Owner Information and Consent Form
A study into the efficacy of a homeopathic medication for use in companion animals
Introduction
This study is being undertaken to gather quality scientific evidence for the efficacy of a homeopathic preparation for the management of various conditions in companion animals. Your pet’s participation is being assessed due to the fact that you have used or are currently using a particular remedy indicated for specific conditions. It should be noted that with some conditions, the animal in question can act as its own placebo control. The terms of the study protocol allow for its potential inclusion into this study.
Your participation in the study is expected to be limited to the validated data collection questionnaire and one subsequent report compiled by us. Based on a completed study you may be asked if you would be willing to join an additional study such as a placebo-controlled study. However, you are under NO OBLIGATION to participate and free to decline at any time.
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. HomeoPet will employ a standard alpha numerical anonymizing system to protect all Owner, Pet and Veterinarian personal information. At no time will any personal information be used in any of the findings. You will provide data to HomeoPet LLC who will record and analyze it to produce a report on owner reporting of safety and efficacy in the use of a homeopathic formula in companion animals.
Why research?
It is common for people whose pets are experiencing chronic problems to try many various treatments for their animals. However, it is not common for animals to get better without specific treatment. If one of these spontaneous recoveries coincides with an owner trying a new treatment it is natural for them to conclude that the treatment is responsible for the cure, when in fact it may just co-incidence.
By examining a number of owner reports relating to their animal’s response, positive or negative, we can determine more accurately any apparent effects that are due to the treatment employed and not other coincidental events. This is standard procedure in the development of many high-quality products which can then be sold with confident and legal claims as to their efficacy. This type of data collection is commonly used to improve products or show their benefits.
You have the option at any time to use other treatments in conjunction with HomeoPet products. The freedom to choose other treatments and medications under direction of your vet is a way to safeguard the welfare of your animal.
Your agreement to take part in this study is also entirely voluntary. You may withdraw your pet at any time, without reason.
Confidentiality and Privacy
All information you supply is completely confidential and will not be used for any other purpose without your written consent.
What is required?
There are two requirements for you to take part in the study:
1. Fill out the questionnaire if you have used the product in the past.
2. If you are currently using a product, keep a record of dosing times using our simple to follow form.
By submitting the completed form, you authorize your involvement in the study, the storage of your records and its transfer as required for the purposes of the study under the above terms.
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
