RESEARCH SUBJECTS PROTECTION DIVISION

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1 NAVAL MEDICAL CENTER PORTSMOUTH RESEARCH SUBJECTS PROTECTION DIVISION Guidebook for Extramural IRB Submissions Kersten Wheeler, MS Elizabeth Dayag, CIP, CCRP Melvina Queen, CIP, CCRP Research Subjects Protection Division Clinical Investigation Department Release: 05 May 2017 RSPD Guidebook for Extramural IRB Submissions Page 1

2 COMMAND APPROVAL OF EXTRAMURAL RESEARCH This submission guidebook is designed for collaborative research that occurs at NMCP but is conducted under the purview of an extramural institution, which serves as the official IRB of record. An IRB agreement (i.e., IAIR or IIA) must be in place before NMCP can be an approved site for extramural research protocols. The collaboration, sharing of data and other resources, generally requires a separate agreement (i.e., CRADA, MOU, EPA, etc.) as this language is not included in the IAIR. Additionally, some sites require, on a case by case basis, that an additional agreement or memo be in place to note which institution will serve as the IRB of record. Extramural research of this nature requires CO approval for all new protocols and CO acknowledgement of post-approval actions. The IRB of record shall maintain primary responsibility for the conduct and oversight of local protocol activities. PROCEDURES/REQUIREMENTS FOR IRB SUBMISSION INITIAL REVIEW OF NEW PROTOCOLS 1. Confirm all collaborative agreements are in place before proceeding. Additionally, Kersten Wheeler, Head RSPD may confirm collaboration approval with the IRB of record. 2. Local CO approval of extramural approved IRB documents is required prior to initial implementation of a protocol. 3. Please visit the CID SharePoint page, or contact Kersten Wheeler, Head RSPD to obtain the Command Approval of Extramural IRB Review application. 4. The protocol number will be assigned by CID. The extramural protocol number will also serve as the local protocol number, whenever possible, in order to facilitate communications between the two institutions. This local protocol number will remain in effect for the life of the protocol at NMCP. 5. Submission of all new protocols should be ed to Ms. Wheeler. Note: Items can only be submitted by research personnel named on the protocol. 6. Documents to be included in the submission package are as follows: Extramural IRB s protocol approval letter Approved version of protocol/research plan Approved documentation of NMCP personnel and documentation of NMCP as an approved site Approved version of consent forms with local contact information Approved version of Data Collection Tools, surveys, questionnaires, etc. Local recruitment materials (flyers, posters, text of recruitment , etc.) Agreement materials (other than those already logged at CID) RSPD Guidebook for Extramural IRB Submissions Page 2

3 Other materials such as Letters of Support, Sponsor Protocol, Investigator Brochure, etc. (if applicable) 6. Ms. Wheeler will route your protocol for CO approval. 7. Once approval is received, Ms. Wheeler will the CO approved Extramural IRB Review Application for your records. 8. If the IRB of record is a non-dod IRB, CID will then forward the required documentation (see Appendix 1) to DON HRPP for DOD headquarters level review. When the package is approved by DON HRPP, CID then releases the approved materials to the Investigator. POST-APPROVAL ACTIONS 1. Post-approval actions items which affect the local site at NMCP (e.g., Amendments, Continuing Reviews, etc.) should be submitted locally within 7 business days of extramural IRB approval. 2. Visit the CID SharePoint page, or contact Kersten Wheeler, Head RSPD to obtain the Command Approval of Extramural IRB Review application. This form needs to be updated and submitted with each post-approval action. 3. Submission of post-approval actions (Amendment, Continuing Review, Protocol Deviation/Violation, SAE, or Final Report) should be ed to Ms. Wheeler. 4. Amendments should only be submitted if they affect the local site. Multiple post-approval items can be combined into one submission along with only one Command Approval of Extramural IRB Review Application. Note: Items can only be submitted by research personnel named on the protocol. 5. Documents to be included in the submission package are as follows: CONTINUING REVIEW Extramural Continuing Review approval letter Approved Research Plan Approved version of consent forms or waiver forms for local use Reports, if applicable (i.e. Non-local SAEs, safety reports, protocol deviation/violations, etc.) Approved version of Data Collection Tool(s) Approved version of survey, questionnaire, etc. Approved version of all recruitment materials (flyers, posters, text of recruitment , etc.) Other materials such as current Sponsor Protocol, Investigator Brochure, etc. (if applicable) AMENDMENT (Protocol and Personnel Changes) Extramural Amendment approval letter Extramural Amendment documentation PROTOCOL DEVIATION/VIOLATION RSPD Guidebook for Extramural IRB Submissions Page 3

