Request to Review Research Proposal/Project s2

Request to Review Research Proposal Research Service - Louis Stokes Cleveland DVA Medical Center

Form Directions: This form is protected (limited access to the fill-in fields). Use the tab key or mouse to navigate the fill-in fields. Formatting is limited in the text fields (no bulleted lists, numbering, etc). In the event that you are unable to navigate through the protected document or would like to format a document or add additional information, you may disable the protected feature by selecting “Tools” and “Unprotect Document.” Please do not delete or modify questions. ALL FORMS REFERENCED IN THIS DOCUMENT CAN BE FOUND ON THE VA INTERNET SITE: http://www.clevelandvaresearch.org/ If you are new to research at the LSCDVAMC please contact the Research & Development Committee Coordinator Jesse Dostal, [email protected] before beginning the submission process. A. PROJECT SUMMARY 1. Principal Investigator (PI): Last First MI Degrees 2. Project Title: (If a VA application maximum of 81 characters. All application titles must be less than 175 characters. 3. Please check the box that best describes this research proposal: Peer reviewed VA Funding Application (VA Merit, VA Career Development, REAP, VISN, etc.). Your submission must be accompanied by two scientific reviews or if this is a resubmission, the prior reviews from the VA funding group can be used. If no review is provided via the funding process please supply two reviews on the Initial Review Form located on the Research Service Webpage. Your submission must be accompanied by the complete application, conflict of interest statements for each individual named in the proposal, and ~500 word abstract (if not included in the complete application). Applications for non-VA Funding (projects funded by the NIH, AHA, etc.) that has been reviewed by a study section review panel – your submission must include the reviews by the funding agency. Additionally, please complete and include the following: All applicable subcommittee (IACUC, IRB, SRS) documents, complete application (research plan, budget justification), ~500 word abstract, conflict of interest statements for each member of the study staff, and any necessary letters of support. Industry sponsored and initiated project – Your submission must be accompanied by two scientific reviews. One must be from a VA investigator. One reviewer must be your Service Chief. Please supply these reviews on the reviewer’s checklist located on the Research Service http://www.clevelandvaresearch.org/forms_research.htm. Additionally, please complete and include the following: All applicable subcommittee (IACUC, IRB, SRS) documents, complete application (clinical protocol, ~500 word abstract, conflict of interest statements for each member of the study staff, and any necessary letters of support. Project that is not funded or has not been submitted for funding – Your submission must be accompanied by two scientific reviews. One of these reviewers must be a VA Investigator. Please supply these reviews on the Initial Review Form located on the Research Service Webpage. Additionally, please complete and include the following: All applicable subcommittee (IACUC, IRB, SRS) documents, a budget, ~500 word abstract, conflict of interest statements for each member of the study staff, and any necessary letters of support.

02/01/2013 Request to Review Research Proposal – Page 1 of 7 Request to Review Research Proposal Research Service - Louis Stokes Cleveland DVA Medical Center

Principal Investigators (PI): All PIs must have a paid VA appointment. A PI is an individual who conducts a research investigation and is the responsible leader of that team. The PI of a study assumes ultimate responsibility for the conduct of the research. As of 6/30/2010 Students, Residents, Fellows, and WOC employees may not act as the PI of a new research project.

B. PRINCIPAL INVESTIGATOR INFORMATION If you are a new PI to the LSCDVAMC please submit a New Investigators Packet 4. Phone: 5. Ext: 6. E-mail: 7. VA Appointment (Check VA Full-Time VA Consultant One): VA Part Time VA Contract Service Line: /hrs wk Without Compensation (WOC) C. STUDY STAFF 8. Project Coordinator or Research Contact (if applicable): 9. Other Personnel Involved in Project: (i.e., Co-Investigators, Collaborators, Nurses, Support Staff) Note: Mark "yes" in the "VA (yes/no)" column for personnel who will have access to VA patients, access to VA patient data and/or access to VA space for research activities. These individuals must hold VA appointments (Paid or WOC) and are required to submit the appropriate forms to the Research Office. These may be found at: http://www.clevelandvaresearch.org/hsp_credentialing.htm. Educational requirements for individuals listed on VA research studies can be found on the Research Website (http://www.cleveland.va.gov/research/training_hsp.asp). To add more rows to this part of the form when done, go to the Review tab, click Protect Document, select unrestricted Access, then highlight the last row, right click the last row, Insert / Insert Rows, Copy and Paste Cells to the new row.

