Informed Consent Process

The following information is for healthcare professionals only. If you are a potential PALomino study patient, please click here.

All potential study patients will be provided with adequate information about the study to make an educated decision about whether to participate. Participation in the study is voluntary. Before obtaining any personal and/or medical information for the study, the patient (or a legally authorized representative) must agree to participate by providing informed consent. If the patient is a minor, written consent must be obtained from the parent(s) or legal guardian(s) per local regulations.

The patient’s and HCP’s contact information details will be collected as well as appropriate medical releases to collect follow-up information.

Each patient (or their legally authorized representative) will receive a copy of their signed Informed Consent Form (ICF). The original ICF will be maintained in the study files.

Patient (or a legally authorized representative) informed consent must be obtained prior to study enrollment and any data collection. Consent will be obtained in compliance with any country-specific regulations or requirements.

Patients (or their legally authorized representative) may withdraw their consent to participate in the study at any time, for any reason and without prejudice.

If a protocol amendment substantially alters the study design or the potential risks or burden to patients, the ICF will be amended and approved by BioMarin and the Institutional Review Board/Independent Ethics Committee/Research Ethics Board (IRB/IEC/REB), and all active patients must again provide informed consent.