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XII. Research Protocols

 

Animal Research

Animal research at UCSC is under the auspices of the Chancellor’s Animal Research Committee. In accordance with various sponsoring and public regulatory agencies, this committee regularly reviews all matters relating to animals for research and teaching purposes. The committee must assure that the use of animals considers both scientific and humane values. Recommendations are made to the Division of Physical and Biological Sciences dean regarding the adequacy of the animal resource facilities and programs in conforming to all applicable laws, regulations, and guidelines.

There are many regulations and policies that affect the use of animals in research, teaching, and testing programs. Accordingly, the university has both legal and ethical obligations to review all use of animals on or off campus. This includes observation, contact, and manipulation of living or dead animals, or significantly altering their environments. University of California Policy, the Animal Welfare Act (and its 1985 amendments), and the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (otherwise known as the National Institutes of Health (NIH) Policy), require appointment of an Institutional Animal Care and Use Committee (IACUC) to oversee the animal care and use program. The IACUC for this campus is named The Chancellor's Animal Research Committee (CARC). Federal funding agencies require IACUCs to approve proposals for the care and use of animals before funds will be awarded. An institution's failure to comply with these regulations and policies may lead to various actions, including the termination of support for all projects.

As the Institutional Animal Care and Use Committee (IACUC) at UCSC, CARC's functions are clearly defined:

  1. Review of all proposed uses of vertebrates for research, teaching, and testing to ensure that research is appropriate and animals are treated humanely;
  2. Review and development of institutional policy on care and use of laboratory animals;
  3. Semiannual inspection and review of UCSC's animal facilities and program for the humane care and use of animals using the current edition of the NIH Guide for the Care and Use of Laboratory Animals (Guide) as a basis for evaluation;
  4. Support the attending veterinarians' functions;
  5. Review of specific concerns or complaints about animal care or use.;
  6. Present recommendations to the institutional official (the dean of the Division of Natural Sciences) regarding all aspects of UCSC's animal care and use program. Significant deficiencies in the institution's program must be identified, and the institution must adhere to an approved plan and schedule for correction of the deficiencies;
  7. Authority to suspend any activity involving the use of animals which is not being conducted in accordance with the current edition of the Guide standards, or with applicable laws, regulations, or institutional policies.

The "US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training" were developed by the US Government's interagency research animal committee. Both PHS Policy and university policy require that all uses of animals conform to these principles:

  1. The transportation, care, and use of animals should be in accordance with the Animal Welfare Act (7 U.S.C. 2131 et. seq.) and other applicable federal laws, guidelines, and policies.
  2. Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society.
  3. The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results. Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered.
  4. Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative. Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals.
  5. Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. Surgical or other painful procedures should not be performed on unanesthetized animals.
  6. Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painlessly killed at the end of the procedure, or, if appropriate, during the procedure.
  7. The living conditions of animals should be appropriate for their species and contribute to their health and comfort. Normally the housing, feeding, and care of all animals used for biomedical purposes must be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied. In any case, veterinary care shall be provided as indicated.
  8. Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. Adequate arrangements shall be made for their inservice training, including the proper and humane care and use of laboratory animals.
  9. Where exceptions are required in relation to the provisions of these Principles, the decisions should not rest with the investigators directly concerned, but should be made with due regard to Principle II by an appropriate review group, such as the institutional animal research committee. Such exceptions should not be made solely for the purposes of teaching or demonstration.

The privilege of using animals for research, teaching, and testing is accompanied by both ethical and legal responsibilities to use them appropriately, both scientifically and humanely. Individual faculty members who use animals in their research or teaching (including those whose research consists of field work involving animals) are, by law, accountable for conforming to the basic regulations and policies governing animal use on this campus. These regulations and policies cover:

  1. the acquisition, care, and use of animals;
  2. efforts to minimize animal pain and distress;
  3. the training of personnel using animals;
  4. consideration of alternatives to animal use; and
  5. methods whereby deficiencies in animal care and treatment are reported

