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Student Human Research Education Session

Alyssa Speier, MS, CIP Paul Hryvniak, CIP February 5, 2013. Student Human Research Education Session. Tel: 617-432-2140 E-mail: qip@hsph.harvard.edu URL: www.hsph.harvard.edu/ohra/qip. Agenda. The IRB’s Function Types of IRB Review Not Human Subjects Research Is your Data Identifiable

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Student Human Research Education Session

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  1. Alyssa Speier, MS, CIP Paul Hryvniak, CIP February 5, 2013 Student Human Research Education Session Tel: 617-432-2140 E-mail: qip@hsph.harvard.edu URL: www.hsph.harvard.edu/ohra/qip

  2. Agenda • The IRB’s Function • Types of IRB Review • Not Human Subjects Research • Is your Data Identifiable • Exemptions • Expedited/Full Board Studies • Plan Ahead! • Tips 2 2 2

  3. IRB’s Primary Function • To Ensure: - Participant Protection: • Rights and Welfare • Safety • Privacy and Confidentiality • Compliance with IRB-approved protocol, Institutional policies, and federal regulations 3 3 3 3

  4. Types of IRB Review • Not Human Subjects Research • Exemption • Expedited Review • Full Board Review Most common for student projects 4 4

  5. Is Your Project Human Subjects Research? Research: A systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizableknowledge. Human Subjects: A living individual about whom an investigator (whether professional or student) conducting research obtains: (1) Data through intervention or interaction with the individual, or (2) Identifiable private information 5 5 5 5 5

  6. Is your Data Identifiable? Coded data is identifiable unless: Codes can be stripped prior to analysis The PI gets an attestation from the data provider De-identified/Anonymized data Cannot contain participant codes/IDs if there is a link to identifiable information in existence unless the PI gets an attestation 6 6 6 6

  7. Is Your Project Exempt? 7 7 7 7 7 • Study procedures must fit within Exemption category(ies) • Research conducted with children cannot be exempt under b(2) unless activities are limited to observation without investigator interaction • Research conducted with prisoners is not eligible • Research regulated by FDA is not eligible • Investigators MUST obtain an exemption determination from the IRB prior to conducting Human Research • No long-form consent document required; however, process to obtain consent must be in place

  8. Exemption Categories, examples Research conduced in commonly accepted educational settings, involving normal educational practices Surveys, interviews, observation of public behavior If identifiers are not recorded OR If risk is not increased Surveys, interviews, observation of public behavior if participants are public officials Collection of existing data, documents, specimens If publicly available OR If no identifiers are recorded Evaluation of public benefit or service programs, etc. subject to approval of Department or Agency heads Taste and food quality evaluation and consumer acceptance 8 8 8 8 8

  9. What to Submit-for NHSR and Exemptions (when applicable) • Electronic IRB Submission System (ESTR): https://irb.harvard.edu • NHSR – Upload NHSR Form • All other submissions- Upload Research Protocol • *English version of consent script or handout which mentions at least • That the activities involve research • Brief description of the study procedures, e.g., focus group, survey, interview, etc. • That participation is voluntary • The PI/Local Contact name and contact information • *English version of recruitment materials • *English version of study tools • E.g. questionnaires, focus group and interview guides, data collection sheets, etc. • Data Use Agreement(s) • If using secondary data from an outside source, the provider may ask you to sign one • CITI training certificates (Exemptions) *Include version date and/or version number within each document. 9 9

  10. Expedited and Full Board Review • If your study does not meet the criteria for “not human subjects research” or “exemption,” it will be reviewed expedited (in office) or at the Full Board Meeting (monthly) • Expedited Research: All study procedures must meet into one or more of the expedited categories AND must be less than minimal risk • Full Board: Activities not under the expedited criteria OR Greater than minimal risk • *Note: A HSPH faculty member must act as the PI – students are not eligible to be PI on Non-Exempt Human Research 10 10 10

  11. If Expedited or Full Board, Additional materials may be required • Research Protocol (Always required-use template on ESTR) • Consent Documents (use template on ESTR) • Ancillary Approvals/Permissions (e.g., radiation safety, biosafety letters of cooperation or support) • PI's Current Curriculum Vitae (only if required by sponsor to follow (ICH-GCP E6) • DOE Requirements Checklist - For Department of Energy (DOE) research, a completed "Checklist for IRBs to Use in Verifying HS Research Protocols are In Compliance with Department of Energy (DOE) Requirements" • HRP-217 - Form - Radiation Safety • HRP-220 Study Personnel • Locally-approved foreign language versions of study documents (when available-see instructions on Translation Attestation Form) • HRP-221 Financial Interest Disclosure • HRP-223 Translation Attestation • HRP-224 IRB Authorization Request • Advertisements (printed, audio, and video) • Recruiting Materials/Scripts • Study Instrument(s), e.g., survey/questionnaire, interview guides, and focus group scripts (do not submit case report forms) • HRP-225 Individual Investigator Agreement • External Approvals (e.g., Local approval) • CITI Training Certs.

  12. Plan Ahead! • Submit as soon as possible. • You cannot begin research with human subjects or identifiable data before obtaining HSPH and Local IRB determination, even if you’ve booked your flight! • Allow sufficient time for review(s) • Review times dependent on completeness of submission • Average review times • Exemptions/NHSR-5 business days • Expedited-2 weeks • Full Board-see submission deadlines online (about a month prior to the meeting) • Continuing Review-21 Days prior to lapse date 12 12 12

  13. Tips • Discuss project with local collaborators • Do you need local review or permission? • Once you submit your application sit tight and let the reviewers do their jobs • If the status of your submission hasn’t been changed to “assigned” within 48 hours check in. • If things change submit a modification request • Come to an ESTR Training session • ESTR FAQs on ORARC home page • Make sure to have the PI hit “submit” in ESTR. 13 13

  14. eIRB (ESTR) System Training

  15. Questions? Quality Improvement Program Staff • Stanley Estime, sestime@hsph.harvard.edu, 617-432-2164 • Alyssa Speier, aspeier@hsph.harvard.edu, 617-432-2140 • Leslie Howes, lhowes@hsph.harvard.edu, 617-432-2153 (ON LEAVE) IRB Operations Staff • Susan Burnside, burnside@hsph.harvard.edu, 617-432-2143 • Cecelia Grano de Oro, bgranode@hsph.harvard.edu, 617-432-2142 • Paul Hryvniak, phryvnia@hsph.harvard.edu, 617-432-2160 • Julie Kaberry, jkaberry@hsph.edu Resources • OHRA Website • QIP’s Service Request Form 15 15 15 15

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