21 CFR Part 50 - Subpart A Flashcards
Clinical investigation
a research study that involves people to test how safe and effective a medical product/procedure is prior to widespread use.
Investigator
the person in charge of a research study involving people who is responsible for protecting the participants and ensuring the research is done ethically and correctly.
Sponsor
an entity who initiates a clinical investigation, but who does not actually conduct the investigation. Often the funding source as well.
Sponsor-investigator
an individual who initiates AND conducts a clinical investigation. Can also be the funding source but less often in this case compared to standard sponsor (I think).
Human subject
an individual who is or becomes a participant in research, either as a recipient of the test article or as a control.
Institution
any public or private entity or agency (including Federal, State, and other agencies). “Facility” is occasionally used as a synonym.
Institutional review board (IRB)
a committee formally designated by an institution to initially/periodically review/approve human subject research.
Test article
anything being studied in a research trial to see if it’s safe and effective for people prior to widespread use.
Minimal risk
means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Legally authorized representative (LAR)
means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research.
Laymen: separates out the “Legally Binding” piece from the consent line.
Assent
means a child’s affirmative agreement to participate in a clinical investigation.
Laymen: Separates out the “I am willing” part of the consent line.
NOTE: While the FDA and HHS regulations do not specifically require assent from cognitively impaired adults, IRBs often extend the principle of assent to populations who may lack full decision-making capacity.
The IRB has the authority to require an assent process (and assent signature lines) to ensure the individual’s willingness to participate, even if a legally authorized representative (LAR) gives formal consent.
Difference between Assent and Consent
respect for the individual’s ability to express a preference vs ensuring legal and ethical authorization from someone with full decision-making capacity.
“Hey, I may not fully understand everything, but I feel comfortable participating based on what I do understand.”
PLUS
“I understand everything fully, and since you’re also willing, I give my legal permission for you to participate.”
Why would you have LAR + Consent + Assent lines?
The inclusion of all three allows the form to be used for different participant situations without needing multiple versions.
Note that LAR + Assent = Consent. You have all three there so you cover all situations. Note that you would never have both the LAR line and the Consent line signed. LAR is there to separate out the legal part, assent line is there to separate out the willingness part.
Children
means persons who have not attained the legal age for consent to treatments or procedures involved in clinical investigations, under the applicable law of the jurisdiction in which the clinical investigation will be conducted.
Family member
means any one of the following legally competent persons: Spouse; parents; children (including adopted children); brothers, sisters, and spouses of brothers and sisters; and any individual related by blood or affinity whose close association with the subject is the equivalent of a family relationship.
Note: I mean…come on, it’s a family member. You know what that is.
Parent
means a child’s biological or adoptive parent.
Ward
a child whose parent or legal guardian (or LAR) is the state, a court, or another government-appointed entity rather than a private individual.
NOTE: A foster parent is not automatically an LAR unless they have been granted legal guardianship, which is a separate thing apparently.
Wards can be involved in research if:
The research is related to their status as wards (e.g., studies on foster care or child welfare systems),
OR
the research is minimal risk and conducted in settings where most other participants are not wards (e.g., a general school-based study)
This is because IRBs must apply extra protections before approving a ward’s participation in research.
Permission
means the agreement of parent(s) or guardian to the participation of their child or ward in a clinical investigation.
Guardian
means an individual who is authorized under applicable State or local law to consent (be an LAR) on behalf of a child to general medical care.
