Chapter 18: Protection of Research Subjects

Chapter 18 provides guidance on policies and administrative procedures that comply with governmental regulations applicable to research subjects protections.

Revision History

Archive of Chapter 18 prior to September 16, 2021:The changes in this chapter, specifically 18-200, conform with the revised Protection of Human Subjects in Research Policy issued on November 6, 2020.

18-100 Introduction

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

18-300 University Policy for Medical Treatment of Human Subjects for Injuries Resulting from Participation in Research

18-400 University Policy on the Use of Animals in Research and Teaching

18-999 Related University References

18-100 Introduction

The University is committed to the principle of protecting the rights of human subjects participating in research and related activities. The University has established policies and administrative procedures which comply with governmental regulations applicable to human research subjects. In addition, the University is committed to maintaining high standards for the care and use of animals in research and teaching and has adopted policies and procedures which conform to governmental regulations on the humane care and use of laboratory animals.

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

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

The revised Presidential Policy on the Protection of Human Subjects in Research was issued on November 6, 2020.

18-210 Basic Policy

UC 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 and protections provided in 45 CFR Part 46 (also known as the “Common Rule”) UC recognizes and accepts responsibility, which it shares with its investigators and other researchers, for conducting human subjects research in a manner that fulfills these ethical principles and protections.

18-220 Applicability of Governmental Regulations and Policies to Human Subjects Research

In order to safeguard the rights and welfare of human subjects in research, UC follows the ethical principles of the Belmont Report and adheres to all applicable federal or state law or regulations, and University policies and guidelines governing the participation and protection of human subjects in research. Coupled with this responsibility, each University of California location, which includes all 10 campuses and the Lawrence Berkeley National Laboratory, holds a current Federalwide Assurance filed with the Department of Health and Human Services Office of Human Research Protection (OHRP) for the protection of human subjects. This assurance applies to all research with human subjects in which the University is engaged and that is funded or supported by a federal agency that has adopted the Common Rule, regardless of the site of the activity.

The University’s commitment to protecting human subjects applies to all human subjects research in which it is engaged, regardless of funding source or the institution that provided the IRB review. When engaged in research that is not subject to the Common Rule (because, e.g., the research is not federally funded), each UC location may replace specific Common Rule requirements with commensurate protections for human subjects so long as the University follows the ethical principles referenced above and that those commensurate protections are consistent with other applicable federal or state laws.

All University of California faculty and staff who are conducting research involving human subjects within the course and scope of their University duties, as well as University of California students who are conducting research involving human subjects within the course and scope of their University studies, regardless of whether the research is funded and regardless of the source of funding, must submit human subject research protocols to the IRB for approval or follow campus policies and/or procedures for obtaining an exempt determination prior to commencing research.

18-230 UC Policies and Guidance related to Human Subject Research Protection

UC policies and guidance documents related to human subjects research protections can be found on the RPAC website.

18-240 Other Institutional Requirements

18-241 Cooperative Research and Single IRB Review

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.

Federally-funded cooperative human subjects research are required to utilize a single IRB of Record (sIRB), unless more than single IRB review is required by law or any Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context. For NIH-funded multi-site research, the study team must designate the sIRB as part of the grant application at the time of proposal submission. For research sponsored by other Federal agencies, the lead institution may propose the sIRB, but the funding agency officially will designate which institution will act as the sIRB. IRB fees should be budgeted according to campus practices.

18-242 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 must, per UC’s Records Retention Schedule (see Section 0012B5*), be retained for at least 10 years after completion of the research, unless otherwise specified in the award agreement.

The 10-year retention period for all IRB administrative records reflects a policy decision adopted in the UC Records Retention Schedule. Previous guidance specified that all categories of IRB administrative records were to be kept for 3 years, except for records relating to: 1) children as research subjects (which were to be kept for 7 years after the child reaches the age of maturity), and 2) research pertaining to in vitro studies or pregnant women (which were to be kept for 25 years). The separate retention periods for research pertaining to children and in vitro/pregnant women were not based on any statutory or regulatory requirement. UC replaced those separate retention periods with the current uniform 10-year retention period (which, it should be noted, exceeds the minimum 3-year retention period specified in 45 CFR 46.115 and 21 CFR 56.115).

b. Inspection and Copying

18-243 Grant Congruency Reviews

Prior to 2018, the Common Rule explicitly required that IRBs complete a review of Federally-funded proposals that involved human subjects research in order to ensure that the proposed research is consistent with any relevant protocol(s) submitted to, or previously approved by, the IRB. Federal regulations no longer require the IRB to review grant applications to ensure congruency.

However, grant congruency remains an institutional responsibility when required by funding agencies. Each campus must determine which office remains responsible for completing a grant vs. IRB protocol review to assess the congruency between funding proposals and IRB protocols.

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18-300 University Policy for Medical Treatment of Human Subjects for Injuries Resulting from Participation in Research

University policy for medical treatment of human subjects for injuries resulting from participating in research, which was issued by Presidential Memorandum, January 19, 1979, is restated in part in 18-310 through 18-340. (See Contract and Grant Memo for full text copy).