For your own protection, and for the protection of this institution, faculty who use animals must know, understand, and comply with applicable laws, regulations, and policies. Furthermore, you are responsible for properly instructing your students and employees. The laws governing the use of animals, like those governing other regulated activities, are framed to ensure compliance via both civil and criminal laws. Failure to comply can carry penalties that range from substantial fines to "cease and desist" orders that can suspend all animal research, and all funding for animal research, at the offending institution. These regulations are typically applied against an entire institution, thus the innocent are punished as well as the guilty. These regulations are not subject to negotiation or individual interpretation by investigators. Both the professional reputation and the financial well-being of institutions which have failed to comply have suffered. For these reasons, the prudent investigator will be attentive to complying with these regulations and will encourage colleagues to do the same. As a matter of educational policy, faculty who do not themselves use animals should be aware of these regulations and policies, since their students may use animals at a later time. Likewise, instruction of students in proper animal use is an essential component of graduate-level science education.

Human Subjects in Research

The UCSC Institutional Review Board has responsibility for reviewing all research involving human subjects conducted at or sponsored by the University of California at Santa Cruz regardless of the source of funding. Further details about what constitutes research are provided below.

If you are doing Human Subjects Research

If the proposed research will involve human subjects, you must submit a Human Subjects Protocol or a Request for Exemption. The protocol must be reviewed and approved by the UCSC IRB before the research begins.

Failure to comply with these rules may have serious consequences, including the suspension or termination of research, allegations of research misconduct, and personal civil and criminal liability.

PLEASE NOTE THERE ARE NO PROVISIONS FOR RETROACTIVE APPROVAL OF RESEARCH PROTOCOLS. If research is begun without UCSC IRB approval, upon discovery of the error, the researcher must stop the research and notify the UCSC IRB immediately. The researcher must then submit a protocol to the UCSC IRB along with a detailed explanation as to why the protocol was not submitted at the appropriate time. If the researcher is a student, a detailed letter from his or her faculty advisor must accompany the materials submitted to the UCSC IRB. NOTE: If the above situation occurs, conducting further research, spending research funds, using data already collected, or filing a thesis may be disallowed.

Determining whether you are doing Human Subject Research

To determine whether you are conducting human subjects research:

  1. Determine whether the activity constitutes “research.”
  2. Determine whether the research involves “human subjects.”

Research: a systematic investigation designed to develop or contribute to generalizable knowledge. Pilot studies and screening tests are usually considered part of "research."

Research does not include:

  • Instruction,
  • Surveys for evaluating the performance of faculty, staff, and students, or other studies for institutional use only,
  • Student course work or undergraduate honors theses, unless they are to be made available to the public or used by other researchers. Even when student work involving human subjects does not constitute research, faculty members who assign or supervise the work are responsible for educating their students to safeguard the well being of the subjects.
  • Oral History Projects are considered research only when they are intended to contribute to generalizable knowledge or there is a possibility that the resulting data will be used to contribute to generalizable knowledge
  • Program Evaluation, Quality Assurance and Quality Improvement Activities are considered research only when they are intended to contribute to generalizableknowledge or there is a possibility that the resulting data will be used to contribute to generalizable knowledge. When the purpose of an activity is to assess the success of an established program in achieving its objectives and the information will be used to provide feedback to improve that program, the activity is not human subjects research. When the evaluation is undertaken to test a new, modified, or previously untested intervention, service, or program to determine whether it is effective and can be used elsewhere, the activity is research.

Human subject: a living person about whom a researcher obtains:

  • data through "intervention" (for example, venipuncture or cognitive tests) or "interaction" (for example, interviews) with the person, or
  • identifiable private information (for example, observations or private records). A person may be a "human subject" when a researcher obtains data about the person from a third party as well as from the person directly.

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.

Interaction includes communication or interpersonal contact between investigator and subject. Identifiable in this context implies that the identity of the subject is or may readily be ascertained by the investigator or associated with the information obtained as part of the research. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).

The researcher should make sure that women and members of minority groups are given the same opportunity as all other persons to be included in the research.

Conducted at or sponsored by the UCSC campus means:

  • using the facilities of the UCSC campus; or
  • paid for by the campus or with funds administered by the campus; or
  • conducted as part of a researcher's progress toward a campus degree or
  • conducted by a campus faculty member or employee in the course of employment by the UCSC campus; or
  • using UCSC students as subjects