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Simple Bone Cyst in Kids

Informed Consent

*Please consult your local research ethics or institutional review board for specific requirements pertaining to the informed consent process at your hospital.

Informed consent must be obtained in writing from patients and/or parents or legally authorized representatives prior to performing any clinical trial procedures. 

Researchers must disclose all relevant information to these individuals in a clear and open manner, and ensure adequate opportunities to ask questions. The needs of vulnerable patients (ie. non-English readers, minors) should be taken into consideration during these discussions. The use of translators, witnesses and simplified recruitment materials is highly recommended.

Each enrolled patient will be given a copy of the signed and dated document. An additional copy will be retained in the research files at the hospital.

Capacity to Consent

The age and capacity of patients should also be taken into consideration with the informed consent process. Capacity must be determined by a health care professional and is defined as possessing the ability to:

  1. Understand the information that is relevant to making a decision
  2. Appreciate reasonable consequences of their decision

Consent to participate in a clinical trial is sought from patients with capacity or parents or legally authorized representatives of patients without capacity. In the latter case, it is still important to allow patients the opportunity to assent (agree) or dissent (disagree) to the research.