21 CFR Part 50 Flashcards
What does 21 CFR Part 50 cover?
Protection of Human subjects
Clinical Investigation
any experiment that involves a test article and 1 or more human subjects and that are subject to requirements for prior submission to the FDA or is not subject to requirements for prior submission to the 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.
Investigator
individual who actually conducts a clinical investigation
Sponsor
person who initiates a clinical investigation, but who does not actually conduct the investigation.
Sponsor-investigator
individual who both initiates and actually conducts, alone or with others, a clinical investigation.
human subjects
an individual who is or becomes a participant in research, either as a recipient of the test article or as a control.
test article
means any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act
General requirements of informed consent
4 requirements
no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative.
- An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.
- The information that is given to the subject or the representative shall be in language understandable to the subject or the representative.
- No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence
Exception of general requirements of informed consent
4 requirements
both the investigator and a physician who is not participating in the clinical investigation certify in writing all of the following:
- subject is confronted by a life-threatening situation necessitating the use of the test article.
- Informed consent cannot be obtained from the subject because of an inability to communicate , or obtain legally effective consent from, the subject.
- Time is not sufficient to obtain consent from the subject’s legal representative.
- no alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject
**documentation required shall be submitted to the IRB within 5 working days after the use of the test article.
Exception from informed consent requirements for emergency research.
The IRB responsible for the review, approval, and continuing review of the clinical investigation may approve that investigation without requiring that informed consent of all research subjects be obtained if the IRB finds and documents each of the following:
- The human subjects are in a life-threatening situation, available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized placebo-controlled investigations, is necessary to determine the safety and effectiveness of particular interventions.
- Obtaining informed consent is not feasible
- Participation in the research holds the prospect of direct benefit to the subjects
- The proposed investigational plan defines the length of the potential therapeutic window based on scientific evidence, and the investigator has committed to attempting to contact a legally authorized representative for each subject within that window of time
- IRB has reviewed and approved informed consent procedures and an informed consent document .
- Additional protections of the rights and welfare of the subjects will be provided
elements of informed consent (8)
- statement that the study involves research, explanation of the purposes of the research, duration of the subject’s participation, description of the procedures to be followed
- A description of any reasonably foreseeable risks or discomforts to the subject.
- A description of any benefits to the subject or to others which may reasonably be expected from the research.
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
- statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records.
- For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
- explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject.
- statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
Additional elements of informed consent (6)
- statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.
- Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent.
- Any additional costs to the subject that may result from participation in the research.
- The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject.
- A statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject.
- The approximate number of subjects involved in the study.
Documentation of Informed consent
informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject’s legally authorized representative at the time of consent. A copy shall be given to the person signing the form.
- A written consent document this form may be read to the subject or the subject’s legally authorized representative, but, in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed.
- A short form written consent document stating that the elements of informed consent required have been presented orally to the subject or the subject’s legally authorized representative. A copy of the summary shall be given to the subject or the representative in addition to a copy of the short form.
