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Steps Required To Conduct Research Involving Human Subjects

Steps Required To Conduct Research Involving Human Subjects. APRIL 10, 2012 Series 2, Session 5 of AAPLS Jennifer Graf, Director, Institutional Review Board (IRB) Applicants & Administrators Preaward Luncheon Series. Goals for this Session. Explain what the role of the IRB office.

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Steps Required To Conduct Research Involving Human Subjects

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  1. Steps Required To Conduct Research Involving Human Subjects APRIL 10, 2012 Series 2, Session 5 of AAPLS Jennifer Graf, Director, Institutional Review Board (IRB) Applicants & Administrators Preaward Luncheon Series

  2. Goals for this Session • Explain what the role of the IRB office. • Discuss what research falls under its purview. • Explain the process of having research approved by the IRB, including post-approval responsibilities. • Discuss what IRB-related information is needed at the Just In Time phase of grant application.

  3. Nuremberg Trials: Nuremberg Code (1947) Tuskegee Syphilis research (1932-1972) • Thalidomide (1962)

  4. Jesse Gelsinger (2000) Ellen Roche (2001) 2001 VCU

  5. Henrietta Lacks(1951-early 1970s; book published 2010) Guatemala Syphilis Experiment (1946-1948; reported October 2010) Susan Reverby Wellesley College John C. Cutler, MD

  6. Applying Ethical Principles • Respect for Persons: Autonomy • Informed consent • Voluntary participation • Freedom to withdraw without penalty • Protect privacy and confidentiality • Beneficence: “Do unto others…” • Risks are minimized; Benefits are maximized • Risks are justified by potential benefits • Conflicts of interest are managed or eliminated • Justice: Distribute Risks and Benefits • Protection of vulnerable populations • Those who may benefit are not excluded

  7. IRB Determinations and Types of Review • Not Human Subject Research • Initial Review • Exempt • Expedited • Convened IRB • Continuing Review • Amendment/Revision • Serious Adverse Events (SAE) and Unanticipated Problems • Other • Case reports Note: Students, fellows, etc., cannot be the PI of research at Tufts.

  8. Regulations and Policies • DHHS: 45 CFR 46 • FDA: 21 CFR 50, 56, 312, 812 • State: • Vary state to state • MA Fetal Research Statute • Be familiar with institutional policies

  9. Does Not Constitute Human Subject Research* • Certain coded or de-identified analyses • http://www.hhs.gov/ohrp/policy/cdebiol.html • Not to be determined by the Investigator • Provide a detailed letter of activities to the IRB; a written determination is • returned to the Principal Investigator • Quality Improvement/Assurance initiatives • Engaged in research: • http://www.hhs.gov/ohrp/policy/engage08.html • * Link to guidance document on IRB website.

  10. Exempt • (minimal risk) • Governed by 45 CFR 46.101(b) • 6 very specific categories • Request for Exemption form • Protocol, any documents given to subjects • PI’s COI disclosure form, others as indicated • Copy of the grant, if applicable • HIPAA documentation

  11. Expedited(minimal risk) • Governed by 45 CFR 46.110(b) – 9 specific categories • Form I • Protocol • Copy of the grant, if applicable • ICF(s) • PI’s COI disclosure form, others as indicated • Education requirements satisfied • Advertisement(s) • Questionnaires, cover letters, surveys, etc. • HIPAA documentation

  12. Database/Medical Record Review • Form VII – specifically designed for database and retrospective medical record review research. • May be exempt, may be expedited – depends on the data collected and the intervention (if any) with subjects. • Form VII is designed to eliminate the need for a separate protocol, ICF, and HIPAA documentation. • Best to complete the education requirements prior to submission.

  13. Convened IRB Review(greater than minimal risk) • Form I (all studies) • Form II (drug/compound) • Form III (device) • Form IV (research radiation) • Form VI • Tissue-banking • Optional TB ICF • PI’s COI disclosure form, others as indicated • Protocol/Site-Specific Appendix • ICF(s)/parent/guardian permission form/assent form • Advertisement(s) • Questionnaire(s), contact letters, surveys, etc. • Education requirements • HIPAA documentation • Copy of the grant, if applicable

  14. Special Populations: Contact the IRB office for guidance when preparing protocol/IRB application Pregnant women Neonates or fetuses Minors Decisionally impaired Prisoners Employees or staff Students

  15. Phases of Clinical Research Studies • Phase I: • metabolic & pharmacologic mechanisms; determine a safe dosage range; small group of people (e.g., 20-80); identify side effects. • Pose a high level of risk due to “initial introduction” of the test article into a human; little or no prior human experience. • Phase II: • controlled; preliminary effectiveness in subjects with the disease of interest; several hundred subjects; determine efficacy and further evaluate safety. Pose a high level of risk due to limited human experience. • Phase III: • controlled & uncontrolled; increased human exposure to the test article (several hundred to several thousand); seek safety & effectiveness data for extrapolation to a larger population; monitor adverse effects. • Phase IV: • conducted after intervention is marketed; long-term safety and efficacy data acquisition in a larger population; information about any Adverse Events associated with widespread use.

