HARVARD UNIVERSITY COMMITTEE ON THE USE OF HUMAN SUBJECTS Request for Approval of Human Subjects Research* DIRECTIONS: 1. Download this form into Microsoft Word. Place cursor on the gray boxes and type. Box size will expand as you type. PLEASE DO NOT SEND YOUR APPLICATION IN PDF FORMAT. 2. Check Quick Tips (http://cuhs.harvard.edu/documents/Quick_Tips.doc) for problems most commonly found in CUHS applications. 3. FOR STUDENT, POSTDOCTORAL, and STAFF applicants: 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. 4. 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 180 Longwood Avenue, Suite 111 Boston, MA 02115 Phone: (617) 432-3192 Fax: (617) 432-5175 Email: orsp@hms.harvard.edu http://www.hms.harvard.edu/orsp/human/human.html Office of Human Research Administration Harvard School of Public Health 1552 Tremont Street Boston, MA 02120 Phone: (617) 384-5480 Fax: (617) 384-5484 Email: hsc@hsph.harvard.edu http://www.hsph.harvard.edu/research/human-research- administration/ **Faculty sponsor must be someone who is PI eligible in your school. ---------------------------------------------------------------------------------------- HARVARD UNIVERSITY COMMITTEE ON THE USE OF HUMAN SUBJECTS Request for Approval of Human Subjects Research INVESTIGATOR: (name, campus address) Additional Contact Person: (if any) TELEPHONE: E-MAIL: PROJECT TITLE: ANTICIPATED FUNDING SOURCE: (for sponsored funding, add name of grant recipient): FACULTY SPONSOR'S NAME (for non-faculty applicants): Supervising lecturer, instructor, or graduate student (if applicable): SPONSOR'S E-MAIL ADDRESS: DURATION OF ENTIRE PROJECT: from to . APPROVAL REQUESTED FOR (maximum one year; must be renewed annually): from to . 1. Please give a brief summary of the purpose of the research in non-technical language. Be sure to include a statement of the research problem, its importance, and how your project will address it. Cite two or three references directly relevant to the proposed inquiry. Briefly explain how your methodology will help to answer the research question(s). 2. Give details of procedures that relate to subjects' participation. (a) How are subjects recruited? What inducement is offered? If participants are paid, what amount and when are they paid? Is there partial pay for partial completion? (Append copy of letter or advertisement or poster, if any.) (b) Salient characteristics of subjects--number who will participate, age range, sex, institutional affiliation, other special inclusion and exclusion criteria (if children, prisoners or other vulnerable subjects are recruited, explain why their inclusion is necessary): (c) Describe how permission has been obtained from cooperating institution(s)--school, hospital, corporation, prison, or other relevant organization. (Append letters.) Is the approval of other research compliance committees or another Institutional Review Board required? (d) What do subjects do, or what is done to them, or what information is gathered? (Append copies of instructions, tests, questionnaires, or interview guides to be used.) How many times will observations, tests, etc., be conducted? How long will their participation take? Are interviews to be tape recorded or videotaped? 3. Describe your research experience and your research ethics training. (a) Cite your experience with this kind of research and/or this population. List any assistants who will be working with you and cite their experience also. (b) Where have you received research ethics training? (check boxes) (Note for NIH funded projects, only (i), (ii), or (iii) satisfy training requirements.) __ (i) HETHR __ (ii) CITI __ (iii) NIH (http://phrp.nihtraining.com) __ (iv) CUHS-led training course __ (v) Research methods course (specify) __ (vi) Other (specify) __ (vii) CUHS website PowerPoint presentation for undergraduates 4. How do you inform subjects about your research and then obtain their consent? (For an explanation of the elements of informed consent and documenting it, please see Appendix A, Intelligent Scholar's Guide http://cuhs.harvard.edu/ISG.html or http://cuhs.harvard.edu/#Samples) (a) Do subjects sign a written consent form and receive a copy for their records? If not, do they receive an information sheet that provides what they need to know before deciding to participate? (In addition to answering parts a. - e., append a copy of consent form, information sheet, or script for oral explanation to subject.) (b) Where (In a lab? Online?) , when (immediately before participation, e.g.), and by whom (anyone other than investigator?) is consent obtained? (c) Are subjects children, mentally infirm, or otherwise not legally competent to consent? If so, how is their assent obtained, and who consents on their behalf? (d) If subjects are vulnerable due, e.g., to legal status, economic status, illiteracy, or other circumstance, describe steps to minimize the risk of coercion or undue influence. Include in your answer how you ensure subjects understand that participation is voluntary. (e) Is there any language barrier that could affect the consent process (your explanation of the research and the subject's agreement to participate)? If so, please provide details, such as plans for use of translators or translating documents. 5. Give details of possible risks of harm to participants. (a) What are the possible risks-physical, psychological, legal, social? (b) If there are any risks, why are they necessary? Is there any other way to conduct the research that would reduce the risk to subjects, and, if so, why have you not chosen that alternative? (c) What steps will be taken to minimize the risk? (If the research may involve greater than minimal risk to participants, describe provisions for monitoring data to ensure participant safety.) (d) Should a subject be injured or otherwise harmed, or experience significant distress, what are your plans for addressing the problem? (e.g., emergency care training for lab staff if physical harm is a risk; referral for evaluation or treatment if there are significant psychological risks) If risks are anticipated to be no more than minimal, please state so here and in the consent form, if used. 6. Are subjects deliberately deceived in any way? If so, what is the nature of the deception? Is it likely to be significant to subjects? Is there any other way to conduct the research that would not involve deception, and, if so, why have you not chosen that alternative? What explanation for the deception do you give to subjects following their participation? 7. How will participation in this research benefit subjects? If subjects will be "debriefed" or receive information about the research project following its conclusion, how do you ensure the educational value of the process? (Append copies of any debriefing or educational materials.) 8. How are confidentiality and/or anonymity assured? For online studies, will IP addresses or other potentially identifying information be collected? What host site will be used (i.e. SurveyMonkey, iCommons, etc.)? Will identifiers be removed from the data? If so, at what point, and if not, please explain why identifiers must be retained. 9. How is the privacy of subjects protected? (e.g., are questions tailored to the research question so subjects are not asked to provide unnecessary information?) 10. Will research data (written or otherwise recorded) be destroyed at the end of the study? If not, where and in what format and for how long will they be stored? To what uses-- research, demonstration, public performance, archiving--might they be put in future? How will subjects' permission for further use of their data be obtained? If there is a key code connecting subjects' data to their identity, when will the link be destroyed? (Include this information in the consent form, information sheet, or consent script.) 11. Do you and/or any other investigators associated with the project described in this application have, or appear to have, any actual or potential conflict of interest with respect to this research? (See http://cuhs.harvard.edu/conflict for what may constitute a conflict of interest that must be disclosed.) ___ Yes ___ No If yes, a CUHS committee member will contact you to determine the extent of any conflict and assist in the development of a management plan. By submitting this application, I certify that the study has been adequately designed to protect human 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: _________________________________________ ATTACHMENTS: 0 Recruitment letter, poster, ad 0 Written consent form, information sheet, or script 0 Subject instructions 0 Tests or questionnaires 0 Interview guides 0 Debriefing materials 0 Other institutional approval 0 Other (c) President and Fellows of Harvard College Rev. 10/22/10