CUIRB # CUIRB Use Only Revised 12/15/94 CUIRB# CUIRB Use Only Revised 12/15/94 CUIRB FORM 1A: CHAPMAN UNIVERSITY INSTITUTIONAL REVIEW BOARD NOTICE OF APPROVAL-HUMAN RESEARCH PRINCIPAL INVESTIGATOR OF PROJECT TITLE OF PROJECT DEPARTMENT FUNDING AGENCY CONTRACT OR GRANT NO. DATES FOR WHICH REVIEWED: FROM TO DATE FOR RE-SUBMISSION: DATE APPROVED: FOR RESEARCH INVOLVING HUMAN SUBJECTS: The Institutional Review Board has reviewed the proposed use of human subjects in the project identified above and has determined that: a) The rights and welfare of the subjects are adequately protected; the risks are outweighed by potential benefits; the informed consent of human subjects will be obtained by methods that are adequate and appropriate. b) Type of Consent: WRITTEN: [ ] ORAL: [ ]: WAIVED:[ ] c) Research involves use of : [ ] Minors [ ] Students [ ] Prisoners [ ] Pregnant Women [ ] Mentally Retarded [ ] Mentally Disabled PRINCIPAL INVESTIGATORS PLEASE NOTE: 1. All unanticipated adverse reactions encountered on any study must be promptly reported to the Institutional Review Board. 2. If significant modifications of this approved study are made, the Institutional Review Board must review them prior to initiation. 3. The principal investigator is responsible for retaining the original signed consent forms for 5 years after completion of the study. 4. All approved informed consent forms given to subjects must have the Institutional Review Board number and expiration date on the first page of the form, and approval stamp on the first and last page of the form. Signature: Chair, Institutional Review Board [ ] Human subjects will be at risk [ ] Human subjects will not be at risk Original to: Principal Investigator cc to: Provost Page 1 of 1 CUIRB FORM 1B: CHAPMAN UNIVERSITY INSTITUTIONAL REVIEW BOARD NOTICE OF APPROVAL- ANIMAL RESEARCH PRINCIPAL INVESTIGATOR OF PROJECT TITLE OF PROJECT DEPARTMENT FUNDING AGENCY CONTRACT OR GRANT NO. DATES FOR WHICH REVIEWED: FROM TO DATE FOR RE-SUBMISSION: DATE APPROVED: FOR RESEARCH INVOLVING ANIMAL SUBJECTS: The Institutional Review Board has reviewed the proposed use of animal subjects in the project identified above and has determined that: a) The transportation, care, and use of animals in the proposed research conform with guidelines specified in the Animal Welfare Act (7 U.S.C. 2131 et. seq.), Guide for the Care and Use of Laboratory Animals , and Principles for the Utilization and Care of Vertebrate Animals Used for Testing, Research and Training . b) The risks are outweighed by potential benefits. The committee has recommended and/or determined that singificant YES [ ] NO [ ] changes have been made in the approved project over that submitted to the granting agency. IF "YES", IT IS THE PRINCIPAL INVESTIGATOR'S RESPONSIBILITY TO FORWARD THE REVISED MATERIAL TO THE GRANTING AGENCY THROUGH THE OFFICE OF CONTRACT AND GRANT ADMINISTRATION. CODICIL: PRINCIPAL INVESTIGATORS PLEASE NOTE: 1. All unanticipated adverse reactions encountered on any study must be promptly reported to the Institutional Review Board. 2. If significant modifications of this approved study are made, the Institutional Review Board must review them prior to initiation. 3. The principal investigator is responsible for retaining the original signed consent forms for 5 years after completion of the study. 4. All approved informed consent forms given to subjects must have the Institutional Review Board number and expiration date on the first page of the form, and approval stamp on the first and last page of the form. Signature: Chair, Institutional Review Board Original to: Principal Investigator cc to: Provost Page 1 of 1 CUIRB FORM II: CHAPMAN UNIVERSITY INSTITUTIONAL REVIEW BOARD APPLICATION TO INSTITUTIONAL REVIEW BOARD for approval of RESEARCH WITH ANIMAL PARTICIPANTS Principal Investigator of Project Chapman University status of Principal Investigator(circle): Faculty / Post-doc / Graduate / Undergrad / Other Exact Title of Project Department Mailing Address Telephone Faculty Sponsor (if applicable) Funding Agency (if any) Contract or Grant Starting date Number (if known) of Approval Previous IRB Approval Number (CUIRB#) (if any) Type of Submission: New [ ]; Continuation [ ]; Renewal [ ]; Addendum [ ]; Other [ ] For evaluation of your project, indicate by [X] that the following conditions have been met: [ ] The study and its associated facilities meet all appropriate federal, state, and local regulations (CUIRB Institutional Assurance Regarding Research , Section III). [ ] The study is designed to be conducted and terminated with due and acceptable regard for the welfare of the animal subjects. [ ] The study is designed to avoid inflicting needless pain and/or suffering. When required, the appropriate tranquilizers, analgesics, and/or anaesthetics will be used. [ ] Adequate safeguard has been made for the safety and comfort of the animal participant. [ ] The biomedical appropriateness of the proposed use of the selected animal models has been considered. Page 1 of 2 CUIRB FORM II: continued THE PRINCIPAL INVESTIGATOR MUST ASSURE THE INSTITUTIONAL REVIEW BOARD THAT ALL PROCEDURES