GUIDELINES FOR CLIENT-OWNED ANIMALS IN RESEARCH

Transcription

1 GUIDELINES FOR CLIENT-OWNED ANIMALS IN RESEARCH Policies and Procedures of the Clinical Research Review Committee College of Veterinary Medicine Texas A&M University May 2003

2 Table of Contents Introduction... 1 Purpose... 1 Policies... 1 Procedures... 4 Attachments A. Guidelines for Preparation of Informed Consent Documents B. CRRC Form entitled, Proposed Use of Client-Owned Animals C. Informed Owner Consent Form D. Project Amendment Form

3 Introduction At Texas A&M University, institutional oversight of the use of animals in research is accomplished by policies and procedures that differ depending on ownership of the subject animals. For animals that are owned by the University, proposed research is reviewed and approved either by the University Laboratory Animal Care Committee (ULACC) or, in the case of agricultural animals used in production agriculture research, by the Institutional Agricultural Animal Care and Use Committee (IAACUC). For animals that are not owned by the university, whether they are owned by individuals or other entities (e.g., corporations, farms, zoos), proposed research in which one of the investigators is a member of the faculty/staff of the College of Veterinary Medicine must be reviewed and approved by the Clinical Research Review Committee (CRRC) in the College of Veterinary Medicine. Additionally, all research involving human subjects must be approved by the University's Institutional Review Board (IRB). Proposals involving multiple categories of research subjects require approval from each relevant oversight committee. Purpose The Clinical Research Review Committee was established by the College of Veterinary Medicine to provide needed institutional oversight of clinical research involving client-owned animals. The goal of the CRRC is to protect animals, animal owners, investigators, and Texas A&M University by assuring the ethical and humane treatment of all participants in clinical research. Policies 1. Clinical research is defined by the CRRC as research involving client-owned animals. Any animal that is not owned by the University is considered to be client-owned, regardless of whether the animal is owned or under the stewardship of an individual person, a business or corporation, or some other entity (e.g., zoo, humane society, animal shelter). 2. Approval is required for all clinical research conducted by persons affiliated with the College of Veterinary Medicine at Texas A&M University, regardless of the locations of animals that are research subjects and regardless of participation by other individuals, groups, agencies or enterprises. 3. All clinical research must be reviewed and approved prior to conduct of the research and regardless of funding sources. 4. Investigators conducting clinical research must obtain written permission from the owner(s) of animal(s) that are included in the study before data or specimens are collected for research purposes. This permission, which is called informed consent, must be provided by persons who are: 1

4 a. The owners or legally responsible stewards of the subject animal(s). b. Sufficiently well informed regarding the risks, benefits, and requirements of the study to make a reasoned decision about participating. c. Not subjected to any expressed or implied penalty if they choose not to participate. 5. Investigators conducting clinical research must fully disclose the foreseeable risks and/or adverse reactions associated with participation in the planned study. Possible discomforts and risks associated with intended methods of patient evaluation or specimen collection, as well as any potential for adverse reactions to medications or other treatments, should be delineated. Studies involving placebo treatments and/or a requirement to withhold therapy that would otherwise be indicated must be accompanied by explanation of the known risks of withholding or deferring such treatment. Risks or adverse reactions that are minor or quite unlikely to occur should be described in such terms, rather than omitted. 6. Investigators conducting clinical research involving use of experimental treatments (e.g., medications, surgery) and/or withholding of available therapy must identify the standard or conventional treatment(s) that might otherwise be used. 7. When clinical research involves use of treatments that are not identified to the owner and/or veterinarian who is caring for the patient (e.g., blinded clinical trials), the investigators must provide a method for breaking the treatment code anytime (including nights, weekends and holidays) that the information is needed because of occurrence of adverse events that might be due to the treatment. 8. Research findings that might affect medical decisions about the animal's care, including but not limited to discovery of unforeseen risks and/or adverse reactions, must be promptly reported to the animal's owner and attending veterinarian. 9. An owner's and/or animal's participation in clinical research must remain confidential, unless disclosure of participation is explicitly authorized by the owner. 10. Certain types of clinical research do not require a Client Consent Form, despite the fact that client-owned animals are the subjects of study. Investigators who are planning clinical research that is believed to be exempt from full CRRC review are expected to submit a written request for exempt status. This request must be accompanied by a copy of the research proposal or some other explanation of the nature of the planned research so that the CRRC can determine whether or not exemption is appropriate. Exempt status will be approved when: 2

