1. 9/17/09 6/20/20131 Introduction to the UIUC Institutional Review Board – Library Summer Workshop June 20, 2013 June 20, 2013 Ron Banks- Human Subjects Coordinator Ron Banks- Human Subjects Coordinator rbanks@illinois.edu; 244-3939 rbanks@illinois.edu; 244-3939

2. 9/17/09 6/20/20132 OVERVIEW: Human Subjects Protections at UIUC The Belmont Report and regulations The Belmont Report and regulations What is human subjects research What is human subjects research Levels of review – NHSR (not human subjects research), exempt, expedited, full board) w/GSLIS or UIUC Library research examples Levels of review – NHSR (not human subjects research), exempt, expedited, full board) w/GSLIS or UIUC Library research examples Overview of IRB procedures/pathways to approval/tips/required training Overview of IRB procedures/pathways to approval/tips/required training Amendments Amendments Informed Consent Informed Consent UIUC IRB application approval criteria UIUC IRB application approval criteria

3. 9/17/09 6/20/20133 History leading to IRB system PHS Syphilis Study (Tuskegee) PHS Syphilis Study (Tuskegee) Willowbrook Willowbrook Milgram Milgram Beecher article in 1966 Beecher article in 1966

4. 9/17/09 6/20//20134 National Research Act 1974 The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research is established, and Congress passes the National Research Act. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research is established, and Congress passes the National Research Act.

5. 9/17/09 6/20/20135 Belmont Report - 1979 Respect for Persons Respect for Persons Beneficence Beneficence Justice Justice

6. 9/17/09 6/20/20136 Respect for Persons People to be treated as autonomous agents with freedom of choice People to be treated as autonomous agents with freedom of choice Protect those with diminished autonomy Protect those with diminished autonomy People must provide informed consent People must provide informed consent Privacy must be respected Privacy must be respected

7. 9/17/09 6/20/20137 Beneficence Obligation to do no harm Obligation to do no harm Obligation to do good Obligation to do good Risk Benefit ratio Risk Benefit ratio

8. 9/17/09 6/20/20138 Justice Fairness in recruiting Fairness in recruiting Distributed justice. Burdens and Benefits shared equally Distributed justice. Burdens and Benefits shared equally Vulnerable populations Vulnerable populations Choice to participate or not Choice to participate or not

9. 9/17/09 6/20/20139 Federal Regulations 45 CFR 46 – Common Rule - Regulations for the Protection of Human Subjects of Biomedical and Behavioral Research 45 CFR 46 – Common Rule - Regulations for the Protection of Human Subjects of Biomedical and Behavioral Research –Basic regulations established in 1974 –Adopted by 16 federal agencies as the Common Rule in 1991 –Proposed changes in the regulations being reviewed

10. 9/17/09 6/20/201310 What is a Human Subject? A living individual about whom an investigator obtains data through intervention or interaction with the individual A living individual about whom an investigator obtains data through intervention or interaction with the individualOR …about whom an investigator obtains individually identifiable, private information

11. 9/17/09 6/20/201311 What is Research? A systematic investigation designed to lead to generalizable knowledge A systematic investigation designed to lead to generalizable knowledge

12. 9/17/09 6/20/201312 What this means for UIUC Researchers… All research involving humans, human tissues or fluids, or records All research involving humans, human tissues or fluids, or records Funded or not Funded or not Regardless of where the research is conducted Regardless of where the research is conducted Regardless of level of risk Regardless of level of risk

13. 9/17/09 6/20/201313 What this means for UIUC Students If you are conducting research with humans including senior theses or dissertation… –Complete an IRB application –Complete the required training –Get IRB approval before starting!

14. 9/17/09 Levels of Review NHSR (Not human subjects research) Exempt Research Expedited Review Full Board

15. 9/17/09 Not Human Subjects Research Overview Some research involving human subjects or analysis of data doesn’t require IRB review/approval (doesn’t fit federal definition) Contact the IRB office first BEFORE filing application if you are not sure

16. 9/17/09 Examples of Not Human Subjects Research Survey done for internal purpose only (e.g., program improvement) Survey done for internal purpose only (e.g., program improvement) Survey/interview requesting factual information only (no opinions/attitudes/perceptions/beliefs) Survey/interview requesting factual information only (no opinions/attitudes/perceptions/beliefs) Course projects policy – student research done solely to learn how to be an effective researcher Course projects policy – student research done solely to learn how to be an effective researcher Certain kinds of oral history Certain kinds of oral history Analyzing data other researchers collected that GSLIS researchers can’t link back to identity of the participants. Analyzing data other researchers collected that GSLIS researchers can’t link back to identity of the participants. Only analyzing data that is publicly available (on a public message board) Only analyzing data that is publicly available (on a public message board)

