Policy, Process and Procedures for Obtaining Approval to Conduct Research at the University of San Francisco that Involves Human Subjects

Student, faculty, or staff researchers affiliated with USF who wish to conduct research at the University of San Francisco that involves human subjects are required to gain approval before they can proceed with their research. The approval process is outlined below and must be fully completed by all researchers except those who are affiliated with another educational institution who have received approval by their institution's review board for the protection of human subjects. All outside researchers are required to obtain permission directly from the Provost before beginning data collection.

Please note that outside researchers do not need USF IRB approval, only approval from their home institution's IRB and the USF Provost, and the *FERPA coordinator (if applicable).

Most questions regarding the protection of human subjects are addressed at the USF Institutional Review Board for the Protection of Human Subjects (IRBPHS) website, http://www.usfca.edu/soe/students/irbphs/  and forms are available there also. Questions can also be addressed by contacting the Institutional Review Board office at IRBPHS@usfca.edu  or extension x6091. The office is located in the Education Building, Room 007 in the Department of Counseling Psychology.

Approval Process

1. Submit an application for approval of the research study, including a detailed plan for the protection of any human subjects who will be participants in the research study, as well as the full research protocol, to the USF Institutional Review Board for the Protection of Human Subjects (IRBPHS). The procedures for obtaining USF IRBPHS approval are detailed in the IRBPHS Manual, which is available online for all interested parties.
2. Approval must be obtained from the IRBPHS before the study can begin. Until approval from the IRBPHS is given, subjects may not be recruited or contacted for potential participation, or any data collected. If such approval is not given, the study cannot be conducted.
3. If the research study involves USF students as human subjects, the University Registrar may also review the application for compliance with the *Family Educational Rights and Privacy Act (FERPA). If the study is not in compliance with FERPA, the study cannot be conducted. The IRBPHS chair will forward the IRB application to the Registrar if FERPA clearance is required. The researcher does not need to contact the Registrar separately.
4. Please note that FERPA grants students significant rights of access to their educational records. It also protects the privacy of student records and requires the University to inform students of all their rights and safeguards. Only material classified as "directory" information can be released without student consent. Directory information as defined by USF includes: the student's name, school of enrollment, credit hour load, periods of enrollment, degree awarded, honors, participation in athletic activities, weight and height of athletic participants, major and minor fields, and dean's list. Research that depends on use of non-directory information, such as students' addresses, will - of necessity - require FERPA review and probable alteration to the research plan in order to proceed.
5. Research that involves only passive observation or archival data (accessible to the public) does not require IRBPHS approval. In these situations, no new information is obtained directly from human subjects and identities are not revealed. Instructors who require research (other than literature searches) as part of course requirements should see the IRB website for guidelines on whether IRB approval is required. Instructors and advisors are urged to contact the IRB office at any time for consultation about student projects.
6. If research subjects are to be obtained through any external organization, written permission to access subjects must be submitted with the IRB application.
7. Once IRBPHS approval (and FERPA compliance approval, if appropriate) has been obtained, data collection must be completed within 12 months from the date of approval or a renewal application must be submitted to the IRBPHS to continue with the study beyond the approved time period.
8. If the research study involves university employees (faculty or staff) as research subjects, the researcher must obtain a letter of permission from the Associate Vice President for Human Resources (415-422-6707) who acknowledges and authorizes the research that is to be conducted. This letter must be included with the application that is submitted to the IRBPHS.
9. If the research study involves classroom or university department time and/or assistance, in addition to IRBPHS and FERPA approval, the researcher must obtain the written permission of the class instructor or department supervisor (as appropriate) before proceeding with the actual study. Approval by the IRBPHS and FERPA clearance do not require or obligate the instructor or supervisor to give permission, as he or she retains the right to deny such permission.
10. USF students, faculty, or staff members have the right to refuse to participate in approved research studies. If USF students, faculty, or staff members are involved as research subjects, their individual permission is required before the researcher can proceed. If they refuse to participate, they cannot be penalized or inconvenienced in any manner for their refusal to participate.
11. Any modification to the approved research protocol or changes in instrumentation (including wording of items) must be communicated in writing to the IRBPHS on a modification application, which must be approved before any proposed changes/modifications are implemented.
12. Researchers are required to report in writing to the IRBPHS within ten (10) working days any adverse reactions or complications on the part of participants in the study. A statement that a subject may contact the IRBPHS with any questions or concerns must be clearly delineated in the consent process prior to the collection of data by the researcher. Interviews that are to be recorded by the researcher are to be explicitly mentioned in the consent form given to the research participant.