5 a. The research will be conducted entirely by telephone or mail and without a requirement for the subject animals to be examined by a veterinarian. Examples include studies in which the data are collected by using questionnaires. When an anonymous survey is used, informed consent is not required for distribution of the questionnaire; however, any study involving human subjects (including surveys or questionnaires directed to animal owners) should also be submitted to the University IRB using its procedures for an exempt protocol. b. The research will be conducted entirely using specimens or data that are or will be routinely collected from the study subjects during activities that would occur even if the research was not ongoing. Examples include studies using data contained in medical records that are derived from ongoing patient care activities and/or observations made in laboratories using specimens (i.e., body fluids or tissues) submitted for tests or other evaluations that also are part of patient care activities. 11. Informed Consent documents must include a statement, This research has been reviewed and approved by the Clinical Research Review Committee of the Texas Veterinary Medical Center. If questions arise regarding your rights as a participant, the Clinical Research Review Committee Contact Person listed below may be contacted. The proper contact person is: Dr. L. Garry Adams Associate Dean for Research and Graduate Studies College of Veterinary Medicine Texas A&M University College Station, TX

6 Procedures 1. Information and assistance, including the forms and guidance needed to obtain CRRC approval of clinical research, can be obtained by contacting: Chairperson, Clinical Research Review Committee C/O: Lisa Reyes, Office of the Dean College of Veterinary Medicine Texas A&M University (MS 4461) College Station, Texas / ; Fax: 979/ For CRRC approval of proposed clinical research, the following documents must be prepared and submitted for review. Lack of suitable documents or omission of requested information will delay the review and approval process. a. A fully completed and signed copy of the CRRC form entitled, Proposed Use of Client-Owned Animals (see Attachment) b. A copy of the Informed Consent document that will be used by the investigators when they obtain owner permission to include subject animals in the study. Having a suitable Informed Consent document is of paramount importance to the CRRC. Detailed guidelines for preparation of Informed Consent documents that will satisfy CRRC expectations are available (see Attachment). c. A written description of the planned research, such as a complete copy of the research proposal or grant request. 3. The assembled packet of required documents should be submitted to the CRRC through the contact person designated above. Time required for CRRC review and approval of proposals having no deficiencies usually is 2-4 weeks. Longer periods are needed to obtain final approval of proposals that are found to have deficiencies that require correction. Packets should be received at least 7 days prior to each monthly meeting for evaluation at that meeting. Contact Office of the Dean for meeting dates. 4. Consideration of submitted clinical research proposals by the CRRC will be conducted as follows: a. The submitted documents will be checked to verify their adequacy to serve as a basis for CRRC action. Packets that lack required documents or other needed information will be returned for correction of the identified deficiencies before distribution to the entire CRRC for full review. 4

7 b. Packets that are ready for CRRC review will be distributed to all members of the committee, and consideration of the proposal will be added to the agenda for the next meeting of the CRRC. c. The CRRC chairperson will select one committee member to serve as lead reviewer for each proposal considered, but all committee members will have the opportunity to review the proposal and offer comments or criticisms before CRRC action is taken by the committee as a whole. d. Members of the CRRC will not participate in discussions of or vote on their own research proposals. e. In CRRC deliberations, motions for approval or disapproval of considered proposals are adopted if a majority of the voting CRRC members vote to pass the motion. f. The CRRC will take one of the following actions after its review of clinical research proposals. Approved as submitted indicates complete, final approval. Approved pending modifications indicates minor revisions necessary. Proposals that receive an Approved pending modifications designation will be given full, final approval (i.e., approved as submitted status) as soon as the investigator(s) provide the CRRC with evidence that the identified problems have been corrected. The CRRC chairperson usually will grant this approval after verifying that the needed revisions have been made, but without having another full CRRC review or committee meeting. Resubmit with modifications indicates that final approval may be granted when specific shortcomings, which the CRRC has confidence can be remedied, are corrected. (Requires re-review by committee) Disapproved indicates existence of shortcomings that the CRRC does not have confidence can be remedied. Reasons for disapproval will be given, and a revised proposal may be resubmitted if the identified problems are corrected. Exempt indicates that the proposal does not require review of an Informed Consent Document by the committee. The principal investigator should submit a letter indicating a request for an exempt status with the original proposal. 5

