INSTITUTIONAL ASSURANCE CONCERNING RESEARCH CHAPMAN UNIVERSITY INSTITUTIONAL REVIEW BOARD (CUIRB) I. GENERAL POLICIES AND RESPONSIBILITIES I.a. UNIVERSITY COMMITMENTS Chapman University is committed to safeguarding the rights and welfare of all people who participate in research conducted by Chapman faculty. It is also committed to insuring humane care and use of animals in teaching and research. Chapman University supports respon- sible experimentation which promises to increase knowledge and under- standing, and encourages the highest ethical standards among Chapman researchers. In addition to assuring compliance with Department of Health and Human Services (DHHS) regulations 45 CFR Part 46, as specified in the Office for Protection from Research Risks (OPRR) 1983 report on \Protection of Human Subjects\, Chapman accepts responsibility for complying with Food and Drug Administration (FDA) regulations (21 CFR Parts 50 and 56) and all other applicable state and local laws as they may relate to research covered by the DHHS policy. Categories of research exempted from this policy are those specifically listed in 45 CFR 46.101 (2) (B) 1 through 5 (see CUIRB HUMAN RESEARCH PARTICIPANTS POLICY Section II.e. to II.g.). Chapman University also abides by the provisions of the DHHS \Guide for the Care and Use of Laboratory Animals\ and \Principles for Use of Animals\; the Animal Welfare Act PL 85-544; and the Standards for Accreditation by the American Association for the Accreditation of Laboratory Animal Care (AAALAC). I.b. CENTRAL AIMS OF THE CUIRB I.b.1. To protect the rights of human participants in research studies, including their rights to give informed consent and to have their safety protected from undue risk. I.b.2. To ensure the humane care and use of animals in research and teaching, and to approve only those experiments using animals which are justified by overriding benefits for teaching and new knowledge. I.c. GENERAL CHARGE TO THE CUIRB The CUIRB has the responsibility and authority to review and approve all research projects by Chapman faculty and students that involve human or animal participants. It will approve only experi- ments which conform to the professional standards as understood within the relevant discipline as well as the standards cited herein. I.d. RESPONSIBILITIES AND AUTHORITY OF THE CUIRB I.d.1. Maintain communication with Federal, State, and local agencies and institutions to insure that CUIRB procedures are current and consistent. I.d.2. Interpret government and University policies per- taining to the protection of human and animal research participants. I.d.3. Develop and publish campus policies and procedures governing review of research involving human or animal participants. I.d.4. Distribute campus guidelines to aid principal inves- tigators in the preparation of their application for approval of research involving human and animal participants I.d.5. Review all new and ongoing projects involving human participants at convened CUIRB meetings with the majority of the Board's membership constituting a quorum; a CUIRB member whose con- cerns are primarily in non-scientific areas must be included in the quorum. Voting on projects is limited to duly appointed Board mem- bers. Excluded from this quorum process are those submissions which are participant to expedited review. I.d.6. Require that the informed consent procedure is in accordance with policy. I.d.7. Observe or have a third party observe the consent process and the research, when appropriate. I.d.8. Notify investigators of the results of CUIRB review. I.d.9. Advise and consult with investigators regarding specific problems associated with protocols involving human partici- pants. I.d.10. Provide consultation through its Chair to any participant or principal investigator. I.d.11. Establish procedures for monitoring implementation of CUIRB action. I.d.12. Review projects on an annual basis or more fre- quently as deemed appropriate. I.d.13. Require written notification by investigators when changes in a research activity are proposed. I.d.14. Require prompt reporting by investigators when unanticipated problems involving risks to participants occur. I.d.15. Suspend or terminate approval of research that has been associated with unexpected serious harm to participants or that is not being conducted in accordance with the CUIRB's decisions. I.d.16. Report to the Provost any suspension or termination of approved research. I.d.17. Maintain complete records. I.d.18. If the research activity is funded in whole or in part by a DHHS grant, contract, or fellowship, report to the Secretary of DHHS on serious or continuing noncompliance by investigators with the requirements and determinations of the CUIRB; suspension or termi- nation of approved research that is not being conducted in accordance with the CUIRB's requirements; or any unexpected serious harm to participants associated with a research project. I.d.19. Coordinate review of research carried out at non- university sites. I.d.20. Through its Chair, report any changes in CUIRB membership to the Provost. I.e. COMPOSITION OF THE CUIRB All review of human participant involvement in research activi- ties covered by this policy shall be carried out by the CUIRB follow- ing the procedures set forth in this policy. CUIRB members are