ࡱ> $&!"#Y RbjbjPP 4 2i2i>!  8<,r:&&&&4'4'4'tvvvvvv$34'4'4'4'4'&&4{5554':&&t54't55~8&un'@܅X`04{'{{p4'4'54'4'4'4'4'.4'4'4'4'4'4'4'{4'4'4'4'4'4'4'4'4' X L: APPENDIX A APPLICATION FOR PERMISSION TO CONDUCT RESEARCH AT ECMCC Project Title FORMTEXT       FORMCHECKBOX Outpatient Study  FORMCHECKBOX Inpatient Study  FORMCHECKBOX Chart Review  FORMCHECKBOX Survey  FORMCHECKBOX Other:____________________________Principal InvestigatorName:  FORMTEXT      Department:  FORMTEXT      Address:  FORMTEXT      City:  FORMTEXT      State:  FORMTEXT      Zip:  FORMTEXT      Email:  FORMTEXT      Phone:  FORMTEXT       Cell:  FORMTEXT      Fax:  FORMTEXT      Affiliation:  FORMCHECKBOX ECMC Employee  FORMCHECKBOX UB Employee  FORMCHECKBOX Volunteer Faculty  FORMCHECKBOX Resident  FORMCHECKBOX Other:________________ Administrative Contact (if different from PI)Check where documents and notifications should be sent:  FORMCHECKBOX PI  FORMCHECKBOX Administrative Contact  FORMCHECKBOX BothName:  FORMTEXT      Department:  FORMTEXT      Address:  FORMTEXT      City:  FORMTEXT      State:  FORMTEXT      Zip:  FORMTEXT      Email:  FORMTEXT      Phone:  FORMTEXT      Cell:  FORMTEXT      Fax:  FORMTEXT      (Attach copy of protocol) Project InformationStart Date:  FORMTEXT      Completion Date:  FORMTEXT       (You must notify ECMCC in writing at completion of the study)Is this project sponsored?  FORMCHECKBOX Yes  FORMCHECKBOX NoIf yes, list sponsor:  FORMTEXT      If yes, what foundation will administer grant funds:  FORMCHECKBOX  Research Foundation (RF)  FORMCHECKBOX  UB Foundation Services, Inc.  FORMCHECKBOX  CTO Contact:______________________________ E-mail: _________________  FORMCHECKBOX  Other:Application may be submitted prior to/at the same time as IRB submission. Indicate IRB Review Status  FORMCHECKBOX Approved (Attach IRB Letter). IRB Study #:  FORMTEXT        FORMCHECKBOX Pending; submitted to  FORMTEXT [IRB name] on  FORMTEXT [Date]  FORMCHECKBOX Will submit to  FORMTEXT [IRB name] on  FORMTEXT [Date]How will potential research subjects be identified? Who will approach the subjects regarding participation? Confirm that you have reviewed ECMCC Policy for Recruiting Patients for Research  FORMCHECKBOX Yes  FORMCHECKBOX No  FORMTEXT      Will the research study require ECMCC to disclose patients protected health information to the researcher?  FORMCHECKBOX Yes  FORMCHECKBOX No If yes, please list the individuals who will do the relevant chart review, create a limited dataset or de-identify data. These individuals must be listed as members of the research team below.  FORMTEXT      Provide a copy of the data collection form (REDCap or other) that will be used for the study.  FORMCHECKBOX Attached  FORMCHECKBOX N/AWhat form of authorization has been obtained for release of protected health information? (If being used, attach sample of Signed Authorization from each patient or the approved copy of the IRB Waiver of Authorization)List all research personnel who have not yet been credentialed as Research Associates at ECMCC: Research PersonnelPlease identify all members of the research team who will be conducting research activities at ECMCC in connection with this project: (attach additional sheets as necessary)NameRoleEmployerPatient ContactNYS license#Certificate of Insurance1. FORMTEXT       FORMTEXT       FORMTEXT       FORMCHECKBOX Yes/ FORMCHECKBOX No FORMTEXT       FORMCHECKBOX Yes/ FORMCHECKBOX No2. FORMTEXT       FORMTEXT       FORMTEXT       FORMCHECKBOX Yes/ FORMCHECKBOX No FORMTEXT       FORMCHECKBOX Yes/ FORMCHECKBOX No3. FORMTEXT       FORMTEXT       FORMTEXT       FORMCHECKBOX Yes/ FORMCHECKBOX No FORMTEXT       FORMCHECKBOX Yes/ FORMCHECKBOX No4. FORMTEXT       FORMTEXT       FORMTEXT       FORMCHECKBOX Yes/ FORMCHECKBOX No FORMTEXT       FORMCHECKBOX Yes/ FORMCHECKBOX NoMedication UseWill medication be dispensed as part of this project?  