21 CFR Part 50 Flashcards
What types of research are subject to 21 CFR Part 50?
Research that is subject to FDA regulations (research involving experimental drugs, devices, or biologics, or marketed drugs/devices/biologics under certain circumstances), and research that supports applications for research or marketing for products regulated by the FDA.
What is 21 CFR Part 50?
Protection of Human Subjects (for research subject to FDA regulations/supporting applications for products subject to FDA regulations)
Which other CFR covers the concepts discussed in 21 CFR Part 50
45 CFR Part 46 is also about Protection of Human Subjects, but covers the requirements set forth by the HHS rather than the FDA
What are the FDA allowances for IRBs to waive or alter informed consent?
FDA regulations mirror HHS regulations:
- No more than minimal risk
- Cannot practicably be carried out without a waiver or alteration
- If identifiable private info or biospecimens are used the investigation could not practicably be carried out without using them in an identifiable format
- Waiver or alteration does not adversely affect the rights/welfare of the subjects
- When appropriate, the pertinent info will be provided after participation
What does the FDA require regarding consent in non-English speaking subjects?
Per 21 CFR 50 - a copy of the consent must be provided; for non-english speakers this would require a translation. If a translation is not available the consent must be orally translated and a “short form” in the subject’s native language used to document the elements of informed consent required by 21 CFR 50 were presented orally
When does the FDA allow waiver of consent for children?
1) The children are incapable of understanding research
2) There is the prospect of direct benefit to the children that is not available outside the research
3) The requirements for a waiver of consent are met
For the FDA - What are the subject related requirements for consent if the subject has an LAR?
Subject should be included in the consent process “to the extent possible and consistent with their desires and abilities.”
This is similar to the recommendations of ICH E6.
FDA also requires assent from children unless the IRB waives the assent requirement.
What is the reporting timeline for when an investigational product was used without informed consent?
5 working days
When can a test article be used without consent?
In treatment situations where an individual has a life-threatening condition and the following requirements are met and documented:
- The investigator and another physician not involved w/ the patient’s care believe the situation necessitates the use of the test article
- The subject and/or LAR are unable to communicate consent
- Insufficent time to obtain consent
- No alternative exists with equal or better chance of saving their life
- IRB is informed w/in 5 working days
What are the 21 CFR 50 requirements for signatures on consents? And how does this differ from ICH E6?
21 CFR 50 only requires subject (or LAR) signature. ICH E6 requires subject (or LAR) signature AND signature of the staff conducting the consent.
What are the FDA’s requirements for providing copies of consents to subjects?
The FDA (21 CFR 50) only requires the subject receive a copy of the consent, either signed or unsigned. ICH E6 requires the subject receive a copy of the consent they signed and dated.
What are the consent requirements of 21 CFR 50 if a subject cannot read?
Someone can read the consent to the subject. Or, research staff can use a short form consent with a written summary of the oral presentation they gave the subject. (ICH E6 does not allow short forms and has specific requirements for reading the consent to a subject).
How does 21 CFR 50 and ICH E6 differ on confidentiality language in consents?
ICH E6 requires consents include a statements about monitors, auditors, the IRB, and regulatory authorities having access to medical records. The FDA only requires there be a statement about the extent to which confidentiality of records will be maintained and that the FDA may review them.
How does ICH E6 and the FDA compare on information regarding payment in consent forms?
ICH E6 requires a description of anticipated prorated payments. FDA also recommends this.