4 WORD version of Command Approval of Extramural IRB Review Application Extramural Deviation/Violation approval letter Protocol Deviation/Violation Report form LOCAL SAE Extramural SAE approval letter Research Monitor report Safety Report (if a non-local SAE) Supporting documents, such as Cover Letters, etc. FINAL REPORT Extramural Final Report approval letter Extramural Final Report Upon receipt of a post-approval action for an extramural protocol, CID will perform an administrative review of the extramural package and the Command Approval of Extramural Post- Approval Actions form, including confirmation that local investigator training requirements continue to be met and that any agreements associated with the project are in good standing. When administrative review is complete, CID will release the approved materials to the Investigator and notify them that they may continue work on the protocol. The extramural postapproval action is presented to the CO for approval within the IRB meeting minutes reporting appendix. This approval is documented when the minutes in which the action is reported are signed by the CO. EXTERNAL AUDIT/COMPLIANCE REPORTING If the local NMCP site or local protocol documentation is part of an external audit, investigators will have the responsibility to notify CID at least 30 days in advance of a protocol audit and must submit a copy of the external audit/monitoring reports to CID within 10 days after receipt. CID LOCAL REPORTING GUIDELINES SAEs AEs UPIRTSOs Protocol Deviations/Violations Breaches of confidentiality Advertisements Audit Reports Report locally after Extramural IRB action is taken Note: If the SAE resulted in a death, local report to CID must be made within 24 hours CID Approval Required (Should include Extramural IRB s stamp/approval) Within 10 days after receipt RSPD Guidebook for Extramural IRB Submissions Page 4

5 QUESTIONS Information about various aspects of research may be found on the CID SharePoint page on the NMCP intranet and the CID web page on the NMCP website, or by request from the IRB Administrators. For more information, please call CID at RSPD Guidebook for Extramural IRB Submissions Page 5

6 APPENDIX 1 Department of the Navy Human Research Protection Program (DON HRPP) List of Required Documents for Administrative Review of Human Subject Research DoD Components must conduct an administrative review of specific categories of non-exempt human subject research that is performed by DoD personnel BEFORE the research can begin (DoDI , Enclosure 3, Sections 3b and 7b(3)). Please complete the following checklist and provide to DON HRPP, with all applicable documents, for headquarters-level administrative review. Documents for Review a. Higher authority approval (SG, SECNAV, ASD(R&E)) b. Command approval document/letter c. Approved protocol or IRB application d. Scientific review e. Instruments, questionnaires, data collection forms etc. f. Recruiting, advertising materials, letters of introduction g. Subject information sheets h. IRB-approved informed consent document i. Parental permission j. Child assent k. HIPAA authorization or waiver of authorization l. Foreign language translations of consent/assent/parental permission m. Other reviews: Safety, radiation safety, laser safety, etc. n. IRB meeting minutes or Expedited review document o. Survey approval documentation p. FDA Determination Letter (IND#, IDE#, Exemption) q. IND Application (including FDA 1571 or 1572) or IDE Application r. FDA-related documents, other s. Command endorsements, permission to recruit t. Agreements (IAIR, IIA, MOU, MOA, etc.) u. Host Country Approval v. Host Country IRB/ethics review w. Other (e.g., Addendums): Attached Not Applicable Do Not Have RSPD Guidebook for Extramural IRB Submissions Page 6

SECNAVINST E ONR Dec 2017 SECNAV INSTRUCTION E. From: Secretary of the Navy. Subj: HUMAN RESEARCH PROTECTION PROGRAM

SECNAVINST E ONR Dec 2017 SECNAV INSTRUCTION E. From: Secretary of the Navy. Subj: HUMAN RESEARCH PROTECTION PROGRAM ONR 343 SECNAV INSTRUCTION 3900.39E From: Secretary of the Navy Subj: HUMAN RESEARCH PROTECTION PROGRAM Encl: (1) Changes (2) References (3) Responsibilities (4) Procedures (5) Definitions (6) Reports