100-16 Research Involving Human Subjects

Effective Date: 1/1/92 (revised 12/07/04)
Office of Origin: Office of Research

I. Purpose

To safeguard the rights and welfare of human subjects of research, UCSF ascribes unequivocally to the principles of The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects in Research by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. UCSF has established policies to assure full compliance with all federal regulations, state laws, and University of California policies governing the use of human subjects in research.

II. Definitions

Committee on Human Research: the specific name for UCSF's Institutional Review Board (see below).
 
Institutional Review Board: the generic name for any board, committee, or other group formally designated by an institution to review the conduct of any biomedical and/or behavioral research involving humans as subjects. Its purpose is to safeguard the rights and welfare of human subjects in research according to the ethical principles described in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects in Research, and according to the applicable federal regulations and guidance.

Human Subject:  An individual about whom an investigator (professional or student) conducting research obtains data through intervention or interaction with the individual or identifiable private information (45CFR46.102). The individual may be living or deceased (according to State and HIPAA privacy regulations). The federal government broadly interprets the definition of “interaction” to include the use of human biological specimens or review of aggregate data as these activities involved interaction with humans at some stage in the process.  

III. Policy

    A. Federal Policy on the Protection of Human Subjects

  1. Any institution that receives funds from and is accountable to departments and agencies of the federal government for funds awarded for the support of research using human subjects is required to safeguard the rights and welfare of those subjects.
  2. No federal grant or contract for research involving human subjects may be made to any institution unless the application for such support has been reviewed and approved by the appropriate Institutional Review Board (IRB). (See Section III.B).
  3. The Food and Drug Administration (FDA) restricts data used in support of market permits to that from IRB-approved studies.
  4. The use of any drug not approved by the FDA in humans is subject to review and approval by an IRB. The sole exception to this requirement is in the case of certain treatment investigational new drugs.
  5. Reviews by an IRB must determine that subjects will be adequately protected according to established criteria involving an evaluation of risks and benefits, equity of selection, and the informed consent process and documentation.
  6. Approved studies must be reviewed at least annually by an IRB. Modifications to a study must be approved before they are implemented.

    B. UCSF Policy on the Protection of Human Subjects in Research

    The IRB at UCSF is the Committee on Human Research (CHR).

    1. Guiding Principles

    The ethical principles espoused in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects in Research have been adopted by UCSF and the CHR for all research involving human subjects.

    2. Scope of Authority

    UCSF holds a Federalwide Assurance of compliance with Department of Health and Human Services regulations on the protection of human subjects (45 Code of Federal Regulations 46). This assurance, which is renegotiated and approved on a regular basis, applies to all research with human subjects (as defined in 45 CFR 46.102[3] and [f]) being conducted by investigators acting as agents of UCSF regardless of the site of the activity. The Assurance applies to all  human research involving any UCSF facilities, personnel, patients, or students or research that is supported either by extramural funds granted to (or applied for through) The Regents of the University of California, or for research conducted with UCSF funding at non-UCSF sites. 

  1. The CHR has the sole authority to approve applications; decisions by the CHR on individual applications are final.
  2. Disapprovals may not be overturned at any higher level.
  3. Implementation of approved studies may be prevented or terminated by decision at any other level in the institution, although the CHR approval will not be voided by such action. 

    3. Jurisdiction

    All faculty and staff paid by UCSF for greater than 50% of their effort who are conducting studies involving human subjects  within the course and scope of their duties, regardless of the source of the funding, or even in some cases in which no funds are involved, are required without exception to have prior approval from the CHR before research is initiated.

    Regardless of percent of effort, prior approval of the CHR is required, without exception, when studies conducted by UCSF faculty access any UCSF or UCSF-affiliated facilities, patients, personnel, or students  and/or when the human research is supported either by extramural funds granted to (or applied for through) The Regents of the University of California, or for research conducted with UCSF funding at non-UCSF sites.

