HARVARD UNIVERSITY COMMITTEE ON THE USE OF HUMAN SUBJECTS Request for Renewal of Approval* (rev. Oct. 01, 2009) DIRECTIONS: 1. Download this form into Microsoft Word. Place cursor on the gray boxes and type. Box size will expand as you type. 2. FOR STUDENTS: You must have your faculty sponsor sign a paper copy of the application or email a note that s/he has reviewed the completed application and is satisfied with the adequacy of the proposed research design and the measures proposed for the protection of human subjects. 3. Return the completed application as an attachment to: cuhs@fas.harvard.edu or mail to: Committee on the Use of Human Subjects FAS Research Administration Services 1414 Massachusetts Avenue, Room 241 Cambridge, Massachusetts 02138 Telephone: (617) 496-CUHS (2847); Fax: (617) 496-7400. Any of the required attachments not available electronically must be sent or delivered to the Committee Office. Thank you! * Note: There are three IRBs at Harvard University. If in doubt as to the proper Committee to review your project, please ask. The Committee on the Use of Human Subjects reviews projects for the University area (The Faculty of Arts and Sciences, including Harvard College, GSAS, and the Division of Continuing Education; Radcliffe Institute; and all the non-medical professional schools). The other two IRB offices are: Office for Research Subject Protection Harvard Medical School Gordon Hall, 25 Shattuck Street Boston, MA 02115 Phone: (617) 432-3192 Fax: (617) 432-3169 Email: orsp@hms.harvard.edu Human Subjects Committee Harvard School of Public Health 1552 Tremont Street Boston, MA 02120 Phone: (617) 384-5480 Fax: (617) 384-5484 Email: hsc@hsph.harvard.edu HARVARD UNIVERSITY COMMITTEE ON THE USE OF HUMAN SUBJECTS Request for Renewal of Approval FROM: (name, campus address) ????? TELEPHONE: ????? EMAIL: ????? PROJECT TITLE: ????? CUHS application number (if known)-- #F - ????? FACULTY SPONSOR (for student/staff applicants): ????? Supervising lecturer, instructor, or graduate student: (if applicable, in addition to the above) ????? SPONSOR'S E-MAIL ADDRESS: ????? RENEWAL REQUESTED FOR: (maximum one year) from ????? to ?????. FUNDING SOURCE: (include grant # if known) ????? 1. Please summarize--briefly--your research procedures. What do subjects do, or what is done to them? What information is gathered? (Use additional pages if necessary.) ????? 2. How many subjects have completed participation in the study? ????? How many are currently participating? ????? How many have withdrawn? ????? Provide the reason for withdrawal. ????? How many have yet to be recruited? ????? 3. Have procedures described in your original human subjects application changed? If so, how? (Append copies of any new instructions, tests or questionnaires. List any new assistants or other investigators and their qualifications.) ????? 4. Since the last CUHS review, have there been any interim findings? If so, please attach a summary of the interim findings. ????? 5. Describe any new, unanticipated risks that arose during the course of the research. What precautions have you taken to minimize the risk to subjects? ????? 6. Describe any harm (physical, psychological, social) experienced by subjects and any complaints received. What happened? How was the problem resolved? What measures have you taken to guard against similar occurrences? ????? 7. since the last CUHS review, have there been any publications in the literature relevant to this research that contain findings that could affect subjects’ willingness to participate? If so, please attach copies and a summary of the findings. ????? 8. since the last CUHS review, has there been any change in your assessment of the risk-potential benefit profile of the study, based on results to date? If so, please explain. ????? 9. Please attach to this application the current consent form, information sheet, or script for informing subjects about the study. ????? 10. If this study is conducted at multiple sites, please attach any reports or communications from sites that contain information about subjects’ experiences, unanticipated problems, or potential risk to subjects. ????? APPLICANT'S SIGNATURE: _____________________________________________ DATE: ????? (For non-faculty applicants) I have reviewed this completed application and I am satisfied with the adequacy of the proposed research design and the measures proposed for the protection of human subjects. FACULTY SPONSOR'S SIGNATURE: _____________________________________ © President and Fellows of Harvard College April 29, 2008 1