1. Human Subjects Research Institutional Review Board (IRB) Training

2. 7/1/09Clarkson IRB Training2 IRB Mandate To protect the rights and welfare of humans who participate in research Applies to all activities related to human subjects research

3. 7/1/09Clarkson IRB Training3 Who Sets the Rules? Office for Human Research Protection (OHRP) in Health and Human Services –www.hhs.gov/ohrp/www.hhs.gov/ohrp/ –Title 45 Part 46: Protection of Human Subjects (The “Common Rule”) www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm Office of Human Subjects Research (at NIH) –http://ohsr.od.nih.gov/http://ohsr.od.nih.gov/ New York State Department of Health –www.health.state.ny.us/nysdoh/provider/volunteerwww.health.state.ny.us/nysdoh/provider/volunteer

4. 7/1/09Clarkson IRB Training4 Ethical Foundations International standards: –The Belmont Report –The Nuremberg Code –Declaration of Helsinki Professional standards –Some professions have additional standards regarding research ethics

5. 7/1/09Clarkson IRB Training5 Human Subjects Training Currently Clarkson requires on-line NIH training Will be switching to CITI (Collaborative Institutional Training Initiative at www.citiprogram.org)Collaborative Institutional Training Initiativewww.citiprogram.org –Basic (human subjects) course required for new approvals –In future years, renewal will require either the Refresher course or Additional training specific to research performed –Biomedical Focus –Social and Behavioral Focus –Good Clinical Practice Course –Health Information Privacy and Security Course (HIPS) –Responsible Conduct of Research (RCR) IACUC will require Laboratory Animal Welfare Courses for animal research investigators

6. 7/1/09Clarkson IRB Training6 To Whom do the Rules Apply? All research conducted at Clarkson All research by Clarkson faculty, staff, assistants, students, or any other research collaborator. Applies to everyone at Clarkson because Clarkson receives federal funds –Requirement of Federal-Wide Assurance (FWA) –Applies to you even if your research is not federally funded

7. 7/1/09Clarkson IRB Training7 What is “Research”? A systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalizable knowledge or scholarship Planned and organized generation of data, whether or not there is a plan for publication or dissemination May be quantitative or qualitative

8. 7/1/09Clarkson IRB Training8 What are “Human Subjects”? Any living individual or group about whom an investigator obtains physiologic or behavioral characteristics or responses Data may be acquired through: –Intervention or interaction with one or more human subjects –Accessing identifiable private information about one or more human subjects (e.g., medical records, academic records, etc.) –Studies involving human tissue or biological specimens (e.g., blood)

9. 7/1/09Clarkson IRB Training9 What Needs IRB Review? All human subjects research –Unless it is Exempt from IRB review –Exemptions must be certified by the IRB Researchers are not authorized to decide if their human subjects research requires IRB review –DOR or IRB should decide What does NOT require IRB review –Classroom-only activities –Quality assurance surveys If in doubt, ask!

10. 7/1/09Clarkson IRB Training10 Types of IRB Review Full committee review –Standard (default) review Expedited review –For “minimal risk” research Exemption from review –If it is not research, does not involve human subjects, or meets specific criteria (detailed later) “Minimal risk” is that which is encountered in normal daily activities. No research can be entirely free of risk.

11. 7/1/09Clarkson IRB Training11 Charts available at: http://www.hhs.gov/ ohrp/humansubject s/guidance/decision charts.htm#c1 http://www.hhs.gov/ ohrp/humansubject s/guidance/decision charts.htm#c1

12. 7/1/09Clarkson IRB Training12 Research involving surveys or interviews of children is NOT exempt

13. 7/1/09Clarkson IRB Training13 Process for Exemptions If Exempt from Review: –Submit Exemption Request form –Exemption does not need to be renewed unless the research changes in a way that impacts involvement of human subjects –Campus surveys require review by Student Affairs office (Kathryn Johnson) Exemptions are ‘certified’ not approved

14. 7/1/09Clarkson IRB Training14 Exemptions: Special Cases Existing data –Needs to be de-identified Existing tissue samples Educational research –Normal educational practices Survey research (not for children) Case reports of data already collected

15. 7/1/09Clarkson IRB Training15 Process for Standard Review Take Human Subjects Research course –So you know what the issues are Complete proposal form –Available on IRB website –Instructions also available on website –Have someone familiar with IRB process review & give feedback –You can contact IRB Chair/member for guidance

16. 7/1/09Clarkson IRB Training16 Student Researchers Students’ advisors must review and have student revise prior to submission Students should proof-read carefully –Sloppy writing indicates sloppy researcher Advisor must sign proposal Advisors are responsible for the quality of the submission

17. 7/1/09Clarkson IRB Training17 Process for Standard Review Compile into a single document –All appendices and attachments must be included in the proposal document Submit at least 1 week before scheduled IRB meeting –Can submit earlier for preview to identify and correct major problems At least 1 full week earlier

