ࡱ> ,.)*+%`  bjbjNN :,, |A|A|A8AHCD7gD@I@I@I@IK N4?O2f4f4f4f4f4f4f$hh%knXfOJ@KOOXf@I@IfSSSO|@I@I2fSO2fSS _|`@ID p՝|AWPl_6ag07g_kQk$`k`SOOOXfXfSSXOOO7gOOOOd '' Brandeis University Brandeis 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-Investigator:  FORMTEXT       Faculty Advisor (students only):  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: FORMCHECKBOX g. Students (describe)  FORMTEXT       FORMCHECKBOX g. marital status FORMCHECKBOX   FORMTEXT      h. Others (describe)  FORMTEXT       FORMCHECKBOX   FORMTEXT      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. online survey FORMCHECKBOX e. class assignment only FORMCHECKBOX *Provide copy of instrument(s).e. standard mail FORMCHECKBOX e. other FORMCHECKBOX   Principal Investigator: Name FORMTEXT      Title FORMTEXT      SignatureDateFaculty Sponsor for Student-Initiated Research: The signature blow 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 Brandeis Committee for Protection of Human Subjects Application Guidelines The Principal Investigator is responsible for providing the following: One signed, hard-copy original of the application (delivered to the Office of Research Administration, Bernstein-Marcus Rm. 121, or mailed to Brandeis Committee for Protection of Human Subjects, MS #116), and One full copy of the application via e-mail (to  HYPERLINK "mailto:irb@brandeis.edu" irb@brandeis.edu). Please note that a submission will not be deemed ready for review until both the e-mailed and hard-copy materials have been received by the IRBAdministrator. Applications must include the following: 1. FORMS: Research Review Form Note: There is a separate Research Review Form for research involving existing data. Principal Investigators Assurance  HYPERLINK "facsponsor.dot" Faculty Sponsor Assurance (for student-initiated research only). Statement of Protected Health Information Use (for projects involving health/mental health information). 2. PROTOCOL: Title of the study. Purpose of the study (including the expected benefits obtained by doing the study). Sponsor of the study (for externally-funded projects). Principal Investigators professional qualifications to do the research (including 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) Recruitment procedures and materials (e.g., brochures, flyers, etc.) Study design (including as needed, a discussion of the appropriateness of research methods). Description of procedures to be performed. Anticipated risks and benefits to participation in study. 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, and using witnesses or translators. Plans for document storage (e.g., signed consent forms, field notes, audiotapes, surveys, etc.). Provisions for protection of subjects privacy. 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for their participation in the study. Brandeis Committee for Protection of Human Subjects Application Guidelines Page 2 3. SUPPORTING DOCUMENTS:  HYPERLINK "C:\\Documents and Settings\\mclark\\My Documents\\FILLABLE FORMS\\piassurance.dot" Principal Investigators Assurance  HYPERLINK "C:\\Documents and Settings\\mclark\\My Documents\\FILLABLE FORMS\\facsponsor.dot" Faculty Sponsor Assurance (student-initiated research only). Statement of Protected Health Information Use (for projects involving health/mental health information). The proposed informed consent documents (including parental permission forms and child assent scripts where applicable), following guidelines stipulated in 45 CFR 46 (see  HYPERLINK "http://www.brandeis.edu/ora/consent.html" Informed Consent Guidelines and Checklist). Recruitment materials (flyers, brochures, etc.) Copies of surveys, questionnaires, interview guides, tests, or other instruments to be utilized in the research. 4. GRANT PROPOSAL (for externally-funded projects only) 5. FOLLOW-UP DOCUMENTATION Modification Request Forms for any modifications, amendments, or addenda to approved protocol and/or attachments. These must be approved by the Committee prior to implementation. Reports of unexpected adverse events. Continuing Review Requests/Progress Reports, as frequently as required by Committee, but no less than annually. Important: 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. Spelling is correct and grammar is accurate. 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 required informed consent elements with headings. Appropriate departmental signatures are documented. Youve kept a copy of the application materials for your records.     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