18-310 Provisions of Medical Treatment or Reimbursement of Medical Costs

The University of California will provide to any injured subject any and all medical treatment reasonably necessary for any injury or illness which a human subject suffers as a direct result of participation in an authorized University activity covered by University policy on the protection of human subjects in research or reimburse the subject for the costs of such treatment, except when the injury or illness is a consequence of a medical research procedure which is designed to benefit the subject directly.

18-320 Conditions of the University's Obligation to Provide Medical Treatment

The obligation of the University undertaken in paragraph 18-310 shall be subject to the following conditions:

a. It must be demonstrated that the injury resulted directly from participation in the specified activity.

b. Written notification of any such injury is to be given to the University by the human subject within a reasonable time after discovery.

c. Any claim for reimbursement is to be supported by appropriate documentation.

18-330 Preference of Location for Medical Treatment

It is the preference of the University that the medical treatment available under this policy be provided at a University of California medical facility.

18-340 Designation of Contact Person or Office

Chancellors and other chief administrators, as appropriate, shall designate an individual or office as a contact for inquiries about implementation of this policy.

18-350 Funding Source for Payment of Medical Claims

It is recognized that the University's policy to provide medical treatment for injured subjects establishes a potential unfunded liability exposure for the University. This is distinct from the University's Professional and Medical Liability Self-Insurance program. The decision on an appropriate fund source with respect to a claim for medical expenses will be made on a case-by-case basis. When it can be ascertained that the claim can be treated as an allowable cost to the organization or entity financing the research, the University, as a matter of policy, shall seek to pass along the cost of the claim to the research sponsor.

18-360 Compensation of Human Subjects for Injury

Except for claims arising from demonstrated negligence on the part of the University, the University's current policy does not provide for compensation of injured subjects through payments for lost wages, cost of pain and suffering, or additional expenses beyond those of medical care. Any compensation claims received for reimbursement of costs and expenses beyond the provision of medical care and not covered under the University's Professional and Medical Liability Self-Insurance program (malpractice) must be handled on a case-by-case basis in consultation with the Office of General Counsel of The Regents and the Office of the Senior Vice President--Academic Affairs.

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18-400 University Policy on the Use of Animals in Research and Teaching

University policy on the use of laboratory animals in research and teaching, which was issued by Presidential Memorandum October 15, 1984, is restated in 18-410 through 18-440. (See Contract and Grant Memo for full text copy).

18-410 Basic Policy

The University of California recognizes the importance of the use of animals in its research and teaching programs. Animals are vital both for understanding basic biological processes and in developing treatment for human and animal diseases.

The University, committed to maintaining high standards for the care and use of animals in research and teaching, therefore adopts as its own principles the National Institutes of Health (NIH) "Principles for Use of Animals" (see 18-F21). The University, including its investigators and researchers, accepts responsibility for determining that research and teaching involving the use of animals fulfill these principles.

18-420 Applicability of Governmental Policies and Regulations to All Research

It is University policy that University practices for the procurement, housing and care of laboratory animals shall conform to the NIH Guide for the Care and Use of Laboratory Animals in Research (see 18-F22) and all requirements and all regulations issued by the United States Department of Agriculture (USDA), including regulations implementing the Animal Welfare Act (P.L. 89-544) as amended (see 18-F23). The Chancellor, Vice President or Director shall take appropriate action to meet such standards. The policy applies to all research and teaching irrespective of whether the research is funded from extramural or internal sources.

18-430 Responsibility for Policy Compliance and Implementation

The Chancellors, the Directors of the Department of Energy Laboratories, and the Vice President--Agriculture and Natural Resources are responsible for compliance with this policy in their institutions. They are authorized to take appropriate action for those activities under their jurisdiction to implement regulations required by all funding and regulatory agencies on the care and use of animals in research and teaching. Each Chancellor and Director and the Vice President shall establish implementing procedures including an animal research committee to assure adequate review of animal facilities, procedures, research and teaching protocols. The composition of the Committee is to be in accordance with current PHS policy requirements (see current requirements listed at 18-461.)

The Senior Vice President--Academic Affairs is responsible, on behalf of the President, for assuring University compliance with the policy and for developing any modifications or exceptions to policy as appropriate.

18-440 Aaalac Accreditation

All facilities in which animals are housed shall be fully accredited by the American Association for the Accreditation of Laboratory Animal Care (AAALAC) or the Chancellor, Vice President, or Director shall take appropriate action to achieve such accreditation.

[AAALAC certifies campus/Laboratory compliance with the provisions of the Animal Welfare Act and with additional standards of animal care, some of which are specified by federal agencies. Accreditation reviews are conducted every three years and include inspection of animal holding facilities and surgical facilities, review of animal protocols, veterinary inspection procedures, and animal census reports. Compliance requires submission of an annual report that includes a census of animals used in research and teaching.]

