Contact Information

Organization

THE COMMITTEE ON HUMAN RESEARCH

UCSF GUIDANCE ON RESEARCH TOPICS AND ISSUES

Working with Other Institutions – Collaborating with Researchers at Academic Medical Centers, Hospitals, Clinics and Practices within the United States and at International Locations (February 2005, Revised March 2008)

• Brief Overview
• Research Activities: What Defines Engagement in Human Subjects Research
• Types of Collaborations: Working With -
  • UCSF-Affiliated Institutions
  • San Francisco Bay Area Hospitals and Academic Institutions
  • Other US-based Academic Institutions
  • US-based Non-academic Hospitals, Clinics, and Practices
  • International Entities
• Federalwide Assurance (FWA) of Compliance
• When the CHR Can Serve as the IRB of Record and When It Cannot
  • Federally Funded Research
  • Research that is Not Federally Funded

Brief Overview

The purpose of this guidance is to help UCSF investigators meet the regulatory requirements involved with conducting human subject research with other institutions such as academic medical centers, hospitals, clinics, and private medical practices, located within the United States, as well as entities located outside US territories. UCSF investigators who work with other institutions must fulfill requirements that may vary depending on:

• The role the collaborating organization plays;



• The type of regulatory infrastructure in place, namely whether the institution has a governing Institutional Review Board (IRB) or Independent Ethics Committee (IEC); and



• The source of funding for the research.
  
  With these issues in mind, some general principles to be aware of when seeking approval to conduct human research with other institutions include the following:



• Research at other institutions, domestic and foreign, requires review by the IRB at UCSF, the Committee on Human Research (CHR), and review from the IRB/IEC at other location(s).



• UCSF Researchers who function as the lead investigator, prime grant holder or serve as a coordinating center for a multi-center study are responsible for :
  
  
  • Obtaining CHR review for the overall project,
  • Ensuring that other sites receive IRB review at their respective institutions, and
  • Ensuring that relevent safety information is apporpriateley recorded and shared between engaged sites.


• Each institution where research activities satisfy the federal definition of engagement in human subjects research must have its own IRB review.



• For federally funded studies, each institution that must have IRB review also must have assurance under the Federalwide Assurance program (FWA)

  IMPORTANT NOTE: CHR policies and procedures for working with other institutions are consistent with guidance set forth by the Office of Human Research Protection (OHRP) and encompass ethical principles accepted internationally.

Top of Page

Research Activities: What Defines Engagement in Human Subjects Research

For the purpose of human research oversight, current guidance from the Office of Human Research Protection (OHRP) defines engagement in human research by the type of research activities the institution conducts. For federally funded studies engaged institutions engaged must obtain Federalwide Assurance (FWA) of compliance.

IMPORTANT NOTE: The Committee on Human Research (CHR) requires review at UCSF, and review from the IRB/IEC at other location(s) regardless of funding.

• The institution is engaged and requires an OHRP-approved assurance of compliance (FWA) if the faculty, staff, students or agents:
  
  
  
  • Intervene with individuals by performing invasive or non-invasive procedures for research purposes, manipulating the environment for research purposes, or interact with living individuals for research purposes.
  
  
  
  • Release identifiable private information or permit investigators to obtain individually private information without subject’s permission (releasing names to outside investigators about potential subjects.)
  
  
  
  • Obtain, receive, or possess identifiable private information that is either directly or indirectly identifiable for research purposes.
  
  
  
  • Obtain, receive, or possess identifiable private information that is either directly or indirectly identifiable for research purposes for the purpose of a coordinating center, statistical center, or operating centers of a multi-site collaborative research study.
  
  
  
  • Receive a direct HHS award to conduct human subject research even if a collaborator or subcontractor conducts all activities.



• The institution is not engaged if the faculty, staff, students or agents:
  
  
  
  • Act as consultants on research but at no time obtain, receive, or possess identifiable private information or perform commercial services.
  