nomi- nated by the nominating committee and approved by the faculty and serve a two year term. The Chair is nominated from continuing members by the nominating committee and approved by the faculty. Should a member not be able to serve the full term, the Faculty Executive Committee shall replace the absent member for the remainder of that member's term. The CUIRB is sufficiently qualified through the experience, expertise, and diversity of its members, and a sensitivity to communi- ty attitudes, to command respect for its advice and counsel in safe- guarding the rights and welfare of research participants. The CUIRB is composed of five or more members from the Universi- ty, representing diverse backgrounds and possessing the professional competence necessary to review the specific research activities as- signed to it. The CUIRB shall not consist entirely of men or women or entirely of persons in one profession. CUIRB includes at least one member whose primary expertise is in a non-scientific area and one additional member with no formal affili- ation with the University. At any time, consultants may be sought, but these persons may not participate by vote in CUIRB actions. I.f. RESPONSIBILITY AND AUTHORITY OF CHAPMAN UNIVERSITY I.f.l. Legal assistance. The University Legal Office is available to the CUIRB and investigators for legal consultation and assistance. I.f.2. Liabilities. The University is legally responsible for the acts and omissions of its investigators while acting in the course and scope of their University duties. In the event of a suit against investigators or members of an CUIRB based on their actions in connection with a research activity involving human participants, the University would be obligated to assume their defense if the research project was approved by an CUIRB in accordance with this policy. If a principal investigator has, or should have, knowledge of the applica- ble University policy requiring that every research activity placing human participants at risk be reviewed by an CUIRB and fails to obtain such approval prior to involvement of human participants, the investi- gator would be acting outside the scope of duties and the University would not be obligated to defend or indemnify the investigator if legal actions were initiated by a participant. II. INFORMATION AND INSTRUCTIONS FOR FILING HUMAN RESEARCH PARTICI- PANT PROTECTION PROTOCOLS WITH THE CHAPMAN UNIVERSITY INSTITUTIONAL REVIEW BOARD II.a. GENERAL INFORMATION In accordance with Department of Health and Human Services regu- lations, Chapman University recognizes three categories of review for research involving human participants: exempt, expedited and full. It is anticipated that most research activities carried out at Chapman will fall under the exempt and expedited review categories in that they involve relatively low-risk procedures. The guidelines that follow should guide the investigator in determining the appropriate application format. The standard review criteria are used regardless of the risk level of the proposed study. It must be emphasized that CUIRB review concerns research and thus a project must be defined. The nature of the procedures in the study defines the level of review required. The following definitions are used by the CUIRB when reviewing research projects using human participants: II.a.l. HUMAN PARTICIPANT is an individual about whom an investigator conducting research obtains data through intervention or interaction with the individual or through identifiable private infor- mation. II.a.2. RESEARCH is a systematic investigation explicitly designed to develop or contribute to generalizable knowledge. (Class- room activities that constitute research as herein described must be reviewed by the CUIRB, Form XI) II.a.3. RISK AND MINIMAL RISK. The term Minimal risks means that risks for harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physi- cal or psychological examinations or tests. Using minimal risk as a goal, the CUIRB will use the reasonable person standard to compare the risks of research to those in the daily life of a typical person in the anticipated participant population. II.a.4. BENEFIT. To a certain extent risk is evaluated relative to the potential benefit(s) of the research. The CUIRB applies two categories when considering risk/benefit relationships of proposed research: II.a.4.a. Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual. II.a.4.b. Research involving greater than minimal risk and no prospect of direct benefit to individual participants but likely to yield generalizable knowledge about the participant's disor- der or condition. This risk can be only a Minor increase over minimal risk. The experience should be reasonably commensurate with those the participant would ordinarily encounter. II.a.5. EVALUATION OF RISKS IN RELATION TO BENEFITS. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reason- ably be expected to result. In evaluating risks and benefits, the CUIRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapy subjects would receive even if not participating in the research). The CUIRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility. (45 CFR 4b.111(a)(2).) II.b. ACTIONS Applying the criteria for IRB research review set forth in 45 CFR 46, the CUIRB will review each proposal and take one of the following actions: II.b.1. \Determine the research as exempt from approval.