18-450 Animal Welfare Assurances

Campuses and Laboratories must satisfy PHS policy requirements for submission of written Animal Welfare Assurances acceptable to NIH. The specific instructions for preparation of such assurances are set forth in Chapter 1-43 of the HHS Grants Administration Manual. The assurance must include statements by the responsible institutional official (generally, the Chancellor or Laboratory Director) indicating (a) acceptance of the PHS "Principles for the Care and Use of Laboratory Animals", (b) implementation of the requirements of the Guide for the Care and Use of Laboratory Animals, and (c) compliance with the Animal Welfare Act and all other relevant Federal statutes and regulations on animal welfare. Other requirements of the Assurance are listed in a. through c. below.

a. Program for Animal Care and Use

The assurance must contain a description of the campus" or Laboratory's program for animal care and use, designating appropriate lines of authority and responsibility for administering the program along with ensuring compliance with PHS policy. It should also designate the veterinarian(s) qualified in laboratory animal medicine who will be responsible for supervising the housing, feeding, care, and use of all animals; the names, positions, titles, and credentials of the Animal Research Committee (ARC) members, the ARC Chairperson; and the responsible institutional official.

b. Institutional Status

The assurance must include a statement indicating that the campus or Laboratory has adopted one of the following options:

(1) Option 1

The campus or Laboratory is fully accredited by the American Association for Accreditation of Laboratory Animal Care (AAALAC).

(2) Option 2

The campus or Laboratory is not accredited by AAALAC but has conducted a self-assessment of its compliance with PHS policy (to be described in detail in the written assurance).

Any campus or Laboratory which has not received accreditation from AAALAC is required to submit an annual report to NIH which will become a part of its institutional assurance. In general, the contents of the annual report must cover a description of the nature and extent of adherence to the PHS policy, a description of deficiencies, if any, and a plan of action, including a specified time frame, for correcting all deficiencies. The annual report must also include the ARC recommendations for changes or improvements and be forwarded by the responsible campus or Laboratory official.

c. Submissions of Assurances, and Reports

In accordance with PHS policy, assurances, annual reports, changes in ARC membership, changes in the description of the institution's program or facilities for animal care or use, and reports on non-compliance with PHS policy are to be submitted to the Office for Protection from Research Risks (OPRR), National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland 20892. Each campus or Laboratory must submit a new and complete assurance to OPRR at least every 5 years. Changes in the ARC membership must be reported promptly to OPRR.

See 18-F23 for submission of certifications and reports to the U.S. Department of Agriculture that are required under the Animal Welfare Act.

18-460 Animal Research Committee and Other Institutional Requirements

As required under University policy, each Chancellor or Laboratory Director must designate an Animal Research Committee (ARC) to be responsible for carrying out the institution's animal subjects policies. The ARC must be established in accordance with current PHS policy requirements as presented in 18-461 through 18-465.

18-461 Composition of Committee Membership

The ARC shall consist of no fewer than five members with varying backgrounds. The composition of the ARC shall be consistent with current PHS policy. Among other things, the policy requires that at least one member shall be a licensed Doctor of Veterinary Medicine, with training or experience in laboratory animal science and medicine, who has direct or delegated program responsibility for activities involving animals at the institution; at least one practicing scientist experienced in research involving animals; at least one member whose primary vocation is in a nonscientific area; and one member shall be unaffiliated with the institution and not a member of the immediate family of a person who is affiliated with the institution.

18-462 Functions of the Animal Research Committee

The Animal Research Committee (ARC) appointed by the Chancellor or Laboratory Director is the principal advisory group on humane care and use of animals for the campus or Laboratory and to researchers who use animals. As necessary, the ARC will recommend to the Chancellor or Laboratory Director and other appropriate institutional officials, changes and improvements regarding the campus' animal program or facilities. (Annual reports to OPRR [required under Option 2, see 18-450 b.(2)] must include any ARC recommendations, as forwarded to the responsible institutional official).

a. Suspension of Research

Whenever the ARC determines that an activity involving animals is not in compliance with PHS policy or the Animal Welfare Act, the ARC may suspend the activity after review of the matter at a convened quorum with the suspension vote of a majority of the quorum present. The institutional official in consultation with the ARC should review the reasons for suspension, take appropriate corrective action, and report that action with a full explanation to OPRR.

b. Other Functions of the ARC

In the conduct of its duties, the ARC at a minimum shall:

(1) review at least annually the institution's program for humane care and use of animals'

(2) inspect at least annually all of the institution's animal facilities, including satellite facilities;

(3) review concerns involving the care and use of animals at the institution;

(4) make recommendations to the institutional official regarding any aspect of the institution's animal program, facilities or personnel training;

(5) review and approve, require modifications in (to secure approval) or withhold approval of those sections of applications or proposals related to the care and use of animals as specified in 18-463;

(6) review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the use of animals in ongoing activities; and

(7) be authorized to suspend an activity involving animals in accord with specifications set forth in 18-462 a.

18-463 Review of Research Applications and Proposals by the ARC

Review and approval of the care and use of animals as set forth in all applications or proposals is required pursuant to PHS and University policies. The ARC shall approve the application or proposal only when the care and use of animals has been reviewed and found to comply with PHS and University policies and with the conditions of the campus' or Laboratory's institutional assurance.

The care and use of animals as set forth in applications and proposals must be reviewed at a convened meeting of at least a majority of the full membership of the ARC and must be approved by a majority of the full membership. Requirements of such review are listed in Chapter 1-43 of the PHS Grants Administration Manual and in Chapter 1-43 of the HHS Grants Administration Manual.