PERFORMED UNDER THE PROJECT WILL BE CONDUCTED BY INDIVIDUALS LEGALLY AND RESPONSIBLY ENTITLED TO DO SO, AND THAT ANY DEVIATION FROM THE PROJECT (E.G., CHANGE IN PRINCIPAL INVESTIGATORSHIP, RESEARCH METHOD, ANIMAL RECRUITMENT PROCEDURES, ETC.) WILL BE SUBMITTED TO THE CUIRB FOR ITS APPROVAL PRIOR TO ITS IMPLEMENTAION. BRIEF DESCRIPTION OF PROJECT. PLEASE INCLUDE ALL INFORMATION WHICH MIGHT INFLUENCE THE REVIEW BY THE INSTITUTIONAL REVIEW BOARD. USE A SEPARATE CONTINUATION SHEET IF NECESSARY. NOTE: Applications and any additional material requested by the CUIRB will not be processed unless typed, properly prepared, and signed personally by the principal investigator and department chair. Date Principal Investigator (Signature) Department Date Faculty Sponsor (Signature) Department Date Department Chair Department REVIEW COPIES WILL NOT BE RETURNED Page 2 of 2 CUIRB FORM III: CHAPMAN UNIVERSITY INSTITUTIONAL REVIEW BOARD U.S. INTERAGENCY RESEARCH ANIMAL COMMITTEE 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 wellbeing of humans as well as other animals requires in vivo experimentation with a wide variety of animal species. Whenever U.S. Government agencies develop requirements for testing, research, or training procedures involving the use of vertebrate animals, the following principles shall be considered. Whenever these agencies actually perform or sponsor such procedures, the responsible institutional official shall ensure that these principles are adhered to: I. The transportation, care, and use of animals should be in accordance with the Animal Welfare Act (7 U.S.C. 2131 et.sep.) and other applicable Federal laws, guidelines, and policies.* II. 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. III. The animals selected for a procedure should be of an appropriate species and quality and the minumum number required to obtain valid results. Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered. IV. Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain (consistent with sound scientific practices) is imperative. Unless the contrary has been established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals. V. Procedures that may cause more than momentary or slight pain or distress to animals should be performed with appropriate sedation, analgesia, or anesthesia. Surgical or other painful procedures should never be performed on unanesthetized animals paralyzed by chemical agents. VI. 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. VII. 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. * For guidance throughout these Principles the reader is referred to The Guide for the Care and Use of Laboratory Animals prepared by the Institute of Laboratory Animal Resources, National Academy of Sciences. Page 1 of 1 CUIRB FORM IV: CHAPMAN UNIVERSITY INSTITUTIONAL REVIEW BOARD APPLICATION TO INSTITUTIONAL REVIEW BOARD for approval of RESEARCH WITH HUMAN PARTICIPANTS Principal Investigator of Project Chapman University status of Principal Investigator(circle): Faculty / Post-doc / Graduate / Undergrad / Other Exact Title of Project Department Mailing Address Telephone Faculty Sponsor (if applicable) Funding Agency (if any) Contract or Grant Starting date Number (if known) of Approval Previous IRB Approval Number (CUIRB#) (if any) Type of Submission: New [ ]; Continuation [ ]; Renewal [ ]; Addendum [ ]; Other [ ] BRIEF DESCRIPTION OF PROJECT. PLEASE INCLUDE ALL INFORMATION WHICH MIGHT INFLUENCE THE REVIEW BY THE INSTITUTIONAL REVIEW BOARD. USE A SEPARATE CONTINUATION SHEET IF NECESSARY. Page 1 of 2 CUIRB FORM IV: continued For evaluation of your project, indicate by a [X] whether the following are involved: [ ] Patients as subjects [ ] Non-patient volunteers [ ] Students as subjects [ ] Trainees as subjects [ ] Minor subjects (less than 18 years) [ ] Subjects whose major language is not English [ ] Mentally retarded subjects [ ] Mentally disabled subjects [ ] Prisoners, parolees, or incarcerated subjects [ ] Subjects studied at non-Chapman locations [ ] Subjects studied at Chapman affiliated hospitals [ ] Subjets in the Armed Services (Active Duty) [ ] Filming, video- or voice-recording of subjects [ ] Department Subject Pool [ ] Questionnaires [ ] Data banks, data archives and/or registration records [ ] Subjects to be paid THE PRINCIPAL INVESTIGATOR MUST ASSURE THE INSTITUTIONAL REVIEW BOARD THAT ALL PROCEDURES PERFORMED UNDER THE PROJECT WILL BE CONDUCTED BY INDIVIDUALS LEGALLY AND RESPONSIBLY ENTITLED TO DO SO, AND THAT ANY DEVIATION FROM THE PROJECT (E.G., CHANGE OF PRINCIPAL INVESTIGATOR, RESEARCH METHOD, SUBJECT RECRUITMENT PROCEDURES, ETC.) WILL BE SUBMITTED TO THE CUIRB FOR ITS APPROVAL PRIOR TO ITS IMPLEMENTATION. NOTE: Applications and any additional material requested by the CUIRB will not be processed unless typed, properly prepared, and signed personally by the principal investigator and department chair. I acknowledge that all procedures will meet relevant local, state, and federal regulations regarding the use of human subjects in research (CUIRB Institutional Assurance Concerning Research Section II). Date Principal Investigator (Signature) Department Date Faculty Sponsor (Signature) Department Date Department Chair (Signature) Department REVIEW COPIES WILL NOT BE RETURNED Page 2 of 2 CUIRB FORM V: CHAPMAN UNIVERSITY INSTITUTIONAL REVIEW BOARD REQUEST FOR EXEMPT STATUS from review by the INSTITUTIONAL REVIEW BOARD The Department of Health and Human Services (DHHS) published in the Federal Register of January 26, 1981 its amended regulations governing research involving human subjects, altering the scope of previous Department regulations by exempting categories of research which present little or no risk of harm to human beings. At Chapman University, the Institutional Review Board accepted the exempted research categories. Exemption from IRB review and approval must be based on the exemptions specified in the Federal Regulations of January 26, 1981, and the responsibility for requesting exemption rests with the principal investigator and the Departmental Chair. This form will assist researchers and Department Chairs in requesting proposed research as exempt and specifying under which of five categories listed in the Federal Register the exemption occurs (see page 3). The Chair of the CUIRB will determine if the study is exempt or requires additional review. In addition: 1) For extramurally funded research projects, a copy must be forwarded to the Office of the Provost so that an institutional certification (DHHS 596) may accompany the application when mailed to the funding agency. The above stated policy is effective as of September, 1994. Investigator Department Exact Title of Project Duration of Project Sponsor Citation of Exempt Category Number (from Page 3) Page 1 of 3 CUIRB FORM V: continued Description of Project and REASON for including it in the exempt category: I request that the above described project be exempt from review by the Chapman University Institutional Review Board. Signature of Investigator Date Signature of Department Chair Date I certify that the above described project is exempt from review by the Chapman University Institutional Review Board. Signature of Chair of CUIRB Date Page 2 of 3 CUIRB FORM V: continued EXEMPTION CATEGORIES (45 CFR 46.101 (b)) Research activities in which the only involvement of human subjects will be in one or more of the folowing categories: l) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as i) research on regular and special educational instructional strategies, or ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. 2)Research involving the use of educational test, (cognitive, diagnostic, aptitude, achievement), if information taken from these sources is recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. 3)Research involving survey or interview procedures, except where all of the following conditions exist; i) responses are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects, ii) the subject's responses, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability, and iii) the research deals with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol. All research involving survey or interview procedure is exempt, without exception, when the respondents are elected or appointed public officials or candidates for public office. 4)Research involving the observation (including observation by participants) or public behavior, except where all of the following conditions exist: i) observations are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects, ii) the observations recorded about the individual, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability, and iii) the research deals with sensitive aspects of the subject's own behavior such as illegal conduct, drug use, sexual behavior, or use of alcohol. 5)Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Page 3 of 3 CUIRB FORM VI: CHAPMAN UNIVERSITY INSTITUTIONAL REVIEW BOARD REQUEST FOR EXPEDITED REVIEW by the INSTITUTIONAL REVIEW BOARD The Department of Health and Human Services (DHHS) published in the Federal Register of March 8, 1983 its amended regulations governing research involving human subjects. This altered the scope of previous Department regulations by allowing an expedited review of research which presents no more than minimal risk of harm to human beings and in which the only involvement of human subjects will be in one or more categories specified in 46 CFR 839 (see page 3). At Chapman University, the Institutional Review Board accepted the expedited research categories. Expedited IRB review and approval must be based on the categories specified in the Federal Regulations of March 8, 1983, and the responsibility for requesting the expedited review category rests with the principal investigator and the Departmental Chair. This form will assist researchers and Department Chairs in certifying that proposed research qualifies for expedited review and specifying which of ten categories of expedited review listed in the Federal Register is/are representative of the proposed research (see Page 3). Three members of the CUIRB will review the request and make recommendations to the Chair of CUIRB. 