SDSU/UC San Diego JDP students who use human subjects in research can submit their IRB application to either the UC San Diego or the SDSU IRB. The “Reviewing” IRB is determined by the affiliation of the faculty mentor responsible for oversight of the research. This cooperative review process is allowed through 45 CFR 46.114 to avoid duplication of effort and reduce burden for investigators, IRB members and staff. At this time, the agreement is limited to SDSU/UC San Diego JDP students. The impact of this agreement will be evaluated over the next six months to determine whether it may be expanded.

It is important that the time required to complete the IRB process is built into the time frame for conducting the research project.  Do not assume that this is a quick process on either campus.  The SDSU IRB convenes monthly to review research.  If the submission deadline is missed, the material will not be reviewed until the following month.   Both university committees have procedures to follow.  If a student is planning to run subjects as part of a research project that has already been approved with a professor as principal investigator, the student must find out from each university what procedures to follow.  Do not assume that a professor’s approval covers the student’s portion of the research. 

Degrees may be delayed or students may be asked to re-run subjects if research that is required for graduation (e.g. second year project, dissertation) has not been approved by both IRBs prior to data collection.

Information can be obtained at the locations listed below.  Both IRBs use electronic submission.  There are special procedures for research projects requiring review by both IRBs.  While these procedures may facilitate the review they must be followed exactly or delays will occur.  These are

SDSU:  Office – AD-222; Phone – 594-3380; E-mail – irb@mail.sdsu.edu; Web site – http://www-rohan.sdsu.edu/~gra/grad/research/hrpp.html

UC San Diego:  Office –Altman Clinical and Translational Institute, Level 2, 9452 Medical Center Drive, La Jolla, CA 92093; Phone – 858-246-HRPP (858-246-4777).  Web site – https://irb.ucsd.edu/Home.FWx

Institutional Review Board (IRB) Process for JDP Students (SDSU/UC San Diego)

Students enrolled in a SDSU/UC San Diego Joint Doctoral Program (JDP) are considered enrolled at both institutions.  JDP students who plan to conduct research involving human subjects must obtain IRB approval from both institutions prior to commencing the research.  A fact sheet is available at http://irb.ucsd.edu/JDP_IRB_SDSU_UCSD_IRB_FactSheet.pdf to assist students in navigating this process.

Notes:

UC San Diego’s IRB requires that the Research Subject’s Bill of Rights be given to participants.  SDSU does not require the Bill of Rights except in studies involving medical experimentation.

UC San Diego verifies the accuracy of translated consent forms. SDSU requires that the PI be responsible for providing accurately translated consent forms.

UC San Diego will only review a certain number of protocols during their full committee meeting.  SDSU will review all full committee protocols that are submitted prior to the deadline.  Reviews that are eligible for exempt or expedited review are done on a first-come-first-served basis.

UC San Diego’s IRB reviews studies on behalf of the VA Medical Center and Children’s Hospital.  There is no need to submit an additional protocol to either of these institutions if they will be included as a research site.

 

Content of joint consent forms:

A consent form is used to document that the informed consent process has occurred and that the person has agreed to participate.  The consent form developed for this purpose will be approved by each IRB.  Providing subjects with two consent forms (one from each IRB) is not acceptable in most cases as it is considered to be a burden to the potential participant. A single consent form that describes the study and includes requirements of each institution should allow for a much clearer and more appropriate consent process.  The following information identifies where the consent form should include reference to both institutions.

In the heading of the form, reference both SDSU and UC San Diego.  For example:

  1. Consent to Participate in Research
  2. University of California San Diego/San Diego State University
  3. Project Title

 

In the ‘Voluntary Nature of Participation’ section, state that the choice whether or not to participate will not influence future relations with SDSU or UC San Diego.

  1. Participation in research is entirely voluntary. Your choice of whether or not to participate will not influence your future relations with San Diego State University or the University of California, San Diego.  If you decide to participate, you are free to withdraw your consent and stop your participation at any time without penalty or loss of rights to which you are entitled.

In the ‘Questions about the Study’ section, include contact information for SDSU’s IRB as well as UC San Diego’s Human Research Protection Program:.

  1. For questions about your rights as a research participant or to report research-related problems you may contact the Institutional Review Board at San Diego State University (619) 594-6622, irb@mail.sdsu.edu or the University of California, San Diego Human Research Protections Program at (858) 455-5050.

If it is necessary to include a statement about what will happen in case of injury, use the UC San Diego injury statement and the SDSU’s injury statement:

  1. UC San Diego Compensation for Injury: If you are injured as a direct result of participation in this research, the University of California will provide any medical care you need to treat those injuries. The University will not provide any other form of compensation to you if you are injured. The researchers for this study will assist you in obtaining appropriate medical treatment, but this study does not provide financial assistance for medical or other costs. You may call the Human Research Protections Program at (858) 455-5050 for more information about this, to inquire about your rights as a research subject or to report research-related problems.
  1. SDSU Compensation for Injury:  If any complications arise as a direct result of participation in this research, we will assist you in obtaining appropriate attention.  If you need treatment or hospitalization as a result of being in this study, you are responsible for payment of the cost for that care.  If you have insurance, you may bill your insurance company.  You will have to pay any costs not covered by your insurance.  San Diego State University or the San Diego State University Research Foundation (if funds are managed through the SDSU Research Foundation) will not pay for any care, lost wages, or provide other financial compensation.  If you feel you have a claim that you wish to file against the State or the Foundation (if funds are managed through the SDSU Research Foundation), please contact Graduate and Research Affairs – Division of Research Administration at (619) 594-6622 to obtain the appropriate claim forms.

In the “Consent to Participate” section, state that the SDSU Institutional Review Board and the Human Research Protection Program UC San Diego has approved this consent form:

  1. The San Diego State University Institutional Review Board and the University of California, San Diego Human Research Protections Program have approved this consent form, as signified by both institutions stamps.