Office of Research Compliance (ORC) 864-656-6460, irb@clemson.edu

1. The Care and Feeding of Your IRB Application Laura A. Moll, M.A., CIP IRB Administrator Hugh D. Spitler, Ph.D. IRB Chair Office of Research Compliance (ORC) 864-656-6460, irb@clemson.edu

2. Overview of Workshop • IRB Review Process • Basic definitions in human subjects research • IRB Review of Exempt Research • IRB Review of Expedited / Full Research • Defining members of the research team • Required training • Materials available on Clemson’s IRB website

3. Workshop Learning Objectives • Have a familiarity with the IRB review process • Have a familiarity with basic definitions in human subjects research • Understand basics of why a protocol might require Exempt / Expedited / Full Review • Understand decisions re: who is a research team member • #1 Lesson – Contact us with questions 

4. Institutional Review Board (IRB) …Here and Elsewhere • Differences in policies and procedures across institutions • Federalwide Assurance (FWA) with Office for Human Research Protections (OHRP) • Institutional policies • Local interpretations

5. IRB Review Process • Researcher develops research project • Researcher completes IRB training • Researcher completes IRB application form • Form and attachments submitted to IRB • Pre-screen by Office of Research Compliance • Committee / Committee member review • Decision in writing (sometimes via email)

6. What Is Research?45 CFR 46.102(d) • Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

7. What Are Human Subjects?45 CFR 46.102(f) • Human subject means 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.

8. Human Subjects or Not? • The owners of businesses complete surveys regarding the number of employees, the percentage of hourly paid vs. salaried, company policies re: family leave, whether any complaints have been filed against the company by employees, etc. • A colleague, who is drawing blood from patients for medical purposes, collects an extra 4 mls of blood for your research project (with informed consent from the patients), and gives it to you with sex, age, height and weight, but no other individually identifying information.

9. Determining Review Category – Which Application to Use • Applications at www.clemson.edu/research/compliance/irb/forms.html • Exempt / Expedited status determined according to 45 CFR 46 (Exempt ≈ 80%; Expedited ≈ 20%) • Full board review (< 1%) • Entire protocol is reviewed at one level, highest level of review required based on research activities • Determinations made by IRB or ORC

10. IRB Exemption Exempt means “exempt from continuing review” NOT “exempt from any review”

11. Exemptions45 CFR 46.101(b) (1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as • (i) research on regular and special education instructional strategies, or • (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

12. Exempt or Not? • Research in a middle school, using journaling entries, test scores, homework assignments, and interviews with students to determine whether different parenting styles have an effect on school performance. • Research in a workshop on preparing grant proposals, using audiorecorded small-group discussions and workshop evaluations to assess the effectiveness of the workshop.

13. Exemptions45 CFR 46.101(b), cont. (2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:

14. Exemptions45 CFR 46.101(b)(2), cont. • (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; AND • (ii) 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.

15. Exempt or Not? • Participant observation and interviews about their job duties with employees of the office in which the researcher works. • Observing and taking notes on the interactions between children who appear to be of different ethnic backgrounds at a public park. • Interviewing teachers about the management style of their principal and its effects on them.

16. Exemptions45 CFR 46.101(b), cont. (6) Taste and food quality evaluation and consumer acceptance studies, • if wholesome foods without additives are consumed, OR • If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture

17. Exempt or Not? • Asking participants to evaluate the freshness of raw meat packaged in a new plastic wrap, when the meat varies from having been packaged one day to one month ago. • Asking participants to taste a newly developed snack containing commercially sold dill pickles, peanut butter, and fresh cherries.

18. Expedited vs. Full Review45 CFR 46.110 • Expedited review procedures for certain kinds of research involving no more than minimal risk. • 45 CFR 46.102(i) 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 examinations or tests.

19. Expedited Categories45 CFR 46.110 • (5) Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). • (6) Collection of data from voice, video, digital, or image recordings made for research purposes.

20. Expedited Categories45 CFR 46.110, cont. (7) 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.

21. Expedited or Full? • Interviewing adults about their personal and family medical histories. • Videorecording interviews with pregnant women about their experiences with back pain during pregnancy. • Interviewing adults with mental illness who are recovering from drug addictions. The interviews include questions on their childhood experiences, their mental illness, and their drug use.

22. Who Is Part of theResearch Team? • Anyone who intervenes or interacts with living individuals for research purposes; or obtains individually identifiable private information for research purposes [45 CFR 46.102(f)]

23. Who Is Part of theResearch Team?, cont. • interacting with living individuals for research purposes (e.g., engaging in protocol-dictated communication or interpersonal contact; conducting research interviews; obtaining informed consent) • obtaining, receiving, or possessing private information that is individually identifiable (either directly or indirectly through coding systems) for research purposes (e.g., obtaining private information from medical records in an individually identifiable form)

24. Engaged in Research or Not? • Secretary who retrieves individual school records off the fax machine and places them in the researcher’s mailbox. • Community partner who provides informed consent form to potential participant and answers any questions they may have. • Professor who distributes informed consent forms and receives signed / unsigned forms back from students in sealed envelopes.

25. What Training Is Needed for theResearch Team? • CITI Course in the Protection of Human Research Subjects (Social / Behavioral Science Research, Biomedical Research, HIPAA only, IRB Reference Resource) www.citiprogram.org • Continuing Education requirement – all team members, every two years

26. IRB Forms for Investigators Exempt and Expedited / Full Applications www.clemson.edu/research/compliance/irb/forms.html Continuing Review form Amendment Request form Adverse Event / Unanticipated Problem form Developmental Approval form Final Summary Report HSSC IRB Request for Cooperative Review – Initial HSSC IRB Request for Cooperative Review – Post-Approval

27. Informed Consent Information www.clemson.edu/research/compliance/irb/forms.html Templates: Informational Letter (no signature) Adult Consent Form Parental Permission Form Minor Assent Form Federally-Defined Criteria for: Waiver of Documentation of Consent (Signature) Waiver of (Elements of) Consent

28. IRB Guidance www.clemson.edu/research/compliance/irb/regulations.html • Advertising for Research Participants • HSSC IRB Collaborative Review • PI / Research Team Member Responsibilities • Post-Approval Monitoring • Research Site Letters • Submitting Research Protocols to GHS • Use of Audio / Videorecording • Use of Deception or Concealment • Use of Human Cell Lines • Use of Students as Research Participants

29. Coming Features • New and improved forms • New and improved website organization • Informed consent templates specific to either exempt or expedited / full requirements • More information and guidance, organized in a user-friendly way!

30. Contact Information Telephone: (864) 656-6460 Email: irb@clemson.edu Office: 223 Brackett Hall www.clemson.edu/research/compliance/irb/