Identify Funding Opportunities Proposal Development Award Management Compliance Review and Oversight Education and Training Technology Transfer
Office of Research and Technology Management
Identify Funding Proposals Proposal Development Award Management Compliance Review and Oversight Education and Training Technology Transfer

Investigator Obligations under HHS Regulations: Everything PIs Want to Know but are Afraid
to Ask Quiz for CREC

Successful completion of this quiz is valid for three (3) continuing credits.

Fill in the appropriate information below (Case Network ID is NOT required) and click on your choice to answer each of the quiz questions.


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Please answer the following questions:

1. The Belmont Report identifies three fundamental ethical principles for all human subjects research. Which of the following is NOT one of these principles?
      a.   Beneficience
      b.   Objectivity
      c.   Justice
      d.   Respect for Persons

2. Which of the following agencies have NOT adopted Subpart A of 45 CFR 46 also known as "The Common Rule"?
      a.   The Department of Agriculture
      b.   National Science Foundation
      c.   The Food and Drug Administration
      d.   The Environmental Protection Agency
      e.   They have all adopted The Common Rule

3. According to OHRP, what does it mean when an institution has "checked the box"?
      a.   The institution applies HHS regulations only when the non-exempt human subjects research is funded through the HHS
      b.   The institution has voluntarily applied HHS regulations regarding non-exempt human subjects in research regardless of source of support
      c.   The institution requires HHS regulations on both exempt and non-exempt human subjects research
      d.   The institution voluntarily waives the HHS regulations on human subjects research for pilot studies

4. Human subjects are involved in research when an investigator obtains:
      a.   Identifiable private information about a subject
      b.   Data through an intervention with a subject
      c.   Identifiable private information about a deceased subject
      d.   A and B only
      e.   All of the above are considered human subjects research

5. Who do the HHS regulations specify can make a determination of exemption at an institution on research involving human subjects?
      a.   The Institutional Review Board
      b.   The Principal Investigator
      c.   Departmental Chairs
      d.   Research Administration
      e.   The regulations do not specify

6. True or False: Research involving prisoners and/or children can never qualify for an exemption
      a.   True
      b.   False

7. When do you need to seek IRB review and approval?
      a.   Prior to involving subjects in research activity
      b.   At least annually
      c.   Prior to initiating any changes to approved research
      d.   A and C only
      e.   All of the above

8. A waiver of written documentation of informed consent may be obtained if the consent form is the only record linking the subject and the research AND what other specific circumstance?
      a.   The principal risk of the study is breach of confidentiality
      b.   The research involves no more than minimal risk
      c.   The research involves no procedures for which consent is normally required outside the research context
      d.   Documentation of informed consent can never be waived