8 g. Investigators will receive written notice of the actions and/or recommendations of the CRRC; however, a member of the CRRC (usually the lead reviewer or the CRRC chairperson) will be available to discuss any issues of concern with the investigator(s). h. Approval of the Informed Consent Document or notification of Exempt status is required prior to initiation of project. 5. Clinical research proposals for which an exempt status is requested will be considered as follows: a. The investigator(s) will prepare and submit: A signed copy of the CRRC form entitled, Proposed Use of Client-Owned Animals, using the space on this form that is provided for RISK SUMMARY to instead provide a brief explanation of the basis for the request of exempt status. A written description of the planned research, such as a complete copy of the research proposal or grant request. b. The CRRC chairperson will review the submitted documents and grant approval of exempt status if the proposal clearly qualifies for the designation. The full CRRC will be advised of such approval at its next meeting. c. When the CRRC chairperson is uncertain that a request for exempt status should be approved, two possible courses of action exist: The investigator(s), after being advised of the CRRC chairperson s concerns, might choose to withdraw the request for exemption and resubmit the proposal and an Informed Consent Document for full CRRC review and approval. The investigator(s), knowing the CRRC chairperson s concerns, might still request exemption, and the issue will then be submitted to the full CRRC for discussion and then a vote on approval/disapproval of the exemption. 6. Following CRRC approval of a clinical research proposal (including approval of exempt status), the investigator is expected to promptly notify the CRRC in writing if any of the following conditions occurs: a. A change in the clinical research plan or protocol that might affect CRRC approval of the project or that might require a change in the Informed Consent document. (See 7. below) 6

9 b. Any unforeseen adverse reaction to treatment or other problem arising from the research protocol that might influence an animal owner s willingness to participate in the study. c. Any foreseen adverse reactions to treatment or other problems arising from the research protocol that are found to be more serious and/or frequent than was expected, and therefore might influence an animal owner s willingness to participate in the study. 7. Investigators who desire to modify an approved Informed Consent document should submit the following to the CRRC: a. A completed Project Amendment Form (see attachment) b. A revised Informed Consent document incorporating the desired revisions. It would be helpful to the Committee if the proposed changes were highlighted in the revised consent document. Following review of the requested modifications, the CRRC will take one of the actions outlined in Procedures 4. f. It is the responsibility of the investigator to insure that all clients participating in the study sign the revised consent form. 7

10 GUIDELINES FOR PREPARATION OF INFORMED CONSENT DOCUMENTS General Principles 1. The process of obtaining informed consent requires an interaction between the animal owner and the investigator (or a designated representative of the investigator) during which the owner becomes sufficiently well informed regarding the risks, benefits, and requirements of the study to make a reasoned decision about participating. The Informed Consent document is intend to: a. Aid the process of obtaining informed consent by presenting the information that is necessary to the process. b. Document, in writing, the understandings and agreements upon which the informed consent was based. 2. Having an Informed Consent document that is clear and comprehensible to animal owners, who usually are lay persons, is crucial. To obtain this objective: a. Exclude extraneous information; if the information is not necessary to the informed consent process, leave it out. b. Use language and nomenclature that lay persons will understand, or explain the meaning of unfamiliar words or phrases that must be used; minimize the use of medical slang or jargon, including acronyms. 3. The Informed Consent document is expected to adequately address each of the elements of consent that are now standard for protection of human subjects engaged in research. See the article by Sloan and Resnick (i.e., The Consent Form Revisited, from Arch Int Med 1993;153: ), for an excellent discussion of common pitfalls and problems associated with preparation of Informed Consent documents. 4. Several examples of Informed Consent documents that have been approved recently by the CRRC can be viewed at 5. Each page of the Informed Consent document should be numbered, and space should be provided at the bottom of each page for the animal owner to date and initial the page as the document is reviewed. Information identifying the specific animal(s) included and owner signature(s) indicating agreement to participate are placed at the end of the document. 6. The animal owner should always receive a personal copy of the Informed Consent document that was signed. 8