18-464 Information Required in Applications and Proposals Involving Use of Animals

Applications and proposals submitted that involve the care and use of laboratory animals shall contain the following information:

a. identification of the species and number of animals to be used;

b. rationale for involving animals, and for the appropriateness of the species and numbers to be used;

c. a complete description of the proposed use of the animals;

d. assurance that discomfort and injury to animals will be limited to that which is unavoidable in the conduct of scientifically valuable research, and that analgesic, anesthetic, and tranquilizing drugs will be used where indicated and appropriate to minimize discomfort and pain to animals; and

e. a description of any euthanasia method to be used.

18-465 Records Retention, Inspection and Copying

Each campus or Laboratory shall maintain:

a. an assurance approved by the PHS;

b. minutes of ARC meetings, including records of attendance, activities of the committee, and committee deliberations;

c. records of applications, proposals and proposed significant changes in the care and use of animals and whether ARC approval was given or withheld;

d. records of any ARC reports and recommendations as forwarded to the institutional official; and

e. records of accrediting body determinations.

All records shall be maintained for at least three years; records that relate directly to applications, proposals, and propose significant changes in ongoing activities reviewed and approved by the ARC shall be maintained for the duration of the activity and for an additional three years after completion of the activity. All records shall be accessible for inspection and copying by authorized OPRR, PHS, and USDA representatives at reasonable times and in a reasonable manner.

With regard to projects funded by non-federal sponsors, ARC records shall also be retained and be accessible for inspection and copying by the sponsor in accordance with applicable law and University policy.

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

18-466 Verification of ARC Approval by Contracts and Grants Officers

The ARC shall advise the responsible Contracts and Grants Officer of approval of the proposed care and use of animals on extramurally funded projects. The Contracts and Grants Officer shall be letter of verification inform the sponsor that the application or proposal has been reviewed and approved by the ARC in accordance with the campus' or Laboratory's institutional assurance. If conditional approval is granted by the ARC subsequent to the submission of the application or proposal, the letter of verification must also inform the sponsor of any modifications to the proposal or application, as prescribed by the ARC.

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18-999 Related University References

Presidential Memorandum dated September 2, 1981, University Policy on the Protection of Human Subjects in Research
Business and Finance Bulletin RMP-8, Legal Requirements on Privacy of and Access to Information
Presidential Memorandum dated January 19, 1979, University Policy for Medical Treatment of Human Subjects for Injuries Resulting from Participation in Research
Presidential Memorandum dated October 15, 1984, University Policy on the Use of Animals in Research and Teaching
Contract and Grant Memo 86-21, Protection of Research Subjects--Source Documents (8/21/86)

Human Subjects

External Requirements Federal

18-F11 Belmont Report, "Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research"

Purpose
The Belmont Report summarizes the basic ethical principles identified by the National Commission in the course of its deliberations as mandated by the National Research Act of July 12, 1974 (P.L. 93-348). It is a statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects.

Applicability
The University of California has determined that the findings of the Belmont Report will apply to all human subject activities regardless of funding source for which the University is responsible.

Summary of Provisions
The summary of the provisions appears in 18-210.

University Policy Implementation and Primary University Responsibility
By Presidential policy memo dated September 2, 1981 the University of California adopted the ethical principles for the protection of human subjects set forth in the Belmont Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (see 18-210).

Primary responsibility for implementation is shared by Chancellors, Laboratory Directors, Institutional Review Boards, and Principal Investigators. The primary responsibility for judging or ascertaining if an extramural program or application falls under the provisions of the University's basic human subjects policy and has received the approval by the IRB rests with the Contracts and Grants Officers. For Office of the President activities and for policy review and compliance, the responsibility rests with the Senior Vice President--Academic Affairs or the Vice President--Agriculture and Natural Resources, as appropriate.

Human Subjects

External Requirements Federal

18-F12 Federal Regulations on the Protection of Human Research Subjects

Identification

The Department of Health and Human Services (HHS) has issued regulations pursuant to the National Research Act (P.L. 93-348), which are codified in the Code of Federal Regulations under 45 CFR, Part 46. There are four Subparts to Part 46 of the Code of Federal Regulations:

Subpart A - Basic HHS Policy for Protections of Human Research Subjects

Subpart B - Additional Protections Pertaining to Research, Development, and Related Activities Involving Fetuses, Pregnant Women, and Human In Vitro Fertilizations

Subpart C - Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects

Subpart D - Additional Protections for Children Involved as Subjects in Research

The Food and Drug Administration has issued regulations pursuant to the Federal Food, Drug and Cosmetic Act, which are codified in the Code of Federal Regulations under 21 CFR, Parts 50 and 56.

Purpose

To protect the rights and welfare of human subjects involved in biomedical and behavioral research which is supported by the Department of Health and Human Services.

