Research Consent for Client Animals

Implementation Date: 6/10/2009

Date of Last Review: 3/30/2023

Next Review Due: 3/29/2025

 

Reviewed by VTH Administrative Team: 4/14/2009

Reviewed by VTH Board: 6/10/2009

 

Reviewed by Legal Counsel: N/A

Reviewed by Biosecurity Subcommittee: N/A

Subject to modification by the VTH Director without approval.

Policy

Research projects require IACUC protocol development and approval, with the exceptions being retrospective studies using clinical records or data, and studies utilizing tissues or other biological samples collected during routine patient care. Informed Owner Consent shall be required for any IACUC-approved research project involving client owned animals. Owner consent shall be indicated by signing an approved consent form.

Only the approved Owner Consent Form (Template) shall be used and can be found on the Intranet’s Resources page: Resources – Veterinary Teaching Hospital (illinois.edu)

Guidelines

The client has the right to be responsibly informed about procedures being performed on their animal. The informed consent should be thought of as a communication process about the research project through which a client makes decisions concerning the care of their animal. This process assists in developing a critical element of trust between the clinician and client in regards to the patient and establishing expectations for both parties. By providing the client adequate information, the hospital minimizes the risk of claims of ‘lack of informed consent’ which may lead to an accusation of malpractice or negligent action on the part of the clinician and hospital.

When providing informed consent, the following should be included:

• Purpose of study
• Eligibility of animal for inclusion in study
• Explanation of the procedure(s) involved
• Alternative procedures
• Potential risks involved
• Benefits 
• Financial responsibility and/or compensation
• Financial responsibility for management of complications

The person providing the information must have a thorough understanding of the facts outlined in the consent.

Procedure (if applicable)

Principal investigator(s) shall prepare an Informed Consent based upon the research protocol using the template found on the Intranet’s Resource page: Resources – Veterinary Teaching Hospital (illinois.edu)

1.  Create Owner Consent
   1. Use the approved form:  ‘Consent Form for Research or Clinical Trial’
   2. Complete the form and Include project name, name of PI, list of procedures paid by research (list needs to be specific and reflect all procedures that will be entered into the patient’s medical record), list of procedures not currently included in the Health Information System (codes will be created with researcher input)
2. Submit the Owner Consent Form to the VTH Director or designee for approval(VTHDirector@vetmed.illinois.edu)
   1. The VTH Director, or their designee, must approve the consent form prior to the recruitment of any participants.
      
      
3. Submit the Approved Owner Consent form to the Hospital Director’s email VTHDirector@vetmed.illinois.edu
   
   
4. Submit the Approved Owner Consent form to the Health Information Systems (HIS)
   1. Submit account creation request to HIS team (HIS@vetmed.illinois.edu)
   2. HIS team will create the research account and create new procedures with research pricing identified in the consent form.
   3. HIS submits research account information (FOP) to the VTH Business office.
      
      
5. ALL client-owned animals MUST be registered when in the VTH.
   1. New patient fees will be waived if the patient is pre-registered.
   2. All procedures will be recorded in the HIS.
      
      
6. Initiate research and ensure the client has signed the approved Owner Consent Form
   1. Investigators are responsible for maintaining signed consent forms for their studies.

Definitions (if applicable)

Client – Person or entity, not part of the University of Illinois, with legal responsibility and claim for an animal or animals.

HIS – Health Information System

Veterinary Teaching Hospital (VTH): The collective clinical services of the Large Animal Clinic, Midwest Equine, the Small Animal Clinic, and the Veterinary Medicine South Clinic.