ࡱ> #` cbjbjmm :hMBBBBBBBVJDV" 2ko!!!!!!!!!!!!!$"#h%tE!BE!BB! BB!!hBB  '.^3c !0"C%[p%  %B \E!E! "VVV$ z$VVVzVVVBBBBBB Brandeis University Committee for Protection of Human Subjects RESEARCH REVIEW FORM - Existing Data Application APPLICATION FOR: USE OF EXISTING DATA, DOCUMENTS, RECORDS, PATHOLOGIC OR DIAGNOSTIC SPECIMENS Use this application for research that only involves the use of existing data, documents, records, pathological specimens, or diagnostic specimens. Criteria: The data must be publicly available or the investigator must record the information so that subjects cannot be identified, either directly or through identifiers linked to the subject. Do not use this application if subjects will be recruited for this study. Project Title:  FORMTEXT       Principal Investigator:  FORMTEXT       Academic Title:  FORMTEXT       Department:  FORMTEXT       Campus Mailing Address/Code:  FORMTEXT       Work Phone:  FORMTEXT       Home Phone:  FORMTEXT       E-mail Address:  FORMTEXT       Home Address  FORMTEXT       City/State/Zip:  FORMTEXT       Co-Investigators: List the name and campus address of additional investigators. If you are a student, list the faculty responsible for supervision and oversight of this research. a. FORMTEXT       b.  FORMTEXT       Funding Status: Funded Pending  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Funding Source  FORMTEXT       Brandeis #: 4- FORMTEXT       1. Data Source: Is the existing data, document, record or specimen publicly available? Yes  FORMCHECKBOX  No  FORMCHECKBOX  1a. If not, attach a letter authorizing your access to the data, document, record or specimen. 2. Subject Identifiers: 2a. Will subject identifying information be recorded? Yes  FORMCHECKBOX  No  FORMCHECKBOX  2b. Will codes be used to link data to the subjects name? Yes  FORMCHECKBOX  No  FORMCHECKBOX  3. Projected Dates of Analysis: Begin Date  FORMTEXT       End Date  FORMTEXT       Findings Used For: Publication  FORMCHECKBOX ; Presentation  FORMCHECKBOX  ; Thesis  FORMCHECKBOX  ; Dissertation  FORMCHECKBOX  ; Other  FORMTEXT       Principal Investigator: Name FORMTEXT      Title FORMTEXT      SignatureDateStudent Initiated Research:. The signature of faculty supervising the research or the person designated by the department to conduct a preliminary review of the proposed research is required. This signature verifies the attached protocol meets with department approval and is in compliance with procedures/regulations designed to protect human subjects Name FORMTEXT      Title FORMTEXT      SignatureDate BCPHS REVIEW: Exempt as per 45CFR46.101(b)(4) Yes  FORMCHECKBOX  No  FORMCHECKBOX  BCPHS Authorization: _____________________________________________________Date: _________ Protocol Outline for use of Existing Data Provide a written description of your proposed research using the following outline if you are using existing data, documents, records, pathologic or diagnostic specimens and no subjects will be recruited for additional data collection. Focus the content of this protocol on your research and use of the existing data. Refrain from describing the original research from which the data was obtained. 1 - Study Abstract Provide a brief summary of your research design. Include the purpose, data source, analyses planned, potential benefits, potential risks, and risk management procedures. 2 - Statement of Purpose and Background a. Provide brief references to the literature that provide background in support of the proposed research. b. Specify aims of the research: Hypotheses, questions to answer, data to be analyzed. 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Identify the source of the data. Include a letter indicating permission for your access to the data if not available to the public. b. If known, briefly describe how data were initially obtained. c. Describe the variables to be analyzed. 4- Methods Summarize the methods used in the proposed analyses of data. 5- Potential Benefits a. Benefits to the population from which the subject is drawn. b. Benefits to science, society, and humanity in general. Note: Do not include benefits to the subject since you will not recruit nor interact with the subjects originally involved in the data collection. 6- Potential Risks Describe any physical, psychological, economic, legal or social risks that may occur as a result of this research. Note: The primary risk when using existing data is violation of confidentiality. Since the data are to be recorded without any identifiers, this risk is minimized because the data will be anonymous. 7- Precautions taken to minimize risk. a. Describe how you will record the data. b. If data are coded, describe the coding scheme. To be eligible for an exempt review, the data must be publicly available or the investigator must record the information so that subjects cannot be identified, either directly or through identifiers linked to the subject. c. State how the data will be stored. d. Identify who will have access to the data. 8- Academic background and experience of investigator(s). Provide a brief description of your academic status, training, and research experience. If you are a student, include reference to the faculty supervising your research. 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