18-200 University Policy on the Protection of Human Subjects in Research

University policy on the protection of human subjects in research, which was issued by Presidential Memorandum, September 2, 1981, is restated in part in 18-210 through 18-240. (See Contract and Grant Memo for full text copy).

18-210 Basic Policy

The University of California is committed to the ethical principles for the protection of human subjects in research set forth in the Belmont Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The University recognizes and accepts responsibility, which it shares with its investigators and other researchers, for determining that research involving human subjects fulfills these ethical principles.

The basic ethical principles outlined in the Belmont Report which guide the Institutional Review Board's deliberations and decision-making include respect for persons, beneficence, and justice. A summary of these principles follows:

a. Respect for persons dictates that researchers must obtain informed consent from all human subjects invited to participate in research. In order to respect subject autonomy, the consent process includes giving subjects full and comprehensible information about the research and providing a clear assurance of the subjects' voluntary participation.

b. Beneficence is the essence of concern for the well-being of subjects, and requires that the risk of harm to subjects is the least possible, and that the sum of benefits to the subject and the importance of the knowledge to be gained so outweigh the remaining harm as to waive a decision to allow this risk.

c. Justice requires that the selection of human subjects should be fair and equitable and that the risks and benefits of research should be distributed among subjects in a fair and equitable manner, with particular concern for subjects whose personal status or condition--as children, prisoners, patients, impoverished persons--places them in a vulnerable or dependent position. See 18-F11 for further details on the Belmont Report.

18-220 Applicability of Governmental Regulations and Policies to All Research

It is University policy that the regulations of the Department of Health and Human Services (HHS), set forth in 45 CFR Part 46, are applicable to all research involving human subjects, as defined by these regulations, for which the University is responsible, regardless of the source of funding or whether the research is funded. In the case of conflict between regulations of the funding or regulatory agency and HHS, the more restrictive regulations shall prevail. The University is also obligated by law to adhere to the regulations of the Food and Drug Administration (21 CFR Parts 50 and 56) governing projects involving investigational new drugs [within the meaning of 21 U.S.C. sections 355(i) or 357(d)], or investigational new devices [within the meaning of 21 U.S.C. section 360(g)]. See 18-F12 for a summary of these federal regulations.

18-230 Responsibility for Compliance

The Chancellors, the Senior Vice President--Academic Affairs, the Vice President--Agriculture and Natural Resources, and the Directors of the Department of Energy Laboratories are responsible for compliance with the University's policies applicable to human subjects. They are authorized to take appropriate action to implement the human subjects regulations of all funding or regulatory entities covering activities under their jurisdiction. In developing implementing procedures for research, the Chancellors, Vice Presidents and Directors shall establish a process for determining whether an activity constitutes research under the regulations and whether the research activity is exempt from formal review. As a minimum, such a process should provide for some form of consultation with investigators.

18-240 Review by the Office of the General Counsel

When significant legal issues are identified by investigators or Institutional Review Boards in connection with a specific research proposal, they shall be forwarded to the Office of the General Counsel for review. The assurances developed to implement government regulations shall also be forwarded to the Office of the General Counsel to assure that legal requirements are met.

18-250 Human Subjects Institutional Assurance Requirements

It is University policy that each campus and Laboratory comply with current Department of Health and Human Services policy requirements to provide written assurances acceptable to the Office for Protection from Research Risks, National Institutes of Health, Department of Health and Human Services. The specific instructions for preparation of such assurances are set forth in 45 CFR Part 46.103. The assurance must include statements of the responsible campus or Laboratory official (generally, the Chancellor or Laboratory Director) which certify (a) the institution's discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution, regardless of source of funding, (b) the designation of one or more Institutional Review Boards (IRBs) established in accordance with HHS requirements, including a list of the IRB members identified by name and qualifications, and (c) the written procedures which the IRBs will follow. Detailed requirements of these elements and other assurance requirements are presented in 18-251 through 18-254.

18-251 Statement of Principles

The assurance must contain a statement of principles governing the campus' or Laboratory's discharge of its responsibilities for protecting the rights and welfare of human subjects in research and may include an appropriate existing code, declaration, or statement of ethical principles, or a statement formulated by the campus itself. The University has adopted and incorporated the Belmont Report (see 18-210 and 18-F11) as its basic statement of ethical principles in its human subjects policy. Refer to 18-X01, Declaration of Helsinki and 18-X02, Nuremberg Code, as other examples of universally accepted statements of ethical principles concerning human subjects in research.

18-252 Designation of IRBs and Membership

The assurance must designate one or more IRBs to be responsible for carrying out the campus' or Laboratory's human subject policies, for which there has been provided sufficient resources for meeting space and staff to support the IRB's review and recordkeeping duties. The assurance must also contain a list of the IRB members identified by name; earned degree; indication of experience such as board certifications, licenses, etc., sufficient to describe each member's chief anticipated contributions to IRB activities; and the employment relationship with the institution.

18-253 Written Procedures to be Followed by IRBs

The assurance must include the written procedures which the IRB will follow for conducting its initial and continuing review of research and for reporting its findings and actions to investigators and the institution. The assurance should discuss the IRB verification procedures, methods for insuring prompt reporting of changes in a research activity, and the reporting of unanticipated problems involving risks to subjects and others.