FORMCHECKBOX Yes  FORMCHECKBOX No1. Who will provide the medication?  FORMTEXT      2. Where will the medication be stored?  FORMTEXT      3. Who will dispense/administer medication to study subject?  FORMTEXT      4. 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FORMCHECKBOX Yes  FORMCHECKBOX No5. Drug information attached?  FORMCHECKBOX Yes  FORMCHECKBOX N/A6. How will the pharmacy or clinic be compensated for the medication storage and distribution?Information Technology ServicesWill any of the following Information Technology services be required?1. New Internet Connection  FORMCHECKBOX Yes  FORMCHECKBOX No2. Provision of access to ECMCC Health Information System on a computer that does not currently have this capability  FORMCHECKBOX Yes  FORMCHECKBOX No3. A new computer connection to the ECMCC network  FORMCHECKBOX Yes  FORMCHECKBOX No4. Custom Software required to support this project  FORMCHECKBOX Yes  FORMCHECKBOX No If yes, please identify:  FORMTEXT      5. Specific download or transfer of data from the ECMCC Health Information System  FORMCHECKBOX Yes  FORMCHECKBOX No6. For sponsored studies how will study personnel access the EMR?  FORMCHECKBOX Over the shoulder  FORMCHECKBOX IT account  FORMCHECKBOX  Credentialing requested  FORMCHECKBOX  N/A7. Where and how will all data and records be stored?Use of Hospital ResourcesWill hospital personnel be utilized?  FORMCHECKBOX Yes  FORMCHECKBOX No If yes, what specifically will they be doing?  FORMTEXT      Will hospital services be required above the standard of care?  FORMCHECKBOX Yes  FORMCHECKBOX No If yes, please answer for each department: (Appendix B must be filled out and signed for each department that will/might be utilized.) Laboratory:  FORMCHECKBOX Yes  FORMCHECKBOX No  FORMTEXT       Lab Manual attached?  FORMCHECKBOX Yes  FORMCHECKBOX N/A Radiology:  FORMCHECKBOX Yes  FORMCHECKBOX No Pharmacy:  FORMCHECKBOX Yes  FORMCHECKBOX No Pharmacy Manual attached?  FORMCHECKBOX Yes  FORMCHECKBOX N/A Nursing:  FORMCHECKBOX Yes  FORMCHECKBOX No EKG:  FORMCHECKBOX Yes  FORMCHECKBOX No Other:  FORMCHECKBOX Yes  FORMCHECKBOX No Will the research be conducted at ECMCC?  FORMCHECKBOX Yes  FORMCHECKBOX No If yes, what space will be used: If no, specify research site: ___________________________________________________________  What reimbursement or compensation will ECMCC receive for this project? NOTE: PI may be asked to present a brief presentation of the proposed project at the ECMC bi-monthly Research Committee Meeting to facilitate evaluation of the proposal.  I agree to notify the Office of Clinical Research Coordination in writing of the conclusion of this project with the last service date, and to provide the Office of Clinical Research Coordination with a copy of each report of the study findings, white paper, article or any other such material about the project. I also agree to acknowledge the contribution to and the participation of ECMCC in this project in any such papers or publications. 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