UCSD Human Research Protections Program

Exempt Research Application — Exempt Categories 1, 2, and 3
Version Date 02/06/09
(Enter text in the white space areas below each numbered heading bar. Expand the size of table cells as needed – to multiple pages if needed.
See accompanying Instructions for explanation of headings and information to be provided)
1.  PROJECT TITLE
[Remove this wording and enter the Project title here. It should match the title entered on the face page. Note: for VA-funded grants, the HRPP application title must be the same as the grant title.]
2. PRINCIPAL INVESTIGATOR and CO-INVESTIGATORS
[Remove this wording and include Principal Investigator’s and co-investigator’s title and department. This is for identification purposes, to match the Research Plan to the project application face page. The complete list of investigators should be entered on the face page.]
3. FACILITIES
[Remove this wording and list all locations where the project will be done. If non-UCSD entities will be used, written proof that approval has been obtained from the appropriate site authority for the study to be done at that site must be provided.]
4. RESEARCH DESIGN AND METHODS
[Remove this wording and briefly describe the study purpose, the study subjects and study procedures associated with the proposed study including whether the study activities differ from standard practice, and if so, how. Also, should data collection instruments be used, please provide a copy of each instrument as well as ensure this item of the application clearly describes procedures associated with the instrument including who will administer and how, such as in person, by phone, mail, e-mail, web site; how often; the amount of time required to complete the instrument; etc. Additionally, this item should describe whether the subject will be audiotaped or videotaped and procedures associated with such taping as well as how tapes will be used, who will have access, final disposition of the tapes, confidentiality issues (and see item 7 below), etc.]
5. RECRUITMENT
[Remove this wording and briefly describe the recruitment procedures associated with the proposed study. Please provide a copy of any materials that will be used to recruit subjects.]
6. INFORMED CONSENT
[Remove this wording and for survey and interview research that is exempt, UCSD requires consent be obtained from subjects with or without collecting identifiers. Please ensure this item describes the procedures associated with obtaining consent. In addition, please provide a copy of the document that will be used to obtain consent such as a consent form, information sheet, survey cover letter, verbal consent script or letter to subjects. Please ensure the document to be used for consent includes the elements of an informed consent document. If a waiver of consent or waiver of documented consent is being requested, please ensure this item provides appropriate justification for such a waiver.]
7. SECURITY AND CONFIDENTIALTY PROCEDURES
[Remove this wording and briefly describe how confidentiality of the subject’s identity will be maintained. Please ensure this item includes whether/how subjects will be identified, procedures for protecting subject identity including security procedures, the final disposition of identifiers, who will have access to subject identifiers, etc.]
8. FUNDING SUPPORT AND CONFLICT OF INTEREST
[Remove this wording and specifically describe the funding support associated with this study and whether a conflict of interest exists with the PI or any key personnel. If such a conflict exists, this must be clearly described and a copy of the COI concurrence letter must be provided.]

Version date: 7/12/16