Research Clearances for Dissertations and Theses
University policy requires that students intending to engage in research involving human or animal subjects, or recombinant DNA, biological or potentially hazardous materials, receive approval of their research procedures before beginning the collection of data.
Detailed information may be obtained from the links provided below. The Graduate Division will not accept the Appointment of
Thesis Committee Form until the necessary approvals have been obtained. See Prodedures
(left-side navigation).
Human Subjects
For research involving human subjects, approval must be obtained
from the
Institutional Review Board (IRB).
The IRB has been established in accord with federal law to ensure that human subjects participating in research activities
sponsored by the university are protected from undue risks and deprivation of human rights and dignity.
Research is defined in the Code of Federal Regulations (45CFR46) as a systematic investigation designed to develop or
contribute to generalizable knowledge.
A human subject is a living individual about whom an investigator obtains (1) data through intervention or interaction
with the individual, or (2) identifiable private information.
Included are all activities (including pilot studies)
where results are intended for publication, distribution, or use outside of the specific instructional setting
(i.e., reported outside the boundaries of this campus and the organization from which data were collected.
Also included as research are student investigations within the campus instructional settings in which the data are
to be used in future research activities of the investigators, faculty, or staff at San Diego State University or by
individuals in another institutional setting.
If you are planning research that involves human subjects, a
protocol must be submitted to the IRB for review in advance of initiating all human subjects related activity. Refer to
the
Research Integrity/Regulatory Compliance
for detailed information regarding the application and review process.
Animal Subjects
For research involving animal subjects, approval must be obtained from the
Institutional Animal Care and Use Committee (IACUC).
This committee has been established in accord with federal law to ensure the humane care and use of laboratory animals used
in research, testing, and/or training activities sponsored by the university.
The process of review for research
involving animal subjects is as follows:
- The student obtains an animal protocol form from the Office of Laboratory Care in the College of Sciences (594-5421).
- The chair of the thesis committee serves as the sponsoring faculty member and assumes ultimate responsibility for the humane care and treatment of animals in research.
- The student submits the protocol and any attachments to the department chair for approval and signature.
- The protocol with department approval is submitted to the chair of the IACUC. (The student should determine whether the departmental chair will forward the protocol or if the student is expected to pick up and deliver the material to the IACUC.)
- The IACUC usually meets once per month. The submission deadline is the fifteenth of each month.
- The IACUC will inform the Office of Graduate and Research Affairs of its action.
Recombinant DNA, Biological or
Potentially Hazardous Materials
SDSU is responsible for ensuring that recombinant DNA research or experiments involving biological materials or
potentially hazardous materials are conducted in compliance with the
NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)
and the
CDC Biosafety in Microbiological and Biomedical Laboratories
guidelines to promote safe and responsible practices. On behalf of SDSU, the Institutional Biosafety Committee (IBC)
reviews research for this purpose. The IBC is a committee of the University Research Council appointed by the Vice President
for Research. Graduate and Research Affairs' Division of Research Administration provides administrative support to the IBC.
The IBC membership is determined based on federal guidance and includes a biosafety officer, an animal expert, scientists,
and private citizens.
Principal Investigators using biohazardous materials or conducting experiments involving
recombinant DNA in their laboratories must obtain approval from the IBC. To initiate this process, the investigator must
complete a Biological Use Authorization (BUA) Form. The
BUA may be reviewed and approved by the Institutional Biosafety Officer (IBO) for BL-1 experiments. The IBO and the IBC
will review research involving BL-2 or BL-3 experiments.
For information regarding SDSU's Biosafety Program please
visit SDSU Department of Environmental Health and Safety
, for Institutional policies see the SDSU Biosafety Manual,
or contact the Institutional Biosafety Officer (BSO), Millie Tran (mdizon@mail.sdsu.edu or (619) 594-2865.
For information specific to the Institutional Biosafety Committee, contact Graduate and Research Affairs' Division of
Research Administration (619-594-0905 or ibc@mail.sdsu.edu).
