Module 6 Informed Consent Flashcards
Informed Consent
What is an example of exculpatory language?
I waive any possibility of compensation for injuries I receive as a result of my participation in the research.
T/F
Informed consent is an ongoing process that begins when the subject is first approached to participate in a study
TRUE
T/F
The informed consent process is over when the study is completed
FALSE
When is the informed consent process over?
it’s only over when there is no additional relevant information to provide the subject.
For emergency use qualifiers (4)
- Reviewed & evaluated in writing by a physician who is not participating in the study
- no available alternative
- documentation submitted to IRB within 5 days after use of test article
- subject is confronted by life-threatening situation.
Emergency Research qualifiers (6)
- the intervention administered before consent from the subjects LAR is feasible
- public disclosure of sufficient information after completion of investigation.
- established independent data monitoring committee to have oversight of the investigation.
- the proposed investigation defies the length of the potential therapeutic window
- consultation by IRB with representatives of the community
- no reasonable way to identify the individuals likely to become eligible for participation.
T/F
A limited English proficient subject must sign both the English summary of consent long form and the short form in their written language.
FALSE.
A limited English speaking subject must sign the 1.__ consent form in their language. The witness signs the 2.__ consent form and the 3.__ consent form.
- short
- short
- long
A cancer patient is interested in a research study. The consent form is only available in English. The patient’s primary language is Spanish, and she has limited English proficiency. Which of the following is true when determining who can serve as the subject’s witness?
A member of the medical department who speaks Spanish and is not a member of the study team may attend the consent discussion and serve as a witness.
A patient is invited to consider a study, however, during screening is identified as possibly lacking capacity to consent. The PI has appropriately assessed capacity to consent and determined the need for a LAR. What is the most correct in determining the LAR?
Check state laws to determine who can serve as the LAR.
T/F
Amended consent must be approved by IRB; the subject must be reconsented with amended consent form.
TRUE.
A pediatric study involves the collection of tissue from the patient. (greater than minimum risk). A subject is 10 years old and attends the consenting conversation with their parent. Which of the following is the appropriate process for consenting the subject? The study team should___
Follow the process for use of “parental permission” and child assent in lieu of consent.
T/F
Per the Common Rule, for each clinical trial conducted or supported by a FDA, one IRB approved consent form used to enroll subjects must be posted on a publicly available institutional website.
FALSE.
Posted on a publicly available FEDERAL WEB SITE
Which of the following statements is an example of exculpatory language?
I waive any possibility of compensation for injuries that I may receive because of participation in this research.
When can informed consent be completely waived in emergency medicine research?
When the research involves an investigational intervention
under FDA special regulation
21 CFR 50.24
This regulation is also referred to as the Common Rule
45 CFR 46
Subpart A
T/F
Investigational new drugs include biological products
TRUE
Which groups regulate compliance of the informed consent process
FDA
Local IRB
OHRP
ALL
ALL
As part of 45 CFR part 46, re-consent determination of subjects is under the review of which regulatory body?
IRB
Basic elements of informed consent per CFR 50.25
(3)
- Disclosure of alternative procedures /tx if any, that would be beneficial to the subject.
- Notice of voluntary participation.
- Explanation of whom to contact for answers to questions.
T/F
A statement regarding the confidentiality of the subject’s study records must be included in all informed consent documents
TRUE
T/F
The FDA is responsible for protecting the public health ensuring safety, efficacy, and security of human and veterinary drugs, biologic products, and medical devices.
TRUE
