1. Stanley Estime, MSCI, CIP Senior QA/QI Specialist Lisa Gabel, CIP QA/QI Specialist IRB Determinations: What type of Review will your study receive?

2. 22 Agenda Is Your Project Human Subjects Research? Is Your Project Exempt? Does it Qualify for Expedited Review? Does it Require Full Board Review? Mode of Review Decision Tree Helpful Tools Case Studies

3. 33 Is Your Project Human Subjects Research? Research: A systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Human Subjects: A living individual about whom an investigator (whether professional or student) conducting research obtains: (1) Data through intervention or interaction with the individual, or (2) Identifiable private information

4. 4 Is the Data Identifiable? Coded data is identifiable unless: – Codes can be stripped prior to analysis – The PI gets an attestation from the data provider De-identified/Anonymized data – Cannot contain participant codes/IDs if there is a link to identifiable information in existence unless the PI gets an attestation

5. 5 Is Your Project Exempt? Study procedures must fit within Exemption category(ies) – Research conducted with children cannot be exempt under b(2) unless activities are limited to observation without investigator interaction – Research conducted with prisoners is not eligible – Research regulated by FDA is not eligible Investigators MUST obtain an IRB exemption determination prior to conducting Human Research No long-form consent document required; however, process to obtain consent must be in place: – That the project is “research” – That participation is “voluntary” – A brief description of the study procedures – Investigator name and contact information 5

6. 66 Exemption Categories, examples – Research conduced in commonly accepted educational settings, involving normal educational practices – Surveys, interviews, observation of public behavior – Surveys, interviews, observation of public behavior if participants are public officials – Collection of existing data, documents, specimens – Evaluation of public benefit or service programs, etc. subject to approval of Department or Agency heads – Taste and food quality evaluation and consumer acceptance

7. 7 Common Exemption Categories Category #2 – Use of educational tests, survey procedures, interview procedures (e.g. focus groups) or observation of public behavior If information is recorded in a manner that human subjects cannot be identified, directly or through identifiers linked to the subjects; OR If human subjects can be identified, any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation *No Minors unless limited to observation of public behavior.

8. 88 Common Exemption Categories 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 Recorded with no identifiers (no links) Examples of links to identifiers that make a study not exempt: – Hospital patient ID – Student ID – Phone number

9. 99 Does it Qualify for Expedited Review? Expeditable research activities must: – Present no more than minimal risk to human subjects, AND – Involve only study procedures published in the Federal Register (see handout) If research is deemed greater than minimal risk and/or does not fit under the expeditable categories, Full Board review is required.

10. 10 Minimal Risk “The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”

11. 11 Expedited categories, examples 1. Some clinical studies of drugs and medical devices 2. Routine collection of blood samples in healthy participants (<550 mL) 3. Collection of specimens by non-invasive means 4. Collection of data routinely used in clinical practice 5. Research involving materials that have been collected or will be collected solely for non-research purposes 6. Collection of data from voice, video, digital image recording for research purposes 7. Research on individual group characteristics or behavior or employing survey, interview, oral history, focus groups, etc. 8. Continuing review of research previously approved by IRB 9. Continuing review of research not covered in 1-8 for which IRB determines no greater than minimal risk have been identified

12. 12 Does it Need Full Board Review? Human Subjects Research Not Exempt Greater than Minimal risk and/or does not fit an expedited category

13. 13 Mode of Review Determination? Human Subjects Research? Exempt? Expedited? Full Board Not Human Subjects Research Determination Exemption Determination Expedited Approval (reviewed on ongoing/rolling basis) Full Board Approval (reviewed at monthly meetings) No Yes No Yes No Yes

14. 14 Case Studies * Case studies from “Exempt Review” presentation by Tasha Osafo, IRB Office, Northwestern University

15. 15 Case #1 Chicago public schools offers SAT preparation workshops to students for the last 10 years. The school system 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.

16. 16 Case #1: 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.

17. 17 Case #1: 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).

18. 18 Case #1: Non-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.

19. 19 Case #2 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.

20. 20 Case #2: 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.

21. 21 Case #2: 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.

22. 22 Case #2: Non-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.

23. 23 Case #3 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.

24. 24 Case #3: 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 research and does not need IRB review.

25. 25 Case #3: 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.

26. 26 Case #3: 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.

27. 27 Questions?  Leslie Howes, OHRA Director (lhowes@hsph.harvard.edu)lhowes@hsph.harvard.edu  QA/QI Specialists  Stanley Estime (sestime@hsph.harvard.edu)sestime@hsph.harvard.edu  Lisa Gabel (lgabel@hsph.harvard.edu)lgabel@hsph.harvard.edu  Alyssa Speier (aspeier@hsph.harvard.edu)aspeier@hsph.harvard.edu  OHRA: www.hsph.harvard.edu/ohrawww.hsph.harvard.edu/ohra  See OHRA web site for department-assigned IRB Review Specialist and contact information