17. 9/17/09 Example of application approved as NHSR (not human subjects research) Gender and Salary in the Illinois Public Libraries, 1993-94 and 2006-07 –Data being analyzed from the Illinois Public Library Annual Report was library specific but not linkable to individual employees by the researchers (library ID was removed) 6/20/201317

18. 9/17/09 Review Levels - “Exempt” Studies Exempt research: Exempt means exempt from the federal regulations and formal board member review. However UIUC essentially adheres to these regulations for all studies, but with more flexibility and a shorter application available. All exempt studies must be designated no more than minimal risk and fit one of the allowable exemption categories as per the federal regulations. Timelines - approximately one to two weeks from submission to approval, improved turnaround time since an Exempt Specialist was hired at the campus IRB

19. 9/17/09 Exempt Category #1 Category 1: Title 45, Code of Federal Regulations §46.101(b)(1) exempts 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.

20. 9/17/09 GSLIS Example of study approved under exempt category #1 Data Curation Education in Research Centers (DCERC) –Evaluating the impact of a data curation educational program –Actitivies – online surveys, data from online forums, interviews, reflections… –Approved under exempt category 1 6/20/201320

21. 9/17/09 Pre-review issues for exempt category #1 study Section 12 – lines 9-12 state: “As part of the case study, one researcher from each DCERC institution (UIUC and Univ. of TN at Knoxville) will serve as a participant observer and record observations of telling moments during the course program. Only moments from those signing permission forms will be recorded with personally identifying information removed.” Please clarify the consent process for the observations in section 20D and if participants will sign and return a consent form for this part of the study, please supply a copy of that consent form with any revisions. Consent letter - please note that the dissemination statement in the consent forms should more closely match what is in section 19F of the IRB-1 form. Issue: consent letter didn’t relate all of the various possibilities mentioned in the application. 6/20/201321

22. 9/17/09 Rationale for exemption (Category #1) Category 1 applies because the study involves surveys, observational case study analysis, interviews, and an end of program debriefing essay by students and principle parties. The goal is to evaluate the impact of the Data Curation Education in Research Centers (DCERC) program on students, the faculty, and institutions involved (therefore the study is occurring in a commonly accepted setting for education and is attempting to determine the effectiveness of an instructional curricula) 6/20/201322

23. 9/17/09 Exempt category #2 Category 2: Title 45, Code of Federal Regulations §46.101(b)(2) exempts research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unlesspublic –information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and –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.

24. 9/17/09 Library Exempt example - category #2 Integration of makerspace technologies in a public computer lab –Interviews with 3 librarians from the Cleveland Public Library about integrating makerspace technology in library computer lab

25. 9/17/09 Pre-review issues Section 6: Please describe the measures you will take to assure confidentiality of the subjects’ responses. For example, will you use pseudonyms? Will the data be stripped of any identifiers to both person and place of employment before disseminated? The consent states that they will be unidentifiable, but the application needs to show me your process. Section 7: Please describe the measures you will take to secure the hand- written notes and audio recordings. For instance, will the notes be kept in a locked office? Will the recordings be kept on a password-protected computer? 6/20/201325

26. 9/17/09 Rationale for Exemption (GSLIS example exempt category #2) The study involves interview procedures, the data is identifiable (coded and audio recordings exist) but any disclosure of responses would not reasonably place the participants at risk of criminal/civil liability nor would it be damaging to their financial status, employability or reputation. 6/20/201326

27. 9/17/09 Review Levels - “Expedited” Review research must be ‘no more than minimal risk’ There are nine categories of expedited research including 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. (NOTE: Some research in this category may also qualify as exempt) experimental manipulation of some kind, blood draws, MRI, deception, etc. TIMELINE - approximately one month from submission to approval. - one board member reviews.

28. 9/17/09 Library Expedited Review: Example #1 Library Collections Visualized: A User Study of Prototype Collection Analysis Tools Procedures: –User testing of tool to analyze use/content of library collections –Morae/Silverback software captures screen, video of interaction, etc.