Name (Last, First) / Role in Study VA (Yes/No) E-Mail Address Phone Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Conflict of Interest: Principal Investigators and any Co-Investigators only must submit a Conflict of Interest Statement. Disclosure of conflicts does not necessarily preclude an individual from engaging in research.

D. PROJECT FUNDING 10. A budget is required for ALL projects, regardless of whether the project is funded or not. Choose one of the following: The budget was generated as a part of the funding application and is included here. The budget is on the LSCDVAMC Research template BUDGET 11. Funding Sources and Administration (if non-funded please enter Not Applicable): Name of Funding Source: Name of institution administering the funds:

E. PROJECT SPECIFICATIONS Yes No 12. Will the project involve Human Subjects Research? If “Yes”, address the following and complete the appropriate IRB forms . Human subject research involves a living individual about whom an investigator conducting research obtains (1) Data through intervention or interaction with the individual and/or (2) Identifiable private information. Use of drugs. If so, submit an application to the Pharmacy &Therapeutics (P & T) Committee – contact [email protected] Use of investigational devices Use of electrically line-operated devices, if not for their standard application or if the device is specially constructed by research staff (If so, submit an application to the Environment of Care (EOC) Committee – contact [email protected]) Tissue Banking (Contact the IRB Office 216-791-3800 x4658) Retrospective chart review 13. Ionizing Radiation (e.g. radioactive material, x-rays)? Radiation Safety Committee approval is needed prior to submission. Contact the Radiation Safety Officer at 216-791-3800 ext 3096 or 5404.

Recombinant DNA? Are there Recombinant DNA procedures used in this project beyond the use of PCR amplification of DNA segments? If “Yes” Case IBC approval is needed prior to submission http://ora.ra.cwru.edu/research/orc/rdna/indxPg_Cwru_ibc.cfm 15. Animal Subjects? If "Yes": complete the appropriate ACORP Forms. The contact person for animal studies is Jaime Shuster, [email protected], 216-791-3800 x6109 16. Biohazards: A Research Protocol Safety Survey (RPSS) or an RPSS Exemption must accompany ALL PROJECTS. The contact person is John Schaffer, [email protected] 216-791-3800 x4263 17. Institutional Considerations - Where will you perform this research?

Institution: Building: Room #: 18. Is Institutional Support Required? If the proposed research involves resources beyond those offered for normal standard of care (e.g., Laboratory Service; Surgical Service, etc.) and this is a non-VA Funded project a Letter of Support must be completed and signed by the appropriate service chiefs or medical center director. 19. Project Focus: (Check relevant item.) Agent Orange: Yes No Females: Yes No Prisoners of War: Yes No 20. Key Words: (Minimum of 3, Maximum of 6. Use MeSH terms only. www.nlm.nih.gov/mesh/)

F. DATA SECURITY 21. Does the proposed research involve the collection of any of the following Personally Identifiable Information (PII) or Personal Health Information (PHI) as it relates to individual, human, research participants? No PII or PHI will be collected (Complete the signatures at the end of this document) (a) Names (j) Certificate/license numbers (b) Any geographic division smaller than a state (k) Vehicle identifiers (c) Any dates (more precise than year) (l) Device identifiers (d) Telephone numbers (m) Web Universal Resource Locators (URL) (e) Fax numbers (n) Internet Protocol (IP) address numbers (f) Electronic mail addresses (o) Biometric identifiers (audio/ video files) (g) Social Security Numbers (fragments or full) (p) Full face photographic images (h) Health plan beneficiary numbers (q) Any other unique identifying code (i) Account numbers or characteristic:

22. Paper Records, On-Site Storage at Louis Stokes Cleveland VAMC Will paper research data/records with PHI/PII be stored at the Louis Stokes Cleveland VAMC? Yes No (If No, skip to #23) If Yes, which PHI/PII letter codes from the list in #21?

