ࡱ>  #` <bjbjmm :<bbbbbbbv$$$$<Z%vF z&0****q,*/D0EEEEEEE$GhJrEb11,@q,11Ebb**JF6661Rb*b*E61E66?hbb?@*n& /JB-$1k?@`F0F{?tJ2tJ ?@tJb?@6111EE{6 111F1111vvvZvvvZvvvbbbbbb Brandeis University Committee for Protection of Human Subjects RESEARCH REVIEW FORM Project Title:  FORMTEXT       Principal Investigator:  FORMTEXT       Academic Title:  FORMTEXT       Department:  FORMTEXT       Work Phone:  FORMTEXT      Home Phone:  FORMTEXT       E-mail:  FORMTEXT       Mailing Address/Code (Campus or Home)  FORMTEXT       Co-Investigators/Faculty Advisor (students only): 1. FORMTEXT       2.  FORMTEXT       Projected Dates of Data Collection and Analysis: Begin Recruitment Date:  FORMTEXT       End Analysis Date: FORMTEXT       Review Type:  FORMDROPDOWN  Funding Status:  FORMDROPDOWN  Funding Source:  FORMTEXT       Brandeis #: 4- FORMTEXT       1. Existing Data: Will study involve use of existing data, documents, records, pathological specimens, or diagnostic specimens?  FORMDROPDOWN  If yes, include authorization to access the data if not publicly available. 2. Subjects to be Recruited (check all that apply)3. Data will include (check all variables included)a. Adults (18+ years) FORMCHECKBOX a. names of people FORMCHECKBOX h. income FORMCHECKBOX b. Children and Minors (under 18) FORMCHECKBOX b. addresses FORMCHECKBOX i. social security number FORMCHECKBOX c. Cognitively Impaired Persons FORMCHECKBOX c. phone numbers FORMCHECKBOX j. job title FORMCHECKBOX d. Prisoners FORMCHECKBOX d. age FORMCHECKBOX k. names of employers FORMCHECKBOX e. Elderly/Aged Persons FORMCHECKBOX e. gender FORMCHECKBOX l. types of employers FORMCHECKBOX f. Minorities FORMCHECKBOX f. ethnicity FORMCHECKBOX m. other unique information  FORMTEXT       FORMCHECKBOX g. Students (describe)  FORMTEXT       FORMCHECKBOX g. marital status FORMCHECKBOX  FORMCHECKBOX h. Others (describe)  FORMTEXT       FORMCHECKBOX i. Using existing data, no subjects will be recruited FORMCHECKBOX 4. Are codes used to link data to subject?  FORMDROPDOWN 5. Is Compensation Offered?  FORMDROPDOWN  6. Number of Subjects:  FORMTEXT       7. Method of Recruiting:  FORMTEXT       8. Will Subject be involved in: a. an Intervention or Manipulation?  FORMDROPDOWN  b. Deception?  FORMDROPDOWN  9. Potential Risk Exposure: Physical  FORMCHECKBOX  Psychological  FORMCHECKBOX  Economic  FORMCHECKBOX  Legal  FORMCHECKBOX  Social  FORMCHECKBOX  10. Instruments 11. Recorded by 12. Administered . . . 13. Findings used for . . . a. standardized tests  FORMCHECKBOX a. written notes  FORMCHECKBOX a. in person (group)  FORMCHECKBOX a. publication  FORMCHECKBOX b. questionnaire  FORMCHECKBOX b. audio tape FORMCHECKBOX b. in person (individual)  FORMCHECKBOX b. evaluation  FORMCHECKBOX c. interview  FORMCHECKBOX c. video tape/film  FORMCHECKBOX c. telephone  FORMCHECKBOX c. needs assessment  FORMCHECKBOX d. other (specify)  FORMTEXT       FORMCHECKBOX d. photograph  FORMCHECKBOX d. electronic mail  FORMCHECKBOX d. thesis/dissertation  FORMCHECKBOX e. standard mail FORMCHECKBOX e. other FORMCHECKBOX Submit a copy of the instrument(s).  Principal Investigator: Name FORMTEXT      Title FORMTEXT      SignatureDateStudent Initiated Research: 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 BCHPS 9/14/00 The Basic Elements of a Protocol The Principal Investigator is responsible for providing an original and six copies of the human subjects proposal to The Brandeis Committee for the Protection of Human Subjects (MS #116) for review and approval. RESEARCH REVIEW FORM PROTOCOL: Title of the study. Purpose of the study (including the expected benefits obtained by doing the study). Sponsor of the study. Principal Investigators professional qualifications to do the research (including a description of necessary support services and facilities). Results of previous related research. Subject characteristics. Subject inclusion/exclusion criteria, e.g. on the basis of ethnicity, gender, etc. Justification for use of any special/vulnerable subject populations (for example, the decisionally impaired, children) Study design (including as needed, a discussion of the appropriateness of research methods). 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Provisions for managing adverse reactions, such as physical and/or psychological harm to subjects or others. Plans for obtaining informed consent, including circumstances surrounding consent procedure (e.g. setting, subject autonomy concerns, special considerations for vulnerable and/or non-English-speaking populations). Procedures to be followed for documentation of informed consent, including any procedures for obtaining parental consent and child assent when subjects are minors, using witnesses or translators, and plans for document storage. Compensation to subjects for their participation. Provisions for protection of subject s privacy. Anticipated costs to subjects for their participation in the study. 3. SUPPORTING DOCUMENTS: The proposed informed consent document, following guidelines stipulated in 45 CFR 46 (see Informed Consent Guidelines and Checklist). Copies of surveys, questionnaires, interview guides, tests, or other instruments to be utilized in the research. Verification of Faculty Supervision (students only). Investigator's Assurance. GRANT PROPOSAL FOLLOW-UP DOCUMENTATION Revisions, amendments, and/or addenda to approved protocol and/or attachments. These must be approved by the Committee prior to implementation. Reports of unexpected adverse events. Progress reports, as frequently as required by Institutional Review Board, but no less than annually. Final report, indicating date of completion and plans for data storage and/or destruction. Before submitting protocol, please make sure that: The protocol is paginated and collated. All sections are complete to the detail requested. The consent and/or parental permission is written in the 2nd person, targeting a 6th-8th grade reading level, and includes all of the key elements with headings. Appropriate departmental signatures are documented. You ve kept a copy of the application materials for your records. Remember to: Submit original and six copies of all materials to be reviewed. Submit 2 copies of the grant application (see Item #4 above). 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