THE OFFICE OF RESEARCH

RESEARCH INVESTIGATOR HANDBOOK

3.11 WORKING WITH AFFILIATES

• Who are the primary UCSF affiliates?
• Do affiliates have their own approval process or requirements?
• Who do I contact for regulatory approval at an affiliated site?
• Are there any special requirements for human research at affiliates?

Who are the Primary UCSF affiliates?

The five primary affiliates that researchers commonly interact which include:

Do affiliates have their own approval process or requirements?

Yes. Depending upon the affiliate, there may be additional requirements to obtain permission to conduct research at these organizations. These can include separate approval processes, additional requirements for training, credentialing, and documentation, and PI status may be granted independently from UCSF. Faulty status does not indicate PI status with different institutions. When contemplating adding an affiliate’s site to your research, you must contact them to determine if there will be additional research requirements.

Who do I contact for regulatory approval at an affiliated site?

First you will need to determine what regulatory approvals you will need for both UCSF and the affiliated institution. Then, you need to know if these approvals can be obtained at the same time or if you will have to obtain approval at one site before the other site will approve your research.

To work with affiliates when you are a UCSF PI, you must:
	•	Determine if you would have research rights at the affiliated site. You may be required to collaborate with a PI at that institution
	•	Obtain all of the relevant UCSF regulatory approvals.
	•	Obtain the relevant approvals from the affiliated site. These will be determined by what type of interaction is planned, such as working only with affiliated data, working directly with the affiliate’s patients, and/or working at the affiliate’s site.
To work with UCSF when you are an affiliate PI, you must:
	•	Determine if you would have PI status at UCSF. You may be required to collaborate with a UCSF PI in order to use UCSF facilities or data, even if you have a faculty appointment. For example, all human subjects studies require UCSF PI status before CHR approval will be given.
	•	Obtain all of the relevant regulatory approvals for their institution.
	•	Obtain relevant approvals from UCSF.

The table below lists the major primary affiliates and whether UCSF or the affiliate’s research committees (or both) have regulatory oversight.

Please note that the UCSF regulatory committees have oversight for the Howard Hughes Medical Institute (HHMI) researchers located at UCSF.

Are there any special requirements for human research at affiliates?

SFGH and the SFVAMC have additional requirements for clinical research:

Clinical Research at SFGH: You must have both UCSF CHR and SFGH Dean’s Office approval for clinical research whether working directly with patients, working with patient data or working on site at SFGH:

Clinical research with SFVAMC: You are required to have both UCSF CHR and VAMC approvals for research. Only approved San Francisco VA Principal Investigators (SFVA PIs) may conduct research at the San Francisco VA. Having PI status at another institution, or another VA, does not automatically grant you privileges at this station.

For UCSF PIs wishing to add the VA to their research project, be sure to include a VA investigator and meet all VA requirements for research approval.

For affiliated PIs wishing to add UCSF to their research project, be sure to apply for all necessary approvals through your institution as well as obtaining CHR approval from UCSF. As an affiliated PI, you must collaborate with a UCSF PI in order to receive CHR approval.