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Navigating the Research Approval Process

Walter Reed National Military M edical Center. Navigating the Research Approval Process. LTC Molly Klote, MD Chief, Department of Research Programs. Disclosure Statement. This CE/CME activity does not have commercial support, and has no conflicts of interest. Learning Objectives.

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Navigating the Research Approval Process

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  1. Walter Reed National Military Medical Center Navigating the Research Approval Process LTC Molly Klote, MD Chief, Department of Research Programs

  2. Disclosure Statement This CE/CME activity does not have commercial support, and has no conflicts of interest. Research Course

  3. Learning Objectives 1. Discuss the Department of Research Programs and how it can assist the researchers with the protocol application process. 2. Familiarize researchers with the protocol flow, review and approval process of conducting research at the Walter Reed National Military Medical Center. 3. Explain to researchers the Federal and DoD requirements. Research Course

  4. Learning Objective 1: Discuss the Department of Research Programs and how it can assist the researchers with the protocol application process.

  5. Where to go for help…… • Your department • Protocol Outreach Program • Clinician, statistician, regulatory reviewer, laboratory scientist • 45 min appointments for research ideas and roadmap • Darnall Biomedical Learning Resource Center (DBLRC) Librarian to help with literature searches • Research Resource Staff: • Dental Research – Dr. Bertrand • Educational Resources – Dr. Higginson • Scientific Review – W. Bernstein, M.D. • Institutional Review Boards – CDR Donahue, LTC Andrews, Ms. Marianne Elliott • Nursing Research – COL Breckenridge-Sproat Research Course

  6. Formats and Forms • The proposal itself • Use the Research Proposal Outline on the IRBNet • Include data collection sheets, flyers, advertisements, questionnaires, surveys • Consent and HIPAA forms • Other supporting forms, such as letters of support, approvals from other institutions Research Course

  7. DMRN Research Resource Center on DKO as oneshared portal accessible across DOD (SSO to IRBNet, DCO, etc)

  8. IRBNet - Project Submission Steps shown in Web Training Materials

  9. IRBNet – Enter Initial Information to Start Building Your Project

  10. IRBNet – Select/Download templates/instructions from library for project type being submitted for review (Research, Publication Clearance, CRADA, QI, etc)

  11. IRBNet – Select library’s protocol materials & download to harddrive to edit (due to signature, etc, changes these may no longer be web page accessible)

  12. IRBNet – Select type & upload all prepared project materials & if a research or publication clearance project add & populate the wizard form (also pdf)

  13. IRBNet – With left menu can administrate, email team, etc. Once ready electronically sign your project and submit for review (once submitted, project locked until unlocked by reviewer). Status alerts, etc, Outlook emailed. Very transparent - log in anytime to check status & interact. Versioning keeps doc history & shown in project ID# such as 43256-x. Every action recorded and leaves a chronological audit history. Publication clearances will be consistent in mechanism as research

  14. IRBNet – On Entry Study Manager displays your Projects by Title, Status, and ID#-Version

  15. Learning Objective 2: Familiarize researchers with the protocol flow, review and approval process of conducting research at the Walter Reed National Military Medical Center.

  16. Usual Sequence for Human Subject Research • DRP receives the proposal • Determination made of review pathway • Research Not Involving Human Subjects • Exempt from the requirement of 32 CFR 219 • Expedited = minimal risk meeting one of 7 categories • Convened Board review = 3 IRBs • 2 Biomedical Boards • 1 Military Oncology Board • Scientific Review Panel reviews proposal • IRB reviews the proposal • Expedited/Exempt review if allowable -- or -- • Full IRB review at its monthly meeting • If approved by IRB and Commander, DRP prepares approval letter • Letter is signed By Direction of the Commander • Investigator may not begin until she/he has the approval letter signed By Direction Research Course

  17. What is Exempt or Expedited Review? Research proposals that meet specific criteria: Exempt Review: 32 CFR 219.101- categories • Existing records, pathologic specimens • Educational testing, surveys Expedited Review: 32 CFR 219.110 – must be minimal risk AND in one or more categories from the list • Existing records, pathologic specimens • Data from voice, digital, image recordings, surveys Research Course

  18. Pitfalls for New Protocols • Question Unclear • Protocol and consent form do not match • All documents not included in the submission package • Missing references • Incomplete literature review • Missing human subjects protection training • If enrolling a vulnerable population (children, pregnant women) not including additional safeguards for this group) • Methods unclear Research Course

  19. Pitfalls for Consent Form • Not using current consent form format • Typos • Not in lay terms – must be in a 8th grade reading level • All procedures not included in the consent • Sample size does not match protocol • Explain what part of the procedure is experimental • Not including all the possible risks Research Course

  20. Scientific Review • Reviews all expedited and convened board protocols • Examines relevance to Military Medicine • Examines scientific merit • SRC’s review template is available on the DMRN website • Departments/Services may establish a Scientific Review Committee • Conflict of interest/Undue influence Research Course

  21. Institutional Review Board Criteria for IRB approval: • Risks to subjects are minimized • Risks are reasonable in proportion to benefits • Selection of subjects is equitable • Informed consent is sought appropriately • Informed consent is documented appropriately • When appropriate, research plan includes data monitoring to ensure safety • When appropriate, provisions to protect privacy and confidentiality are adequate IRB disapproval cannot be overruled Research Course

