Exempt Review

1. Exempt Review Tasha Osafo, CIP Assistant Director IRB Office

2. OBJECTIVES • Review Basic IRB Concepts • Overview of Exempt Categories TKO

3. COMMON EXPRESSIONS • “I’m not interacting with humans. My project is exempt from the IRB.” • “The PI is receiving de-identified data; her project is exempt.” • “I’m doing a QI project; is my project exempt?” WHAT IS WRONG HERE? TKO

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 TKO

5. Basic Decision Tree 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 TKO

6. Quick Facts about Exempt Research • 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 TKO

7. OVERVIEW OF EXEMPT CATEGORIES • Review the Exempt Categories and overlapping Expedited Categories. • Case Scenarios TKO

8. Exempt Category 1 Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as • research on regular and special education instructional strategies, or • research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. TKO

9. Exempt Category 1 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 TKO

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. TKO

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. TKO

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). TKO

13. Not Exempt Scenario • Dr. Kim will assess if the workshops would be more effective if held outdoors by randomizing ½ the students to the normal workshop in the classroom; the other ½ 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. TKO

14. Exempt Category 2 Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: • 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. TKO

15. Exempt Category 2 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 subject’s 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 TKO

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. TKO

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 TKO

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. TKO

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. TKO

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. TKO

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. TKO

22. Exempt Category 3 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 (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. TKO

23. Exempt Category 3 Key Points: Research that otherwise doesn’t 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. TKO

24. Exempt Category 4 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. TKO

25. Exempt Category 4 Key Points: • Existing is defined as “on the shelf” at the time of initial IRB review. • Information must be immediately recorded without identifiers & codes. Nobody should be able to link the data back to the subjects. Examples: • Analysis of existing dataset in which the PI immediately removes MR# TKO

26. Exempt Category 4 v Expedited Category 5 • Expedited Category 5: Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis). TKO

27. Exemption applies if: • All data is existing, and • Immediately recorded without identifiers or codes Expedited applies if: • Data is existing but identifiers retained, and/or • Data will be prospectively collected for non-research purposes (identifiers can be kept) TKO

28. Case Scenario • Dr. Adams has a freezer of blood samples that were originally collected for a research study which ended several years ago. Patient codes (which can be linked to the Medical Record) remain on the samples. The consent form originally signed by the subjects of Dr. Adams indicated whether or not their stored blood could be used for future research. TKO

29. Not Human Subjects Research Scenario A researcher wishes to use the samples for his own study (non-FDA regulated). Dr. Adams removes the patient code from the samples before giving the samples to the researcher. • Key Points: The researcher is conducting research. However, the samples were not originally collected for his project, and he is not receiving identifiable information. Therefore, he is not conducting human subjects researchand does not need IRB review. TKO

30. Exempt Scenario Dr. Adams gives the researcher the samples with the patient code. The researcher immediately removes the code upon receipt of the samples. • Key Points: Because he is given samples with the patient code, the researcher is engaged in human subjects research. However, Exempt Category 4 applies as he is using existing samples and he plans to immediately remove the patient code. TKO

31. Non-Exempt Scenario The researcher retains the patient code just in case he needs to contact the patient for follow-up information. • Key Points: Exempt Category 4 does not apply as the researcher retains the patient code. The study may qualify for Expedited Category 5 (research involving materials that have been collected), as well as Expedited Category 7 if he eventually contacts subjects for follow-up information. TKO

32. Exempt Category 5 Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:(i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs. TKO

33. Exempt Category 5 requirements • The program under study must deliver a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutrition services as provided under the Older Americans Act). • The research or demonstration project must be conducted pursuant to specific federal statutory authority. • There must be no statutory requirement that the project be reviewed by an Institutional Review Board (IRB). • The project must not involve significant physical invasions or intrusions upon the privacy of participants. TKO

34. Exempt Category 6 (overlaps with FDA) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the FDA or approved by the EPA or the Food Safety and Inspection Service of the U.S. Department of Agriculture. TKO

35. Exempt Category 6 Examples • Taste testing whole grain food products • Comparing taste or smell of molasses, cheese or milk • Sampling texture of ice cream TKO

36. Questions? TKO

37. Contact Information Tasha K Osafo, BA, CIP Assistant Director Institutional Review Board Office Email: t-osafo@northwestern.eduPhone: 312-503-4225Fax: 312-503-0555 TKO