  16. PI Post-Approval Responsibilities • Report serious adverse events • Report unanticipated events • Continuing Review • Submit requests to change or amend the research for review and approval prior to initiating changes.

  17. Expedited and Exempt Reviewed by IRB Chair or Vice-Chair Clarification requested. PI submits additional information. Approval letter generated, signed and sent to the PI. IRB members notified.

  18. Convened IRB • Assigned to an IRB agenda • Assigned a Primary and Secondary Reviewer • Reviewed at a convened IRB meeting IRB comment letter sent to PI within 2 weeks of the meeting

  19. Principal Investigator responds to IRB review stipulations/requests for clarification: Submission is reviewed by “expedited review procedures. • If necessary, additional information, etc., • is requested from the PI. • Approval letter is generated, signed, and sent to the PI. • IRB members are notified.

  20. Helpful Tips For Submission Preparation • Ensure the protocol details all procedures. • Ensure the ICF is in simple language (8th grade reading level) • Proof read! And make sure all documents are present and required signatures are present. • Review information on the IRB website, use templates • If applicable, provide a copy of the grant • Provide requisite supporting documentation. • Provide tracked and untracked copies of revised documents; always include a version date or number on all documents. • Ensure education requirements are satisfied; retain copies of certificates of completion (subject to audit!) • COI form(s) complete and submitted, as needed.

  21. The Best Advise for a Quick and Successful IRB Review… PLAN IN ADVANCE • Review IRB website, get familiar with issues. • Discuss the project with other research-experienced faculty, develop a plan (and a protocol). • Call the IRB office – schedule an appointment to meet with a member of the office. • Speak with an IRB member.

  22. IRB Leadership • IRB Chair: Andreas K. Klein, MD • IRB Vice-Chairs: Susan Hadley, MD • Gordon Huggins, MD • Roman Schumann, MD • IRB Members are from more than 20 different divisions at Tufts MC and Tufts University, including TUSM, TUSDM, HNRCA, etc., non-scientists, and community representatives who are not affiliated with either institution.

  23. IRB office • Director, IRB Operations: Jennifer A. Graf • IRB Coordinators: Julie Morelli Novak (Red) Ashley D. Hicks (Blue) • Continuing Review Coordinators: Christine Choy (Blue) Andrew L. Simon (Red) • Assistant IRB Coordinator: Jesslyn Jamison • Administrative Assistants: Robert J. Santoro (PT) TBA (FT)

  24. IRB Office Box 817 (617) 636-7512 15 Kneeland Street, 1st floor http://tnemcirb.tufts.edu/

  25. Presenter Zoya Hamilton, CRA, EdD Sr. Associate Director Research Administration Office of the Vice Provost Tufts University zoya.hamilton@tufts.edu

  26. Externally-Funded Projects with Human Subjects • Sponsor agency requires confirmation that the project funded by the award is approved by Tufts IRB • This confirmation is necessary before the release of the funds by the agency (Just In Time – JIT) • If award is pass-through, the prime recipient requests a copy of the IRB approval letter with subcontract paperwork

  27. Communicating IRB Approval to Sponsor • Your Signing Official (SO) from the Office of Research Administration (ORA) will confirm the IRB approval to sponsor • SO will determine whether or not the sponsor requires a copy of the IRB letter or just the IRB approval date • NIH typically only requires the approval date unless the IRB letter is specifically requested • ORA requires a copy of the IRB approval letter in order to communicate the IRB approval to sponsor • It is PI’s responsibility to provide a copy of the IRB approval to ORA

  28. Just In Time • JIT information is an administrative piece that is necessary for the release of funds • In most cases when JIT is requested via personal email funding will be awarded • JIT link in Commons is not an indicator of funding decision • Occasionally (most often before the federal fiscal year end) award may be issued with a restriction on the use of human subjects when the IRB approval is not in place

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