes must an advocate representing a ward have? (4)
1) serve in addition to any other individual acting on behalf of the child as guardian
2) can be an advocate for more than one child
3) must have the background and experience to act in the best interest of the child for the duration of the research participation
4) can’t be associated with the investigation or guardian organization
