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1 SLU eirb Conversion Charts Saint Louis University ***** eirb Paper to Electronic Protocol Conversion Charts ***** Institutional Review Board August Institutional Review Board Saint Louis University Caroline Building, Room C Caroline St. St. Louis, MO (314) (314) (fax)
2 Conversion Charts: Behavioral & Social Sciences This chart details which sections of the previous paper application and protocol match to the new e-form questions. NOTE: Some portions of the paper protocol were broken down into several eirb questions- please be sure to copy and paste the appropriate information into the new question as it makes sense for your protocol. eirb Section eirb Behavioral & Social Sciences (BSS) Form Question Personnel Information Paper Section A (application) Subject Population Checklist Study Location Checklist General Checklist Funding Checklist C, D1 (application) B1 (application) face page, D2 (application) face page Protocol Info Expedited Paragraph(s) Request for Exp Review form Tab 1-3 1a: Intro/background info/literature review/past findings 1b & 1c (protocol) 2a: Lay summary 1a (protocol) 2b: Research objectives/aims/hypotheses 2 (protocol) 2c: Study design description 3 (protocol) 3a: Study procedures description 7a & 8 (protocol) 3b: Data analysis/reliability information 9 (protocol) 3c: Audio/Video recording 14d (protocol) Tab 4 4a: Number of subjects E1 (application), 4a (protocol) 4b: Age range of subjects E1 (application), 4a (protocol) 4c: Description of participants C, D1 (application), 4a (protocol) 4d: Rationale for vulnerable subjects 4b (protocol) 4e: Rationale for excluding women, minorities or minors 4c (protocol) 4f: Use of students or employees as subjects D1 (application), 4b, 15 (protocol) 4g: Subject recruitment 5b (protocol) 4h: Inclusion/Exclusion criteria 6a & 6b (protocol) 4i: Subject compensation G1 (application), 12a (protocol) 4j: Study costs G2 (application), 12b (protocol) 4k: Duration of study & subject participation E2 (application) Application Conversion 2
3 Conversion Charts: Behavioral & Social Sciences, con t eirb Section eirb Behavioral & Social Sciences (BSS) Form Question Paper Section Tab 5 5a: Physical, psychological, social, legal, or other risks 11a & 11b (protocol) 5b: Plan for protecting against and minimizing risks 11c (protocol) 5c: International research NEW QUESTION 5d: Intervention plan for distressed subjects 11c (protocol) 5e: Data safety monitoring committee/board & plan K (application), 11d (protocol) Tab 6,7 6a: Potential benefits to subjects & society 10a & 10b (protocol) 6b: Study alternatives 13 (protocol) Tab 6,7 7a: Procedures to maintain electronic data confidentiality F3a (application) 7b: Procedures to maintain hardcopy data confidentiality F3b (application) 7c: Protection of subjects privacy, confidentiality 14a & 14c (protocol) 7d: Who has access to the data F5a, F5c (application), 14b 7e: Protection of data collected via or Internet 14e (protocol) Tab 8 8: Conflict of Interest H (application) Tab 9 9.1: How consent is obtained (when and where) 15 (top), 15c, & 15d (protocol) 9.2: How risks, benefits, and alternatives will be discussed 15b (protocol) 9.3: Consent with cognitive impaired populations 15e (protocol) Tab : Justify assent with minors 15e.1 (protocol) 10.2: If a minor says no 15e.2 (protocol) 10.3: Assessing a minor s ability to assent 15e.3 (protocol) Tab : Is there health information? F4a (application) 11.2: Personal identifiers received or collected NEW QUESTION 11.3: Sources of Protected Health Information F4b (application) 11.4: Data shared outside of research team F5b (application) Final Steps Page I (application) Application Conversion 3
4 Conversion Charts: Biomedical This chart details which sections of the previous paper application and protocol match to the new e-form questions. NOTE: Some portions of the paper protocol were broken down into several eirb questions- please be sure to copy and paste the appropriate information into the new question as it makes sense for your protocol. eirb Section eirb Biomedical (BIO) Form Question Paper Section Personnel Information Subject Population Checklist Study Location Checklist General Checklist Funding Checklist A (application) C, D1 (application) B1 (application) face page, D2 (application) face page Protocol Info Expedited Paragraph(s) Request for Exp Review form Tab 1-3 1a: Past findings leading to formulation of