Researchers’ Guide to the LMU Institutional Review Board (IRB) Process

1. Researchers’ Guide to the LMU Institutional Review Board (IRB) Process Fall 2019 Faculty-Staff Conference 8/12-13/19

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3. The Belmont Report (1978) The principles of the Belmont Report govern all research supported by the U.S. Government and your 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. 8/12-13/19

4. The Common Rule 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. The revised Common Rule was implemented January 21, 2019. 8/12-13/19

5. Protective Mechanisms Established by the Common Rule • Institutional Assurances of compliance—LMU holds a Federal-wide Assurance agreement with HHS/OHRP • Review of research by an Institutional Review Board (IRB) and/or Ethics Committee • Informed consent of subjects 8/12-13/19

6. What is the IRB? • An Institutional Review Board (IRB) is charged with protecting the rights and welfare of people participating in research and reviews proposals for research involving human subjects. • The Institutional Review Board (IRB) is comprised of faculty/staff at LMU who have knowledge and experience in social/behavioral /educational (SBER) and biomedical research. • The regulations require a minimum of five members including at least one non-scientist and one local community person. • Members are usually appointed by a high level administrator (President, Provost, VPAA) for a two or three year term and may be provided with reassigned time on workload. 8/12-13/19

7. 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). Support the responsible conduct of research. Goals of the IRB 8/12-13/19

8. 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 8/12-13/19

9. 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 and 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 8/12-13/19

10. 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” 8/12-13/19

11. Does the research involve a vulnerable population? • Vulnerable populations include: • Children (all minors younger than 18 years of age in most states must also have parental consent) • Pregnant women • Institutionalized individuals (e.g., prisoners, individuals in group homes, nursing homes, mental institutions) • Cognitively impaired individuals 8/12-13/19

12. 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/student athletes • Employees 8/12-13/19

13. IRB Training Requirements • All persons named on the application (Principal Investigators, Co-investigators, Research assistants, and Faculty Sponsors) must complete online IRB training and submit proof of completion along with their IRB application. Researchers in schools should also be familiar with FERPA guidelines and researchers in medical facilities should be familiar with HIPAA/PHI guidelines. • Members of the IRB are also required to complete specialized training modules through CITI and the University. • LMU location: MyLMU Administration ORGSP Institutional Review Board CITI Training Website Register (Add LMU if you have already completed at another institution) Social Behavioral Education or Biomedical • https://www.lmunet.edu/administration/office-of-research-grants-and-sponsored-programs-orgsp/institutional-review-board-irb/ 8/12-13/19

14. Things to consider when completing your application • Is the proposal • Clear? • Concise? • Consistent? • Complete? • Have I addressed • Why? • Who? • What? • Where? • When? • How? 8/12-13/19

15. Application Form • Project Title • Project dates—approval date by IRB vs. researcher’s planned dates • Principal Investigator, co-investigators, faculty sponsor, with signatures of all plus department chairs/deans • IRB Training and Certification dates (CITI on file, recertify every 5 years) • Outside researcher information - Signature of a university sponsor to allow research at LMU • Funding/Conflict of Interest statement • 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, anonymous online survey, language issues • Data & Consent collection methods—data with identifiers, how confidentiality/anonymity will be protected, how and where will the data be stored—delete data and survey from SurveyMonkey, Google docs, etc.—discuss handling, retention time, and disposal of video or audio tapes • 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, international issues • Risk factors—to subjects in any area • Submission of all materials—recruitment flyers and emails, 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-investigators, research assistants • NOTE: IRB Processing may be delayed due to missing information, incomplete information, inconsistencies, or the need for clarification of statements describing processes 8/12-13/19

16. Guidelines for Class Research Assignments Instructor Form • This form does not cover students conducting research for independent study, theses, dissertations, articles, publications, or presentations outside the research class. • For these exempt research class assignments, the instructor serves as the Principal Investigator and the students serve as research assistants. Please note that recruitment of participants outside the research class requires a complete, formal IRB application with either the instructor or student as the Principal Investigator. • The secondary analysis of de-identified, non-restricted public data or a data set developed/provided by the instructor, content analysis of articles/published speeches/public web sites (not FB, Twitter, etc.), surveys distributed within the research class, and focus groups within the research class would be covered by this form. Observation of public behavior with no interaction or intervention by the researcher would also be covered. • School-based educational “action research” projects that are part of learning research methods may also be conducted under this exempt research class form. • The instructor may choose to have the students complete the IRB application so that he/she can make sure the student understands the process and can spot times when the student is going beyond the limits of this class research exempt status. 8/12-13/19

17. Examples of social science projects that will likely require IRB submission • Interviews—structured, semi-structured, open, even oral history if analyzed • Focus groups • Pretest – intervention – posttest (eg., analysis of writing samples) • Surveys, including Internet-based surveys • Experimental and quasi-experimental studies with intervention and control groups • Data analysis of primary or secondary data that contain identifiers or codes—chart reviews 8/12-13/19

18. The basic differences in the review categories are: • Exempt (Minimal risk for the study participants – reviewed by the chair or designee, quick turnaround time—1-2 weeks) NOTE: Exempt does not mean exempt from review. • Expedited (No more than minimal risk, reviewed by the chair and at least one IRB member, turnaround time--allow 2-3 weeks) • Full (More than Minimal Risk or vulnerable populations (children, pregnant women, prisoners, etc.); longer turnaround time, must be reviewed by full committee and discussed at monthly meeting--allow 6-8 weeks) • NOTE: Review may take longer if application is not complete or permission to use site is delayed. 8/12-13/19

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20. “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. 8/12-13/19

21. Risk to Researcher • The risk of conducting the research in the selected setting or with specific clients is usually addressed by the Faculty sponsor, Department Chair, School ethics/research committee, or Legal/Risk Management office. • Some IRBs have worked out procedures with Departments and Schools to cover home visits and other settings before submitting the applications to the IRBs. 8/12-13/19

22. 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 (PI, Faculty Sponsor, ORGSP/IRB) • Participation is voluntary,refuse to participate without penalty, and discontinue participation at any time 8/12-13/19

23. 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. • Mandated reporters? 8/12-13/19

24. 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 scheduled to be held once a month. • Submissions must be processed at least 10 working days prior to meeting. • Protocol 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. 8/12-13/19

25. Protocol Revisions, Continuations, and Closure • Before Approval: The IRB may ask for clarification of parts of the protocol and/or require specific changes to the protocol before the study is approved to begin. • After Approval: 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. • Continuation: Approvals issued after January 21, 2019, do not expire. • Closure: The PI is to submit a statement to the IRB when the project is completed. (Closure Form) 8/12-13/19

26. Recommendations for Researchers • Be aware of the timeline for submissions and for the University holiday closing times. • Exempt and expedited applications can be submitted any time; full review applications must be submitted 10 business days before the scheduled meeting. • Check the current IRB website that includes forms, guidelines, and schedules along with contact information for office staff/administrators and the IRB chair. • IRB members are willing to and do provide training during faculty orientation, faculty meetings, monthly workshops, individual consultation, and speaking to classes. • Double check your IRB applications and supporting documents before submitting. 8/12-13/19