Applicability

Federal regulations codified under 45 CFR, Part 46, are applicable to HHS grants and contracts supporting biomedical or behavioral research, development, and related activities which involve human subjects.

a. Relation to Other Federal Agencies: 45 CFR, Part 46 also applies to human subject research supported by funds from the DOD, Commerce, Energy, HUD, Justice, Agriculture, State, Transportation, Treasury, EPA, USF, VA, USIA, the Consumer Product Safety Commission, the Civil Service Commission, and NASA, which have all adopted 45 CFR, Part 46, in whole or in part, by reference.

b. Applicability of Governmental Regulations and Policies to All University Research: University policy in 18-220 extends the regulations set forth in 45 CFR, Part 46 to all University research involving human subjects, regardless of funding source.

Federal Regulations codified under 21 CFR, Parts 50 and 56 are applicable to clinical investigations regulated by the Food and Drug Administration.

Lead Agency for Interpretation of Guidance

Office for Protection from Research Risks (OPRR), Office of the Director, National Institutes of Health, is the lead agency responsible for:

a. interpreting the regulations for administrators, and for grantee and contractor institutions; and

b. responding to requests for clarification and guidance on ethical issues raised in connection with biomedical or behavioral research involving human subjects.

Summary of Provisions/required Compliance Mechanism

a. Description: Grantees or contractors requesting or receiving HHS support for activities involving human subjects are required to submit written assurance of compliance with regulations calling for institutional review of all activities involving human subjects, conducted or supported by the institution. Assurances are evaluated by OPRR. Grantees or contractors are also required to submit certification of review and approval of each activity involving human subjects to be supported by HHS.

Applications or proposals involving human subjects submitted to HHS are also evaluated for compliance by HHS and are subject to review and approval by appropriate Councils or Committees or other bodies as required by law. On the basis of any such evaluations, the Secretary of HHS may take further action or impose additional restrictions which in the judgment of the Secretary are necessary to protect human subjects.

The awarding agency is responsible for resolving any problems or questions raised in the review procedure.

b. Penalties for Non-Compliance: No activity involving human subjects can be supported or conducted by HHS without prior certification of review and approval by an institutional review board established in accordance with an assurance approved by HHS and concurred with by an official authorized to act on behalf of the recipient institution.

If an institution has failed materially to comply with respect to a particular grant or contract, the Secretary of HHS may terminate or suspend the grant or contract. In addition, the Secretary, in making any future awards, may take into account the previous record of an institution in discharging its responsibilities for the protection of the rights and welfare of human subjects in research at the institution, whether or not HHS funds were involved.

c. Burden of Proof: Written documentation in the form of an institutional assurance of compliance, approved and on file with OPRR and in the form of certification of review and approval of specific activities, is evidence of compliance. Monitoring of compliance is initiated on the basis of any indication of failure to protect the rights and welfare of subjects or of questions or complaints directed to OPRR. In the case of monitoring, the burden of proof of compliance falls on the recipient institution. The judgment of the Secretary of HHS is the final basis for determining compliance or non-compliance.

Primary University Responsibility

Primary responsibility for implementation of 45 CFR, Part 46 and related Federal regulations governing the protection of human subjects is shared by Chancellors, Laboratory Directors, Institutional Review Boards, and Principal Investigators. For Office of the President activities and for policy review and compliance, the responsibility rests with the Senior Vice President--Academic Affairs or the Vice President--Agriculture and Natural Resources, as appropriate.

University Policy Implementation

University policy implementation is located in 18-220.

Human Subjects

External Requirements Federal

18-F13 Informed Consent

Identification

45 CFR, Part 46, Subpart A (Section 46.116); and 21 CFR, Part 50 (Sections 50.20 and 50.25).

Purpose

To establish standards and compliance mechanisms for legally effective informed consent to permit the prospective subject or the representative sufficient opportunity to consider whether or not to participate as a subject in research without coercion or undue influence.

Applicability

Refer to 18-F12, "Applicability"

Summary of Provisions

Doctrine of Informed Consent

a. Definition

Informed consent means the knowing consent of an individual (or of a legally authorized representative when a vulnerable or dependent person is to be involved) to his or her participation in a research activity without coercion or undue influence. Consent information, oral or written, must be expressed with words and in a language which are understandable to the subject or the representative. The text of the consent information must not involve any exculpatory language through which the subject is made to waive, or to appear to waive, any legal rights, including release of the University or its agents from liability for negligence. All subjects or their authorized representatives must receive a copy of any consent document which has been completed by them.

B. Summary of Basic Elements of Informed Consent

(1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;

(2) A description of any reasonably foreseeable risks or discomforts to the subject;

(3) A description of any benefits to the subject or to others which may reasonably be expected from the research;

(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

(5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;

(6) For research involving more than minimal risk, an explanation as to whether any compensation or any medical treatments are available if injury occurs and, if so, what they consist of or where further information may be obtained;

(7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject (see University policy for Medical Treatment of Human Subjects for Injuries Resulting from Participation in Research at 18-300); and

(8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Additional elements of Informed Consent to be used when appropriate are summarized in section 46.116 (b), 45 CFR, Part 46, Subpart A and section 50.25(b), 21 CFR, Part 50.

c. Documentation of Informed Consent

Section 46.117, 45 CFR Part 46, Subpart A and section 50.27, 21 CFR, Part 50 require that informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative, with a copy given to the person signing the form. Section 46.117 of the HHS regulations permits waiver by the IRB of documentation for purpose of confidentiality when requested by the subject, or if the research presents no more than minimal risk or of harm and involves no procedures for which written consent is normally required.