1) For extramurally funded research projects, a copy must be forwarded to the Office of the Provost so that an institutional certification (DHHS 596) may accompany the application when mailed to the funding agency. The above stated policy is effective as of September 1, 1994. Investigator Department Exact Title of Project Duration of Project Sponsor Citation of Exempt Category Number (from Page 3) Page 1 of 3 CUIRB FORM VI: continued Description of Project and REASON for including it in the expedited category: I request that the above described project receive an expedited review by the Chapman University Institutional Review Board. Signature of Investigator Date Signature of Department Chair Date Page 2 of 3 CUIRB FORM VI: continued 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: 1. Collection of hair and nail clippings in a non-disfiguring manner. 2. Collection of excreta and external secretions, including sweat and uncannulated saliva. 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 privacy. It also includes such procedures as weighing, electrocardiography, electromyography, electroencephalography, 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). 4. Collection of blood samples by venipuncture, in amounts not exceeding 450 ml in an 8-week period and no more often than 2 times per week, from participants who are 18 years of age or older, who are in good health and who are not pregnant. 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 accomplished in accordance with accepted prophylactic techniques. 6. Voice recordings made for research purposes such as investigations of speech defects. 7. Moderate exercise by healthy volunteers. 8. The study of existing data, documents, records, pathological specimens or diagnostic specimens. 9. Research on individual or group behavior and characteristics 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. 10. Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required. Page 3 of 3 CUIRB FORM VII: CHAPMAN UNIVERSITY INSTITIUTIONAL REVIEW BOARD GUIDELINES AND REQUIREMENTS for the preparation of INFORMED CONSENT FORMS Each subject must receive a copy of the consent form. Consent forms must be written in simple lay terms. Also, consent forms must contain no language through which a subject is made to waive any of his/her legal rights. Signed consent forms must be retained in a secure location for a minimum period of five years beyond the end of the project. Consent forms must contain all of the following points: l. A title describing the research project. 2. The date of preparation or revision. 3. Pagination (as Page l of 3, etc.). 4. A signature space with provision for dating the subject's signature. 5. A statement that the project is research: An explanation of the purpose of the study, the procedures to be followed, and the expected duration of the subject's participation. 6. An identification of the individuals conducting the experiment and their degrees (i.e., M.D., Ph.D., etc.: the title "Dr." should not be used exclusively). 7. A description of the benefits to subjects and/or others which may reasonably be expected. 8. A description of the reasonably foreseeable risks or discomforts that may result from a subject's participation (if none, so state). 9. An offer to answer any questions concerning the study at any time, and an address and phone number where the principle investigator can be reached. 10. Every consent form must contain the following statement: "I understand that I may refuse to participate or may withdraw from this study at any time without any negative consequences. Also, the investigator may stop the study at any time. I also understand that no information which identifies me will be released without my separate consent, and that all identifiable information will be protected to the limits allowed by law. If the study design or the use of the data is to be changed, I will be so informed and my consent reobtained. I understand that if I have any questions, comments, or concerns about the study or the informed consent process, I may write or call the Office of the Provost, Chapman University, 333 North Glassell, Orange, CA 92666, (714) 997-6626. I acknowledge that I have received a copy of this form." Page l of 5 CUIRB FORM VII: continued Special Circumstances: Include in your consent form any of the following information which may be applicable to your study: 11. If subjects are to be remunerated, describe conditions, if any, under which remuneration may be partially or totally withheld. 12. If subjects will incur any additional costs as a result of their participation in the research, this must be stated in the consent form. 13. If audio or video-tape recordings are to be made, so state and inform subjects whether the tapes will be destroyed at the end of the study, or retained for research and/or teaching purposes. 14. If the subject is a legal minor both parents or guardians should sign the consent form. 15. If the subject is a legal minor, provision should be made for him/her to sign in addition to parents or legal guardians where appropriate, an appropriate assent form. 16. If the subject cannot sign, through physical disability or illiteracy, but is otherwise capable of being informed and giving verbal consent, a third party not connected with the study, or next of kin or guardian shall sign for the subject. 