Owner Information and Consent Form

A controlled study into the efficacy of a homeopathic drug for use in companion animals

Introduction

Your pet has been assessed as having a condition within the terms of the study protocol which allows its potential inclusion into this study. This study is being undertaken to see if we can provide good scientific evidence of the efficacy of a homeopathic preparation for the management of conditions in companion animals.

Your participation in the study is expected to be to be limited to the validated data collection questionnaire and one subsequent report. You might, based on the completed study be asked if you would be willing to join an additional study such as a placebo-controlled study.

The study is being sponsored by Homeopet LLC. This means that HomeoPet ‘s I.R.B. (Internal Review Board) is responsible for ensuring the integrity of the study and that all ethical standards are met to ensure owner and animal welfare at all times during the study period. HomeoPet will employ a standard alpha numerical anonymizing system to protect Owner, Pet and Veterinarian personal information. You will provide data directly to HomeoPet LLC who will record and analyze it in order to produce a report on owner reporting of safety and efficacy in the use of a homeopathic formula in companion animals.

What is the study testing and why?

It is common for people with a chronic problem to try lots of different treatments; however, it is also not too common for animals to get better without specific treatment. If one of these spontaneous recoveries coincide with an owner trying a new treatment it is natural for them to think that the treatment is responsible for the cure, when in fact it is just co-incidence. By examining the difference between owners reports to their animal’s response, positive or negative, we can determine how confident that any apparent effect is due to the treatment and not some other coincidental event. This is standard procedure in the development of many high-quality products which can are then sold with confident and legal claims that they do what they claim. It is a method employeed by companies that have had products on the market for an extended period like HomeoPet Leaks No More, to confirm that the product continues to meet owner expectations.

You have the option to use other treatments if you feel things are not progressing as you would like as we do not believe there is any significant cross reaction. We will use this decision as one of the measures to compare the product being reported here, so it is important that you record any measures like this. The freedom to choose other treatments such as medication, is a way that we can safeguard the welfare of your pet.

Your agreement to take part in this study is also entirely voluntary. You may withdraw your pet at any time without giving any reason, however, if you are able to give us a reason it might help us in future studies.

Confidentiality and Privacy

You should also appreciate that all the information you supply about yourself, and your pet is completely confidential and will not be used for any other purpose without your consent. HomeoPet will employ a standard alpha numerical anonymizing system to protect Owner, Pet and Veterinarian personal information.

What is required?

There are two major requirements for you to take part in the study:

  1. A daily dosing of your pet with the homeopathic formulation
  2. Daily record keeping
  3. Weekly monitoring.

Dosing the instructions are on the packaging

By signing the consent form, you authorize your involvement in the study, the storage of your records and its transfer as required for the purposes of the study.

Patient privacy rights are covered in all areas that HomeoPet products hold registrations with a competent authority that regulates medicines. ICH G.C.P. 4.8.10(O) International; GDPR, UK & EU; 45 CFR 46 USA; ACCC Medicines rules, Australia and Health Canada, Canada.

Appendix

Informed consent declaration:

I, yo11r name

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‘Your address.\ and phone number

Being the owner of 1011r dogs m ne:

  • Agree to our participation in a study to uate the efficacy of a homeopathic preparation for the treatment of «Pet’s name’s. I understand that this program involves providing an electronic report to HomeoPet.
  • I understand that the treatment program is designed to uate the efficacy of the homoeopathic treatment in a scientifically rigorous way, but that I will:

A    Have the option to undertake any treatment I or my veterinarian believe might improve my pet’s health during the reporting period.

  • Have the right to withdraw at any time without offering any explanation. In which case I will return all material including treatments to the investigators.

To the best of my ability I will:

  1. complete the daily diary sheet and supplemental record sheet as necessary
    1. make myself available for a 10-minute telephone conversation with the researchers
    1. inform the researchers of any changes to my circumstances.
      1. I understand that all information relating to me will remain confidential and will not be made available to anyone other than the researchers involved in the study. I will not be identified in any report relating to the work
      1. As a participant in this study, I understand that I also have a right to access all information relating to me as a result of this study.
      1. I confirm that the details above are correct

By ticking the relevant box on our research survey you declare that you understand the nature of this study and agree to the undertaking described above.