1. Human Research Protection and the Institutional Review Board (IRB) 2015-2016 August 10 - 11, 2015

2. IRB Role The sole mission of the IRB is the protection of humans who participate in research. As part of that mission, the IRB: – Establishes policies and procedures – Monitors regulatory and institutional compliance – Manages the LMU Federal Wide Assurance (FWA) August 10 - 11, 2015

3. Institutional Assurance LMU has negotiated with the Office for Human Research Protections (OHRP) that all of the institution’s human subject research activities, regardless of funding, will be guided by the Belmont Report, will comply with the Common Rule, and other regulations as applicable. This is referred to as a Federal wide Assurance (FWA). August 10 - 11, 2015

6. The Belmont Report (1978) The principles of the Belmont Report govern all research supported by the U.S. Government and Lincoln Memorial University. The ethical principles outlined in the report (respect for persons, beneficence, and justice)are the basis for subsequent regulations designed to ensure protection of human subjects in research. August 10 - 11, 2015

7. Federal Regulations and Policy stemming from Belmont Principles 45 CFR 46 – DHHS Policy for Protection of Human Research Subjects- Subpart A Originally adopted January 13, 1981 Revised June 18, 1991 “The Common Rule” – adopted by 17 federal agencies, including FDA-regulated research in 1991 August 10 - 11, 2015

8. The Common Rule (1991) The “Common Rule” is the set of regulations which were developed to ensure compliance with the principles of the Belmont Report. The regulations fall under the Department of Health and Human Services. These regulations have been adopted by many other federal departments which regulate human research. August 10 - 11, 2015

9. Protective Mechanisms Established by the Common Rule  Institutional Assurances of compliance  Review of research by an Institutional Review Board (IRB) or Ethics Committee  Informed consent of subjects August 10 - 11, 2015

10. What is the IRB?  An Institutional Review Board (IRB) is charged with protecting the rights and welfare of people participating in research.  The Institutional Review Board (IRB) is comprised of faculty and staff at Lincoln Memorial University who have knowledge and experience in social/behavioral and biomedical research. In addition, one local community person serves on the board.  The IRB reviews proposals for research involving human subjects. August 10 - 11, 2015

11. Goals of the IRB  Protect the rights and welfare of people participating in research.  Assist investigators in conducting ethical research that complies with the U.S. Code of Federal Regulations, DHHS (CFR), Title 45 Part 46 (45 CFR 46).Title 45 Part 46 (45 CFR 46)  Support the responsible conduct of research. August 10 - 11, 2015

12. Activities Needing IRB Approval  All federally-funded research projects involving the use of Human Subjects. (Source: 45 CFR 46).  LMU requires review for ALL research projects involving the use of Human Subjects, federal or not.  Rule of Thumb: Will the research be published or presented in a professional setting? August 10 - 11, 2015

13. Do I really need IRB review?  RESEARCH –  A systematic investigation designed to develop or contribute to generalizable knowledge.  45 CFR 46.102(d )  HUMAN SUBJECT -  A living individual about whom an investigator…conducting research obtains  1) data through intervention or interaction with the individual, or  2) identifiable private information  45 CFR 46.102(f) August 10 - 11, 2015

14. Start with ‘research’  ‘Systematic’: use of statistical analyses, scientific methods – can include ‘nonresearch’ AND  What about ‘generalizable’?  Is the intent of this project to contribute to knowledge in the field or discipline?  Are there hypotheses or research questions?  Will analysis of data lead to generalizable claims?  Is there an intent to publish or present the project as research? If ‘yes’ >>>>> the project is research August 10 - 11, 2015

15. NOT ‘generalizable’, i.e. Not research  Quality improvement/ assessment/ assurance projects – designed with goal of improving institutional/organizational practice  Case reports, case series, anecdotal narratives – if no systematic investigation, i.e. no statistical or data analysis; no outcome measures; no predictive claims August 10 - 11, 2015

16. When does an Observational Study need IRB Review? IRB approval is NOT needed if people are in public places and the behavior they are engaging in is public. However, IRB approval is needed when there is any interaction or intervention or when children (minors) or any other sensitive groups (e.g., institutionalized) are involved. August 10 - 11, 2015

17. Human Subjects in Research Living individuals about whom an investigator-- whether a professional or a student--conducting research obtains data through: intervention,or interaction with the individual, or identifiable private information. Source: OHRP, 45 CFR 46 August 10 - 11, 2015

