25. CIP Exam Strategy, 50-Question Mixed Review, and Recertification

Practice quiz

1. Question 1
   The Belmont principle of beneficence is applied through:

   • A) Informed consent
   • B) Assessment of risks and benefits
   • C) Selection of subjects
   • D) IRB registration

   Check answer
2. Question 2
   Which document introduced the requirement for independent committee review in its 1975 revision?

   • A) Nuremberg Code
   • B) Declaration of Helsinki
   • C) Belmont Report
   • D) CIOMS

   Check answer
3. Question 3
   The 2018 Requirements' general compliance date was:

   • A) January 19, 2017
   • B) July 19, 2018
   • C) January 21, 2019
   • D) January 20, 2020

   Check answer
4. Question 4
   "Systematic investigation designed to develop or contribute to generalizable knowledge" defines:

   • A) Clinical investigation
   • B) Research
   • C) Human subjects research
   • D) Practice

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5. Question 5
   Under FDA regulations, a clinical investigation is:

   • A) Any HHS-funded study
   • B) An experiment involving a test article and human subjects subject to FDA requirements or intended for submission to FDA
   • C) Any study of a marketed drug
   • D) Public health surveillance

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6. Question 6
   Which FDA exemption exists at 56.104?

   • A) Educational research
   • B) Taste and food quality evaluation
   • C) Secondary data analysis
   • D) Benign behavioral interventions

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7. Question 7
   Significant risk devices are defined in:

   • A) 21 CFR 50.3
   • B) 21 CFR 812.3(m)
   • C) 21 CFR 56.102
   • D) 45 CFR 46.102

   Check answer
8. Question 8
   IND safety reports for unexpected fatal or life-threatening suspected adverse reactions are due within:

   • A) 7 calendar days
   • B) 10 working days
   • C) 15 calendar days
   • D) 30 days

   Check answer
9. Question 9
   The Humanitarian Use Device population threshold is:

   • A) 4,000
   • B) 8,000
   • C) 10,000
   • D) 200,000

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10. Question 10
    Emergency use of a test article must be reported to the IRB within:

    • A) 24 hours
    • B) 5 working days
    • C) 15 working days
    • D) 30 days

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11. Question 11
    21 CFR 50.24 applies to:

    • A) Individual emergency use
    • B) Planned emergency research with an exception from consent
    • C) HDE approval
    • D) Expanded access

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12. Question 12
    Department of Defense research involving greater than minimal risk requires:

    • A) A research monitor
    • B) FDA approval
    • C) Two IRBs
    • D) OHRP certification

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13. Question 13
    Research in the Federal Bureau of Prisons is governed by:

    • A) 45 CFR 46 Subpart C only
    • B) 28 CFR 512
    • C) 21 CFR 56
    • D) 34 CFR 98

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14. Question 14
    NIH Certificates of Confidentiality became automatic for NIH-funded identifiable sensitive research in:

    • A) 2000
    • B) 2015
    • C) 2017
    • D) 2019

    Check answer
15. Question 15
    Under Belmont, an overt threat of harm to obtain compliance is:

    • A) Undue influence
    • B) Coercion
    • C) Deception
    • D) Exploitation

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16. Question 16
    The minimum IRB membership is:

    • A) 3
    • B) 5
    • C) 7
    • D) 10

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17. Question 17
    Quorum requires a majority of members including at least one:

    • A) Physician
    • B) Nonscientist
    • C) Unaffiliated member
    • D) Alternate

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18. Question 18
    An institution may:

    • A) Approve research the IRB disapproved
    • B) Disapprove research the IRB approved
    • C) Override IRB modifications
    • D) Substitute for the IRB

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19. Question 19
    Exemption (d)(3) benign behavioral interventions applies only to:

    • A) Children
    • B) Adults
    • C) Prisoners
    • D) Employees

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20. Question 20
    Limited IRB review is required for exemption categories:

    • A) (d)(1) and (d)(5)
    • B) (d)(2)(iii), (d)(3)(iii), (d)(7), (d)(8)
    • C) (d)(4) and (d)(6)
    • D) All categories

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21. Question 21
    Exemptions do not apply to research targeting:

    • A) Pregnant women
    • B) Prisoners
    • C) Adults
    • D) Students

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22. Question 22
    An expedited reviewer may not:

    • A) Approve
    • B) Require modifications
    • C) Disapprove
    • D) Review minor changes

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23. Question 23
    Expedited category 2 blood draw limit for healthy nonpregnant adults of at least 110 pounds:

    • A) 50 mL in 8 weeks
    • B) 550 mL in 8 weeks
    • C) 1,000 mL in 8 weeks
    • D) No limit

    Check answer
24. Question 24
    Under FDA regulations continuing review must occur:

    • A) Only when the IRB decides
    • B) At least annually
    • C) Every two years
    • D) Never after approval

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25. Question 25
    Research may continue after approval lapses only:

    • A) For 30 days
    • B) If the sponsor agrees
    • C) Where the IRB finds stopping would harm enrolled subjects, for those subjects
    • D) If the PI documents the lapse

    Check answer
26. Question 26
    Which is excluded from IRB risk analysis under 46.111(a)(2)?

    • A) Physical risks
    • B) Long-range effects of applying knowledge
    • C) Psychological risks
    • D) Confidentiality risks

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27. Question 27
    46.111(b) requires additional safeguards when subjects are likely to be vulnerable to:

    • A) Loss of funding
    • B) Coercion or undue influence
    • C) Adverse publicity
    • D) Data breach

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28. Question 28
    Since the 2018 Requirements, consent must begin with:

    • A) IRB contact information
    • B) Key information
    • C) Signature lines
    • D) HIPAA authorization

    Check answer
29. Question 29
    Compensation for research-related injury is a basic element when research involves:

    • A) Any risk
    • B) More than minimal risk
    • C) Drugs only
    • D) Children

    Check answer
30. Question 30
    How many criteria must all be met for a general waiver of consent under 46.116(f)?

