21 CFR Part 50 Flashcards
Who does 21 CFR Part 50 apply to?
All FDA regulated studies and all food/drug/medical device studies
Why was 21 CFR Part 50 created?
To protect the rights and safety of subjects involved in investigations filed with the FDA
What is the definition of assent?
A child’s affirmative agreement to participate in a clinical investigation. Mere failure to object should not,
absent affirmative agreement, be construed as assent.
General requirements of informed consent in 21 CFR part 50?
-must gain consent
-must have time to consider
-no coercion or undue influence
-understandable
-no exculpatory language
Who can waive prior consent for a military member?
The president, if consent is not feasible, is contrary to the best interests of the military member, or is not in the interests of national security
What are some additional elements of informed consent?
-statement that there are unforeseeable risks to the subject or embryo or fetus
-when subject’s participation may be terminated
-additional costs
-consequences of withdrawing/how to withdraw
-statement that new findings about research will be given to subject
-approximate number of subjects
How should short form written consent be given?
-presented orally to subject or LAR (needs witness)
-IRB must approve written summary
-SF will be signed by subject or LAR
-witness signs SF and copy of the summary
-person obtaining consent signs copy of summary
-copy of summary and SF is given to subject or LAR
When may children be used as subjects?
If the IRB finds that there is minimal risk and the child assents and the parent gives permission
If there is greater than minimal risk, risk must be justified by benefit, benefit must be as favorable as alternatives, the child must assent and the parent must give permission
If greater than minimal risk and no benefit, risk must be minor, intervention must be similar to other situations(like medical procedures), study will get vital knowledge for understanding/helping subject’s disorder, child must assent and the parent must give permission
What is required for studies on the health or welfare of children?
-IRB must think research can help further understanding/prevention/help
-meets other conditions of child research
-sound ethical principles
-assent of child and permission from parent
When is the assent of a child not necessary?
If the IRB determines the capability of the children is too limited, or the intervention might benefit the children and is only available here
When might the IRB waive assent requirement?
-no more than minimal risk
-does not affect rights and welfare
-could not be carried out without the waiver
-when appropriate subjects are provided with info after the study
Who can determine that informed consent is not feasible?
The investigator AND an uninvolved physician
Requirements when informed consent is not feasible
1) life threatening without the test article
2) cannot communicate with subject
3) no time to get consent from LAR
4) no alternative life saving method
If informed consent is not feasible and the investigator does not have enough time to consult, how long do they have to get the decision reviewed and evaluated by an outside physician?
5 working days
If informed consent is not feasible, how long does the investigator have to submit documentation to the IRB?
5 working days