The FDA does not permit waiver of documentation by the IRB.

Primary University Responsibility and University Policy Implementation

Refer to 18-F12, "Primary University Responsibility" and "University Policy Implementation."

Human Subjects

External Requirements--state

18-s01 Experimental Subject's Bill of Rights

Identification

Health and Safety Code, Section 24172

Applicability

Medical Experiments

Under California Health and Safety Code, Section 27172, all persons requested to take part in a "medical experiment" or any person asked to consent on behalf of another person's participation in a "medical experiment" must be given a copy of a specific bill of rights in a language in which the person is fluent. Health and Safety Code section 27176 provides for civil and criminal sanctions for researchers who do not comply with section 27172.

Medical experiment is defined in the law as:

a. the severance or penetration or damaging of tissues of a human subject or the use of a drug or a device as defined in the California Health and Safety Code, use of electromagnetic radiation, heat or cold, or use of a biological substance or organism, in or upon a human subject in the practice or research of medicine in a manner not reasonably related to maintaining or improving the health of such subject or otherwise directly benefiting such subject;

b. the investigational use of a drug or device licensed by the Federal Food and Drug Administration or the California Department of Health Services (when the study is being conducted under California law); or

c. withholding medical treatment from a human subject for any purpose other than maintenance or improvement of the health of such subject.

In preparing protocols for research projects covered by this law, the Institutional Review Board (IRB) may request that investigators indicate their intention to distribute the bill of rights to their prospective subjects, and add the following notice to their proposed written consent forms: "I acknowledge receiving and reading the Medical Research Subject's Bill of Rights," or words to this effect.

Summary of Provisions

Under the Experimental Subject's Bill of Rights, any person who is asked to consent to participate as a subject in a medical experiment or who is asked to consent on behalf of another, has the following rights:

a. To be told what the study is trying to find out.

b. To be told about what will happen in the study and whether any of the procedures, drugs or devices is different from what would be used in standard medical practice.

c. To be told about the risks, side effects or discomforts of the things that may happen to the subject.

d. To be told if the subject can expect any benefit from participating and, if so, what the benefit might be.

e. To be told what other choices are available and how they may be better or worse than being in the study.

f. To be allowed to ask any questions concerning the study both before agreeing to be involved and during the course of the study.

g. To be told what sort of medical treatment is available if any complications arise.

h. To refuse to participate at all, either before or after the study is started. This decision will not affect any right to receive the standard medical care.

i. To receive a signed and dated copy of the consent form and the Subject's Bill of Rights.

j. To be allowed to decide to consent or not to consent to participate without any pressure being exerted by the investigators or others.

Primary University Responsibility

The primary responsibility for implementing the requirements under this law are to be assumed by Principal Investigators engaged in "medical experiments" as defined by the law. The responsibility is also shared by the IRB which has a responsibility to review research involving human subjects in compliance with prescribed University policy and applicable law.

In accordance with 18-262 c., the IRB has authority to suspend or terminate research that is not being conducted in accordance with prescribed human subject requirements.

University Policy Implementation

There is no specific University policy relating to Health and Safety Code section 24172.

Human Subjects

External Requirements International

18-X01 The Declaration of Helsinki

(Adopted by the 18th World Medical Assembly, Helsinki, Finland, 1961, and as revised by the 29th World Medical Assembly, Tokyo, Japan, 1975).

"Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects"

Issuing Organization

World Medical Association

10 Columbus Circle

New York, New York 10019

Purpose

The Declaration, comprised of recommendations, was issued to establish standards of proper and responsible conduct of human experimentation in research.

Applicability

The standards established by the recommendations require voluntary adoption by medical doctors engaged in biomedical research involving human subjects. The recommendations are useful in helping to guide Institutional Review Boards' deliberations and decision making responsibilities.

Summary of Provisions

Full text copies of the Declaration are distributed by Contract and Grant Memo.

Primary Responsibility

Primary responsibility for determining whether the Standards and recommendations under the Declaration of Helsinki should be adopted for use rests with Chancellors, Laboratory Directors, Institutional Review Boards, and Investigators.

University Policy Implementation

Although the University's basic human subjects policy has specifically adopted only the Belmont Report as its statement on ethical principals, the use of other universally accepted declarations, codes, principles or even Statements formulated by campuses or laboratories are permissible.

Human Subjects

External Requirements--international

18-X02 "NUREMBERG CODE"

Issuing Organization

Nuremberg Military Tribunals: U.S. v. Karl Branch

USA Reference

Trials of War Criminals Before the Nuremberg Military Tribunals, Vol. II, pp. 181-82; U.S. Government Printing Office 1949. (Text from which the "Nuremberg Code" is derived).

Purpose

The Code was established as a result of the outcome of World War II to establish the proper and responsible conduct of human experimentation in research.

Applicability

The standards established by the Code require voluntary adoption. The standards prescribed by the Code are useful in helping to guide Institutional Review Boards' deliberations and decision making responsibilities.