11 7. The Informed Owner Consent Form should address the following areas. a. Purpose of the project b. Eligibility for participation c. Expected duration of participation d. Description of Procedure e. Possible Discomforts and risks f. Possible benefits of Study g. Alternative diagnostics, procedures, or treatments h. Confidentiality i. Financial Obligations j. Compensation or therapy for accidental injury or complications k. Primary Contact person(s) l. Voluntary participation and right to withdraw m. Termination of participation by principal investigator(s) n. Unforeseen risks o. Clinical Research Review Committee Contact Person 9

12 CRRC No. Clinical Research Review Committee College of Veterinary Medicine Proposed Use of Client-Owned Animals Principal Investigator: Dept.: Phone Number: Title of Project: Granting Agency (if any): Anticipated Starting Date: Species: Anticipated Ending Date: Number of Animals: Explanation for using client-owned animals: Justification for the number of animals being used: Where will the research be conducted (please check all that apply)? TAMU Small Animal Hospital TAMU Large Animal Hospital Veterinary Hospitals outside of TAMU other location(s) please specify and explain why research is not conducted at a veterinary hospital: Who will be performing the veterinary medical procedures outlined (please check all that apply)? N/A this project only involves data collection N/A this project only involves non-traumatic sample collection (e.g., collection of naturally passed urine or fecal samples) faculty or staff veterinarians with an institutional license licensed veterinarians (must be licensed in one of the 50 states of the US) other please specify and describe the expertise of the individual(s) as it relates to the work that is being proposed: Materials and Methods: Comments:

13 Statement: I certify that all investigators listed on the consent form have read and approved the attached document. All investigators are aware of their participation and duties as they relate to this project. Signature: Date: Please do not write below this line Committee Action: Exempt Approved as submitted Approved pending modifications Disapproved Resubmit with modifications Signature: Date:

14 Note: An informed owner consent form must be filed for approval with the Clinical Research Review Committee for any project involving a faculty or staff member affiliated with the College of Veterinary Medicine that involves client-owned animals. Please note that research projects that involve any university-owned animals must be approved by the University Animal Care and Use Committee. The sole goal of this document is to make sure that consenting owners fully understand the study in which they are about to enroll their pet. Therefore, the document should be short but comprehensive. Please use lay language whenever possible! Some medical terms should be explained in parentheses. You are currently viewing an outline of the CRRC form containing instructions. You are encouraged to use the second copy without the instructions for drafting your informed consent document. Please only change default statements if they don t apply to your study. Informed Owner Consent Form ---Study Title--- Note: Please note that the title should be short and meaningful for the average owner of the patient that you are planning to enroll ---Name(s) and title(s) of the principal investigator(s) Purpose of the project Note: Please state the primary purpose of the study in one or two sentences. 2. Eligibility for participation Note: Please give short criteria for eligibility for participation. 3. Expected duration of participation Note: Please state the maximum time period each single animal subject will be enrolled in this project. Do not state the overall study period for the study. 4. Description of Procedure Note: Please describe all procedures that will be performed on the enrolled animal, whether they be diagnostic or therapeutic. Please include who is conducting each procedure (licensed veterinarian, veterinary technician, veterinary student, owner, etc). Note the collection of biological samples but please do not describe the analyses that will be performed on the collected samples. Please limit your description to procedures that are performed for the sole purpose of this study. Procedures that would be performed even if the pet was not enrolled in the study should not be described. 5. Possible discomforts and risks Note: Please list all known risks and discomforts. If there is any morbidity and mortality associated with any of the proposed procedures such risk must be clearly stated in this paragraph.