Please explain how the records will be kept secure:

23. Electronic (computer) Records, On-Site Storage at Louis Stokes Cleveland VAMC Will electronic research data/records with PHI/PII be stored at the Louis Stokes Cleveland VAMC? Yes No (If No, skip to #24) If Yes, which PHI/PII letter codes from the list in #21?

Please indicate the devices/ media you will use for storage of research data at the VA: VAMC Network Server (an m-drive or similar Encrypted CDs or DVDs: bldg/rm: arrangement): VA Desktop Computer: bldg/rm: VA Audio Recorder: bldg/rm: Encrypted VA Laptop Computer: bldg/rm: VA Video Recorder: bldg/rm: Encrypted VA USB Thumb Drive Other (describe) How will the data be kept secured (encryption, password protected, etc)?

G. DATA TRANSFER 24. Paper Records, Off-Site Transmission/Storage Will paper research data/records with PHI/PII be transmitted or stored outside of the Louis Stokes Cleveland VAMC? Yes No (If No, skip to #25) If Yes, which PHI/PII letter codes from the list in #21? FORMTEXT Please describe the method of data transfer: US Postal Service or other trackable courier services Other (Describe) (not campus mail) (Specify) Please explain how the PHI/PII will be kept secure:

Note: The location (facility, bldg., rm., type of electronic storage, if available) of where the PHI/PII will be stored should be identified in the HIPPA Authorization 25. Electronic (computer) Records, Off-Site Transmission/Storage Will electronic research data/records with PHI/PII be transmitted or stored outside the Louis Stokes Cleveland VAMC? Yes No (If No, Skip to 26) If Yes, which PHI/PII letter codes from the list in #21?

Please indicate the devices/ media you will use for storage of research data outside the VA: File Server Encrypted USB Thumb Drive Encrypted Desktop Computer: Encrypted External Hard Drive: Encrypted Laptop Computer: Encrypted CDs or DVDs: Encrypted Portable Data Assistant (PDA) Other (Describe) How will the data be kept secure (encryption, password protected, etc)?

Please describe the method of data transfer:

Note: The location (facility, bldg., rm., type of electronic storage, if available) of where the PHI/PII will be stored should be identified in the HIPPA Authorization.

H. OFFSITE DATA APPROVALS 26. Data Transfer and Permission to Remove Have the following approvals been obtained? Data Transfer Agreement (DTA) – If PII or PHI will be transferred or transmitted offsite to a non-VA entity, and this study is not associate with a CRADA or CSP, a DTA is required (the DTA template is available here http://www.clevelandvaresearch.org/forms_research.htm). Data Transfer Agreement (DUA) – If PII or PHI will be transferred or transmitted offsite to a VA entity, and this study is not associate with a CRADA or CSP, a DUA is required (the DUA template is available here http://www.clevelandvaresearch.org/forms_research.htm). Memo to Remove Sensitive Information – If PII or PHI will be transferred offsite by a VA employee a Memo to Remove Sensitive Information is required (the Memo to Remove Sensitive Information template is available here http://www.clevelandvaresearch.org/forms_research.htm). If either a DTA, DUA, or Memo to Remove Sensitive Information is required please contact either Courtney Collum (email [email protected] / phone 216 849-4330) I. HIPAA AUTHORIZATION 27. Will PII/PHI be acquired for this study before obtaining authorization from individual subjects? Yes (HIPAA Authorization Waiver required from IRB) No 28. Will PII/PHI be used/released in the course of this research project? Yes (HIPAA Auth. Required) No

Additional Information

G. ASSURANCE SIGNATURES Signatures listed below are required for project review by the Research Service. This entire submission package will be returned to you if signatures are not provided. My signature certifies that all of the information provided in this application is true and accurate. As the designated investigator for the described research study, I will ensure that the protocol is carried out in full compliance with the policies and procedures of the LSCDVAMC, and other applicable regulatory bodies. Principal Investigator’s Signature: Date

I have reviewed the information contained in this application and concur with the proposed research activities. The time and resources necessary for the performance of these proposed studies are available and adequate. Principal Investigator’s Service Line Chief Signature: Date

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