1. IRB Triage: What Path Do I Follow? IRB Administrators 2012 PRIDE/ Theresa M. Straut, CIP, RAC May 30, 2012

2. 2 Incoming

3. 3 Or…

4. 4 One key to managing workload: Triage Recognizing the correct review path can save time and potentially reduce regulatory burden. Standardized forms can guide submitters, however, forms can be answered incorrectly. Recognize if you have enough information to make a determination.

5. 5 Review submissions to determine: Is it Research? Is it Human Subjects Research? Is it exempt? Is the study expeditable?

6. 6 Where to begin: Is this project Research? Common Rule Definition of Research: Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge [38 CFR 16.102(d)]

7. 7 A systematic investigation is a project that is planned in advance and that uses data collection and analysis to answer a question Generalizable knowledge is information that expands the knowledge base of a scientific discipline or other scholarly field of study. [VHA handbook 1058.05 par 4]

8. 8 Project is Not Research if: Designed and implemented for VA purposes, and Is not designed to produce information that expands the knowledge base of a scientific discipline or other scholarly field. [VHA handbook 1058.05 par 5]

9. 9 Examples of “Not Research” Quality Improvement Competence or qualification reviews of VA employees and health care professionals Business planning and development, such as cost-management and planning analyses Case studies Additional examples are in VHA handbook 1058.05

10. 10 Project is Always Research if: Funded or supported as research Clinical investigations as defined under Food and Drug Administration (FDA) regulations. [VHA Handbook 1058.05, par. 5d]

11. 11 Probable Research Design Characteristics Stratification, Matched pairs, Double blinding, Placebo Assessment of an intervention that is not yet standard or accepted practice Comparison of two or more interventions Collection of clinical information that is not medically necessary Interventions not designed for direct patient benefit [[VHA Handbook 1058.05, par. 5e]

12. 12 If Research, does it involve Human Subjects? Common Rule Definition of Human Subject: Human subject means a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction, or (2) identifiable private information [38 CFR 16.102(f)]

13. 13 I f Research, does it involve Human Subjects? Common Rule Definition of Human Subject (continued): An intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes Interaction includes communication or interpersonal contact between investigator and subject [38 CFR 16.102(f)]

14. 14 I f Research, does it involve Human Subjects? Common Rule Definition of Human Subject (continued): Private information includes information about: Behavior in which an individual can reasonably expect that no observation or recording is taking place, and Information provided for specific purposes which the individual can reasonably expect will not be made public (e.g., medical record) [38 CFR 16.102(f)]

15. 15 I f Research, does it involve Human Subjects? Common Rule Definition of Human Subject (continued): Private information must be individually identifiable to constitute research involving human subjects (identity of the subject is or may readily be ascertained by the investigator or associated with the information) [38 CFR 16.102(f)]

16. 16 If it is human subjects research, is it exempt? Exempt: Research activities in which the only involvement of human subjects will be in one or more of the categories outlined in 38 CFR 16.101(b) may be exempt from the provisions of VHA Handbook 1200.05 and the Common Rule. The exempt status must be determined by the Institutional Review Board (IRB) Chair or an IRB voting member designated by the Chair [VHA Handbook 1200.05 par. 16]

17. 17 Categories of Exempt Research* [See full text @ 38 CFR 16.101(b)] 1.Research conducted in established/commonly accepted educational settings, involving normal educational practices 2.**Research involving educational tests, surveys, interviews, or observation of public behavior unless “identifiable” and “sensitive/risky” 3.Same as #2, but covers public officials/candidates and confidentiality maintained 4.Existing data, documents, records, pathologic specimens, or diagnostic specimens (if publicly available, or recorded by investigator so participants cannot be identified) 5.Research and demonstration project (if approved by VA Secretary) 6.Taste and food evaluation/consumer acceptance with conditions * None apply to research with prisoners **Exception with children as subject (e.g., no surveys)

18. 18 Can Human Subjects Research be Reviewed by an Expedited process? 1.Must fit one or more of the expedited review categories, and be no more than minimal risk -OR- 2.Minor changes in previously approved research during the period for which the approval is authorized [38 CFR 16.110] 18

19. 19 What is Minimal Risk? Minimal Risk means that 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 tests 38 CFR 16.102(i) SACHRP : Understanding Minimal Risk (case examples) www.hhs.gov/ohrp/sachrp/sachrpminrisk20080131.html

20. 20 Expedited Categories (See VHA Handbook 1200.05 for Full Text) 1. Some clinical studies of drugs and medical devices 2. Collection of blood (limited by volume and frequency) 3. Prospective collection of specimens by noninvasive means 4. Noninvasive collection of data (excluding x-rays) 5. Materials collected for non-research purposes 6. Voice, video, digital, or image recordings 7. Group Characteristics, Surveys, Interviews, and Quality Assurance 8-9. Continuing review under specific conditions

21. 21 The Old Glory VA Medical Center establishes a special geriatric clinic Old Glory implements a process to refer patients for special services (e.g., vision care, physical therapy) For internal quality assurance, Nurse Nicols audits patient charts to evaluate whether the referral process is working He surveys patients to evaluate their satisfaction Case Study # 1

