August 2024 SOCRA Source Journal - Journal - Page 16
SELF STUDY QUESTIONS
1. Any reasonably foreseeable risks or discomforts to the subject need to be described in the informed consent form; thus, it is
necessary to describe all possible risks, especially if doing so could make the form overwhelming for subjects to read.
a. True
b. False
2. If payments, including reimbursements for research-related expenses incurred by subjects due to participation, are provided,
the consent process should not identify them as __________.
a. risks
b. compensation and medical treatment in the event of an injury
c. bene昀椀ts
d. gifts
3. If contact information changes during the clinical investigation, then the new contact information must be provided to the
subject according to 21 CFR _________.
a. 50.25(a)(7)
b. 50.25(a)(4)
c. 50.25(a)(2)
d. 50.25(b)(5)
4. The Patient Protection and Affordable Care Act added section 2710 to the Public Health Service Act (42 U.S.C. 300gg-8).
Among other things, this provision prohibits a group health plan or health insurance issuer in the group and individual health
insurance market from denying certain individuals’ participation in certain clinical trials and from denying or limiting coverage of
routine patient costs for items or services furnished in connection with participation in such trials.
a. True
b. False
5. When appropriate, the informed consent process must state the approximate number of subjects involved in the clinical
investigation (21 CFR 50.25(b)(6).
a. True
6.
b. False
Potential bene昀椀ts should be explained in terms of any __________.
a. direct impact of the prospective subject
b. anticipated societal bene昀椀t of the research
c. indirect impact of the prospective subject
d. both a. and b.
7. The consent process should outline what the subject’s participation will involve in order to comply with the protocol, for
example, __________.
a. the number of clinic visits
b. maintenance of diaries
c. medical or dietary restrictions
d. all the above
8. The FDA believes that removing procedural details from the consent form will __________.
a. reduce its length
b. enhance its readability
c. focus on content related to the risks and anticipated bene昀椀ts if any
d. all the above
9. The FDA regulations identify eight basic elements of informed consent to be provided to the subject according to Section 21
CFR 50.25(a). Which of the following is correct?
a. Clinical investigation description, involuntary participation, contacts, and bene昀椀ts
b. Risks and discomforts, voluntary participation, bene昀椀ts, and alternatives
c. Additional costs to subject, voluntary participation, contacts, and bene昀椀ts
d. Clinical investigation description, involuntary participation, unforeseeable risks, and bene昀椀ts
10. When disclosing appropriate alternative procedures or courses of treatment, the FDA recommends that a description of any
reasonably unforeseeable risks or discomforts and potential bene昀椀ts associated with these alternatives should be disclosed during
the informed consent process, although not necessarily included in the written informed consent document.
a. True
b. False
This self study quali昀椀es for one hour of SOCRA CE (Continuing Education).
See answer key on page 24. Please retain this document for your CE record.
Name ________________________________________________________ Date __________________
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SOCRA SOURCE © May 2024