NOT FINISHED 21 CFR Part 50 - Subpart B Flashcards
Exception from informed consent requirements for minimal risk clinical investigations - What does 21 CFR 50.22 do?
This regulation allows IRBs to approve certain minimal risk studies without the standard informed consent, aligning FDA regulations with the Common Rule’s provisions for such waivers.
Exception from informed consent requirements for minimal risk clinical investigations - 21 CFR 50.22 - The 5 exceptions, without defining them.
(a) Minimal Risk, (b) Practicability, (c) Identifiable Information, (d) Rights and Welfare, and (e) Additional Information
Exception from informed consent requirements for minimal risk clinical investigations. 21 CFR 50.22 (a)
The clinical investigation involves no more than minimal risk to the subjects
Exception from informed consent requirements for minimal risk clinical investigations. 21 CFR 50.22 (b)
The clinical investigation could not practicably be carried out without the requested waiver or alteration;
Exception from informed consent requirements for minimal risk clinical investigations. 21 CFR 50.22 (c)
If the clinical investigation involves using identifiable private information or identifiable biospecimens, the clinical investigation could not practicably be carried out without using such information or biospecimens in an identifiable format;
Exception from informed consent requirements for minimal risk clinical investigations. 21 CFR 50.22 (d)
The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
Exception from informed consent requirements for minimal risk clinical investigations. 21 CFR 50.22 (e)
Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.
Exception from General Requirements for Informed Consent (Emergency Use) 0 What does 21 CFR 50.23 (a) do?
Allows the emergency use of a test article (e.g., an investigational drug or device) without prior informed consent under specific conditions.
Exception from General Requirements for Informed Consent (Emergency Use) - 21 CFR 50.23(a) (1)
The subject is confronted by a life-threatening situation requiring immediate intervention.
Exception from General Requirements for Informed Consent (Emergency Use) - 21 CFR 50.23(a) (2)
Obtaining informed consent is not feasible because the subject is incapacitated (e.g., unconscious, in shock).
Exception from General Requirements for Informed Consent (Emergency Use) - 21 CFR 50.23(a) (3)
Time is not sufficient to obtain consent from the subject’s legal representative.
Exception from General Requirements for Informed Consent (Emergency Use) - 21 CFR 50.23(a) (4)
No alternative treatment is available that provides an equal or better chance of saving the subject’s life.
Exception from General Requirements for Informed Consent (Emergency Use) - 21 CFR 50.23(a) - _____ using the test article, both _____ and _____ must certify in writing points 1-4 outlined in this section.
Investigator; a physician not involved in the clinical investigation.
Note: The addition physician is there to ensure investigators don’t go crazy.
Exception from General Requirements for Informed Consent (Emergency Use) - What does 21 CFR 50.23(b) do?
Allows for immediate use of a test article if the PI determines this is necessary to preserve the life of the subject, without certifying in writing the points outlined in part (a) beforehand.
Exception from General Requirements for Informed Consent (Emergency Use) - Difference in reporting between 21 CFR 50.23(a) and 21 CFR 50.23(b)
The documentation for both need to be submitted to the IRB within 5 working days after use of the test article, but this requires that (b) needs the independent review of a physician not involved in the clinical investigation within 5 working days as well, since they both have the same reporting requirements.
Exception from General Requirements for Informed Consent (Emergency Use) - 21 CFR 50.23(c)
The documentation required in paragraph (a) or (b) of this section shall be submitted to the IRB within 5 working days after the use of the test article.
Exception from General Requirements for Informed Consent (Emergency Use) - Difference between 50.23(a) and 50.24(a)?
50.23(a) is for emergency use on a single patient without IRB review before treatment.
50.24(a) is for planned emergency research where informed consent is waived for all subjects, but IRB approval is required beforehand.
I stopped at 21 CFR 50.24 on https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-50/subpart-B