study 1c (protocol) 1b: Animal experiment. leading to formulation of study 1c (protocol) 2a: Lay summary 1a (protocol) 2b: Research objectives/aims/hypotheses 2 (protocol) 2c: Study design, timeline, etc 3 (protocol) 2d: Justification of placebo use 3 (protocol) 3a: Multi-center study information B3 (application) 3b: Description of study procedures 7a (protocol) 3c: Treatment compared to placebo or treatment group NEW QUESTION 3d: Data analysis/reliability information 8 & 9 (protocol) Tab 4 4a: Radiographic diagnostic & therapeutic procedures sum Appendix B, question 1 (app) 4b: Radiation not standard of care vs. standard of care Appendix B, question 2 (app) 4c: Research radiation procedures limited to x-ray only Appendix B, question 3 (app) 4d: Total radiation exposure Appendix B, question 3 (app) 4e: Not Standard of Care radiation procedures Appendix B, question 4 (app) Tab 5 5a: Investigational device L (application) 5b: FDA Approved device L (application), 1e (protocol) Tab 6 6a: Study phase L (application) Application Conversion 4
5 Conversion Charts: Biomedical, con t eirb Section eirb Biomedical (BIO) Form Question Paper Section 6b: Investigational drugs, reagents, chemicals, bio products L (application), 1d (protocol) 6c: FDA approved drugs, reagents, chemicals, bio products L, App. A (app), 1d, 1e (protocol) Tab 7 7.1: University Radiation Safety J (application) 7.2: Institutional Biosafety J (application) 7.3: PTNT Committee J (application) 7.4: SLU Hospital B2 (application) 7.5: SSM STL NEW QUESTION 7.6: SLU Department of Marketing NEW QUESTION Tab 8 (a-g) 8a: Age range of subjects E1 (application), 4a (protocol) 8b: Number of subjects at SLU E1 (application), 4a (protocol) 8c: Number of subjects study wide E1 (application), 4a (protocol) 8d: Rationale & protective measures for vulnerable populations 4b (protocol) 8e: Rationale for excluding women, minorities, or minors 4c (protocol) 8f: Use of students, employees, or lab personnel 4b, 15 (protocol) 8g: Subject recruitment 5b (protocol) Tab 8 (h-k) 8h: Inclusion/exclusion criteria 6a & 6b (protocol) 8i: Subject compensation G1 (application), 12a (protocol) 8j: Study costs G2 (application), 12b (protocol) 8k: Duration of study & subject participation E2 (application) Tab 9 9a.1: Risks of Investigational devices 11 a-c (protocol) 9a.2: Risks of Investigational drugs 11 a-c (protocol) 9a.3: Risks of FDA approved drugs 11 a-b (protocol) 9a.4: Risks of FDA approved devices 11 a-b (protocol) 9a.5: Risks related to performing study procedures 11b (protocol) 9a.6: Risks of use of radioisotopes/radiation machines NEW QUESTION 9a.7: Risks of alternative treatments 13 (protocol) Application Conversion 5
6 Conversion Charts: Biomedical, con t eirb Section eirb Biomedical (BIO) Form Question Paper Section 9a.8a: Physical, psychological, social, legal, or other risks 9a.8b: Termination of subjects, plans for intervention 9a.8c: Reproductive risks, drug pregnancy category 9a.8d: Data safety monitoring committee/board & plan 11a (protocol) 11c (protocol) L-end (application) K (application), 11d (protocol) Tab 10,11 10a: Potential benefits to subjects & society 10a & 10b (protocol) 10b: Study alternatives 13 (protocol) Tab 10,11 11a: Procedures to maintain electronic data confidentiality F3a (application) 11b: Procedures to maintain hardcopy data confidentiality F3b (application) 11c: Protection of subjects privacy, confidentiality 11c & 14a (protocol) 11d: Data or specimens shared outside of research team F5a & F5c (app), 14b (protocol) 11e: Data or samples received from outside source 14c (protocol) 11f: Protection of data collected via or Internet 14e (protocol) 11g: Audio/Video recording 14d (protocol) Tab 12 12: Conflicts of Interest H (application) Tab : How consent is obtained (when and where) 15 (top), 15c, & 15d (protocol) 13.2: How risks, benefits, and alts. will be discussed 15b (protocol) 13.3: Consent with cognitive impaired populations 15e (protocol) Tab : Justify assent with minors 15e.1 (protocol) 14.2: If a minor says no 15e.2 (protocol) 14.3: Assessing a minor s ability to assent 15e.3 (protocol) Tab : Is there health information? F4a (application) 15.2: Personal identifiers received or collected NEW QUESTION 15.3: Sources of Protected Health Information F4b (application) 15.4: Data shared outside of research team F5b (application) Final Steps Page I (application) Application Conversion 6
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