IRB History, Ethical Foundations, & Researcher Responsibilities

1. IRBHistory, Ethical Foundations, & Researcher Responsibilities

2. Considerations • Basis for review • What is reviewed • Process and other issues • Resources

3. IRB= Institutional Review Board Mission Protect rights and welfare of human research subjects / participants

4. People harmed by research • Nazi experimentation • Milgram’s Obedience Study (1963) • Willowbrook (1963-66) • Radiation experiments (1930s-60s) • Stanford Prison Experiment (1971) • Tuskegee Syphilis Study (1932-1972) • More…. http://irb.ufl.edu/ethics/

5. Nazi Experimentation http://www.ushmm.org/research/doctors/indiptx.htm

6. Tuskegee Syphilis Study1932-1972 http://www.cdc.gov/nchstp/od/tuskegee/time.htm

7. Belmont Report Cornerstones • Respect for Persons • Informed Consent process • Privacy and Confidentiality • Beneficence • Risk/Benefit Analysis • Scientific Merit • Justice • Review of subject selection http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm

8. Federal Regulations

9. Problems protecting subjects continue… • U Penn – gene therapy 1999 • Hopkins – hexamethonium bromide2001 • Stratton VA – eligibility falsification 2002 • Criminal conviction in Feb 2006 • http://ori.dhhs.gov/misconduct/cases/Kornak.shtml

11. Human Subject Living individualabout whom an investigator (whether professional or student) conducting research obtains: • data through intervention or interaction with the individual, or • identifiable private information. 45 CFR 46.102.(f)

12. Research A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. 45 CFR 46.102.(d)

13. Examples of research • Clinical Trials (therapeutic research) • Survey, observational, or educational research • Review of medical records or databases • Tissue or data • Identifiable vs coded vs anonymous • Exisiting? IRB APPROVAL REQUIRED

14. REQUIRED: All Research • Research must be approved before being conducted

15. 4. Full Board 3. Expedited 2. Exempt 1. Non-Human Increasing Protection, Requirements, & Paper Work Increasing Involvement Or Risk Review Process

16. Indefinite Plans / Non-human • Research involves human tissue, data, etc., but • NO interaction or intervention with living person,AND • NO exposure to or collection of privately identifiable data

17. Exempt • Interaction/intervention with living individual or their identifiable data • Survey, observational, educational research • Either no risk to subject, or • If potential risk recorded anonymously • Survey does not collect identifiers

18. Exempt • Review of existing data, documents, records or specimens that is recorded anonymously : • All data exists BEFORE submission • Researcher sees identifiers, but collects data such that it cannot be linked back to subject • 17 HIPAA identifiers apply • No codes or links, permanent or temporary

19. Expedited • Interaction/intervention with living individual or their identifiable data • Prospective minimal risk research • Collection of data from voice, video, digital, or image recordings made for research purposes. • 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.

20. Expedited • Approved for a maximum of 1 year • must obtain approval for Continuing Review • Adverse Events • Researcher can do more, so more protection needed.

21. Full Board • Required if Greater than Minimal Risk • Use of vulnerable populations* • Data collection on: • Conditions that can affect insurability, employability, reputation • Criminal activity, drugs, sexual misconduct • Therapeutic research / Radiation / X-ray / Genetics

22. Full Board • Approved for a maximum of 1 year • must obtain approval for Continuing Review • Adverse Events • Researcher can do more, so more protection needed.

23. Full Board vs Expedited • Full Board • IRB-01 = 1st and 3rd Wednesday of each month • IRB-02 = 3rd Thursday of each month • Deadline prior • Expedited • forwarded “daily” to chairs

24. REQUIRED: All Research • Any changes, no matter how minor, must be approved before implementation • Unanticipated Problems • Adverse Events • Loss of data • Breach of confidentiality

25. “Outside” Issues • Secondary subjects: anyone you collect data on is a subject • Conducting research at other locations • International Research • Involving outsiders in research • Conflict of Interest

26. Privacy & Confidentiality • Privacy • Subject’s ability to control how other people see, touch, or obtain information about the subject. • Confidentiality • the ways identifiable information will be stored and shared

27. Non-compliance • Conducting research prior to initial approval • Conducting research after approval expires • Implementing revisions without prior IRB approval • Over-enrolling • Enrolling subjects not approved by IRB • Vulnerable populations

28. Non-compliance • Enrolling subjects who do not fit enrollment criteria in protocol • Need approval from Sponsor & IRB • Failure to obtain/document consent • Losing copies of signed consents • Failure to document procedures “If it’s not documented it didn’t happen” Regulatory non-compliance is reported bythe institution to the appropriate Federal agencies

