Informed Consent
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ScribdTranslationsInformed Consent
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ScribdTranslationsINFORMED CONSENT DOCUMENT
The following model is suggested for the preparation of informed consent in
research projects with the participation of subjects in our hospital.
It is important that according to the scope of the project you are presenting, you adjust each one.
from the highlights in the document as deemed appropriate.
PROJECT TITLE
(Must include the contact of the hospital researcher)
Institution:
Telephones:
Service or Department:
Invitation to participate: We are inviting you to participate in the project of
research "……………………………........………………", due to ……….......……………
Before making the decision to participate, please read this document carefully.
Objectives: This research aims to...
in a way that is understandable for people at the eighth grade education level.
The study will include a total of….......................... subjects, from…..................
hospitals or health centers of...
Procedures: If you agree to participate, you will be subjected for a period of......... to the
following procedures: ………………………. (types of medications, administration of
placebo, number and frequency of medical visits, type and number of exams of
laboratory, amount of blood drawn, method of randomization, surveys or
interviews, video recording, diets, abstaining from usual medication, etc. described
in a clear and chronological form
Risks: The administration of………. (Or the application of a technique) may
accompanied by the following undesirable effects: ………………………. Any other
effect that you consider may arise from the use of................ You must
communicate it to.............................. at the phone......................
This intervention does not pose risks for you.
Costs: The medications (or techniques) under study (name the medication and manufacturer)
will be provided by ............ at no cost to you during the development of this
project. All exams or services that are not necessary for the study or
the usual treatment for your illness will also be financed by...
My participation does not incur additional costs.
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Benefits: Besides the benefit that this study will mean for progress of the
knowledge and the best treatment of future patients, their participation in this
this study will bring you the following benefits: ...
I have been informed that I will not receive any medical benefits.
Alternatives: If you decide not to participate in this research, you will receive the study and
treatment that is commonly applied, which can also have effects
adverse (list if applicable to allow comparison with those described for the
drug under study
Compensation: You will not receive any financial compensation for your participation.
in the study. (Mention if applicable whether transportation expenses are funded or
nutrition for special controls).
Confidentiality: All information derived from your participation in this study
will be kept in strict confidentiality, which includes access to the
researchers or supervising agencies of the research. Any publication or
scientific communication of the research results will be complete
anonymous.
Additional information: You or your treating physician will be informed if during the
from the development of this study, new knowledge or complications may arise that could
affect their willingness to continue participating in the research.
Voluntariness: Your participation in this research is completely voluntary and you
you can withdraw at any time by informing the researcher and your doctor
broker, without this meaning modifications in the usual study and treatment of
your illness. Similarly, your treating physician or the researcher may determine
his withdrawal from the study if they consider that this decision is in his benefit.
Complications: In the unlikely event that you experience complications
directly dependent on the administration (or application) of …………… , you.
will receive the complete medical treatment for said complication, funded by ....., and without
any cost for you or your pension system. This does not include the complications.
specific to their illness and its natural course.
Participant Rights: You will receive a signed copy of this document. If
If you require any other information about your participation in this study, you can
communicate with:
Researcher: Names and phone numbers (For studies with medications contact 24
hrs.)
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Other Rights of the participant
In case of doubt about your rights, contact the Scientific Ethical Committee or
Research of the Clinical Hospital University of Chile, Phone: 29789008, Email:
comiteetica@hcuch.cl, located at Santos Dumont No. 999, 4th Floor Sector D, Commune of
Independence, Santiago.
If more committees are applied, add the information.
Conclusion:
After having received and understood the information in this document and having
I have been able to clarify all my doubts, I grant my consent to participate in the project
“……………………………………………”.
___________________
Name of the subject Company Date
Rut.
____________________
Name of the Researcher Company Date
Rut.
_______________________
Name of the Director or Delegate Company Date
Rut.
If it is an illiterate subject, non-sighted etc., register the name of the subject and that of their
Attorney-in-fact (Witness).
Name of the Witness Company Date
Rut.
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