Informed consent

Glycolic acid peeling is a medical procedure that requires the informed consent of the patient. The medical doctor must obtain from the patient a well-standardized formal consent that shows that all information about the medical procedure performed was explained to the patient. We include below the formal consent form submitted to the patient before the glycolic acid peeling procedure. 

I have been well informed about side effects that the procedure could cause. 

I confirm that I have informed the medical doctor about all actual pathologies or pathologies that I have had. 

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International Code of Conduct on the Distribution and Use of Pesticides, United Nations Pood and Agriculture Organization, New York, 1985 amended to include provisions for "Prior Informed Consent," 1990. 

An informed consent may be required in some institutions before this procedure. 

Freely given informed consent should be obtained from every subject... 

Unlike human trials. Institutional Review Boards/Independent Ethics Committees are not involved, while informed consent is only required from the owner of the trial animals. In addition to the standard items associated with human trials, aspects such as management and housing of animals, diet and disposal of trial animals and their produce should be included in the trial protocol. Studies may be blinded from the investigators in order to avoid bias in the reporting of animal observations. 

The investigator s brochure, the case report forms, the confirmation of insurance of subjects and the documents used to obtain informed consent... 

While there is no FDA involvement in such investigations, ethical considerations and institutional regulations would generally dictate that informed consent and the approval of the local institutional review board be obtained. However, due to the negligible risks involved these are likely to be a formality and will not involve extensive review or scrutiny. 

Obtain document and retain records of informed consent V V... 

Report use of device without informed consent to sponsor and IRB Compile records of adverse effects and complaints V V V V... 

Copies of forms and informational materials used to obtain informed consent from subjects IRB Information... 

Data from clinical investigations on human subjects, plus statements as regards investigators, IRBs and informed consent. 

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