29. 9/17/09 Pre-review issues - expedited review study Section 18b/18c/18e – clarify whether the NetID login remains with the data or whether this is replaced by any kind of participant number. If there is such a system is an identity key created that links the number (or pseudonym) back to the real name of the participant. If there is an identity key explain how its stored securely in 18c and for how long its retained in 18e. Section 18b – are the audio recordings of interviews and video collected through the Morae Software for transcription/research analysis only (not dissemination)? WAIVER of DOCUMENTATION: – Please add details as to the study represents no more than minimal risk of harm why there are no procedures for which signed consent would be necessary outside of the research context (such as if the results were being used for internal evaluation only to see if the system assists library research rather than broader research purposes signed consent wouldn’t be required?) CONSENT LETTER - suggest adding a sentence or two being more specific about what the user testing session entails, what they are asked to do, find, etc. 6/20/201329

30. 9/17/09 GSLIS expedited review (example #2) Data Sites: Collaborative Practices and Data Repositories –To investigate data practices, data sharing, and interfaces with data repositories in the natural environment –Activities – document analysis, interviews, and observations of work environments Rationale for expedited review: –Expedited under 45 CFR 46, categories 6 and 7. Category 6 applies since observations of meetings and interviews may be audio recorded with permission and participants and workplaces may be photographed. Category 7 applies since the study involves individuals at specific scientific sites being observed, participating in interviews, and providing work related documents in order to investigate data practices, data sharing, and interfaces with data repositories in the natural sciences. It was felt the category 2 exemption would not apply since observations are not public.

31. 9/17/09 6/20/201331 Board member issues prior to approval - Expedited review GSLIS example #2 Section 20a- since the research occurs in the participants work environment please add some specific discussion about any possible risks related to employment (such as if they had different opinions about the organizations approach than that advocated by administration) and if there might be any how these risks are minimized. Section 18b- seems from the interview consent that participants could choose to allow their response to be connected to their identities, is that true of the observational data as well? Explain this in the data collection section, and if there is to be such an option add a discussion in section 18b to make it clear that participants can choose confidential participation or to allow identities to be linked to their research contributions in research dissemination efforts. NOTE: if there is not such an option just delete that information from paragraph 2 on the interview consent. Section 19d- so for the various observations would the researchers always need to have obtained consent from everybody in the meeting or work area prior to conducting observations? If even one person has not consented do no observations occur in other words for that given meeting, in that work space, etc.?

32. 9/17/09 Review Levels - “Full Board” Review IRB applications that require full board review are thought to involve potentially higher levels of risk to subjects. Research involving the study of illegal activity, some drug and alcohol studies, X ray studies, prisoners, or that involves maximal exercise require full board review. Small percentage of IRB applications require IRB review. TIMELINE - submit by deadline date (typically first Friday of month) for meeting that occurs in the 2nd week of the following month (e.g. submit by May 4 for June 12th meeting) Board can approve, defer approval to the next month’s meeting, or vote to reject the study

33. 9/17/09 6/20/201333 GSLIS full board example Community Informatics Across the Curriculum Community Informatics Across the Curriculum Procedures: Procedures: –Done in part at the Champaign County Juvenile Detention Center (subpart C applies) –Focus on the incarcerated youth’s perceptions of the library collection and services (informal conversations and collections analysis

34. 9/17/09 Full Board Concerns (prior to approval) If an incarcerated youth doesn’t agree to be part of the study they are still given access to the library when it is not staffed, but is that equivalent access? The youth who do not assent should still be able to enter the room when the librarians are there, so there needs to be a system in place that keeps track of who opts out of participation. An alternative plan could also be developed such as observing for research purposes only in one-half of the staffed time so that youth who don’t participate in the research could still access the library when librarian assistance is available. In other words a reasonable plan should be developed that assures that any incarcerated youth who chooses not to participate will have the same equal access to the library that they have always had. Section 10a, 12 and 19b- Be more specific than stating that “data will involve conversations with youth” by clarifying what the limits would be for these conversations in terms of topics that are eligible for research data collection.

35. 9/17/09 6/20/201335 UIUC IRB Procedure Submit an IRB-1 application OR Application for Exemption along with: –Consent documents –Measures –Recruitment flyers Pre-review procedure Board member review if study is not exempt

36. 9/17/09 IRB Application Tips Be consistent throughout your application Have patience with process, planning in advance will lead to less stress, IRB is service oriented, you can meet with us, call with questions, etc. Try to be as detailed as possible on first submission. Fill in all boxes/sections, go through form carefully. Read and respond to questions that appear on the form.