  
  
  • Inform prospective subjects about research or provide prospective subjects with information about contacting investigators for information or enrollment but do not obtain subjects' consent or act as authoritative representatives of the investigators.
    

    Examples of Not Engaged:
    • A clinician provides patients with literature about a research study, including a copy of the consent form, and explains how interested patients should contact the investigator to enroll.
    
    • A clinician provides investigators with contact information about potential subjects after receiving explicit permission from each potential subject.

  
  
  
  • Permit the use of facilities (e.g., schools, nursing homes, businesses) for intervention or interaction with subjects by research investigators.

    Important Note: The UCSF investigator must provide a letter of support from the institution to the CHR.

  • Release identifiable private information with the prior written permission of the subject.
  
  
  
  • Release identifiable private information or specimens to state or local health department for legitimate public health purposes within the recognized authority of that department.
  
  
  
  • Release information and/or specimens to investigators without personal identifiers (i.e., de-identified), where such information/specimens have been obtained by the institution for purposes other than the investigators' research.
    
    

    Examples of Not Engaged:
    • Nursing home employees provide investigators with a data set containing a data set abstracted from medical record information. The data set contains no direct or indirect identifiers through which the identity of individual subjects could be ascertained, either by the investigators or by nursing home personnel.
    
    • A hospital pathology department releases excess tissue specimens and relevant medical record information to investigators, but these materials include no direct or indirect identifiers through which the identity of individual subjects could be ascertained, either by investigators or by hospital personnel, including the pathology department.

  
  
  
  • Receive information or specimens for research from IRB-approved repositories.

Top of Page

Types of Collaborations

USCF researchers participate in a broad range of collaborative relationships including those with:

• UCSF-affiliated institutions;



• Other US-based academic institutions;



• US-based, non-academic hospitals, clinics, and practices;



• International entities

Although these collaborations may vary widely in scope and complexity, all human research studies must be reviewed and approved by the Committee on Human Research (CHR), the Institutional Review Board at UCSF. In most cases, approval by the collaborator’s IRB or by the Independent Ethics Committee (IEC) in the host country is also required.

In addition, UCSF must be sure that collaborative research at other institutions meets the requirements of the Federalwide Assurance (FWA) Program. Through the FWA program Institutional Review Boards and Independent Ethics Committees (IRB/IEC) charged with reviewing and approving human research are registered and the respective institution receives approval from the Office of Human Research Protection indicating assurance of compliance with federal regulations (45 CFR 46.103) for the protection of human subjects.

• Working with UCSF-Affiliated Institutions: Many UCSF investigators collaborate with researchers at UCSF-affiliated units. UCSF’s Committee on Human Research (CHR) serves as the IRB of record for the organizations listed below. Links to each organization’s homepage and their respective FWA numbers are provided.
  

IMPORTANT NOTE: Although UCSF is the IRB of record for these UCSF-affiliated institutions, each may have local submission requirements that must be met prior to beginning the human subjects research (e.g. SFGH and SFVAMC).

• Working with San Francisco Bay Area Hospitals and Academic Institutions: UCSF investigators interact with many hospitals and other academic institutions in the San Francisco Bay Area. The CHR provides a list of organizations including IRB contact information.



• Working with other US-Based Academic Institutions: Most, if not all, academic institutions within the US, if they receive federal funding will have already obtained assurance of compliance through the FWA program. Investigators need to ensure that they or their collaborators meet the respective IRB-review requirements.



• Working with US-Based Non-Academic Hospitals, Clinics, and Practices: Hospitals, clinics, and practices that are not affiliated with academic medical centers may not already have in place the IRB and FWA programs necessary for federally-funded research to take place. If investigators are committed to working in these settings, they may be faced with finding a local IRB to review the study and with guiding the organization’s pursuit of assurance of compliance through the FWA program. More information can be found in the section Federalwide Assurance of Compliance.
  
