Human Subjects Protection Issues in Student Research

1
Human Subjects Protection Issues in Student
Research

• Felice J. Levine, Ph.D.
• and
• Paula R. Skedsvold, Ph.D.

2
Research Defined

• Code of Federal Regulations, Sec 102.d
• Research means a systematic investigation,
  including research development, testing and
  evaluation, designed to develop or contribute to
  generalizable knowledge.

3
Application to Student Research?

• Much student research is not intended to
  contribute to generalizable knowledge and thus by
  definition falls outside the purview of IRB
  review
• Even with research experiences unlikely or not
  intended to yield generalizable knowledge, what
  issues are at stake from the vantage of
• Human subjects
• Students

4
Should student research be evaluated?

• Human participants in research have interests
  even when the work is no more than minimal risk
• Opportunity for training students in ethical
  principles and regulations
• Students in SBS fields engaged early in human
  subjects research
• Some IRBs are requiring that all student research
  be reviewed

5
If so, how should student research be evaluated?

• Distinguish various forms of student research
• Design review processes that will provide
  protection at a level commensurate with risk
• SBS Working Group reviewing issue

6
Categories of Student Work

• Three Broad Categories
• (1) Classroom exercises
• (2) Course-based research
• (3) Independent research (e.g.,
• theses)
• Generalizability linked to level of research
  training (continuum from lower division undergrad
  through doctoral dissertation)

7
Analysis and Preliminary Recommendation

• (1) Classroom Exercises
• Exercises or demonstrations that do not involve
  human participants outside class
• Showing research principles or practices, but not
  research
• No review by Dept or IRB
• Left to discretion of instructor
• Considered a teaching exercise

8
Analysis and Preliminary Recommendation

• (2) Course-Based Research Experiences
• Research or research-related experiences that
  involve human participants outside classroom
• Dept review or other Dept mechanism
• Depending on research, may require IRB review
• Note Excludes observation in public places and
  use of public data bases

9
Analysis and Preliminary Recommendation

• Determining how to review course-based research
• Minimal risk and anonymous
• Instructor review or internal department review
  of instructors plan
• Minimal risk and identifiable
• Dept Review
• More than minimal risk
• IRB Review
• Special populations
• IRB Review

10
Analysis and Preliminary Recommendation

• (3) Independent Research
• Independent research at an education and training
  level not likely to contribute to generalizable
  knowledge
• Dept review
• Student research such as MA and PhD theses
  designed to contribute to generalizable knowledge
• IRB review

11
Other Recommendations

• Student members of faculty research teams
  should continue to receive training in the
  ethical principles and regulations regarding
  research with human participants

12
Other Recommendations

• All students undertaking human subjects research
  should be exposed to ethical underpinnings,
  regulations, and professional ethics codes
• Depth of coverage should depend on educational
  level and nature of research (theses or course
  project)

13
SBS Working Group Recommendations

• Will be posted to a web site for comment
• E-mail announcements requesting feedback (will
  provide the URL)
• Final recommendations forwarded to OHRP, other
  federal agencies, AAHRPP, other partners