18. When Planning A Research Project, An Investigator Should Consider the Following Questions:  Does the activity or project involve minimal risk? —”probability and magnitude of harm or discomfort are not greater in and of themselves than those ordinarily encountered in daily life or doing the performance of routine physical or psychological examination or tests?” August 10 - 11, 2015

19. How much intervention is involved?  Intervention means manipulations of subjects or subjects’ environment that are performed for research purposes.  Interaction includes communication or interpersonal contact between investigator or subjects.  Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and …..privacy August 10 - 11, 2015

20. Privacy Private information is information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., academic record). Private information must be individually identifiable in order for it to constitute “research” involving human subjects. August 10 - 11, 2015

21. Does the research involve a vulnerable population?  Vulnerable populations include:  Children (all minors younger than 18 years of age must also have parental consent)  Pregnant women  Institutionalized individuals (e.g., prisoners, individuals in group homes, nursing homes, mental institutions)  Cognitively impaired individuals August 10 - 11, 2015

22. Populations specifically protected in federal regulations 45CFR46 – Pregnant women - Subpart B – Prisoners – Subpart C – Children – Subpart D August 10 - 11, 2015

23. Other considerations may also count as “Vulnerable”: Language Culture Current Events or Incidents Age (elderly) Age (adolescents) Educationally, economically disadvantaged Transient Cognitive Impairment Substance Use Health Status Students Employees August 10 - 11, 2015

24. IRB Training Requirement Investigator and all parties (including students) named on the application must complete an on- line IRB training and submit proof of completion along with their IRB application. August 10 - 11, 2015

25. LMU IRB Application Submission and Review Process August 10 - 11, 2015

26. Path to LMU IRB Application Submission http://www.lmunet.edu/curstudents/ORGSP/I RB/index.htm http://www.lmunet.edu/curstudents/ORGSP/I RB/index.htm All the information and forms needed to submit an IRB application are on the ORGSP webpage. August 10 - 11, 2015

28. Things to consider when completing your application Is the proposal – Clear – Concise – Consistent Have I addressed – Why – Who – What – Where – When – How August 10 - 11, 2015

29. Basic Steps to IRB Application Process Get the current application from the webpage. – http://www.lmunet.edu/curstudents/ORGSP/IRB/inde x.htm http://www.lmunet.edu/curstudents/ORGSP/IRB/inde x.htm Make sure you have the required signatures. – Principal Investigator – Chair – Dean – Any Co-Investigator August 10 - 11, 2015

30. Basic Steps to IRB Application Process Continued Include the following items with your protocol when submitted if applicable: – Consent form(s) – Data collections instruments (with permission to use or proof of purchase if not developed by the investigator) to be used (e.g. surveys, questionnaires, tests, etc.) – Recruitment flyers – Letters of permission – CITI Training certificate – Debriefing statements – Media clips  All the above documents should be emailed to (melissa.miracle02@lmunet.edu), then a copy should be hand delivered or sent through the mail to the ORGSP attention, Melissa Miracle, Duke room 304.melissa.miracle02@lmunet.edu August 10 - 11, 2015

31. Application Form Project Title Type of review—IRB makes final decision Project dates—approval date by IRB vs. researcher’s planned dates Principal Investigator, co-investigators, faculty sponsor, with signatures IRB Training and Certification date Student/Outside researcher information - Signature of a university sponsor Funding Research statement: purpose of study and/or research question(s) Participants—subjects, number of subjects, method of solicitation Informed consent (consent and assent forms), method to obtain Data & Consent collection methods—data with identifiers, how confidentiality/anonymity will be protected, how will/where the data is to be stored Methodology details—specifics regarding contact, selection and exclusion, consent and assent process, data instruments (permission or purchase issues), distribution and collection of instruments, location with permission to distribute at school, agency, company Risk factors Submission of all materials—recruitment flyers, informed consent, data collection instrument(s), letters of permission, debriefing, media to show to participants Certification statement – signatures have been completed from PI, chair, dean (if applicable) and co-PI’s NOTE: IRB Processing may be delayed due to missing information, incomplete information, inconsistencies, or the need for clarification of statements describing processes August 10 - 11, 2015

32. The Review Process Once the chair receives the application, all research projects are categorized into one of three categories for the IRB review process. Each category is different in the level of review it receives from the IRB. The IRB is responsible for making the final decision of which category a research project falls under. Exempt Expedited Full August 10 - 11, 2015

