______________________________________________________________________________
(name of the protocol and institution)
We kindly invite you to participate in monitoring the effects of the therapy, which is
applied due to your illness. Before you decide whether to participate, it is important to
understand why this monitoring is done and what it involves.
Please carefully read the following information and if you want, talk about it with people
you would like to consult with if you feel it necessary. If anything is unclear or if you want more
information, we will be happy to answer your questions. You have plenty of time to decide if
you agree to participate.
Thank you for dedicating time to reading this information.
What is the purpose of this additional monitoring the effects of therapy? 1
Why have you been chosen? 2
Are you required to participate?
What will happen if you decide to participate in monitoring the effects of therapy?
What are the potential benefits and problems of participation?
Will your participation and all the data will be kept as confidential information?
What is the purpose of monitoring and what the results will be used for?
Who organizes and finances this additionally monitor the effects of therapy? 3
What will happen if you are concerned, if you have any question regarding monitoring
the effects of treatment and/or if there is an emergency?
If you agree to participate in this additional monitoring of the effects of therapy that is
applied to you, we'll give you a copy of the list with information and signed informed consent form
to keep, because the procedure provides that you have this kind of information also.
Additional explanations for the candidates that are not part of the document for the Respondent:
General recommendations:
The first observation relates to the need for patient, reading this information and giving their consent to be about his
disease and its progression leads to additional medical records, in addition to the existing regular medical
procedures, not for a moment feel like the subject of an experiment, and that in every aspect of documentation is
respected his integrity as a person.
It is essential that the language used in the documents for patients is adapted to the general speech, with avoidance
of medical terms. If necessary, it is recommended to define and describe the used term.
( 1 ) The term "therapy" is used in general, but this text should be adapted to what is otherwise the subject of your
research.
( 2 ) The patient should be able to communicate about the effects of therapy or therapeutic approach, accurate
diagnosis, healing or relief problems, and it is very important that patients recognize their own interests, and that we
follow the effects of the disease for their own prosperity.
( 3 ) If there is a financier, it must be noted, whether it is a project, pharmaceutical company or personal resources.