\ Research in the exempt from approval category represents projects which involve minimum risk to the participants (refer to section II.f.). II.b.2. \Approves the research.\ Although the research may involve some risk to the participants, the CUIRB may find that the risk is minimum, and that the investigator has taken all practical steps to minimize the risk. II.b.3. \Conditionally approve the research.\ This action entitles the investigator to proceed with the project provided that certain conditions are fulfilled as specified by the CUIRB. Condi- tions may include items such as revising the consent form to explain the procedure more clearly, adding a foreign language version of the consent form or receiving clearance from the student health service. II.b.4. \Disapprove the research with a request for resub- mission of the protocol.\ This occurs when the CUIRB believes that it has insufficient information to take action, or when it feels the research design contains flaws or characteristics that should be revised to reduce risks to participants. The CUIRB may ask the inves- tigator to provide for emergency back-up medical care, to take further steps to protect the confidentiality of the participants, or to devel- op a substitute procedure. II.c. INFORMED CONSENT Except as provided in these documents, legally effective informed consent must be obtained from any research participant or the partici- pant's legally authorized representative who, in the course of a research protocol, is exposed to the risk of physical, psychological, or social injury. Informed consent is defined as the knowing consent of an individual or their legally authorized representative so situat- ed as to be able to exercise free power of choice without undue in- ducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion. The term participant shall, where appro- priate, mean the participant or the participant's legally authorized representative. Legally effective informed consent, at least includes both the investigator's oral explanation to the participant of the research and the potential participant's expected participation therein as well as the investigator's response to any and all questions that the partici- pant may have concerning the research protocol. In certain instances, this will require documentation of consent using a CUIRB-approved consent form which is signed by the participant or the participant's legally authorized representative and the investigator. Informed consent is to be obtained only under circumstances which provide the participant with sufficient opportunity to freely consider whether or not s/he wishes to participate in the research and mini- mizes any possibility of coercion or undue influence. In those research settings in which risk to participants may be increased by written record of their names (e.g., studies of deviant populations), or in observational studies of naturally-occurring human interaction, the requirement of informed consent must nevertheless be met. The researcher must provide a written explanation to the CUIRB of how the participants' rights to privacy and anonymity will be protected. It is strongly recommended that in such instances, inves- tigators develop an informational letter to be given to the partici- pants. The informational letter (CUIRB Form X) should be submitted with the CUIRB application, and it will be subject to committee re- view. Any or all of the requirements for obtaining consent may be waived by the CUIRB during its review of the study, but only under certain circumstances as specified in 45 CFR 46.101 (b). The following guidelines are to be followed when preparing a Consent Form (CUIRB Form VII): II.c.l. The consent form is to be written in narrative form and include all information the participant should know in making his/her decision of whether or not to participate. II.c.2. Statements must be easily readable and understand- able. Technical terminology and abbreviations are not to be used unless clearly defined. II.c.3. The consent form must be in the fluent language of the participant. However, translations of consent forms should not be done until the English language version has been approved by the CUIRB. Furthermore, translations MUST either be done or verified by a qualified faculty member of the University or their designee. II.c.4. PARTICIPANTS ARE TO BE GIVEN SUFFICIENT TIME TO CONSIDER WHETHER OR NOT THEY WISH TO PARTICIPATE BEFORE SIGNING THE CONSENT FORM. II.c.5. The investigator is reminded that the consent form is simply the written documentation of the consent process. Oral explanations are to be given to each prospective participant and the participant encouraged to ask questions. II.c.6. In reviewing research protocols and consent forms, CUIRB is particularly cognizant of research involving minors. All research involving minors must conform to Department of Health and Human Services regulations stated in Additional Protection for Chil- dren involved as Subjects in Research (45 CFR 46.401-409). The spe- cific requirements are specified in Section d., below. II.d. RESEARCH INVOLVING MINOR PARTICIPANTS The Department of Health and Human Services issued regulations, effective June 6, 1983, giving additional protection for children