29. Local Info: IRB-01 http://irb.ufl.edu/irb01/ • 352-846-1494 • irb1@grove.ufl.edu

30. Local Info: IRB-02 http://irb.ufl.edu/irb02/ • 352-392-0433 • irb2@ufl.edu

31. Research at • UF • Shands • NF/SG VHS • Other Offices: • VA R&D • IBC • HURRC • Pharmacy • CTSI

32. HELP! Page http://irb.ufl.edu/irb01/help/

33. Researcher “To do” • Required Readinghttp://irb.ufl.edu/education/trainreq.htm • Belmont Report • 45 CFR 46 • IRB-01 Policies & Procedures • Researcher responsibilities • http://irb.ufl.edu/irb01/researcherresponsibilities.htm • HIPAA – required training every year

34. Resources • IRB researcher listserv • http://irb.ufl.edu/irb01/april04announce.htm • Newsletter • http://irb.ufl.edu/education/InvestiGATORS.htm • Ethics Links • http://irb.ufl.edu/ethics/ • Assistance with NEW studies • Renee Collins rbcollins@ufl.edu 273-8788

35. DSR • Division of Sponsored Research • http://rgp.ufl.edu/research/ • Grants & Contracts • Judy HarrisGrinter Hall room 207(352) 392-9267 jaharris@ufl.edu

36. HURRC • Human Use of Radioisotopes and Radiation Committee • http://www.ehs.ufl.edu/Rad/RCGuide/HURRC.htm • http://www.ehs.ufl.edu/Rad/ • Don MunroeBox 118340Gainesville, FL 32611-8340(352) 392-7359 don@ehs.ufl.edu

37. Shands Pharmacy • UF - Susan Beltz, PharmDBox 100316Gainesville, FL 32610-0486beltze@shands.ufl.edu

38. IBC • Institutional Biosafety Committee • Studies involving Human Gene Therapy • http://www.ehs.ufl.edu/Bio/default.asp • Dr. Phillip S. CollisBox 112190 (352) 392-1591pcollis@ehs.ufl.edu

39. CTSI • Clinical and Translation Science Institute • Variety of resources open to all researchers • http://www.ctsi.ufl.edu/ • Kathryn St. CroixBox 100219 (352) 273-8770stcroixk@ufl.edu

40. NF/SG VHS • North Florida / South Georgia Veterans Health System • R&D = Research & Development Committee • SCI = Subcommittee for Clinical Investigations • http://www1.va.gov/visn8/nfsg/Research/ • Separate submission requirements • Hattie Grant376-1611 ext 4956Hattie.Grant@va.gov

41. Summary IRB = Protect rights and welfare of subjects

42. Summary • IRB = protect rights and welfare of subjects • Need approval BEFORE starting research • On-going approval required • Host of requirements • We’re here to help!

43. Remember • The ends do NOT justify the means • Research is a privilege

45. IACUC www.iacuc.ufl.edu Dorian Lucey Coordinator, Training & Quality Assurance IACUC, University of Florida luceydg@ufl.edu Institutional Animal Care & Use Committee

46. IACUC contact information: Main office: Communicore Bldg CB-151B Main number: (352) 392-9917 Fax: (352) 392-9919 Email: iacuc@grove.ufl.edu Web site: www.iacuc.ufl.edu List-serv:http://www.iacuc.ufl.edu/IACUCmail.htm

47. Outline • History • Role of the IACUC • Animal Care & Use Protocols • Protocol Review • Training • Inspections • Quality Assurance • Questions?

48. Setting the stage • From Mid 1800s on, increased use of animals in medical research • Public concerned about animal welfare • British Cruelty to Animals Act of 1876 • Establishment of several Antivivisection Societies (late 1800’s-early 1900’s) • Following World War II • Economic boom, large increase in scientific research • Hygienic Laboratory renamed National Institutes of Health (NIH) • Huge Increase (approx 40x) in NIH budget

49. IACUC History • 1961, “The Guide” was created which was supported by National Institutes of Health. http://grants.nih.gov/grants/olaw/olaw.htm • 1963, The Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC) was formed. UF has been AAALAC accredited since 1965.

50. IACUC History (cont.) • 1966, article in Life magazine prompted creation of the Laboratory Animal Welfare Act (USDA). • Established minimum standards in 8 areas: housing, feeding, watering, sanitation, shelter, separation of species, ventilation, & adequate veterinary care.