Summary of Provisions

Full text copies of the Code are distributed by Contract and Grant Memo.

Primary Responsibility

Refer to 18-X01

University Policy Implementation

Refer to 18-X01

Animal Subjects

External Requirements Federal

18-F21 Public Health Service Policy on Humane Care and Use of Laboratory Animals

Identification

Vol. 14, No. 8, NIH guide for Grants and Contracts, June 25, 1985; Chapter 1-43, "Animal Welfare", HHS Grants Administration Manual; and Chapter 1-43, "Animal Welfare", PHS Grants Administration Manual

Purpose/applicability

The purpose of the Policy, as revised, effective December 31, 1985, is to describe the responsibility of institutions for establishing and maintaining proper measures to ensure the appropriate care and use of all animals involved in research, research training, and biological testing activities supported by the Public Health Service (PHS). The policy is applicable to all PHS-supported activities involving animals, whether the activities are performed at an awardee institution or any other institution. Through University policy implementation at 18-420 the PHS policy applies to all University research and teaching irrespective of whether the research is funded from extramural or internal sources.

Summary of Provisions

Humane care and use of animals in PHS-awarded projects is the responsibility of investigators and institutions receiving awards. The policy prescribes that no award will be made to any institution for use of animals or animal facilities unless a responsible official of that institution has submitted an acceptable assurance to the Office of Protection from Research Risks, National Institutes of Health, PHS, and until the institutional animal care and use committee has reviewed and approved those sections of applications for PHS funds that relate to the care and use of animals. Other pertinent provisions of the Policy are summarized in the University's basic policy issuance at 18-450 through 18-465. Full text of the Policy is published in the NIH Guide and in the PHS and HHS Grants Administration Manuals.

Primary University Responsibility

Primary responsibility for assurance that University practices for the care and use of animals conform to the PHS Policy on Humane Care and Use of Laboratory Animals is shared by Chancellors, Laboratory Directors, Animal Research Committees, and investigators utilizing animals in their research or other activities. Primary responsibility for policy review rests with the Senior Vice President--Academic Affairs.

University Policy Implementation

University implementation of this policy is located at 18-410 through 18-440.

Animal Subjects

External Requirements Federal

18-F22 NIH Guide for the Care and Use of Laboratory Animals

Identification

NIH Publication No. 85-23, Revised 1985, NIH Supplement Guide for Grants and Contracts, Vol. 14, No. 8, June 25, 1985, Special Edition

Purpose

The purpose of the Guide is to assist scientific institutions in using and caring for laboratory animals in ways judged to be professionally appropriate. The recommendations are based on scientific principles, expert opinion, and experience with methods and practices that have proved to be consistent with high quality animal care. The Guide conforms to the prescribed standard for animal care required by the Animal Welfare Act and is the accepted primary reference on standards on animal care for the scientific community.

Applicability

The Guide is implemented under University policy in 18-420 and applies to all University practices and activities involving the procurement, housing, and care of animals.

Summary of Provisions

The Guide provides information and recommendations for the care and use of animals under four broad areas:

a. Laboratory Animal Management

(1) Housing

(2) Sanitation

(3) Husbandry

b. Laboratory Animal Quality and Health

(1) Veterinary Care

(2) Multiple Survival Surgery

(3) Genetics

(4) Nomenclature

(5) Environmental Factors affecting Laboratory Animals

c. Institutional Policies

(1) Monitoring the Care and Use of Animals

(2) Veterinary Care

(3) Personnel Qualifications

(4) Personal Hygiene

(5) Occupational Health

(6) Experimentation Involving Hazardous Agents

d. Physical Plant

(1) Functional Areas

(2) Service Areas in Relation to the Total Size of the Animal Facility

(3) Physical Relationship of Animal Facilities to Research or Teaching Labs

(4) Construction Guidelines

(5) Aseptic Surgery

(6) Large Domestic Animals

(7) Special Facilities for Conducting Animal Research with Hazardous Agents

(8) Space Recommendations for Laboratory Animals

Primary University Responsibility

Primary responsibility for assurance that University practices for the housing and care of animals conform to the NIH Guide for the Care and Use of Laboratory Animals in Research is shared by Chancellors, Laboratory Directors, Animal Research Committees, and investigators utilizing animals in their research or other activities. Primary responsibility for policy review rests with the Senior Vice President--Academic Affairs.

University Policy Implementation

The University policy implementation of the Guide is located in 18-420.

Animal Subjects

External Requirements Federal

18-F23 Animal Welfare Act

Identification

Title 7 United States Code, section 2131 et seq.

Regulations and standards implementing this requirement have been published and subsequently amended on several occasions and are contained in Title 9, Code of Federal Regulations, Subchapter A, Parts 1, 2, 3.

Purpose

To ensure that Federally established minimum standards for the humane care and handling of warmblooded animals are observed by common carriers, intermediate handlers, research facilities, dealers, exhibitors, and other users of animals falling under the purview of the Animal Welfare Act, and to prohibit the cruel practice of holding animal fighting events.

