IRB and Educational Research

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  • 1. Tracy L. Dietz, Ph.D. Chair, UCF IRB

2. When is IRB Approval Required? According to the OHRP: If the activity: Involves any element that is research Includes humans subjects: identifiable data about humans, identifiable cell lines, data from humans According to UCF Policy: Only the IRB can determine if study is exempt Investigators or others may not make this determination 3. What is Research? 45 CFR 46.112 defines research as: 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. 4. What is a Human Subject? 45 CFR 46.112 defines a human subject as: a living individual about whom an investigator (whether professional or student) conducting research obtains Data through intervention or interaction with the individual, or Identifiable private information Thus, this includes actually interacting or intervening to obtain data but it also means identifiable cell lines and identifiable data taken from records (which are not public records) 5. What is Identifiable? Names Social Security Numbers Addresses Also, if the information that is obtained is specific enough with the different variables to allow someone to determine identity, then it is identifiable (such as in a very small population size). 6. What is a Public Record? Public records are those data sources that are available to anyone from a public source (such as on the internet, from associations, from licensing agencies, etc). What is not a public record? Items that are part of a sealed report or record Student records Employee records Medical records Counseling records MANY, MANY others. Just because they are existing does not mean they are public 7. What About Institutional Level Data? Studies involving aggregate level data do not require IRB approval. Examples include: Numbers of people treated in any given month Doctor to patient ratio Policies that govern decisions at the clinic, etc. 8. How are studies classified Full Board greater than minimal risk or needing group decision as to risk, ethics, or other problem areas. Expedited according to specific federal regulation list and minimal risk only. See list. Exempt according to specific federal regulation list and minimal risk only usually this is research involving databases, secondary data use, or existing (already collected and/or stored) data, documents, records, pathological specimens or diagnostic specimens. See list. 9. Federally designated vulnerable populations For more information http://www.hhs.gov/ohrp/irb/irb_chapter6ii.htm Fetuses and Human in vitro fertilization Pregnant women Children The Cognitively impaired Prisoners Traumatized and comatose patients Terminally ill patients Elderly/aged ONLY when there is cognitive impairment or institutionalization Socially and economically disadvantaged Students, employees, and normal volunteers WHEN there are procedures that may create feelings of coercion, etc. International research* 10. International Research Several regulatory standards provide foundation and ethical codes. Much of it medically-focused. The International Compilation of Human Subject Research Protections lists laws, regulations, and guidelines governing human subjects research world- wide http://www.hhs.gov/ohrp/international/HSPCompila tion.pdf 11. Strategies for Protecting Human Subjects in Global Project See summary report http://www.rti.org/pubs/protecting_research_subject s.pdf Informed Consent Local language Adequate explanation Consent from gatekeepers or community leaders Avoid undue inducement and avoid social harm (or perception of it) Consider solicitation of community input Signed consent not mandatory (consider literacy) 12. Strategies for Protecting Human Subjects in Global Project (cont) Communities can be unaware of their rights Communities can be distrustful of researchers Issues of concern: Confidentiality and privacy protection Intellectual property Access to medicines and vaccines Involvement of children in clinical research Use of stem cells Research with biological weapons Appropriate compensation 13. Things to consider in International Research Risks of Research can be different in an international setting What is considered private may be different Age of majority may be different May be gender differences Cultural expectations about what is appropriate to do/ask 14. HIPAA The Health Insurance Portability and Accountability Act of 1996, also known as the Privacy Rule Established a set of national standards for the protection of certain health information. Requires that an IRB or a Privacy Office review research involving identifiable health information. Protected Health Information (PHI): What it is. What it isnt. UCF HIPAA components Communication Sciences & Disorders and Health Services 15. What are the PHI identifiers? Name Geographic subdivisions Phone numbers Fax numbers E-mail address Social Security number Medical record number Health plan beneficiary number Account numbers URLS Certificate/license numbers VIN, serial number, license plate number Device identifiers and serial numbers IP address Biometric identifiers Full face/comparable images Any other unique code 16. HIPAA Authorization & Waiver of Authorization HIPAA Authorization Waiver of HIPAA Authorization (example: retroactive chart review for data collection) To qualify for a Waiver of Authorization Research use of PHI does not represent more than a minimal risk to privacy Research could not be done without the requested PHI It would not be practical to obtain signed authorizations from research subjects (if you are talking to them, it is practical) Specific elements of PHI are not more than the minimum necessary to accomplish study goals. 17. Biosafety Committee Review Research involving hazards require biosafety and/or radiation committee approval. Microbiological/viral agents, pathogens, toxins and other selected agents Human cell or tissue samples Recombinant DNA Chemicals Controlled substances Ionizing Radiation Physical agents such as ultraviolet light, lasers (class 3b or 4) 18. FDA FDA regulation occurs with all medical devices http://www.fda.gov/oc/ohrt/irbs/irbreview.pdf What is a medical device? IRB is to make determination of significant versus non-significant risk How are medical devices classified by FDA? Class 1 Examples: elastic bandages, exam gloves) Class 2: Examples: powered wheelchairs, surgical drapes, infusion pumps Class 3: Examples: replacement heart valves, implanted cerebellar stimulants 19. Other information on FDA Premarket notification 510(k) Premarket approval PMA http://www.fda.gov/cdrh/devadvice/ Humanitarian use device -- HUD Humanitarian device exemption -- HDE Medical device clinical investigation IDE Request for pre-IDE conference or classification 513(g) Small Manufacturers Division 1-800-638-2041 20. IDE Investigational Device Exemption Significant Risk Device Intended as implant and presents potential for serious risk For use in supporting or sustaining life and presents serious risk Substantial importance in diagnosing, curing, mitigating, treating disease and presents serious risk Otherwise presents serious risk Regulations for IRB review, marketing, labeling, etc. apply as per 21 CFR 812 21. Non-significant Risk Non-significant risk device An NSR device is an investigational device that does not meet the definition of a significant risk device IRB determination that a device is non-significant risk relies upon: Sponsors description of why it is not SR Whether proposed NSR research meets the definition of significant risk Use of device & protocol related procedures/tests (not just device alone) Additional information from sponsor PIs are responsible for abbreviated requirements at 21 CFR 812 Exempt Studies Subject to informed consent Off-label USE of legally marketed device does not require IRB approval as in the normal practice of medicine, but research to make claims or change the label does require IRB review and approval 22. Collaboration Collaborators from other institutions engaged in the research must be identified as well as their roles, such as: Administer research interviews, questionnaires, etc. Perform invasive or non-invasive procedures or experiments Manipulate a subjects environment Receive or access identifiable private information Obtain informed consent The collaborating institution must have a Federalwide Assurance if it receives federal research funding Collaborators must complete CITI training 23. Institutions Not Engaged Release individually identifiable information or specimens to another institution Permit investigators from another institution to use their facilities, students, employees, etc. for research Provide information about research to prospective subjects Perform commercial or non-collaborative service 24. IRB Contact Information Barbara Ward, CIM IRB Coordinator Phone: 407-882-2276 Joanne Muratori, CIM IRB Coordinator Phone: 407-823-2901 Janice Turchin, CIP IRB Assistant Phone: 407-882-2012

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