17. An appropriate translation of the approved informed consent form must be provided to subjects whose natural language is not English, and who are poorly versed in the English language. 18. When appropriate, add a statement that the procedure may involve risks to the subject which are currently unforseeable. 19. When appropriate, indicate the approximate number of subjects involved in the study. 20. When appropriate, include a statement that significant new findings developed during the study which may relate to the subject's willingness to continue participation will be provided to the subject. 21. For studies involving therapeutic procedures, subjects shall be informed of appropriate alternative procedures or courses of treatment that might be advantageous, including any risks and/or benefits. 22. When appropriate, detail the consequences of a subject's decision to withdraw from the research. 23. If the research project involves more than minimal risk to subjects, the following statement must be included verbatim:"I understand that Chapman University will provide any and all medical treatment reasonably necessary for any injury or illness which I suffer as a direct result of my participation in this research project. The University does not provide any other form of compensation for injury." Page 2 of 5 CUIRB FORM VII: continued However, if the research project involves more than minimal risk to subjects, and the research is designed to benefit the subject directly, the statement should read: "I understand that Chapman University will provide any and all medical treatment reasonably necessary for any injury or illness which I suffer as a direct result of my participation in this research project, except when the injury or illness is a consequence of the procedure which is designed to benefit me directly. The University does not provide any other form of compensation for injury." WAIVER OF WRITTEN INFORMED CONSENT FORMS A written informed consent form may be waived for some research projects in which either of the following conditions applies: 1. The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. 2. The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. Requests for waiver of a written informed consent form must be made in writing to the Committee and include a statement citing which of the above conditions applies to the study in the opinion of the principal investigator. In any case, the Institutional Review Board holds the final determination of whether or not a written informed consent form is necessary for any individual research project. In cases where the documentation requirement is waived, the Institutional Review Board may require the investigator to provide subjects with a written statement regarding the research. Page 3 of 5 CUIRB - FORM VII: continued SAMPLE INFORMED CONSENT FORMAT INFORMATION ABOUT: (give title of study) CHAPMAN UNIVERSITY ORANGE, CA 92666 RESPONSIBLE INVESTIGATOR: (give name of responsible investigator and coinvestigator) TITLE OF CONSENT FORM: (if different from study title) I have been asked to participate in a research study that investigates (describe purpose of investigation, how it relates to other knowledge and what use may be made or the results obtained). In participating in this study I agree to (describe briefly and in lay terms procedures to which participant is consenting). (Be specific in describing treatments or tests, how often and how much given, time limits of study, invasive techniques, any restrictions on normal activities, longterm follow-up examinations or the possibility of receiving inactive material in a double-blind trial). I understand that a)The possible risks of this procedure include (list known risks or side effects: if none, so state; if unpredictable, so state; include measures that will be taken to minimize hazard or discomfort). b)The possible benefits of this study to me are (payment, known treatment benefits; if none, so state). c)Any questions I have concerning my participation in this study will be answered by (first and last name(s) and degree(s) of investigator(s) available to answer questions and phone number(s) where the person may be contacted). d)I understand that I may refuse to participate or may withdraw from this study at any time without any negative consequences. Also, the investigator may stop the study at any time. I also understand that no information which identifies me will be released without my separate consent, and that all identifiable information will be protected to the limits allowed by law. If the study design or the use of the data is to be changed, I will be so informed and my consent reobtained. I understand that if I have any questions, comments, or concerns about the study or the informed consent process, I may write or call the Office of the Provost Chapman University, 333 North Glassell, Orange, CA 92666, (714) 997-6826. I acknowledge that I have received a copy of this form. e)I