18. 7/1/09Clarkson IRB Training18 Review Criteria Research is scientifically sound Risks are minimized and reasonable Subject selection is fair Safeguards for vulnerable populations –Children, instructors’ students, staff… –Protect against coercion Informed consent process adequate Privacy & confidentiality maintained

19. 7/1/09Clarkson IRB Training19 Types of Risk Coercion Physical Psychological Economic Social

20. 7/1/09Clarkson IRB Training20 Informed Consent Process IC is an ongoing process Need to answer subjects’ questions Use IC template form IC must be understandable –8 th grade reading level standard Subjects get to keep a copy

21. 7/1/09Clarkson IRB Training21 Who is on the IRB? 5-7 voting members One person from each School –Provides a range of knowledge & experience At least one non-scientist –Whose focus is on subject welfare One non-Clarkson member –To ensure lack of bias All receive training in IRB regulations

22. 7/1/09Clarkson IRB Training22 IRB Decisions Accept proposal without changes Request clarifications or changes –Approval conditional upon addressing IRB concerns Reject –Problems insurmountable or would require such significant changes that a new proposal needs to be submitted Response letter sent within 5 working days

23. 7/1/09Clarkson IRB Training23 After Approval Project assigned an approval number Need to submit the signed cover sheet –Signed by PI and Dept Chair/advisor This is a ‘contract’ stating the PI’s responsibilities

24. 7/1/09Clarkson IRB Training24 PI Responsibilities All individuals interfacing with subjects or data should be adequately trained –Necessary research procedures –Human subjects research Data kept secure & confidential Report Adverse Events (including risk) Submit Project Modifications Continuation Request annually Allow for IRB audits if requested

25. 7/1/09Clarkson IRB Training25 IRB Audits How are projects selected? –Several projects are audited each year –Randomly selected projects –If any concerns have been raised –High risk projects Audit process –Review proposal –Observe data collection process –Interview researchers (including students) –Interview subjects Submit a report to the PI and IRB –May request changes or monitoring

26. 7/1/09Clarkson IRB Training26 Clarkson Forms Available IRB Proposal template –Proposal Guidelines Exemption Request Project Modification Request Continuation Request Adverse Event Report Investigational Device Exemption At: www.clarkson.edu/dor/compliance/human_subjects.html www.clarkson.edu/dor/compliance/human_subjects.html

27. 7/1/09Clarkson IRB Training27 Additional Resources Title 45 Part 46: Protection of Human Subjects –www.hhs.gov/ohrp/humansubjects/guidanc e/45cfr46.htmwww.hhs.gov/ohrp/humansubjects/guidanc e/45cfr46.htm OHRP IRB Guidebook –www.hhs.gov/ohrp/irb/irb_guidebook.htmwww.hhs.gov/ohrp/irb/irb_guidebook.htm Professional organizations…

28. 7/1/09Clarkson IRB Training28 Professional Organizations The American Psychological Association, section 8 of: –http://www.apa.org/ethics/code2002.htmlhttp://www.apa.org/ethics/code2002.html American Physical Therapy Assoc. Integrity in Research: –www.apta.org (search for Integrity in Research)www.apta.org NIH HIPAA regulations for research involving patients: –http://privacyruleandresearch.nih.gov/irbandprivacyrule.asphttp://privacyruleandresearch.nih.gov/irbandprivacyrule.asp Research Involving Human Biological Materials: –http://bioethics.georgetown.edu/nbac/hbm_exec.pdfhttp://bioethics.georgetown.edu/nbac/hbm_exec.pdf American Anthropological Association: –http://www.aaanet.org/stmts/irb.htmhttp://www.aaanet.org/stmts/irb.htm The Association of Internet Researchers: –www.aoir.org/reports/ethics.pdfwww.aoir.org/reports/ethics.pdf The American Educational Research Association: –http://www.aera.net/AboutAERA/Default.aspx?menu_id=90&id=669http://www.aera.net/AboutAERA/Default.aspx?menu_id=90&id=669 The Academy of Management code of ethics: –http://www.aomonline.org/aom.asp?ID=268&page_ID=240http://www.aomonline.org/aom.asp?ID=268&page_ID=240

29. 7/1/09Clarkson IRB Training29 Contacts IRB web site: –http://www.clarkson.edu/dor/compliance/http://www.clarkson.edu/dor/compliance/ Dr. Russek (for policy and guideline ?) –Lnrussek@clarkson.eduLnrussek@clarkson.edu Becky Thatcher (for administrative ?) –rthatche@clarkson.edurthatche@clarkson.edu Kim Klatt (for DOR/grant ?) –kklatt@clarkson.edukklatt@clarkson.edu