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THE HUMAN RESEARCH PROTECTION PROGRAM

THE COMMITTEE ON HUMAN RESEARCH

ABOUT THE COMMITTEE ON HUMAN RESEARCH

WHO MUST HAVE CHR APPROVAL BEFORE ENROLLING HUMAN SUBJECTS IN RESEARCH (Revised October 2004, Revised March 2008)


Types of Research Covered

The following requirements apply to all types of research involving human subjects, including chart reviews, retrospective studies, access to UCSF data banks and repositories, collection and/or use of human biological specimens and, of course, research involving direct contact with human subjects, including compassionate use protocols and emergency use requests. Human research that is exempt from review under Federal regulations must be submitted to the CHR for formal certification of exemption.

Requirements for UCSF Researchers

UCSF-affiliated researchers using human subjects must receive prior approval from the CHR if any of the following circumstances apply:

Researchers Paid > 50% Time by UCSF

All faculty and staff paid by UCSF for greater than 50% of their effort must have CHR approval before they begin research using human subjects. This requirement applies regardless of the source of funding and even when no funds are involved, and regardless of the site of the study activities.

 

Researchers Paid < 50% Time by UCSF

If researchers are paid by UCSF for less than 50% of their effort, they need not obtain CHR approval for human research, unless one of the following conditions applies:

  The funding is granted to or applied for through UCSF, or
  Subjects will be recruited at UCSF, SFGH, or the SFVAMC, or
  The research will take place at a UCSF, SFGH or SFVAMC facility.
  A UCSF-affiliated institution holds an FWA that identifies the UCSF CHR as the
IRB of record for all its human research.
  If the above conditions apply, researchers must arrange for an eligible faculty member (PI eligibility requirements at UCSF or the PI eligibility requirements of the various affiliates) to serve as the Principal Investigator for the study, or they may obtain a waiver from the Department Chair. This is because researchers paid less than 50% time are not typically eligible to serve as Principal Investigator at UCSF nor are they eligible to have research reviewed by the CHR.
 

Important Note: Even if CHR review is not required, any investigator holding a UCSF appointment must obtain approval from another Institutional Review Board (IRB) before conducting human research. Anyone accepting the privilege of a UCSF faculty title must also assume the duty of obtaining prior approval from a duly-constituted IRB in order to conduct human research.

 

Funding Awarded Through UCSF

If the human research is supported either by extramural funds granted to (or applied for through) the Regents of the University of California or by University funds, CHR review is required.

If UCSF is the primary recipient of a grant, then the UCSF PI must obtain CHR approval, even if only for the scope of the work if the research is being conducted elsewhere. If multiple sites are involved, the CHR will require evidence of the various and relevant IRB approvals at all subcontracted sites.

If UCSF has been awarded a subcontract, and is not the prime recipient of the grant, then the CHR need review only the subcontracted portion of the study that will be completed by the UCSF researcher.

Post Docs, Student Research and House Staff

Postdoctoral Fellows are allowed to serve as PIs on CHR applications if the following two conditions are met:

  • A UCSF faculty member who would otherwise qualify as a Principal Investigator is identified as the Co-PI on the application, and

  • A cover letter from the Co-PI faculty member is attached to the application stating that he or she agrees to serve as faculty support and/or a mentor to the Postdoctoral Fellow.

Neither students nor house staff are eligible to serve as PIs. They are required to seek the sponsorship of a UCSF faculty member, who will serve as the PI on the study. These studies are often smaller scale unfunded studies.

Students who are doing research at sites that are not affiliated with UCSF may not need individual approval from the UCSF CHR if:

  • their mentor (PI) is not a UCSF faculty member;
  • they already have an IRB approval from the other institution; and
  • they are not accessing UCSF facilities, medical records, patients or personnel.

If they are accessing any of these, they will need individual UCSF CHR approval with a qualified UCSF faculty member to serve as the PI.

Researchers from Other UCSF-Affiliated Institutions for which the CHR Is the IRB

Several institutions have signed agreements and Federal Wide Assurances designating the UCSF CHR as the institution’s IRB (e.g., SFGH, SFDPH, SFVAMC, Gladstone Institutes, Gallo Institutes). Researchers working under the auspices of those institutions must obtain CHR approval for human research as required by individual institutional policies, and are eligible to obtain CHR review as determined by UCSF institutional policies.

IMPORTANT NOTE: Investigators who wish to use facilities, involve patients or employees, or recruit subjects from any UCSF-affiliated institution must contact each institution to see what if any their additional requirements are. For example, the San Francisco Veterans Affairs Medical Center (SFVAMC) has its own set of requirements.

Research Not Being Conducted by a UCSF Principal Investigator but Accessing UCSF Facilities, Patients or Personnel

All human subjects research conducted at UCSF facilities or involving UCSF patients or employees (including students, faculty and staff) must either identify a UCSF faculty member to serve as the Principal Investigator for the project or submit their research proposal to the CHR for an administrative review using the form called UCSF CHR Administrative Review for Human Research Studies Not Being Conducted by a UCSF Principal Investigator But Accessing UCSF Facilities, Patients or Personnel Form. Review of this form will help determine the following:

Whether the study must have a UCSF faculty member serve as the PI, or
Whether the study can be certified as exempt according to federal regulations and UCSF policies, or

Whether the study will require an additional review and approval by the Office of the Associate Vice Chancellor for Research.

Important Note: This policy applies to the use or collection of human biological specimens or the review of medical records for research purposes as well as the recruitment or direct involvement of patients, staff, or faculty.

Important Exception to the Policy: An exception to the requirement for administrative review for research being conducted by outside faculty or groups is a survey of faculty by their professional organizations. These do not require administrative approval.

Research Conducted by UCSF Emeritus Professors

Emeritus Professors may ask that the UCSF CHR review their studies, provided any funding is brought through UCSF, if there is funding.