1. Institutional Review Board How-to’s Tracy L. Dietz, Ph.D. UCF IRB Chair

2. What must be reviewed? According to the OHRP:According to the OHRP: –The general rule is that if there is any element of research in an activity and that activity involves the use of human subjects or identified cell lines, then that activity should undergo review for the protection of human subjects.

3. What is a human subject? The research obtains identifiable private information which includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation is taking place, then it is a human subject.The research obtains identifiable private information which includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation is taking place, then it is a human subject.

4. IRB Responsibilities Identify RisksIdentify Risks Determine that risks are minimizedDetermine that risks are minimized Determine that risks are reasonable in relation to anticipated benefitsDetermine that risks are reasonable in relation to anticipated benefits Determine that subjects are adequately informed about reasonably foreseeable risks or discomforts.Determine that subjects are adequately informed about reasonably foreseeable risks or discomforts.

5. IRBS shouldn’t rely on investigators No one can be truly objective about their own research.No one can be truly objective about their own research. People tend to underestimate the risks of their own work.People tend to underestimate the risks of their own work. People tend to overestimate the benefits of the things that are important to them.People tend to overestimate the benefits of the things that are important to them. Thus, the cost benefit analysis is often off.Thus, the cost benefit analysis is often off.

6. How to Apply for IRB Approval On-line forms: http://www.research.ucf.edu/Compliance/For ms/UCF_IRB_Protocol_Submission_Form.docOn-line forms: http://www.research.ucf.edu/Compliance/For ms/UCF_IRB_Protocol_Submission_Form.doc http://www.research.ucf.edu/Compliance/For ms/UCF_IRB_Protocol_Submission_Form.doc http://www.research.ucf.edu/Compliance/For ms/UCF_IRB_Protocol_Submission_Form.doc Move to on-line submission: September, 2006 Timeline: Expect 2-3 weeks, provided all materials are submitted and do not need to be revised during the pre-review.

7. Pitfalls http://www.research.ucf.edu/Compliance/For ms/Fast%20IRB%20Approval.pdfhttp://www.research.ucf.edu/Compliance/For ms/Fast%20IRB%20Approval.pdfhttp://www.research.ucf.edu/Compliance/For ms/Fast%20IRB%20Approval.pdfhttp://www.research.ucf.edu/Compliance/For ms/Fast%20IRB%20Approval.pdf The above website has some helpful hints that can help your approval go more smoothly.The above website has some helpful hints that can help your approval go more smoothly.

8. Consent Forms Importance of Compliant Consent FormsImportance of Compliant Consent Forms SamplesSamples http://www.research.ucf.edu/Compliance/Forms/Sam ple_Consent_Forms_with_Instructions.dochttp://www.research.ucf.edu/Compliance/Forms/Sam ple_Consent_Forms_with_Instructions.dochttp://www.research.ucf.edu/Compliance/Forms/Sam ple_Consent_Forms_with_Instructions.dochttp://www.research.ucf.edu/Compliance/Forms/Sam ple_Consent_Forms_with_Instructions.doc Waiver of Documentation of Consent What is it? When can you use it? When can you use it? Why would you want to? Why would you want to?

9. Helpful Webpages K-12 students, PPRA, http://www.ed.gov/policy/gen/guid/fpco/ppra/index.htmlK-12 students, PPRA, http://www.ed.gov/policy/gen/guid/fpco/ppra/index.html http://www.ed.gov/policy/gen/guid/fpco/ppra/index.html http://www.ed.gov/policy/gen/guid/fpco/ppra/index.html College students, FERPA, http://www.ed.gov/policy/gen/guid/fpco/ferpa/inde x.htmlCollege students, FERPA, http://www.ed.gov/policy/gen/guid/fpco/ferpa/inde x.html http://www.ed.gov/policy/gen/guid/fpco/ferpa/inde x.html http://www.ed.gov/policy/gen/guid/fpco/ferpa/inde x.html Sensitive information, Certificate of Confidentiality, http://www.ed.gov/policy/gen/guid/fpco/ppra/index.htmlSensitive information, Certificate of Confidentiality, http://www.ed.gov/policy/gen/guid/fpco/ppra/index.html http://www.ed.gov/policy/gen/guid/fpco/ppra/index.html http://www.ed.gov/policy/gen/guid/fpco/ppra/index.html

10. Parts of Submission 4. Collaborating institution(s) and researcher(s)4. Collaborating institution(s) and researcher(s) –Make sure you get dual approval or have investigator sign UCF Individual Investigator Agreement http://www.research.ucf.edu/Compliance/Forms/ UCF_Individual_Investigator_Agreement.doc http://www.research.ucf.edu/Compliance/Forms/ UCF_Individual_Investigator_Agreement.doc http://www.research.ucf.edu/Compliance/Forms/ UCF_Individual_Investigator_Agreement.doc 5. Dates of proposed project5. Dates of proposed project Make sure it is a date a couple of weeks in the futureMake sure it is a date a couple of weeks in the future

11. Parts 7. Scientific purpose of the investigation7. Scientific purpose of the investigation –Must matches methodology & title. 8. Describe the research methodology in non- technical language8. Describe the research methodology in non- technical language –Data collection –Data storage (audio- or video-taping) –On-line delivery, is it a secure server, etc. –Give every detail. –Provide copies of everything (questionnaires, interview schedule, emails or letters, debriefing statements, etc.)

12. Parts Describe the potential benefits and anticipated risks and the steps that will be taken to minimize risks and protect participantsDescribe the potential benefits and anticipated risks and the steps that will be taken to minimize risks and protect participants –to the participants not to society or research community. –Is your study anonymous or confidential? Anonymous means even you don’t know whose answers go with whom.Anonymous means even you don’t know whose answers go with whom. Confidential means you can match the answers with the person but will keep that information confidential.Confidential means you can match the answers with the person but will keep that information confidential. Describe how participants will be recruited, how many you hope to recruit, the age of participants, and proposed compensationDescribe how participants will be recruited, how many you hope to recruit, the age of participants, and proposed compensation –Answer all parts to this. –At least 18? –Students? Your students: how limit coercion.Your students: how limit coercion. –Fliers, emails, etc. (provide copies)

13. Parts Describe the informed consent process Describe the informed consent process –Describe. –Waiver of documentation of consent –Will you collect formal consents? –Provide copies either way. –How will you store these? (separately from all study documents in a locked cabinet for a minimum of 3 years) Describe any protected health information (PHI) you plan to obtain from a HIPAA-covered medical facility or UCF designated HIPAA componentDescribe any protected health information (PHI) you plan to obtain from a HIPAA-covered medical facility or UCF designated HIPAA component –At UCF only a few places are billing for medical services or are collecting protected medical information so this does not apply to most.

14. Investigator Training UCF now requires investigators to comply with federal regulations that require you to document that you have completed an investigator training course. We recommend:UCF now requires investigators to comply with federal regulations that require you to document that you have completed an investigator training course. We recommend: http://www6.miami.edu/citireg/http://www6.miami.edu/citireg/http://www6.miami.edu/citireg/ Once you complete it, Barbara Ward will receive an email that you are compliant and it is good for 3 years.Once you complete it, Barbara Ward will receive an email that you are compliant and it is good for 3 years.