37. 9/17/09 IRB Application Tips Use online help available on the IRB web site. Use lay language in section 7 and throughout (especially on consent), when academic jargon is necessary define what it means. Respond to each request for revision from the pre- review or board member review, helpful to have a response letter. On pre-review when requested changes aren’t made clarify why! 99+% of studies get approved, but great range in terms of how stressful the process is prior to approval! IRB Web Site

38. 9/17/09 6/13/201338 Pathway to Approval Submit application and complete the required training Respond to IRB Office comments quickly (pre-review from office staff reviewer) Review level determination will be made at the IRB Office - exempt, expedited, full board –if exempt approval after pre-review complete –If not exempt, sent to one board member or full board Respond to board member modifications letter Approval is good for three years for exempt, one year for expedited or full board (sometimes just 6 months)

39. 9/17/09 6/20/201339 Required online training – CITI Program Belmont Report and CITI Course Introduction History and Ethical Principles - SBR Defining Research with Human Subjects - SBR Assessing Risk in Social Behavioral Sciences - SBR Informed Consent - SBR Privacy and Confidentiality - SBR

40. 9/17/09 6/120/201340 Research Amendments AFTER initial approval if anything changes in procedures, participants, consent letters, etc. –If approved via expedited or full board review: Submit a Research Amendment form –If approved as exempt just summarize changes in an email –Supply ‘markup’ versions of anything is changed – no need to supply materials that are not changing –Supply final versions and anything new –Minor modifications approved in office, major changes approved via board member after pre-review.

41. 9/17/09 6/20/2013 41 Elements of Informed Consent Purpose Purpose Procedures Procedures Risks and Benefits Risks and Benefits Voluntariness Voluntariness Confidentiality Confidentiality Contact Information Contact Information Signature Statement Signature Statement

42. 9/17/09 6/20/201342 Informed Consent Overview Signed (written) Informed Consent Signed (written) Informed Consent Waiver of Informed Consent Waiver of Informed Consent Alteration of Informed Consent Alteration of Informed Consent Waiver of Documentation Waiver of Documentation

43. 9/17/09 6/20/201343 Informed Consent Overview Cont’d Informed consent is an ongoing process rather than just given/obtained at a moment of time. Informed consent is an ongoing process rather than just given/obtained at a moment of time. no exculpatory language, 8th grade reading level, correct grammar/typos no exculpatory language, 8th grade reading level, correct grammar/typos Give participants opportunities to ask questions Give participants opportunities to ask questions Ensure participants understand what they have consented to do Ensure participants understand what they have consented to do Ensure participants understand that they can discontinue at any time Ensure participants understand that they can discontinue at any time

44. 9/17/09 9/20/201344 Purpose and Composition of UIUC IRB To facilitate safe and ethical research with human subjects conducted by UIUC faculty, staff and students. To facilitate safe and ethical research with human subjects conducted by UIUC faculty, staff and students. Two boards – Social/Behavioral/Educational and Biomedical Two boards – Social/Behavioral/Educational and Biomedical Approximately 15 faculty, community members, physicians on each board Approximately 15 faculty, community members, physicians on each board IRB office - 8 person staff IRB office - 8 person staff

45. 9/17/09 45 Seven Criteria for Approval Risks to subjects are minimized. Risks to subjects are minimized. Risks to subjects are reasonable in relation to anticipated benefits and the importance of the knowledge that may reasonably be expected to result. Risks to subjects are reasonable in relation to anticipated benefits and the importance of the knowledge that may reasonably be expected to result.

46. 9/17/09 6/20/201346 Seven Criteria for Approval cont’d Selection of subjects is equitable. Selection of subjects is equitable. Informed consent will be sought from each prospective subject. Informed consent will be sought from each prospective subject. Informed consent will be appropriately documented. Informed consent will be appropriately documented.

47. 9/17/09 6/20/201347 Seven Criteria for Approval cont’d The research plan makes adequate provision for monitoring the data collected. The research plan makes adequate provision for monitoring the data collected. Adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. Adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

48. 9/17/09 Connection Belmont to Review Criteria Respect for Persons –Informed consent, assent, privacy/confidentiality, vulnerable populations Beneficence –Risk/benefit analysis, data safety, experimental design, qualifications of PI Justice –Subject selection, inclusion/exclusion, recruitment

49. 9/17/09 6/20/201349 Assistance Available Tip sheets online with examples Tip sheets online with examples Phone: 333-2670 Phone: 333-2670 Email: irb@illinois.edu Email: irb@illinois.edu Schedule appointments with IRB staff Schedule appointments with IRB staff