Institutional Review Board How-to’s. Tracy L. Dietz, Ph.D. UCF IRB Chair. What must be reviewed?. According to the OHRP:
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Institutional Review Board How-to’s Tracy L. Dietz, Ph.D. UCF IRB Chair
What must be reviewed? • 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.
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.
IRB Responsibilities • Identify Risks • Determine that risks are minimized • Determine that risks are reasonable in relation to anticipated benefits • Determine that subjects are adequately informed about reasonably foreseeable risks or discomforts.
IRBS shouldn’t rely on investigators • No one can be truly objective about their own research. • People tend to underestimate the risks of their own work. • People tend to overestimate the benefits of the things that are important to them. • Thus, the cost benefit analysis is often off.
How to Apply for IRB Approval • On-line forms: http://www.research.ucf.edu/Compliance/Forms/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.
Pitfalls • http://www.research.ucf.edu/Compliance/Forms/Fast%20IRB%20Approval.pdf • The above website has some helpful hints that can help your approval go more smoothly.
Consent Forms • Importance of Compliant Consent Forms • Samples • http://www.research.ucf.edu/Compliance/Forms/Sample_Consent_Forms_with_Instructions.doc Waiver of Documentation of Consent What is it? When can you use it? Why would you want to?
Helpful Webpages • K-12 students, PPRA, http://www.ed.gov/policy/gen/guid/fpco/ppra/index.html • College students, FERPA, http://www.ed.gov/policy/gen/guid/fpco/ferpa/index.html • Sensitive information, Certificate of Confidentiality, http://www.ed.gov/policy/gen/guid/fpco/ppra/index.html
Parts of Submission • 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 • 5. Dates of proposed project • Make sure it is a date a couple of weeks in the future
Parts • 7. Scientific purpose of the investigation • Must matches methodology & title. • 8. 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.)
Parts • Describe 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. • 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 compensation • Answer all parts to this. • At least 18? • Students? • Your students: how limit coercion. • Fliers, emails, etc. (provide copies)
Parts • 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 facilityor 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.
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: • 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.