tasha osafo, cip assistant director irb office exempt review

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  • Slide 1
  • Tasha Osafo, CIP Assistant Director IRB Office Exempt Review
  • Slide 2
  • OBJECTIVES 10/14/2011 IRB Retreat TKO Review Basic IRB Concepts Overview of Exempt Categories
  • Slide 3
  • 10/14/2011 IRB Retreat TKO Im not interacting with humans. My project is exempt from the IRB. The PI is receiving de-identified data; her project is exempt. Im doing a QI project; is my project exempt? WHAT IS WRONG HERE? COMMON EXPRESSIONS
  • Slide 4
  • Misuse of the term Exempt when referring to Non-human subjects research From IRB perspective, the project is either Non-human subjects research or Human subjects research that meets Exempt, Expedited, or Full Board review criteria 10/14/2011 IRB Retreat TKO
  • Slide 5
  • Basic Decision Tree 10/14/2011 IRB Retreat TKO Step 1: Research? Yes No No IRB Step 2: Human Subjects? Yes No No IRB Step 3: Exempt, Expedited or Full Board? Step 4: Submit to IRB for final determination
  • Slide 6
  • Quick Facts about Exempt Research 10/14/2011 IRB Retreat TKO No continuing review required At NU, IRB Reviewer makes Exempt determination 6 OHRP & 4 FDA categories(1 category overlaps) No prisoners; pregnant women allowed; minors allowed, but restrictions apply (Subpart B & D determination not needed) HIPAA requirements apply if PHI used or disclosed
  • Slide 7
  • OVERVIEW OF EXEMPT CATEGORIES 10/14/2011 IRB Retreat TKO Review the Exempt Categories and overlapping Expedited Categories. Case Scenarios
  • Slide 8
  • Exempt Category 1 10/14/2011 IRB Retreat TKO Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
  • Slide 9
  • Exempt Category 1 10/14/2011 IRB Retreat TKO Key Points: Research in established or commonly accepted educational settings, and Research of normal education practices Examples: Evaluating the use of accepted or revised standardized tests A program evaluation of pharmacy continuing education
  • Slide 10
  • Case Scenario Chicago public schools have offered SAT preparation workshops to its students for the last 10 years. The school tracks SAT results for its own purposes. Professor Kim from NU wishes to study the impact of these workshops on SAT scores in the schools. 10/14/2011 IRB Retreat TKO
  • Slide 11
  • Not Human Subjects Research Scenario The schools will give Dr. Kim de-identified SAT scores from 2006 to 2011 for her research. Neither Dr. Kim or the schools will be able to link the scores back to the students. She will collect basic demographics about the school from their websites. KEY POINTS: Dr. Kim is receiving a de-identified dataset that was not originally collected for her study. Human subjects are not involved; therefore, IRB review is not required. 10/14/2011 IRB Retreat TKO
  • Slide 12
  • Exempt Scenario Dr. Kim plans to administer a pre and post workshop survey to participating students to measure satisfaction and effectiveness of the workshop. Key Points: Dr. Kim is conducting research with human subjects due to administration of the survey. However, it meets Exempt category 1 as it is in a commonly accepted education setting (high school) and is studying the effectiveness of standard instruction techniques (the workshops). 10/14/2011 IRB Retreat TKO
  • Slide 13
  • Not Exempt Scenario Dr. Kim will assess if the workshops would be more effective if held outdoors by randomizing the students to the normal workshop in the classroom; the other are randomized to the woods. Key Points: While Dr. Kim is still studying a normal educational practice (the workshops), the setting in the woods is not considered a commonly accepted educational setting and the research does not qualify for Exempt status. Expedited review or Full Board review is required. 10/14/2011 IRB Retreat TKO
  • Slide 14
  • Exempt Category 2 10/14/2011 IRB Retreat TKO Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
  • Slide 15
  • Exempt Category 2 10/14/2011 IRB Retreat TKO Key Points: Minors cannot be surveyed or interviewed. Investigator may observe public behavior of children, but cannot participate in that behavior or activity. Identifiers can be recorded if disclosure of the subjects responses will not place them at risk Examples: Survey of physicians regarding new pt. triage process Focus group to study impact of exercise on QOL
  • Slide 16
  • Exempt Category 2 v Expedited Category 7 Expedited Category 7 Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. 10/14/2011 IRB Retreat TKO
  • Slide 17
  • Exemption applies if Data is identifiable but not sensitive Data is sensitive but recorded without identifiers Children are only undergoing educational tests or observation of public behavior without interaction with the investigator Expedited applies if: Data is identifiable and sensitive but measures are in place to protect confidentiality Children are to be surveyed, interviewed, or observed with interaction by the investigator 10/14/2011 IRB Retreat TKO
  • Slide 18
  • CASE SCENARIO Dr. Jones, the Chair of the IRB, plans to survey researchers at his institution to assess satisfaction with the IRB review process. Approximately 50 researchers will be randomly selected to complete an online survey. 10/14/2011 IRB Retreat TKO
  • Slide 19
  • Not Human Subjects Research Scenario Dr. Jones does not plan to disseminate the results of his interviews. The results will be used within the IRB Office to assess what changes can be made to improve the review process. Key Points: While Dr. Jones is interacting with individuals, this is not research (a systematic investigation designed to develop or contribute to generalizable knowledge). It is a QI project and does not need IRB review. 10/14/2011 IRB Retreat TKO
  • Slide 20
  • Exempt Scenario Dr. Jones and his colleagues at other sites believe there is a correlation between satisfaction with the IRB and departmental support. Each site will send surveys to 50 researchers. The surveys will be anonymous. Key Points: Dr. Jones is engaged in research with human subjects and IRB review is required. Even though the survey may ask sensitive information, he meets Exempt Category 2 because results are recorded without identifiers. 10/14/2011 IRB Retreat TKO
  • Slide 21
  • Not Exempt Scenario Dr. Jones plans to retain identifiers on the surveys so that he can send out a second survey to those researchers who score extremely high on the dissatisfaction scale. Key Points: This project does not qualify for Exempt review due to retention of identifiers. Expedited Category 7 may apply if the IRB reviewer believes there are adequate measures in place to protect confidentiality and the risk is minimal. 10/14/2011 IRB Retreat TKO
  • Slide 22
  • Exempt Category 3 10/14/2011 IRB Retreat TKO Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or(b)(2) (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
  • Slide 23
  • Exempt Category 3 Key Points: Research that otherwise doesnt qualify for exemption under Category 2 due to collection of identifiable information that could place subjects at risk, qualifies under this category if the human subjects are elected or appointed public officials or candidates for public office; or federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. 10/14/2011 IRB Retreat TKO
  • Slide 24
  • Exempt Category 4 10/14/2011 IRB Retreat TKO Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
  • Slide 25
  • Exempt Category 4 10/14/2011 IRB Retreat TK