18-254 Submission of Assurances and Changes in IRB Membership

In accordance with HHS policy, assurances and changes in IRB membership are to be submitted to the Office for Protection from Research Risks, National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland 20892. See 18-240 concerning University requirement for General Counsel review of assurances prior to submission to HHS.

18-260 the Human Subjects Institutional Review Board (Irb)

As discussed in 18-252, each campus and Laboratory must designate one or more IRBs to be responsible for carrying out the institution's human subjects policies. The IRB must be established and function in accordance with current HHS policy requirements as summarized in 18-261 through 18-262.

18-261 Composition of Committee Membership

Each campus or Laboratory is to appoint one or more IRBs in accordance with prescribed HHS policy. The IRB shall consist of no fewer than five members with varying backgrounds, some of whom should possess the professional competence to review specific research and teaching activities. The composition of the IRB shall be consistent with current HHS requirements which specify that:

a. Each IRB shall include at least one member whose primary concerns are in nonscientific areas; for example: lawyers, ethicists, members of the clergy.

b. Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.

No IRB may consist entirely of men or entirely of women, or entirely of members of one profession. Also, no IRB may have a member participating in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. An IRB may, at its discretion, invite individuals with competence in special areas to assist in the review of complex issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.

18-262 Responsibilities and Functions

The responsibilities and functions of the IRB are to be consistent with current HHS requirements. The primary duties are summarized as follows:

a. Review and Approval of Proposed Research Projects

The IRB has the responsibility to review, approve, disapprove, and when necessary require the PI to modify proposed research involving human subjects at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. Expedited review procedures involving research with minimal risk are to be in compliance with current HHS requirements. Research activities which are exempt from the regulations are specified in Section 46.101(b), 45 CFR Part 46, Subpart A.

The IRB is responsible for notifying investigators and the responsible Contracts and Grants Officer in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the proposed research activity is disapproved, the IRB shall include in its written notification a statement of the reasons and provide the investigator an opportunity to respond in person or in writing.

An IRB shall require documentation of informed consent or may waive documentation in accordance with current HHS policy (Refer to 18-F13, "Informed Consent" and Section 46.117, 45 CFR Part 46, Subpart A).

An IRB has a responsibility to conduct continuing review of research covered by University policy and HHS regulations appropriate to the degree of risk, but no less than annually, and should have authority to observe or have a third party observe the consent process and the research as appropriate.

b. Reporting of Noncompliance

The IRB also has the responsibility for reporting to appropriate institutional officers and to the Secretary of HHS any serious or continuing noncompliance by investigators with the requirements and determinations of the IRB.

c. IRB Authority to Suspend or Terminate Research

The IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. The IRB's action of suspension or termination shall be reported promptly to the investigators, appropriate institutional officers, and the Secretary of HHS.

18-270 Other Institutional Requirements

18-271 Cooperative Research
When the University contracts or subcontracts research to a cooperating institution, the University as a grantee or prime contractor is committed to and remains responsible for safeguarding the rights and welfare of human subjects. The University may use joint review, seek reliance upon the review of the qualified IRB at the cooperating institution, or undertake other appropriate arrangements aimed at protecting the rights of human subjects in research.

18-272 Records Retention, Inspection and Copying

a. Records Retention

The University keeps and maintains systems of records and documentation (i.e., minutes, correspondence, approved consent documents, et al) of IRB activities. IRB records relative to research funded by Federal agencies or regulated by FDA are generally required to be retained for at least 10 years after completion of the research, unless otherwise specified in the award agreement. However, records relating to VA research are considered Federal Records and are currently considered unscheduled Federal Records. As unscheduled records, the original format of the record must be retained as the official recordkeeping copy until a proposed record retention and disposition schedule is submitted for review, appraisal, and approval by the National Archives and Record Administration (NARA).

b. Inspection and Copying

The IRB records under Federally-funded or regulated projects shall be accessible for inspection and copying by authorized representatives of HHS/FDA and the Federal sponsor at reasonable times and in a reasonable manner. In the case of projects funded by non-Federal sponsors, IRB records shall be retained and be accessible for inspection and copying by the sponsor in accordance with applicable law and University policy. If required to negotiate inspection, access or copying provisions for IRB or other academic research records under a non-Federal agreement, Contracts and Grants Officers should contact the Coordinator of Information Practices and Special Projects in the Office of the President, who is responsible for policy review of such matters. As a matter of University policy, privacy of records and access to records are governed by the Federal Privacy Act, the State Public Records Act, and the State Information Practices Act. (Refer to Business and Finance Bulletin RMP-8, "Legal Requirements on Privacy of and Access to Information").

For rights of the public to inspect and copy University records, see Chapter 17 of this manual.

18-273 Verification of IRB Approval by Contracts and Grants Officers

In accordance with 18-262 above, the IRB shall advise the responsible Contracts and Grants Officer of IRB approval of an application or proposal to an extramural sponsor involving the use of human subjects.

For HHS applications and proposals the responsible Contracts and Grants Officer shall comply with submission of HHS Form 596 (or equivalent verification form) to indicate that the application or proposal has been reviewed and approved by the IRB in accordance with the campus' or Laboratory's (and when applicable, the cooperating institution's) approved HHS General Assurance(s). For non-HHs applications or proposals, the verification of IRB approval shall be submitted in accordance with the individual sponsoring agency's prescribed format and timing requirements.

If conditional approval is granted by the IRB subsequent to the submission of the application or proposal, the sponsor must be informed of any modifications to the proposal or application, as prescribed by the IRB.