45 CFR Part 46 Flashcards
What does 45 CFR Part 46 Cover?
HHS Policy for protection of human research subjects
What is a legally authorized representative?
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 procedures involved in the research
What is covered under Subpart B of 45 CFR 46?
Additional protections for PREGNANT WOMEN, FETUSES, and NEONATES (nonviable or of uncertain viability) involved in research
What is covered under Subpart C of 45 CFR 46?
Additional protections for PRISONERS in biomedical and behavioral research
What is covered under Subpart D of 45 CFR 46?
Additional protections for CHILDREN
If an IRB regularly reviews research that involves a category of subjects vulnerable to coercion or undue influence, what consideration should be made?
The IRB should consider inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.
If reflected in the informed consent, identifiable private information or identifiable biospecimens may be stored and maintained or used for research for an ___________ period of time.
Indefinite
The person signing the ICF shall be given a ________ __________ of the ICF
written copy
When using a short form written ICF and an IRB approved written summary of what’s said to the subject, who must sign the short form and who must sign the summary?
The subject/LAR and the witness must sign the short form.
The witness and the person obtaining consent must sign the summary.
The subject/LAR receives copies of both the summary and the short form.
Pregnant women or fetuses may only be involved in research if ALL of the following conditions are met:
1) Preclinical and clinical studies have been conducted and provide data for assessing potential risks
2) Risks to the fetus are solely the result of interventions with the prospect of direct benefit to the fetus or woman OR the risk is no greater than minimal and the potential knowledge cannot be obtained any other way
3) Least possible risk for achieving objectives of the research
4) Generally only woman’s consent is required
5) Father’s consent is additionally required if research holds only prospect of direct benefit to the fetus (i.e. not the woman, and more than minimal risk to fetus) except if he is incompetent, incapacitated, or the pregnancy resulted from rape or incest
6) For children who are pregnant, see Subpart D
7) No inducements, monetary or otherwise, to terminate a pregnancy
8) Individuals involved in research will have no part in decisions about timing, method or procedures used to terminate a pregnancy
9) Individuals involved in research will have no part in determining viability of neonate
A neonate of uncertain viability may NOT be involved in research unless one of the following 2 conditions are met:
1) Research holds the prospect of enhancing probability of survival of the neonate to the point of viability
2) Potential to develop important knowledge which cannot be obtained by other means and no added risk to the neonate
Nonviable neonates may only be involved in research if ALL of the following conditions are met:
1) Vital functions will NOT be artificially maintained
2) Research will not terminate the heartbeat or respiration of the neonate
3) No added risk to the neonate
4) Potential to develop important knowledge which cannot be obtained by other means
5) The consent of both parents is obtained (except in the case of rape, incest when consent of father is not required); LAR of either parent is NOT sufficient
What additional requirements apply to the composition of an IRB where prisoners are involved?
1) A majority of the Board shall have no association with the prison(s) involved.
2) At least one member shall be a prisoner or prisoner representative
When prisoners are involved in research there must be adequate assurances in place that ______ ______ will not take into account a prisoner’s participation in research in making decisions regarding ________.
Parole boards
Parole
Research involving prisoners may only study the following:
1) Study of possible causes, effects, and processes of incarceration, and of criminal behavior (no more than minimal risk)
2) Study of prisons as institutional structures or prisoners as incarcerated persons (no more than minimal risk)
3) Research on conditions particularly affecting prisoners as a class
4) Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject
