Are You Conducting Human Subjects Research

1
Are You Conducting Human Subjects Research?

• Presentation for CCNY Faculty, Students, and
  Staff, Prepared by the IRB

2
What Is Research?

• A systematic investigation designed to develop or
  contribute to generalizable knowledge
• May or may not be work intended for
  publishingpublishing is not the determining
  factor!

3
What Is Research?

• Research practicum
• Work not intended to lead to generalizable
  theoretical body of knowledge
• Conscientious, guided practice, with clear
  intentions

4
Are Humans Involved?

• Does the research involve obtaining information
  about living individuals directly or
  indirectly?Yes
• Does the research involve intervention or
  interaction with the individuals?--Yes

5
Is There Interaction or Intervention?

• Observation may be considered intervention,
  depending on what you are looking for and
  recording and whether three basic events are
  co-occurring

6
Is There Interaction or Intervention?

• Co-occurrence of events
• Information being collected/recorded is
  individually identifiable
• Information is private
• Interaction communication or interpersonal
  contact between investigator and subject

7
Private Information?

• Private information
• Context of subjects expectations is the
  yardstick here
• Information provided for specific purposes by an
  individual and which the individual can
  reasonably expect will not be made public or used
  in a way that would offend or harm the individual

8
Research in Educational Settings

• You may be exempt under category 1 of 45 CFR
  46.101
• In commonly accepted educational settings,
  including schools, colleges or other sites where
  educational activities take place

9
Research in Educational Settings

• You may be exempt under 45 CFR 46.101 B Category
  1
• The research involves only NORMAL educational
  practices
• Research on regular and special education
  instructional strategies
• Research on effectiveness of or the comparison
  among instructional techniques, curricula, or
  classroom management methods

10
Tests, Surveys, Interviews

• Your research may be exempt under 45 CFR 46.101 B
  Category 2 if it involves
• Educational tests
• Surveys
• Interviews
• Observation of public behavior
• But not if it involves children, and not if the
  information is not anonymously recorded

11
Tests, Surveys, Interviews

• And not if the nature of the questions is
  invasive, or of such a nature that the subjects
  are subjected to more than a minimal level of risk

12
Making the Determination

• Determining exemption can be very tricky because
  there are many grey areas
• Exemption should not be determined by the
  researcher but only by another trained individual
  such as the IRB administrator, chair, or trained
  faculty