have received a copy of this consent form and the Research Participants' Bill of Rights. f)This study is supported by funding from (funding source must be listed only if is a commercial company). Page 4 of 5 CUIRB - FORM VII: continued SAMPLE INFORMED CONSENT FORMAT (continued) I have read the above and understand it and hereby consent to the procedure(s) set forth. DATE PARTICIPANT OR RESPONSIBLE PARTY PARTICIPANT SSN AUDITOR/WITNESS INVESTIGATOR PAGE OF Page 5 of 5 CCIRB - FORM VIII: CHAPMAN UNIVERSITY INSTITUTIONAL REVIEW BOARD RESEARCH PARTICIPANTS' BILL OF RIGHTS Any person who is requested to consent to participate as a subject in an experiment, or who is requested to consent on behalf of another, has the following rights: 1. To be told what the study is attempting to discover. 2. To be told what will happen in the study and whether any of the procedures, drugs or devices are different from what would be used in standard practice. 3. To be told about the risks, side effects or discomforts of the things that may happen to him/her. 4. To be told if he/she can expect any benefit from participating and, if so, what the benefits might be. 5. To be told what other choices he/she has and how they may be better or worse than being in the study. 6. To be allowed to ask any questions concerning the study both before agreeing to be involved and during the course of the study. 7. To be told what sort of medical treatment is available if any complications arise. 8. To refuse to participate or discontinue participation after the study is started without any adverse effects. 9. To receive a copy of this form and the signed and dated consent form. 10. To be free of pressures when considering whether he/she wishes to agree to be in the study. If at any time you have questions rergarding a research study, you should ask the researchers to answer them. You also may contact the Chapman University Institutional Review Board, which is concerned with the protection of volunteers in research projects. Page 1 of 1 CUIRB FORM IX: Revised:11/15/94 CHAPMAN UNIVERSITY INSTITUTIONAL REVIEW BOARD CHILDREN'S ASSENT In March of 1983 the Department of Health and Human Services issued the most recent human subject regulation, ie., "Additional Protection for Children Involved as Subjects in Research" (45CFR46-Subpart D). These regulations governing children in research situations decree that investigators need to take into consideration age, maturity, and psychological state of the participating children and include them in the consent form and the investigator must solicit the assent of younger children. The regulation defines "assent" as the child's affirmative agreement to participate. "mere failure to object should not, absent affirmative agreement, be construed as assent." The following items should be addressed in an assent procedure*, utilizing language appropriate to the child's age and/or developmental level: a) Why the child is asked to participate. b) What is going to take place from the child's point of view. c) The risk to the child. d) The benefit to the child. e) Identification of the researcher by name and telephone number in case questions should arise. f) In non-therapeutic research, a statement that the child has a choice to participate or to withdraw at any time without negative consequences. g) A statement that the child may retain a copy of the assent form. h) Date and signature lines for the researcher and, if appropriate, for the child. * represented by an assent form, or by a prepared script of the explanation to be tendered. Page 1 of 1 CUIRB - FORM X: CHAPMAN UNIVERSITY INSTITUTIONAL REVIEW BOARD INFORMATIONAL LETTER Date: Dear (Employee, Student, Study Participant, etc.): We are a group of (educators, sociologists, biologists, psychologists, etc.) in the (Department Name) at Chapman University who are conducting a study on (briefly describe in lay terms in two to three sentences). We are asking your assistance in the study by participating in an (interview, group discussion, etc.) which will take from (30 to 60 minutes, etc.) and be set up at a time convenient to you. If you agree to (participate in an interview; have an observer present; etc.) you may be assured that it will be completely confidential. No names will be attached to any notes or records from the interview. All information will remain in locked files accessible only to the researchers. No (employer, supervisor, agency - whatever is applicable) will have access to the (interview) information. You will be free to stop the (interview, discussion, etc.) and withdraw from the study at any time with no negative consequences. Further, you may be assured that the researchers are not in any way affiliated with (the administration, the employing agency, the applicable supervisory organization, etc.). The research director, (name), or a research team member (if applicable) is available in (office or department name) at (phone number), to answer any questions you may have. Your participation would be greatly valued. Sincerely, (Name and Professional Title) enclosure: Research Participants Bill of Rights Page 1 of 1