ࡱ> #` _bjbjmm 4rx~~~~:T( n,# '''''''$)hH,t'  '(!!! '! '!!V}%@A& ,~ j% &<(0(%x,/!,A&,A&T! ''! ( d :D: Brandeis University Committee for Protection of Human Subjects REPORT OF PROGRESS AND REVIEW REQUEST Research that has received BCPHS approval must be reviewed at least annually or more often as determined by the BCPHS in its initial review of the project. A continuation of approval is needed if you 1) are continuing to recruit subjects and/or plan to continue data collection or 2) are analyzing data collected on this project. A final report is necessary if you have completed all procedures that involve human subjects (e.g., recruitment, data collection and analysis). I. Investigator Information: Principal Investigator:  FORMTEXT       Project title:  FORMTEXT       Department:  FORMTEXT       Work phone: ( FORMTEXT      )  FORMTEXT       Home phone: ( FORMTEXT      ) Email Address:  FORMTEXT       Present Brandeis Affiliation: Faculty  FORMCHECKBOX  Student  FORMCHECKBOX  Staff  FORMCHECKBOX  Other (describe):  FORMTEXT       Faculty Sponsor (for non-faculty projects):  FORMTEXT       Mailing Address/Code (Home or Campus):  FORMTEXT       Is this Project Funded? No  FORMCHECKBOX  Yes  FORMCHECKBOX  Brandeis #4- FORMTEXT       BCPHS Protocol #:  FORMTEXT       II. Type of Review Requested: a. FORMCHECKBOX  Continuing Project - Subjects are being recruited or will be recruited. b. FORMCHECKBOX  Continuing Project - Subject recruitment is complete. Please check one of the following:  FORMCHECKBOX  Data collection will continue.  FORMCHECKBOX  Data collection is complete. Data are being analyzed. c. FORMCHECKBOX  Final Report - All activities involving human subjects are complete as of  FORMTEXT      . III. Update of Project Activity: Since the last review period, a. Have there been any complications, reactions, or adverse effects on human subjects?  FORMCHECKBOX  Yes  FORMCHECKBOX  No b. Have there been any changes in the literature that would affect your study?  FORMCHECKBOX  Yes  FORMCHECKBOX  No c. Have there been any modifications to your study protocol? Yes  FORMCHECKBOX  No  FORMCHECKBOX  Note: If you have answered Yes to any of the preceding questions, attach a brief report to summarize the changes or events. IV. Status of Subject Recruitment: a. How many subjects were originally planned for inclusion in this study?  FORMTEXT       b. How many subjects have been studied?  FORMTEXT       c. How many subjects do you still plan to recruit?  FORMTEXT       d. How many subjects have refused to participate?  FORMTEXT       V. Proposed Modifications:  FORMCHECKBOX  Yes  FORMCHECKBOX  No Are you requesting any modifications to your study protocol at this time? A modification is any change to the previously approved protocol (e.g., subject selection, recruitment procedures, survey/interview revisions, and personnel involved, etc.). If Yes, submit a completed Request for Modification form and supporting documents for approval by the BCPHS. VI. Principal Investigator: (check one of the two choices, sign and date)  FORMCHECKBOX  Final Report: I certify that this progress report is accurate and that the research activities involving human subjects were conducted as stated in the CPHS approved protocol. This research project is now complete.  FORMCHECKBOX  Continuing Project: I certify that this progress report is accurate. I will submit to BCPHS for approval any proposed modifications in the research activities prior to implementation. I will abide by the Federal and University policies related to research involving human subjects. Principal Investigator: Name FORMTEXT      Title FORMTEXT      SignatureDate Student Initiated Research: The signature of the faculty advisor is required in research where the student is identified as the principal investigator. 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The faculty advisor is expected to monitor the research activity to insure that the protocol approved by Brandeis University s BCPHS is followed. Your signature below verifies understanding of these responsibilities. Faculty Advisor: Name FORMTEXT      Title FORMTEXT      SignatureDate VII. Submission Instructions: a.Complete each section of this reportb.Submit original plus 6 copies of the following: this form, the current approved protocol, a brief summary of protocol changes/events (see Section III of this form), and informed consent document(s) if this protocol received initial review by the full committee and you are continuing to recruit or test subjectsc.Submit original plus 1 copy of the following: this form, the current approved protocol, a brief summary of protocol changes/events (see Section III of this form), and informed consent document(s) if this protocol was expedited during initial review and you are continuing to recruit or test subjectsd.Submit the original plus 1 copy of the following: this form and the current approved protocol if research activity on this protocol will be limited to data analysis or this report is submitted as a final report.e.Mail or deliver this application and supporting documents to: Brandeis Committee for Protection of Human Subjects Brandeis University, MS #116 PO Box 549110 Waltham, MA 02454-9110 For questions, please call 781-736-2121 or e-mail mclark@brandeis.edu or access the BCPHS web site at http://www.brandeis.edu/osp/. BCPHS Use Only. 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