  22. Informed Consent • The Belmont Report - Respect for Persons - Justice - Beneficence • Types of Consent • Written • Altered • Short form • Legally Authorized representatives • Parental permission/assent Research Course

  23. What’s an MOU? • Memorandum of Understanding • Collaboration between Federal institutions • Transfer of funds • Sharing of services • Mutual expectations • Commander signs all agreements Research Course

  24. What’s a CRADA? • Cooperative Research and Development Agreement • Collaboration between a Federal institution and a civilian institution • Transfer of technology • Sharing of services • Issues regarding patents Commander signs all agreements Research Course

  25. Learning Objective 3: Explain to researchers the Federal and DoD requirements. Command Approval of Research • Command Approval Letter • Required by DoD Directive for all research involving WRNMMC “funding, personnel, facilities, and all other resources”; applies to trainee research elsewhere • Research being done at WRNMMC gets IRB review/approval • Research elsewhere also must have IRB/SRC review and approval; WRNMMC may accept the other institution’s review under a DoD Institutional IRB Review Agreement Research Course

  26. Approval of research is specific • Enrollment dates and number of subjects are specified and must be either followed or amended • Protocol specifics such as data elements and analysis plan must also be either followed or amended • Amendments must have IRB review but this is often expedited and does not require full committee • All amendments must have an specific Amendment Approval Letter Research Course

  27. Continuing Review Interval is at least once every 365 days, determined by the IRB Purpose To ensure that human subject protection continues Completion Report Due after data collection and analysis; does not have to wait until after publication Purpose To ensure that research is completed and disseminated Should include a brief account of the important findings: ABSTRACT Ongoing Research Obligations Research Course

  28. Documents the PI Must Keep • Research protocol (original and all subsequent versions) • Amendments - extensions, investigator changes, etc. • Records of all IRB communication – Initial approval, continuing review approval, amendment approval etc. • IRB approvals from other institutions Research Course

  29. Documents the PI Must Keep • Materials used in recruiting subjects (e.g. flyers, telephone scripts, posters) • Subjects’ research file • IRB approved and stamped consent form • Original signed consent forms and HIPAA forms • Instruments – surveys, questionnaires, interviews • Agreements Research Course

  30. Record Keeping • All protocol records must be kept for a minimum of three years after completion of the study (unless IRB directs holding longer) • If FDA regulated they must be kept for 2 years after FDA approval of drug or device or withdrawal of the IND/IDE application • HIPAA authorizations must be kept for 6 years • Records may be digitized Research Course

  31. Amending or Changing a Research Protocol • Your research proposal - plan for what you intend to do • The IRB expects it to be followed • If changes are need: • Describe and justify the requested amendment Research Course

  32. Amending or Changing a Research Protocol • State whether there is any change in the risk-benefit assessment • Submit a track changed version of the currently approved documents • If GTMR – medical monitor must review and endorse • Don’t implement changes until they are approved! Research Course

  33. How Does Continuing Review Work? • Continuing review occurs at least once every 365 days from initial IRB approval date • The IRB determines the frequency of continuing review (any interval less than 1 year) • IRB members and investigator receive a notification from IRBNet 60 days prior to the protocol expiration • Depending on your protocol CR may include an audit visit from a DRP staff member or IRB member Research Course

  34. What do I have to do for Continuing Review? • Investigators must have available for the review: • Research protocol file • Number of subjects enrolled • List of enrolled subject and date of enrollment • List of withdrawn subjects, date, and reason they withdrew • Original signed consent forms and HIPAA forms • Any amendments since the last review • Records of adverse events, unanticipated problems, deviations Research Course

  35. Continuing Review Approval • Following IRB approval of continuing review, DRP will send the following: Results of the continuing review audit, Newly stamped consent/HIPAA form, New IRB approval expiration date • Approximate date of next scheduled review Research Course

  36. Regulatory Pitfalls • Beginning enrollment before the date of the Commander’s approval letter • Not using the latest IRB-approved version of the consent form (check for the IRB stamp) • Enrolling more patients than the IRB approved (see the approval letter) • Acquiring collaborators without adding them to the protocol via update with IRB • Not reporting protocol deviations to the IRB Research Course

  37. More Regulatory Pitfalls • Presenting research without DRP/PAO clearance • Submitting research for clearance after it has already been accepted for a conference or a journal • Engaging in research elsewhere without notifying DRP • Engaging in research under the umbrella of Process Improvement without notifying DRP • Implementing changes to protocol without IRB-approved amendments Research Course

  38. Questions? Research Course

  39. Thank You! • My contact Information: LTC Molly Klote Email: mary.klote@med.navy.mil Phone: 301-295-8271 Research Course

  40. Discussion Questions Exempt from IRB Review Which of the below may determine whether a research protocol meets the criteria for exemption: a. investigator b. research study nurse c. trained DRP staff members Research Course

  41. Survey Research What is the principal risk posed by survey research? a. physical harm b. privacy/confidentiality c. coercion d. legal claims Research Course

  42. Research Protection Program The primary responsibility of the investigator is to the welfare of: a. the institution b. the IRB c. society d. the human subject in the investigation Research Course

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