Flagler Hospital, Inc. Human Subjects Research Training Post-Test & Evaluation

Post-Test

Participant demographics:

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* 1. Full Name:

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* 2. Please indicate credentials

Physician-MD/DO

PA/ARNP

Other

Other (please specify)

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* 3. What type of certificate do you wish?

CE Broker reporting only; no certificate needed

Electronic

Paper

E-mail or physical address to send certificate

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* 4. Florida license number for CE Broker reporting:

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* 5. How many credit(s) are you claiming:

0.50

0.75

1.00 (maximum)

Other (please specify)

Flagler Hospital, Inc. Human Subjects Research Post-test (a passing score of 80% is required).

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* 6. Which of the following was not historical key triggering events that lead to the establishment of ethics in research?

Helsinki Declaration

Willowbrook State School research

Tuskegee Syphilis study

Nazi experiments in concentration camps

None of the above

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* 7. Respect for person is implemented in research through which of the following?

Informed consent

Beneficence

Justice

Autonomy

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* 8. The Belmont Report encourages debate and careful consideration for which of the following groups?

Hospital Ethics Committee

Patient Safety and Compliance Committee

Peer Review Committee

Institutional Review Board members

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* 9. What key function was established by the Common Rule, Federal Regulation (45 CFR 46)?

Federal Wide Assurance Office

Department of Health and Human Services

Institutional Review Board and informed consent

Office of Human Research Protection

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* 10. The "Revised Common Rule" published by OHRP in 2018 clarifies definition of research as follows:

A systematic investigation, including research development, testing, and evaluation, designed to devlop or contribute to generalizable knowledge.

A non-systematic investigation, designed to develop to support existing knowledge

Informal investigation including research development for the purpose of increasing informal knowledge

None of the above

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* 11. The "Revised Common Rule" published by OHRP in 2018 defines identifiable private information as including which of the following?

Private information for which identity of the subject is or may readily be ascertained by researcher

Identifiable biospecimens for research subjects only.

Protected health information for research subjects only

Identity of research subjects

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* 12. The primary purpose of the Flagler Hospital Institutional Review Board (IRB) is to:

Protect the human subjects through informed consent

Protect the human subjects rights and welfare from undue research risk

Protect the human subjects from invasion of privacy

All of the above

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* 13. Which of the following criteria is not a requirement that must be satisfied for Flagler Hospital, Inc. IRB approval of a proposed research study?

Not necessary to obtain and/or document informed consent

The selection of human subjects is equitable

A procedure has been established to monitor data collection to ensure safety of human subjects

The research protocol adequately provides protection of human subjects' privacy including maintenance of their data confidentiality

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* 14. Which of the following is included in the Revised Common Rule definition of the Limited IRB Review?

Functions may include disapproval of research

Performed only by IRB Chair

Requires consideration by a full convened board

Can occur on an expedited basis and does not require consideration by a full convened board

None of the above

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* 15. Which of the following is required for an initial exemption review of a Humanitarian Use Device (HUD)?

Limited Review by IRB Chair

Limited Review by full convened IRB meeting

Review by full convened IRB meeting

Continuing review by Limited IRB

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* 16. Which of the following statement(s) is true for Emergency Use Exemption IRB Review?

Any emergency use exemption must be reported to the Flagler Hospital, Inc. IRB by the treating physician within five (5) working days of the emergency use

Emergency use exemption can be used in a life-threatening situation or with serious diseases or conditions when there is no available alternative and no time to obtain FDA approval

The emergency use exemption allows for one emergency use of a test article without prospective full IRB review

All of the above

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* 17. According to the Revised Common Rule, which of the following stated in the beginning of the informed consent process (and consent form)?

The purpose of research, expected duration participation in research, research methodology

Benefits to research participants or others reasonably expected from research results

Informed consent is being sought for research and participation is voluntary

Foreseeable risks and/or discomforts to research participants

Appropriate alternative procedures or course of treatment

All of the above