involved as participants in research. The regulations contained in Additional Protection for Children Involved as Subjects in Research (45 CFR 46.401-409) must be applied to all research involving minors which is reviewed by the CUIRB. A minor is a person under age 18 who does not have the legal authority to consent. Emancipated minors, whom the state gives the right to consent and contract as adults, are to be treated as adults. The regulations governing children in research decree that investiga- tors need to consider the age, maturity, and psychological state of the participating children and include them in the consent process. The older and more mature children should be allowed to sign the consent form, while \assent\ must be obtained from all children. Regulations define assent as the child's affirmative agreement to participate. Further, mere failure to object should not, in the absence of affirmative agreement, be construed as assent. The assent procedure may be represented by an assent form, or by a prepared script of the explanation to be tendered by the investiga- tor. The following areas must be addressed in the assent procedure, utilizing language appropriate to the child's age and/or developmental level: II.d.l. Why is the child asked to participate. II.d.2. What is going to occur from the child's point of view. II.d.3. The risk to the child. II.d.4. The benefit to the child. II.d.5. Identification of the researcher by name and tele- phone number in case questions should arise before and after partici- pation. II.d.6. In non-therapeutic research, a statement that the child has a choice to participate in or to withdraw from the research at any time without any negative consequences. II.d.7. A statement that the child can retain a copy of the assent form. II.d.8. Date and signature lines for the investigator and, if appropriate, for the child. II.e. PROCEDURE FOR FULL REVIEW Unless expedited or exempt review is specifically requested, all research proposals will undergo full review by the CUIRB. The inves- tigator will complete the Application to the Institutional Review Board for Approval of Research with Human Participants (CUIRB FORM IV). For full review, the investigator should submit 8 copies of the application, with any applicable supporting material, to the Chair of the CUIRB. All members of the CUIRB will review the proposal and supply written recommendations. When necessary, the opinions of an outside consultant expert (i.e., medical, legal, etc.) may be sought. At any time during the review process, the CUIRB may request further information. By a majority vote of all its members, the CUIRB will take one of the three actions specified in Section II.b., subparts b.2, b.3, b.4. A written decision, with explanation where necessary, will be sent to the investigator and to the Provost. The review process typically will require four weeks. II.f. CATEGORIES OF HUMAN RESEARCH EXEMPT FROM CUIRB REVIEW: In accordance with 45 CFR 46.101, the following research activi- ties may be exempt from review by the CUIRB: II.f.1. Research conducted at established or commonly accepted educational settings, involving normal educational practices, such as: II.f.l.a. research on regular and special education instructional strategies or II.f.l.b. research on the effectiveness or of the comparison among instructional techniques, curricula or classroom management methods. II.f.2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) if information taken from these sources is recorded in such a manner that participants cannot be identified, directly or through identifiers linked to the participants. II.f.3. Research involving survey or interview procedures with adults age 18 or over except where all of the conditions below (II.f.4.a.1, 2, 3) apply. All research, involving survey or interview procedures is exempt, without exception, when the respondents are elected or appointed public officials or candidates for public office. II.f.4. Research involving the observation (including observation by participants) of public behavior except where all of the conditions below apply. II.f.4.a. Conditions for #3 and #4 above: Il.f.4.a.1. Responses/observations are recorded in such a manner that the human participants can be identified, directly or through identifiers linked to the participants, and, II.f.4.a.2. The participant's responses (or observations recorded about the participant) if they become known outside the research, could reasonably place the participant at risk of criminal or civil liability or be damaging to the participant's financial standing or employability, and, II.f.4.a.3. The research deals with sensitive aspects of the participant's own behavior such as illegal conduct, drug use, sexual behavior, or use of alcohol. II.f.5. Research involving the collection or study of existing data, documents, records, pathological specimens or diagnos- tic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that participants cannot be identified, directly or through identifiers linked to the participants. PROCEDURE FOR APPLYING FOR EXEMPT REVIEW Investigators seeking the exempt from review category will com- plete a Request of Research Exempt From Review (CUIRB FORM V). This form will assist researchers and the Chair of the CUIRB in determining whether the proposed research qualifies