INFORMED CONSENT

It is a process of communication between a patient and physician that results in the patient's authorization or agreement to undergo a specific medical intervention. All medical care requires the patient’s consent.

In the communications process, the physician provides or perform the treatment and/or procedure (not a delegated representative), should disclose and discuss with the patient:

• The patient's diagnosis, if known;

• The nature and purpose of a proposed treatment or procedure;

• The risks and benefits of a proposed treatment or procedure;

• Alternatives (regardless of their cost or the extent to which the treatment options are covered by health insurance);

• The risks and benefits of the alternative treatment or procedure; and

• The risks and benefits of not receiving or undergoing a treatment or procedure.

In turn, the patient should have an opportunity to ask questions to elicit a better understanding of the treatment or procedure, so that he or she can make an informed decision to proceed or to refuse to participate in the trial.

The ICF is an ethical obligation and a legal requirement spelled out in statutes and case law in all 50 states. Providing the patient relevant information has long been a physician's ethical obligation.

The main purpose of the informed consent process is to communicate to you, the patient, the requirements of the study. You have the right to make decisions about your own health and medical conditions.

Informed consent for a clinical trial involves two parts: a document and a process.

As a document Consent form is a record of Information conveyed, Subject’s willingness to participate and is a proof that consent was sought/obtained

Information in the ICF must be in language understandable to the subject and may not include exculpatory language.

If the patient refuse and doesn´t sign the ICF, no one can persuade him/her to change his/her mind and no procedure can be done to the patient without his/her authorization.

When someone is in no condition of giving or signing the consent form, if it’s a minor, parents can be the one giving the consent otherwise consent can be given by the legal representative.


PATIENT REGISTRATION

Boca Raton Clinical Research follows HIPAA Guidelines and maintains patient confidentiality. Patient registration, medical history, family history and trial participation is stored in our patient database and is never shared or sold