    • A) 3
    • B) 4
    • C) 5
    • D) 6

    Check answer
31. Question 31
    Broad consent is recognized under:

    • A) FDA regulations
    • B) 45 CFR 46 only
    • C) Both
    • D) Neither

    Check answer
32. Question 32
    In the short form procedure, the witness signs:

    • A) The short form only
    • B) The summary only
    • C) Both the short form and the summary
    • D) Neither

    Check answer
33. Question 33
    Which waiver-of-documentation criterion is HHS-only?

    • A) Principal risk is breach of confidentiality
    • B) Minimal risk and no procedures needing written consent outside research
    • C) Distinct cultural group where signing is not the norm
    • D) Emergency

    Check answer
34. Question 34
    Consent forms for federally funded clinical trials must be posted no later than:

    • A) Before enrollment
    • B) 60 days after the last study visit
    • C) 1 year after completion
    • D) At IRB approval

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35. Question 35
    A HIPAA authorization waiver may be approved by:

    • A) Sponsor
    • B) IRB or Privacy Board
    • C) OCR only
    • D) Investigator

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36. Question 36
    A limited data set may retain:

    • A) Names
    • B) Dates
    • C) SSNs
    • D) Full-face photos

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37. Question 37
    Which is an exception to Certificate of Confidentiality protection?

    • A) Civil subpoena
    • B) Disclosure required by state child abuse reporting law
    • C) Criminal subpoena
    • D) Legislative request

    Check answer
38. Question 38
    Under 46.204(e), the father's consent is required when direct benefit is:

    • A) To the woman
    • B) Solely to the fetus
    • C) To neither
    • D) To society

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39. Question 39
    Subpart C requires the IRB to include:

    • A) A warden
    • B) A prisoner or prisoner representative
    • C) A parole officer
    • D) A DOJ attorney

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40. Question 40
    46.306 categories A and B are limited to:

    • A) Greater than minimal risk
    • B) Minimal risk and no more than inconvenience
    • C) Therapeutic research
    • D) Drug trials

    Check answer
41. Question 41
    Permission of both parents is required under:

    • A) 404 and 405
    • B) 406 and 407
    • C) 404 only
    • D) Never

    Check answer
42. Question 42
    A child's assent means:

    • A) Failure to object
    • B) Affirmative agreement
    • C) Parental signature
    • D) Silence

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43. Question 43
    Wards may be enrolled in 406 or 407 research only if:

    • A) A judge approves
    • B) The research is related to their status as wards or conducted in settings where most subjects are not wards, with an advocate appointed
    • C) FDA approves
    • D) The IO signs

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44. Question 44
    An unanticipated problem must be:

    • A) Serious and fatal
    • B) Unexpected, related or possibly related, and suggesting greater risk
    • C) Reported to FDA
    • D) An adverse event

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45. Question 45
    UADE reporting by the investigator to sponsor and IRB is due within:

    • A) 5 working days
    • B) 10 working days
    • C) 15 calendar days
    • D) 30 days

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46. Question 46
    Research misconduct under 42 CFR 93 excludes:

    • A) Fabrication
    • B) Falsification
    • C) Plagiarism
    • D) Honest error

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47. Question 47
    The misconduct standard of proof is:

    • A) Reasonable doubt
    • B) Clear and convincing
    • C) Preponderance of the evidence
    • D) Probable cause

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48. Question 48
    Suspension of IRB approval must be reported to:

    • A) Sponsor only
    • B) Investigator, institutional officials, and the department or agency head
    • C) Subjects only
    • D) The press

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49. Question 49
    IRB minutes must record votes as:

    • A) Pass or fail
    • B) Numbers for, against, and abstaining
    • C) Names of voters
    • D) Percentage

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50. Question 50
    Controverted issues must be summarized in minutes:

    • A) Only when votes split
    • B) With their resolution regardless of outcome
    • C) Only for drug trials
    • D) Never

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51. Question 51
    The single IRB requirement in 46.114 took effect:

    • A) January 25, 2018
    • B) January 21, 2019
    • C) January 20, 2020
    • D) January 20, 2021

    Check answer
52. Question 52
    An exception to 46.114 exists where more than single IRB review is required by:

    • A) Sponsor policy
    • B) Tribal law
    • C) The lead site
    • D) AAHRPP

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53. Question 53
    Under reliance, which typically stays with the relying institution?

    • A) 46.111 determinations
    • B) Consent approval
    • C) Investigator COI management
    • D) Continuing review

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54. Question 54
    IRB records must be retained for at least:

    • A) 1 year
    • B) 3 years after completion
    • C) 6 years
    • D) 10 years

    Check answer
55. Question 55
    HIPAA documentation retention is:

    • A) 3 years
    • B) 5 years
    • C) 6 years
    • D) 7 years

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56. Question 56
    The PHS SFI threshold for publicly traded remuneration plus equity is:

    • A) $1,000
    • B) $5,000
    • C) $25,000
    • D) $50,000

    Check answer
57. Question 57
    Which are reportable to OHRP under 46.108(a)(4)?

    • A) All AEs
    • B) UPs, serious or continuing noncompliance, suspensions or terminations
    • C) Amendments
    • D) Enrollment totals

    Check answer
58. Question 58
    NIH GCP training refreshes at least every:

    • A) Year
    • B) 2 years
    • C) 3 years
    • D) 4 years

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