22. 22 Is the nurse conducting a systematic investigation? Yes Activity planned in advance Activity uses data collection and analysis to answer a question Is this activity designed to develop or contribute to generalizable knowledge? No Activity is for internal operations Will not expand the scientific understanding or the knowledge base of a scholarly field Case Study # 1: Q & A

23. 23 Is this Research? No Knowledge is not generalizable Case Study # 1: Q & A (continued)

24. 24 Same as Case #1, plus… Nurse Nicols will pull “extra data” not needed for QA He will compare the process to another intervention done at The Red White & Blue VA He plans to generalize the findings beyond VA and hopes to expand the knowledge base of treatments for geriatric patients Case Study # 2

25. 25 Is this activity designed to develop or contribute to generalizable knowledge? Yes The information will expand knowledge base of geriatrics. Is this Research? Yes Meets criteria for “systematic investigation” and “generalizable knowledge” Case Study # 2: Q & A

26. 26 Dr. Thomas wants to conduct research on interventions for gastric ulcers in patients at the VA He requests coded data from a VA Database which tracks private identifiable healthcare information about living VA patients The Database Administrator will provide “coded” data Dr. Thomas can readily ascertain the identity of patients He will pull additional patient data from CPRS to correlate the results for his study Case Study # 3

27. 27 Does the research involve obtaining information about living individuals? Yes - data pertains to living individuals Does the research involve an intervention or interaction with the individuals? No interventions or interactions with individuals are described Is the information individually identifiable? Yes. Dr. Thomas can readily ascertain the identity of subjects based on the data set Case Study # 3: Q & A

28. 28 Is the information private? Yes A patient can reasonably expect that healthcare data will not be made public Is the activity research involving human subjects? Yes Dr. Thomas is obtaining individually identifiable private information about living individuals Case Study # 3: Q & A (continued)

29. 29 Case Study # 4: Q & A Dr. Sheppard is interested in identifying barriers that keep Veterans from using MOVE resources for weight management and exercise. He plans to conduct surveys and focus groups with VA employees who are involved in MOVE and veterans who are eligible to use MOVE but currently do not. He is recording name and basic demographics.

30. 30 Case Study # 4 Is this activity eligible for an exemption? Yes Research involves the use of surveys and focus groups Any disclosure the information is not reasonably expected to place subjects at risk. If yes, under which category should be documented? Exemption category # 2

31. 31 Dr. Reynolds wants to conduct human research on hepatitis All of the materials are existing at the time of the proposal and will be borrowed from other areas She will record data in a spreadsheet in such a manner that subjects cannot be identified She returns all materials to the archives No one will be able identify patients by looking at the spreadsheet, including Dr. Reynolds Case Study # 5

32. 32 Is this activity eligible for an exemption? Yes Research involves the study of existing records Information is recorded by the investigator in such a manner that subjects cannot be identified If yes, under which category should be documented? Exemption category # 4 Case Study # 5: Q & A

33. 33 Case # 5 continued Dr. Reynolds decides to enhance her research by surveying different patients about how they possibly contracted hepatitis. The survey will include questions about the patients IV drug use and sexual behavior. Patients’ information will be coded.

34. 34 Is this activity eligible for an exemption? No Research includes survey of behavior that is sensitive and risky and coded (not de-identified). Case Study # 5 continued: Q & A

35. 35 Dr. Everett proposes human research on endocrinology patients The research presents no more than minimal risks to human subjects Only clinical data will be recorded from the medical records as patients visit the endocrinology clinic over the next 5 years Case Study # 6

36. 36 Can this activity be reviewed using an expedited review process? Yes No more than minimal risk Involve materials collected solely for non-research purposes If yes, under which category should be documented? Expedited Category # 5. Case Study # 6: Q & A

37. 37 Key Points Answer questions in proper sequence when determining whether an activity is research, human subjects research, exempt, or can be expedited 1.Is this project research? 2.If so, does it involve human subjects? 3.If so, is it exempt? 4.If it is not exempt, is it eligible for expedited review?

38. 38 Key Points (continued) Consider all the details of the case. One small detail can change the determination from: Research to Human Subject’s Research Exempt to Expedited Expedited to Convened IRB.

39. 39 Key Points continued Seek more information if needed Consult relevant resources to make appropriate determinations -- call PRIDE for help

40. 40 Contacts 1200.05 Questions: VHACO120005Q@va.govVHACO120005Q@va.gov Contacts: Soundia Duche: 202-443-5658; soundia.duche@va.govsoundia.duche@va.gov Lucindia Shouse: 202-443-5659; lucindia.shouse@va.govlucindia.shouse@va.gov Theresa Straut: 202-443-5654; theresa.straut@va.govtheresa.straut@va.gov Lynn Cates, Director, PRIDE: 202-443-5648; lynn.cates@va.gov lynn.cates@va.gov

41. 41 Questions?