21 CFR 50
Protection of Human Subjects
Sponsor
a person who initiates a clinical investigation, but who does not actually conduct the
... [Show More] investigation
Sponsor-investigator
an individual who both initiates and actually conducts (alone or with others) a clinical investigation
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
Institutional Review Board (IRB)/ Institutional Review Committee (IRC)
any board, committee or other group formally designated by an institution to review biomedical research involving humans as subjects, to approve the initiation of and conduct periodic review of such research.
Legally Authorized Representative (LAR)
an individual, judicial, or other body authorized under applicable law to consent on behalf of a prospective subject to participate in the research study
Under 21 CFR 50, what are (2) general requirements of informed consent?
"○ No person can participate in research unless they sign an informed consent document
○ No informed consent (oral or written) can contain exculpatory language waiving the subjects legal rights or release or appear to release the investigator, sponsor, institution or its agents from liability of negligence"
Under 21 CFR 50, what are the documentation requirements of an informed consent?
"○ Consent must be written and approved by the IRB
○ Must be signed and dated by the subject or the LAR
○ Written consent document; that may be read to the subject or LAR and given adequate time to read prior to signing; or
○ Verbal informed consent (has additional requirements)
"
Under 21 CFR 50, what are the 7 requirements to documenting a verbal informed consent?
"1. A short form written consent document that incorporates the basic elements of the informed consent can be read orally to the subject or LAR
2. A written Summary of what will be read to the subjects or LAR is approved by the IRB
3. Witness needs to be present for the oral presentation
4. Subject or LAR will sign the short form document
5. Witness will sign both the short form document and the copy of the summary
6. Person obtaining the consent sign a copy the summary
7. A copy of the signed written summary and the short form is given to the subject or the LAR"
Under 21 CFR 50, what are the 4 Exceptions from general requirements
"
Investigator and physican to certify in writing:
○ The human is facing a life threatening situation needing the test article and available treatments are unproven or unsatisfactory
○ Informed consent cannot be obtained because of inability to communicate
○ Time is not sufficient to obtain consent from the LAR
○ There is no alternative method that provides an equal or greater likelihood of saving the subjects life "
Under 21 CFR 50, what are the emergency research exception of informed consent (7) requirements?
"○ Obtaining informed consent is not feasible
○ Participation in the research holds out the prospect of direct benefit to the subjects
○ The clinical investigation could not practically be carried out without the waiver
○ The proposed investigational plan defines the length of potential therapeutic window based on scientific evidence and the investigator has committed to attempting to contact a LAR within that window rather than proceeding without consent
○ The IRB has reviewed and approved informed consent procedures and an informed consent document consistent with 50.25.
○ The IRB is responsible for ensuring that procedures are in place to inform (at the earliest possible opportunity) each subject or LAR of the subject's inclusion in the clinical investigation
○ Protocols involving exception to the informed consent must be performed under a separate new drug application (IND) or investigational device exemption (IDE)"
Under 21 CFR 50.25, what are the 8 basic elements of informed consent?
"1. statement that involves research, an explanation of the purposes of the research and the expected duration of the subjects participation, a description of the procedures to be followed, and identification of any procedures which are experimental
2. A description of foreseeable risks or discomforts to the subject
3. A description of foreseeable benefits to subject or others
4. Disclosure of alternative procedures or courses of treatment that might be advantageous to the subject
5. A statement describing the extent to which confidentiality of the identifiable records of the subject will be maintained and notes that the FDA may inspect the records at anytime
6. For research involving more than minimal risk and explanation as to whether compensation and explanation as to whether any medical treatments are available if injury occurs
7. An explanation of whom to contact for answers about the research and subjects rights and who to contact in the event of a research related injury
8. A 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"
Under 21 CFR 50, what are the (7) additional elements of informed consent?
"1. A statement that the particular treatment of procedure may have unforeseeable risk that the treatment or procedure may cause harm to the embryo if you become pregnant
2. Anticipated circumstances under which the subject's termination in the trial by the investigator may occur
3. Any additional costs that the subject may incur as a result to participation in the trial
4. The consequences of a subjects decision to withdraw from research and procedures for orderly termination of participation by the subject
5. A statement that significant new findings developed during the course of research which may impact the subjects willingness to continue in the trial will be provided to the subject
6. The approximate number of subjects involved in the trial
7. "a description of this clinical trial will be available on http://www.clinicaltrials.gov..""
What section in 21 CFR 50 provides Additional Safeguards for Children in Clinical Investigations?
subpart D
Under 21 CFR 50.51 subpart D, what are the requirements for clinical investigations that are not involving greater than minimal risk ?
"○ No greater than minimal risk to children
○ Adequate provisions have been made for soliciting assent of children and permission from parents and legal guardians"
Under 21 CFR 50.52 subpart D, what are the requirements for Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects?
"○ IRB must find that
■ The risk is justified by the anticipated benefit to the child
■ The relation of anticipated benefit to the risk is at least favorable to the subject as that presented by alternative approaches
■ Adequate provisions have been made for obtaining assent of the child and permission from parents/guardians"
Under 21 CFR 50.53 subpart D, what are the (4) requirements for Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition?
"○ IRB Must find that
■ The risk represents a minor increase over minimal risk
■presents experiences to subjects that are reasonably comparable with those inherent in their actual or expected medical, dental or psychological, social or educational situations
■ likely to yield generalizable knowledge about the subjects disorder or condition that is of vital importance for understanding or eliminating the subject's disorder or condition
■ Adequate provisions have been made for obtaining assent of the child and permission from parents/guardians"
Under 21 CFR 50 subpart D, if investigations don't satisfy 50.51, 50.52, 50.53, what are the requirements for a clinical investigation to continue with approval from IRB?
"■ The trial presents a reasonable opportunity to understand, prevent or alleviate a serious problem affecting health and welfare of children; or
■ The commissioner of the FDA determines The investigations satisfies conditions of 50.51, 50.52 or 50.53 and conditions that must be met:
○ The clinical investigation is being conducted with sound ethical principles
○ Adequate provisions have been made for obtaining assent of the child and permission from parents/guardians
"
Under 21 CFR 50.55 subpart D, what are Requirements for permission by parents or guardians and for assent by children?
"○ IRB must determine under which conditions a child is capable of providing assent
○ Assent by the child is not a necessary condition for proceeding with the trial
○ IRB must determine the conditions where consent is required from the parent(s) or guardian" [Show Less]