for exempt review and in specifying which of the five categories of exempt research listed in 45 CFR 46.101 is/are representative of the proposed research. II.g. CATEGORIES OF RESEARCH SUBJECT TO EXPEDITED REVIEW In accordance with DHHS 45 CFR 46.111, research activities with human participants involving no more than minimal risk and involving one or more of the following categories (carried out through standard methods) may be reviewed through an expedited review procedure: II.g.1. Collection of hair and nail clippings in a non- disfiguring manner. II.g.2. Collection of excreta and external secretions, including sweat and uncannulated saliva. II.g.3. Recording of data from participants who are 18 years of age or older, using noninvasive procedures routinely employed in clinical practice. This category includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amount of energy into the participant or an invasion of the participant's priva- cy. It also includes such procedures as weighing, electrocardiogra- phy, electromyography, eletroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography. This category does not include exposure to electromagnetic radiation outside the visible range (e.g., x-rays or microwaves). II.g.4. Collection of blood samples by venipuncture, in amounts not exceeding 450 ml in an 8-week period and for more often than 2 times per week, from participants who are 18 years of age or older and who are in good health and not pregnant. II.g.5. Collection of both supra and subgingival dental plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth, and the process is accom- plished in accordance with accepted prophylactic techniques. II.g.6. Voice recordings made for research purposes such as investigations of speech defects. II.g.7. Moderate exercise by healthy volunteers. II.g.8. The study of existing data, documents, records, pathological specimens of diagnostic specimens. II.g.9. Research on individual or group behavior and char- acteristics of individuals such as studies of perception, cognition, game theory, or test development where the investigator does not manipulate participants' behavior and the research will not involve stress to participants. PROCEDURE: Those investigators seeking the expedited review should submit three copies of the Request for Expedited Review (CUIRB FORM VI). The CUIRB will appoint a three-person subcommittee to review the registra- tion form. When two members have read and approved the application, it is referred to the Chair of the CUIRB who reviews and, if in agree- ment, signs an approval letter. The approval letter is then sent to the investigator and the action is reported to the full committee at the next scheduled meeting. The full committee is likely to approve but has the option of requesting more information or disapproving. Any of the three reviewers may object to expedited review or may have further questions and has the option of referring the application to the full CUIRB. Investigators should be aware that though applications for expe- dited review are simpler and involve less paper and duplication then involved in full review, the review and evaluation process may be no faster than that of the full review procedure. To be safe, allow 4 weeks for the process (before the time planned to commence research). III. INFORMATION AND INSTRUCTIONS FOR FILING ANIMAL RESEARCH PARTICI- PANT PROTECTION PROTOCOLS WITH THE CHAPMAN UNIVERSITY INSTITUTIONAL REVIEW BOARD III.a. PRINCIPLES FOR THE UTILIZATION AND CARE OF VERTEBRATE ANIMALS USED IN TESTING, RESEARCH AND TRAINING The development of knowledge necessary for the improvement of the health and well-being of humans as well as other animals may require in vivo experimentation with a wide variety of animal species. All research involving the use of animals must conform with Department of Health and Human Services regulations and guidelines specified in the \Laboratory Animal Welfare\ edition of the \NIH Guide for Grants and Contracts\, 1985, \14\. Included are specific requirements for con- formance both with policies of the Public Health Service and the American Association for the Accreditation of laboratory Animal Care. By law, these policies became effective December 31, 1985. Instructional projects involving animal participants in normal educational practices, such as commonly used experiments in teaching laboratories, shall be exempt from review. However, these projects will fully comply with all appropriate rules and guidelines. Research projects involving animal participants must receive full review by the CUIRB if this is requested by one CUIRB member. The review of pro- posed projects will focus on the degree of adherence to the following procedures: III.a.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 poli- cies. III.a.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 the socie- ty. III.a.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. III.a.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. III.a.5. Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appro- priate sedation, analgesia, or anesthesia. Surgical or other painful procedures should not be performed on unanesthetized animals paralyzed by chemical agents. III.a.6. Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painlessly sacrificed at the end of the procedure or, if appropriate, during the procedure. Methods of euthanasia used will be consistent with the recommendations of the American Veterinary Medical Association (AVMA) Panel on Euthanasia, unless a deviation is justified for scientific reasons in writing by the investigator. III.a.7. The living conditions of animals should be appro- priate 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 scien- tist 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. III.a.8. Investigators and office personnel shall be appro- priately qualified and experienced for conducting procedures on living animals. Adequate arrangements shall be made for their in-service training, including the proper and humane care and use of laboratory animals. III.a.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 by the CUIRB. Such exceptions should not be made solely for the purposes of teaching or demonstration. III.b. DEFINITIONS The CUIRB will use the definitions of RESEARCH and RISK previous- ly described in relation to human research participants. In addition, the following definitions will apply to research with animal partici- pants: III.b.l. ANIMAL is any live, vertebrate animal used or intended for use in research, research training, experimentation or biological testing or for related purposes. III.b.2. ANIMAL FACILITY is any and all buildings, rooms, areas, enclosures, or vehicles, including satellite facilities, used for animal confinement, transport, maintenance, breeding or experi- ments inclusive of surgical manipulation. A satellite facility is any containment outside of a core facility or centrally designated or managed area in which animals are housed for more than 24 hours. III.c. PROCEDURE FOR REVIEW The CUIRB will conduct a review of all proposed research involv- ing animal participants following procedures specified by the Depart- ment of Health and Human Services for Institutional Animal Care and Use Committees. Specific attention will be given to those sections of proposed research which relate to the care and use of animals and determine that the proposed activities are in accord with all applica- ble policies. In making this determination, the CUIRB will confirm that the research will be conducted in accord with the Animal Welfare Act insofar as it applies to the research, and that the research is consistent with the \Guide for the Care and Use of Laboratory Animals\ unless acceptable justification for a departure is presented. Prior to the review, each CUIRB member shall be provided with a list of applications and proposals to be reviewed. Those sections of applications and proposals that relate to the care and use of animals shall be available to all CUIRB members, and any member of the CUIRB may upon request obtain full committee review of those sections. If full committee review is not requested, at least one member of the CUIRB, designated by the chairperson and qualified to conduct the review, shall review those sections and have the authority to approve, require modifications in (to secure approval) or request full commit- tee review of those sections. If full committee review is requested, approval of those sections may be granted only after review at a convened meeting of the CUIRB and with the approval vote of a majority of the members present. No member may participate in the CUIRB review or approval of an application or proposal in which the member has a conflicting interest (e.g., is personally involved in the project), except to provide information requested by the CUIRB; nor may a member who has a conflicting interest contribute to the constitution of a quorum. The CUIRB may invite consultants to assist in the review of complex issues. Consultants may not approve or withhold approval of an application or proposal or vote with the CUIRB. The CUIRB shall notify investigators and the institution in writing of its decision to approve or withhold approval of those sections of applications or proposals related to the care and use of animals, or of modifications required to secure CUIRB approval. If the CUIRB decides to withhold approval of an application or proposal, it shall include in its written notification a statement of the rea- sons for its decision and give the investigator an opportunity to respond in person or in writing. The CUIRB shall conduct continuing review of applications and proposals covered by this policy at appropriate intervals as designat- ed by the CUIRB, but not less than once every three years. III.d. INFORMATION REQUIRED IN PROPOSALS INVOLVING ANIMAL RESEARCH PARTICIPANTS (CUIRB Forms II and VII) Proposals submitted to the CUIRB that involve the care and use of animals shall contain the following information: III.d.1. Identification of the species and approximate number of animals to be used. III.d.2. Rationale for involving animals, and for the appropriateness of the species and numbers to be used. III.d.3. A complete description of the proposed use of the animals. III.d.4. Assurance that discomfort and injury to animals will be limited to that which is unavoidable in the conduct of scien- tifically valuable research, and that analgesic, anesthetic, and tranquilizing drugs will he used where indicated and appropriate to minimize discomfort and pain to animals; and III.d.5. Description of any euthanasia to be used. 1-25-1995