21 CRF Part 50 Flashcards
Requirements of short form written consent
- A witness must be present for the oral presentation
- The IRB must approve a written summary of what is to be said to the subject or
representative - The witness must sign both the written summary and the short form itself
- The subject must only sign the short form
- the person obtaining consent shall sign copy of written summary
- A copy of the written summary and short form consent is given to subject
Must the subject or representative sign both the written summary and the short form consent itself?
No
What is necessary for a clinical investigation not involving greater than minimal risk to involve children as subjects?
- The permission of the children’s parents or guardians is obtained.
- Adequate provisions are made for soliciting the assent of the children
- No greater than minimal risk to children is presented
Do available treatments must be unproven or unsatisfactory to involve children in a clinical investigation?
No
Can a clinical investigation involve children if there is more than minimal risk to children.
Yes
Under what circumstances is assent of children not required?
The IRB determines that
- the capability of some or all of the children is so limited they cannot reasonably be consulted
OR
- the intervention or procedure involved in the clinical investigation holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the clinical investigation
Requirements for the advocate for children who are wards of the state
- Must have the experience to serve the best interest of the child
- one individual may serve as advocate for more than one child
- advocate will serve in addition to any other individual acting on behalf of the child as guardian or in loco parentis
- the advocate must not be associated in any way with the clinical investigation
Additional elements of informed consent
- A statement that the particular treatment or procedure may involve risks to the subject which are currently unforeseeable
- Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regards to the subject’s consent
- Any additional costs to the subject that may results from participation
- 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
Basic elements of informed consent
- statement that the study involves research, purpose of study, expected duration of participation, description of procedures, identification of experimental procedures
- description of risks/discomforts
- description of benefits to subjects or others
- disclosure of alternative procedures or treatments that might be advantageous
- statement describing extent that confidentiality of identifiable records and that FDA may inspect at any time
- greater than minimal risk: compensation and treatment for injury
- contact for questions about research and in event of injury
- statement that participation is voluntary
A written exemption from informed consent must be submitted within this many days to the IRB
5 working days
Whose responsibility is to review clinical investigations involving children as subjects and approve only those clinical investigations that satisfy the criteria described
IRB
exceptions to the requirement to obtain informed consent
- The human subject is confronted by a life-threatening situation necessitating the use of
the test article. - Time is not sufficient to obtain consent from the subject’s legal representative.
- There is available no alternative method of approved or generally recognized therapy
that provides an equal or greater likelihood of saving the life of the subject. - informed consent cannot be obtained from the subject because of an inability to communicate or obtain legally effective consent from the subject
**all of above must be true
What is necessary for a clinical investigation involving greater than minimal risk but providing direct benefit to involve children as subjects?
- The risk is justified by anticipated benefits to subject
- Relation of benefit to risk is at least as favorable as available alternative approaches
- Adequate provisions made to solicit assent from children and permission from parents