    Prior approval of the CHR is not required when part-time or unpaid faculty are not acting as staff members, employees, or agents of the University, when no University facilities, patients, personnel or students are used and  when the activity  is not represented to subjects as being conducted under the aegis of the University.. However, in such cases investigators holding University appointments must nevertheless obtain approval for the use of human subjects from a duly constituted IRB.

    4.  Activities Accessing UCSF Facilities, Patients, Staff, or Students    Not Being Conducted by a UCSF Principal Investigator

    All non-UCSF investigators involving human subjects in research projects that access any UCSF facilities, patients, staff or students 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.  This CHR administrative review will determine the following: 

  1. Whether the study must have a UCSF faculty member serve as the Principal Investigator, or
  2. Whether the study can be certified as exempt, and/or
  3. Whether the study will require an additional review and approval by the Office of the Associate Vice Chancellor for Research.  

    5. Treatment and Compensation for Injured Research Subjects

    The University policy on treatment and compensation for injured research subjects must appear on all consent forms for studies in which there is more than a minimal risk of biomedical harm.

    6. Experimental Subject's Bill of Rights

    Any individual who is asked to consent to participate as a subject in a medical experiment or who is asked to consent on behalf of another must be given a copy of the UCSF Experimental Subject's Bill of Rights in a language in which the person is fluent.

IV. Responsibility

  1. The Executive Vice Chancellor is responsible for implementation of and compliance with federal regulations, state laws, and University policy;
  2. The Executive Vice Chancellor appoints the CHR chairs and members after consultation with appropriate constituencies;
  3. The Executive Vice Chancellor has delegated the daily operation of the Research Involving Human Subjects program to the Associate Vice Chancellor for Research.

    B. Committee on Human Research

  1. The CHR is obligated and authorized to:
  1. Ensure that subjects are adequately informed of the nature of the study;
  2. Ensure that subjects' participation is voluntary;
  3. Ensure that the benefits of a study outweigh its risks;
  4. Ensure that the risks and benefits of the study are evenly distributed among the possible subject populations; and
  5. Suspend any human subjects activity that violate regulations, policies, procedures, or an approved protocol, and report such violation and suspension to the Executive Vice Chancellor and appropriate federal agencies.
  1. The CHR is responsible for conducting timely review of all applications for the use of human subjects.
  2. The CHR will notify investigators and appropriate UCSF officials in writing of its decision to approve or withhold approval of applications or modifications of ongoing activities.
  3. The CHR develops policies and procedures in consultation with the Executive Vice Chancellor as appropriate.
  4. The CHR refers legal issues to the UCSF Office of Legal Affairs which may seek the advice of the UC General Counsel.
  5. The CHR reviews and investigates concerns about issues of human subjects protection and directs corrective action as needed.

    C. Principal Investigators

  1. Principal investigators must submit applications to the CHR for review and approval before initiating, modifying, or extending any research project that uses human subjects.
  2. Principal investigators shall consider racial, cultural, and gender diversity among the subject populations and be sensitive to community attitudes in both the design and conduct of research involving humans.
  3. Principal investigators must report any serious or unexpected adverse events  experienced by a subject within 10 working days to the CHR. Also report any problems related to the conduct of a study or patient participation, including those in the recruitment or consent process.
  4. Principal investigators shall report any violation of an experimental protocol or any use of subjects not approved by the CHR to the CHR or the Executive Vice Chancellor.

    D. Department Chairs

    Department chairs are responsible for reviewing the activities within their department to determine that proper review and approval have been obtained.

  1. Proper review and approval have been obtained; and
  2. Appropriate resources are available to conduct the research.

    E. University

  1. The University of California assures the federal government that the campus is in compliance with federal regulations on the use of human subjects research (45 CFR 46 and 21 CFR 50 and 56) and that no research involving human subjects is conducted without prior review and approval.
  2. The University of California may provide treatment and compensation for injured research subjects.
  3. The University of California is legally responsible for the acts and omissions of its employees acting in the course and scope of their University duties. In the event of a suit against an employee in connection with a CHR-approved research activity using human subjects, the University assumes the employee's defense and indemnification.

V. Related Policies

VI. References