15 6. Possible benefits of study Note: Please list direct and likely benefits to the enrolled patient only. Do not list benefits to the owner of the enrolled patient or any long-term benefits to the breed or species. Also, please do not list any potential benefits to human patients. If it is not likely that there will be a benefit to the individual animal that is being enrolled please state this clearly. 7. Alternative diagnostics, procedures, or treatments Note: Please indicate if alternative diagnostics, procedures, or treatments are available to the pet owner if he or she were not to enroll in the study. 8. Confidentiality Owner and patient confidentiality will be maintained. No identification of individuals shall be made when reporting or publishing the data arising from this study. Note: Or alternative text as appropriate for your study. 9. Financial obligations There are no financial obligations by the owner to Texas A&M University for participation in this study. Note: Or alternative text as appropriate for your study. 10. Compensation or therapy for accidental injury or complications The owner of any participating animal will be financially responsible for costs associated with the treatment of complications or accidental injuries associated with this study. Note: Or alternative text as appropriate for your study. 11. Primary contact person(s) To obtain further information regarding this study contact: Note: Please list the name(s) and contact address(es) for the principal or key investigator(s). 12. Voluntary participation and right to withdraw Participation in this study is voluntary, and refusal to participate involves no penalty or loss of care to which the patient is otherwise entitled. Participants have the right to withdraw from the study without penalty at any time and for any reason. Note: Or alternative text as appropriate for your study. 13. Termination of participation by principal investigator(s) The investigator(s), ---enter name of investigator(s)--- has/have the right to terminate the study for any or all participants at any time and for any reason. Note: Or alternative text as appropriate for your study. 14. Unforeseen risks Unforeseen risks might arise at any time during the study. The investigator(s) will promptly inform owners of all animals enrolled in this project of any new information that may affect their willingness to participate.

16 Note: Or alternative text as appropriate for your study. 15. Clinical Research Review Committee Contact Person This research has been reviewed and approved by the Clinical Research Review Committee of the Texas Veterinary Medical Center. If questions arise regarding your rights as a participant, the Clinical Research Review Committee Contact Person listed below may be contacted: Dr. Garry Adams Associate Dean for Research and Graduate Programs College of Veterinary Medicine Texas A&M University College Station, TX

17 INFORMED OWNER CONSENT ---Study Title--- I, (name), of (address) (City, Zip) hereby consent to the participation of the following animal in the study of ---enter the name of the study here---. I certify that I am the legal owner (or agent of the owner) of, and am responsible for, this animal. I have read and I understand the Informed Owner Consent Form. Animal Details Name: Breed: Age: Signature of Owner or Agent: Signature of Investigator: Witness: Date: Date: Date:

18 Principal Investigator: Clinical Research Review Committee College of Veterinary Medicine Project Amendment Form Dept.: Phone Number: Title of Project: CRRC project number: Changes to the following sections: Please check all sections for which changes are requested. Please be aware that changes in one section may affect other sections as well. Only check sections for which changes are requested. 1. Purpose of the project 2. Eligibility for participation 3. Expected duration of participation 4. Description of Procedure 5. Possible discomforts and risks 6. Possible benefits of study 7. Alternative diagnostics, procedures, or treatments 8. Confidentiality 9. Financial obligations 10. Compensation or therapy for accidental injury or complications 11. Primary contact person(s) 12. Voluntary participation and right to withdraw 13. Termination of participation by principal investigator(s) 14. Unforeseen risks

19 Signature: Date: Please do not write below this line Committee Action: Approved as submitted Approved pending modifications Resubmit with modifications Disapproved Exempt Signature: Date: Version July-03