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

Children as Research Subjects: Regulations, Rights and Reality
Quiz for CREC

Successful completion of this quiz is valid for four (4) 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.


*First Name:

*Last Name:


Case Network ID (if applicable):

*University Department (for Case Faculty and Staff):


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Please answer the following questions:

1. All projects involving children as defined by the NIH Policy and Guidelines on the Inclusion of Children (NIH Policy) should be reviewed under local IRB policies for research involving children.
      a.   True
      b.   False

2. Research can be approved via 45 CFR 46.404 if it involves no more than minimal risk, which is defined as those risks encountered by:
      a.   Normal, average, healthy children living in safe environments
      b.   Children in the same age group as the subject population
      c.   Children who experience risk equal to the study on a regular basis
      d.   None of the above

3. For research approvable via 45 CFR 46.406, permission of both parents is required unless one of the parents states that he/she is giving permission on behalf of both parents.
      a.   True
      b.   False

4. Lack of appropriate expertise and facilities appropriate for the involvement of children in research is an acceptable justification to exclude children involved in NIH-funded studies.
      a.   True
      b.   False

5. Investigators should consider which of the following when designing research involving children:
      a.   Availability
      b.   Developmental Differences
      c.   Potential Attention Span
      d.   Level of Emotional Control
      e.   All of the above

6. In order to justify that proposed research is approvable under 45 CFR 46.405, which states that the anticipated benefit must be at least as favorable as that of alternative approaches, the investigator should provide which of the following to the IRB:
      a.   Risks of the condition under study
      b.   Risks and benefits of alternatives
      c.   Risks of not participating in study
      d.   Both A and C

7. NIH research proposals that are limited to utilizing identifiable tissues or data do not need to include the requirements outlined in the NIH Policy.
      a.   True
      b.   False

8. With appropriate justification by the investigator, parental permission from just one parent can be approved by the IRB under:
      a.   45 CFR 46.404
      b.   45 CFR 46.405
      c.   45 CFR 46.406
      d.   Both A and B
      e.   Both B and C

9. An IRB-approved consent and assent process will guarantee that the investigator has obtained true informed consent in all cases.
      a.   True
      b.   False

10. Requesting a waiver of assent is unnecessary as it is up to the investigator to decide on a case-by-case basis whether to obtain assent.
      a.   True
      b.   False