  
  
  • For information on IRB requirements and on determining whether the CHR can serve as the IRB of record, refer to the section When the CHR Can Serve as the IRB of Record and When It Cannot



• Working with International Entities: Researchers who wish to conduct human subjects research in countries outside the United States or its territories must obtain approval from the host country’s ethics committee and from the Committee on Human Research at UCSF.
  
  
  
  • The CHR expects the standards for human subjects protection are no less than those that apply to US-based research.
  
  
  
  • The appropriate Institutional Review Board (IRB) or Independent Ethics Committee (IEC) must be in place and all federally funded studies must have Federalwide Assurance (FWA) before the study can begin.
  
  
  
  • Refer to the Office of Human Research Protection website for:
    
    
    • Lists of the international sites that have approved assurances.
    
    
    
  • Additional topics to consider when conducting international research:
    
    
    
    • Cultural differences that influence study design and the consent process.
    
    
    
    • The rationale for conducting the study with an international population.
    
    
    
    • A description of the host country’s ethics review and oversight mechanism for participant protection.

Top of Page

Federalwide Assurance (FWA) of Compliance

If an institution is engaged in human subjects research that is conducted or supported by any agency of the U.S. Department of Health and Human Services (HHS), the institution must have assurance of compliance with the HHS regulations (45 CFR 46.103) for the protection of human subjects. Assurance of compliance and federal oversight are managed by the Office for Human Research Protections (OHRP) under the provisions of the Federalwide Assurance (FWA) program. Links to additional information are provided below:

• Obtaining an approved assurance from OHRP: Obtaining assurance is a two-step process:
  
  
  1. The IRB(s) designated under the Assurance must be registered with OHRP. If not, submit the registration.
  
  
  
  2. Complete the Assurance application.

Top of Page

When the CHR Can Serve as the IRB of Record and When It Cannot

The Committee on Human Research (CHR) is the Institutional Review Board (IRB) at UCSF and, as described elsewhere, serves as the IRB for many UCSF-affiliated organizations. In general, UCSF cannot be considered the IRB of record for non-affiliated institutions or investigators. However, there are a few exceptions and the conditions wherein the CHR can and cannot serve as the IRB for institutions not affiliated with the University are presented below.

Federally Funded Research: The CHR will agree to be the IRB of record if and only if the scope of human subject research at the collaborating site is considered minimal risk and discussed in the CHR Application.The UCSF PI must also complete and submit the IRB Approval Certification Supplement with their CHR Application.

IMPORTANT NOTE: If the risk is greater than minimal, the site engaged in human subject research must obtain its own FWA and designate a registered IRB, or register its own IRB. Refer to the FWA section for details.


• Non-Affiliated Institutions: For the CHR to be the IRB of record, the following must occur:


• The institution must designate the UCSF registered Institutional Review Boards on its Federalwide Assurance application.


• Once this has been signed and posted on the OHRP website, the institutions must complete an IRB Authorization Agreement. The IRB Authorization Agreement must designate whether the IRB review is for all research or specific to one study.


• The research may begin only after the Institutional Officials at the respective organization have signed the IRB Authorization Agreement.
  
  


• Non-Affiliated Individual Investigators: For the CHR to be the IRB of record, the following must occur:


• The individual investigator signs an Individual Investigator Agreement.


• This document requires various assurances of the individual investigator as well as the signature of the FWA Institutional Official.
  
  IMPORTANT NOTE: The Individual Investigator Agreements are rarely approved.

Research that is NOT Federally Funded: There is no formal mechanism for the CHR to be the IRB of record for non-affiliated institutions when federal funds are not involved. However, the CHR may agree to be the IRB of record if and only if the scope of human subject research at the collaborating site is considered minimal risk and discussed in the CHR Application. Because this type of research is handled on a case-by-case basis, contact the CHR to discuss the details of the proposed study. The UCSF PI must also complete and submit the IRB Approval Certification Supplement with their CHR Application.

IMPORTANT NOTE: If the risk is greater than minimal, the site engaged in human subject research must contract with a private IRB.