Applicability

Applicable to: All research, teaching, testing or experimentation using warmblooded animals where Federal funds or commerce are involved, including Federal, State, local government, academic, industrial, or private entities. All persons involved in buying, selling, transporting or holding warmblooded animals for purposes of research, exhibition or for use as pets at the wholesale level. All persons involved in live animal transportation. Persons involved in prohibited animal fighting ventures.

Under the provisions of the Animal Welfare Act (as amended) the care of animals housed by "research facilities" (includes universities, medical schools, hospitals and other research centers) is regulated by the U.S. Department of Agriculture. The Secretary of Agriculture has been authorized to promulgate regulations to ensure that animals intended for experimentation in "research facilities" are provided humane care and treatment. (The Act does not cover the "design, outlines, guidelines, or performance of the actual research experimentation" to be carried out or determined by the Principal Investigator of a research project). Implementing rules and regulations are published in the Code of Federal Regulations, Title 9, Subchapter A--Animal Welfare, Parts 1, 2 and 3. All amendments to the rules and regulations are periodically published in the Federal Register under the heading, Department of Agriculture, Animal and Plant Health Inspection Services.

Excluded from Coverage: Individual pet owners, members of breed fanciers selling at retail only, certain retail pet stores, rodeos, purebred animal shows, birds, rats, mice, domestic farm animals.

Summary of Provisions

a. Registration Requirement

In accordance with the provisions under the Act the University has registered as a "research facility" with the U.S. Department of Agriculture, Area Veterinarian in Charge, State of California. The registration No. 9344 is under the University's legal corporate name, The Regents of the University of California, and covers the operation of all research facilities of the University. As a registrant under the Act, the University has agreed to comply with all applicable standards under the Act. The "registration" with the Department of Agriculture should not be confused with, and does not substitute for, the "accreditation" process administered by AAALAC (see 18-440).

b. Compliance Mechanism

Compliance is attained by making periodic unannounced inspections of USDA licensees and registrants and making written reports of such inspections. Unannounced inspections are made of each licensee or registrant as frequently as needed to bring them into full compliance with the Act, its standards, and regulations.

(1) Penalties for Non-Compliance: Penalties for non-compliance are based on the severity of the situation. In severe instances of non-compliance, penalties include a cease and desist order, 21-day summary license suspension, license suspension which remains in effect until full compliance is gained, $1,000 civil penalty, and license revocation. In less severe instances, a letter of warning is usually issued unless the licensee or registrant has a history of noncompliance.

(2) Burden of Proof: The burden of proof lies with the Federal Government to show recipient noncompliance. This is done most typically by recorded inspection reports. Photographs, witness affidavits and other investigatory measures are undertaken as circumstances dictate.

c. Records and Inspection

In accordance with the provisions under the Act, the University is required to keep and maintain systems of records on various live animals which it acquires and to follow authorized retention schedules on such records as promulgated by the Secretary of Agriculture (see 18.465).

The University is required during ordinary business hours to permit Veterinary Services representatives, and other Federal officers or employees designated by the Secretary of Agriculture to examine records required to be kept pursuant to the Act, to make copies of such records, and to inspect University facilities, property and animals.

d. Reports Required Under the Animal Welfare Act

Compliance requirements under the Act include submission by campuses and Laboratories of an animal census on the total numbers of laboratory animals used in research and teaching; assurance on the humane treatment of animals regarding the minimizing or eliminating of pain during an experiment; and certification by the institutional Veterinarian that rules pursuant to the Act are being followed. The Act requires that each campus or Laboratory shall submit the report signed by a "legally responsible official" to the Veterinarian in Charge for the State of California, on or before December 1 of each calendar year covering the previous Federal fiscal year of October 1 through September 30.

e. Veterinarian in Charge for the State of California

The cognizant USDA office having oversight responsibilities for the University's compliance with the Animal Welfare Act is as follows:

U.S. Department of Agriculture
Animal and Plant Inspection Service
83 Scripps Drive
Sacramento, California 95825
Attention: Area Veterinarian in Charge

(916) 484-4891

This office has responsibility for carrying out the U.S. Department of Agriculture's regulations under the Animal Welfare Act for the State of California, including requirements for audit, inspections, and receipt of annual reports.

Primary University Responsibility

For policy review and satisfying the registration requirements, the primary responsibility rests with the Senior Vice President--Academic Affairs who has registered the University under its legal corporate name, The Regents of the University of California. For satisfying all other requirements and standards under the Act (including maintenance of specified records systems, submission of annual reports, and upholding prescribed standards on humane care and treatment of animals), the responsibility is shared by Chancellors, Laboratory Directors, Animal Research Committees, and Investigators utilizing animals in their research.

University Policy Implementation

By Presidential policy memo dated October 15, 1984, the University's basic policy on the use of animals in research and teaching provides that "...University practices for the procurement, housing and care of laboratory animals shall conform to the NIH Guide for the Care and Use of Laboratory Animals in Research (DHEW 78-23), reprinted in 1980 (DHEW 80-23 or succeeding editions) (see 18-F09), all requirements of the United States Department of Agriculture (USDA), and all regulations issued by the USDA implementing the Animal Welfare Act (P.L. 89-544) as amended...."

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