ࡱ> 3 ,bjbj jbb(l:LLL88:t$"$$$%?)+$t +%%++6$$666+h$$6+6n6<>,$ 0'ތ:Lg1>x0_46666."Missouri Department of Health and Senior Services REQUEST FOR REVIEW OF RESEARCH PROTOCOL IRB FORM 1 A. Request for: 1.  FORMCHECKBOX  IRB Review 2.  FORMCHECKBOX  Expedited Review 3.  FORMCHECKBOX Exemption from Review B. Investigator information: 1. Title of Study:  FORMTEXT       2. Expected Begin Date:  FORMTEXT   / FORMTEXT   / FORMTEXT      3. Expected End Date:  FORMTEXT   / FORMTEXT   / FORMTEXT      4. Principal Investigator:  FORMTEXT       5. Principal Investigator s Position:  FORMTEXT       6. Principal Investigator s Institution:  FORMTEXT       7. Federalwide Assurance #:  FORMTEXT       8. Business Address 1:  FORMTEXT       9. Business Address 2:  FORMTEXT       10. City, State Zip:  FORMTEXT       11. Business Telephone: ( FORMTEXT    )  FORMTEXT    - FORMTEXT      12. Business Fax: ( FORMTEXT    )  FORMTEXT    - FORMTEXT      13. Principal Investigator E-Mail:  FORMTEXT       14. Funding Source:  FORMTEXT       15. DHSS Division, Office, Bureau, or Program Involved with Study: FORMTEXT        Your signature below indicates that you accept responsibility for conducting this research in accordance with the guidelines set forth in the Belmont Report. PRINCIPAL INVESTIGATOR DHSS CO-INVESTIGATOR ________________________________________________________________________SignatureSignature  FORMTEXT        FORMTEXT      Typed NameTyped Name  FORMTEXT   / FORMTEXT   / FORMTEXT       FORMTEXT   / FORMTEXT   / FORMTEXT     DateDate B. Investigator information, continued List the name, title and position of other investigators. Include all persons who will work on this study and/or who will have access to data. Name Title Role in Study 1.  FORMTEXT       FORMTEXT       FORMTEXT      2.  FORMTEXT       FORMTEXT       FORMTEXT      3.  FORMTEXT       FORMTEXT       FORMTEXT      4.  FORMTEXT       FORMTEXT       FORMTEXT      5.  FORMTEXT       FORMTEXT       FORMTEXT       C. Sites of investigation List expected sites of investigation: FWA #: 1.  FORMTEXT       FORMTEXT      2.  FORMTEXT       FORMTEXT      3.  FORMTEXT       FORMTEXT      4.  FORMTEXT       FORMTEXT      5.  FORMTEXT       FORMTEXT       Attach copies of memorandums of agreement/understanding or other documentation that provides evidence that all collaboration institutions and investigators have agreed to collaborate on the project. D. Other IRB Information 1. Has this proposed study been reviewed by an Institutional Review Board (IRB)?  FORMCHECKBOX  YES (  FORMCHECKBOX  IN PROCESS ( Date review requested (mm/dd/yy): FORMTEXT   / FORMTEXT   / FORMTEXT     ,  FORMCHECKBOX  NO, go to E If YES, or IN PROCESS, in the box below provide the name, address and the federal Department of Health and Human Services, Office for Human Research Protection registration number of the IRB(s) involved. List the lead IRB first, if more than one IRB is reviewing the study. IRB Name and Institution: IRB registration # 1.  FORMTEXT       FORMTEXT      2.  FORMTEXT       FORMTEXT      3.  FORMTEXT       FORMTEXT      4.  FORMTEXT       FORMTEXT      5.  FORMTEXT       FORMTEXT       2. Was the study approved by the above named IRB?  FORMCHECKBOX  YES (  FORMCHECKBOX  NO, go to E If YES, attach a copy of the letter that includes the date of approval from the IRB(s), including any modifications, limitations or conditions required by the IRB(s). E. Research methods Check all that apply:  FORMCHECKBOX  Arterial and/or venipuncture (blood drawing)  FORMCHECKBOX  Existing pathologic or diagnostic  FORMCHECKBOX  Data banks, archives, medical records, specimens birth or death certificates  FORMCHECKBOX  Normal educational practices  FORMCHECKBOX  Direct observation  FORMCHECKBOX  Secondary data analysis  FORMCHECKBOX  DNA sampling  FORMCHECKBOX  Survey or interview procedure  FORMCHECKBOX  Educational tests  FORMCHECKBOX  Other, specify:  FORMTEXT       F. Subject information Check all that apply:  FORMCHECKBOX  Employees  FORMCHECKBOX  Students  FORMCHECKBOX  Mentally or physically impaired persons  FORMCHECKBOX  Subjects less than 18 years old  FORMCHECKBOX  Normal, healthy subjects  FORMCHECKBOX  Subjects whose main language is not English  FORMCHECKBOX  Patients or clients  FORMCHECKBOX  Terminally ill persons  FORMCHECKBOX  Pregnant women  FORMCHECKBOX  Prisoners, parolees, incarcerated persons  FORMCHECKBOX  Other, specify:  FORMTEXT       Will researcher(s) have contact with study participants?  FORMCHECKBOX  YES (  FORMCHECKBOX  NO, go to G If yes, check all that apply:  FORMCHECKBOX  Anonymity will be maintained (i.e., no identifiers)  FORMCHECKBOX  Confidentiality will be maintained  FORMCHECKBOX  Recruitment incentives are used  FORMCHECKBOX  Subject payment offered G. Data and Record Security Describe the measures that will be taken to secure data.  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