Title 21, Part 50 - Protection of Human Subjects Flashcards
Exceptions to informed consent - General
- the human subject is confronted by a life-threatneing situation necessitating the use of the test article
- consent cannot be obtained because of an inability to communicate with, or obtain legally effective from the subject
- Time is not sufficient to obtain consent from the subject’s legally authorized representative
- There is no available alternative method of approved therapy that provides an equal or greater likelihood of saving the life of the subject
If informed consent is not required due to exceptions in general requirements, how many days should the documentation be submitted to the IRB
FIVE (5) working days
Exceptions from Informed Consent - Requirements for Emergency Research
“Informed consent will not be obtained if….”
- The human subjects are in a life-threatening situation
- Obtaining informed consent is not feasible
- Participation in research holds out the prospect of direct benefit
- The clinical investigation could not properly be carried out without the waver
Consent documentation used in emergency research should be kept for
THREE (3) years
Who and when must consent documentation used in emergency research be accessible for?
-The records shall be accessible for 3 years for inspection and copying by the FDA
Elements of Informed Consent
- Statement about study –> purposes of study and the expected duration of a subject’s participation
- Description of risks/discomforts
- Description of benefits
- Disclosure of alternative procedures
- Statement describing confidentiality of records
- Explanation of compensations if study is deemed more than minimal risk
- Contact information of study team
- Statement that participation is voluntary
Despite exceptions, how must informed consent be obtained?
- Informed consent is documented through the use of a written consent form approved by the IRB
- Must be dated by the subject/subject’s legally authorized representative at the time of consent
Two types of consent forms (excluding exceptions to general consenting requirements)
- A written consent
- A short form written consent
-This shows that the elements of the consent form have been presented orally to the subject/subject’s legally authorized representative
Written Consent Document
- This is a document that embodies the elements of an informed consent
Short Form Written Consent
-This shows that the elements of the consent form have been presented orally to the subject/subject’s legally authorized representative
-A witness is needed
-The short form should be signed by the subject/representative, but the witness shall sign the short form and a copy of the summary
-Research team member will sign a copy of the summary
Children in Clinical Investigations
Children can be involved in research if
1. The investigation does not involve greater than minimal risk
2. Investigation does involve greater than minimal risk BUT there is a direct benefit to participating
3. Investigation involves greater than minimal risk with NO direct benefits to the individual subjects, BUT will lead to generalizable knowledge
21 CFR 50 FDA
§50.20 General requirements for
informed consent.
§50.23-Exception from general
requirements.
§50.24 Exception from informed
consent requirements for
emergency research
§50.25 Elements of informed
consent.
§50.27-Documentation of
informed consent.
§50 Subpart D Additional
Safeguards for Children in
Clinical Investigations
45 CFR 46 HHS
§46.116 General requirements for
informed consent
§46.117 Documentation of informed
consent
Subpart B. Additional Protections
for Pregnant Women, Human
Fetuses and Neonates Involved in
Research
Subpart C. Additional Protections
Pertaining to Biomedical and
Behavioral Research Involving
Prisoners as Subjects Subpart
D. Additional Protections for
Children Involved as Subjects in
Research