33. The basic differences in the review categories are: – Exempt (Minimal risk for the study participants – reviewed by the chair, quick turnaround time--allow 1- 2 weeks.) Exempt does not mean exempt from review. – Expedited (No more than minimal risk, reviewed by the chair and at least 1 IRB member, turnaround time--allow 2-3 weeks.) – Full (More than Minimal Risk or vulnerable populations (children, pregnant women, prisoners); longer turnaround time, must be reviewed by full committee and discussed at monthly meeting--allow 6-8 weeks, may take longer if application is not complete.) August 10 - 11, 2015

34. Examples of social science projects that will likely require IRB submission Interviews – quantitative or qualitative approaches Focus groups Pretest – intervention – posttest (eg., analysis of writing samples) Surveys, including Internet-based surveys Randomized intervention and control group Data analysis of primary or secondary data that contain identifiers or codes School-based research August 10 - 11, 2015

35. Most research projects conducted by students and faculty are:  Exempt (poses minimal risk to human subjects) and is reviewed the chair of the IRB, or  Expedited (poses potential risk) and is reviewed by at least 2 members of the IRB (including the chair). August 10 - 11, 2015

37. Exempt Expedited Full IRB Review Continuum Low R isk High Level of potential risk determines route of review for biomedical and social-behavioral research August 10 - 11, 2015

38. “Risk/Benefit Assessment” IRB considers the risk of criminal/civil liability, financial risk, employment risk, stigmatization, insurability, and embarrassment in deciding if risk is truly minimal. August 10 - 11, 2015

39. Privacy and Confidentiality “When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data” 45 CFR 46.111(a) Breaches of privacy and/or confidentiality are the main risk in social- behavioral research or research that is no greater than minimal risk August 10 - 11, 2015

40. Exempt Review Exempt Certification: Research may be eligible if it meets the criteria specified in one or more of 6 allowable categories. In general, projects involving public observation, taste tests, and some surveys or interviews with adults may be eligible. –The six categories of research eligible for exemption are available on the IRB website. –The IRB Chair reviews all claims of exemption. –An Exempt Checklist is available for your use in determining if your proposal is exempt on the IRB website. August 10 - 11, 2015

41. Expedited Review Expedited Review: Research may be eligible if it involves no more than minimal risks, and meets the criteria specified in one or more of 9 allowable categories. In general, projects involving interventions, surveys of a sensitive nature, and/or child participants may be eligible. –Expedited review is performed by the chair and 1 board members. –The categories of expedited review are available on the IRB website. –The categories of research eligible for expedited review or exemption are specified by federal regulations. August 10 - 11, 2015

42. Full Review Full Board: According to 45 CFR 46.110(b), full board review is required of all research studies that are neither exempt, nor subject to expedited review. – IRB Committee must review and vote at a fully convened meeting. – Meeting held once a month. – Submissions must be processed at least one week prior. – Needs to be reviewed annually under 45 CFR 46.109 (e). – Deception/ Non disclosure of information to subjects. – Studies with greater than minimal risk. – Special/ Vulnerable Populations. August 10 - 11, 2015

43. Upon Review  IRB certifies that protocol conforms to Federal Regulations.  If necessary, conditions are given to investigator for REVISIONS before approval.  The ORGSP administrative assistant will notify an investigator of the decision first with an email, followed with an official letter of approval to be kept by the investigator for their records. August 10 - 11, 2015

44. Required elements of informed consent – BASIC ELEMENTS 45 CFR 46.116(a) Statement that the study involves research Reasonably foreseeable risks/discomforts Reasonably expected benefits Disclosure of appropriate alternative procedures Confidentiality of identifiable records For high risk, what happens if injured in research Whom to contact about research, problems, or concerns Participation is voluntary, refuse to participate without penalty, and discontinue participation at any time August 10 - 11, 2015

45. Revising your study based on the conditions set forth by the IRB The study may receive Approval with Recommendations, or Approved Pending Revisions.  The ORGSP administrative assistant will email the Investigator.  The investigator must submit any revisions and the revised application back to the IRB office.  The study does not have approval.  Study cannot begin. August 10 - 11, 2015

46. Protocol Revisions and Continuations Any changes to the protocol including, but not limited to instrument revision and data collection methods (group administration of surveys to email distribution, focus groups to individual interviews, etc.) require submittal of the revisions to the IRB; these revisions will be reviewed at the same level as the proposal Expiration of the IRB approval occurs on the 365 th day from the date on the approval letter—all activities stop including recruitment, consent, data collection, or data analysis August 10 - 11, 2015

47. Also see the US Office for Human Research Protections for more information about these levels of risk and the federal regulations in place to protect human research participants from risk.US Office for Human Research Protections http://www.hhs.gov/ohrp/ August 10 - 11, 2015