Purpose
The purpose of this document is to provide guidance to sponsors and investigators on the information to be provided to trial participants as part of the informed consent process, prior to collecting human tissue in clinical trials regulated under the Health Products Act and the Medicines Act.
Background
Informed consent is a fundamental ethical and legal requirement in clinical trials. Freely given informed consent should be obtained from every trial participant prior to clinical trial participation. The Health Products (Clinical Trials) Regulations and the Medicines (Clinical Trials) Regulations specify the consent requirements for clinical trials.
In most clinical trials, human tissue (e.g., blood, biopsy samples) is collected from trial participants and used for various trial-related purposes, including eligibility assessment, safety monitoring and to meet research objectives as specified in the clinical trial protocol. To safeguard the rights, safety and well-being of trial participants, it is good ethical practice to ensure that informed consent for tissue collection is obtained and the subsequent use of the tissue is in accordance with the consent provided. This guidance has been developed to specify the consent elements for clinical trials that involve the collection and use of human tissue.
This ensures that trial participants are fully informed prior to giving consent to provide tissue in clinical trials. The Human Biomedical Research Act (HBRA), in part, articulates the general principles of proper consent for tissue collection and use to safeguard the rights, safety and well-being of trial participants. For consistency, and as far as is relevant and appropriate to clinical trials, the consent elements stipulated in this guidance are aligned with the consent elements prescribed in the HBRA.
**Scope **
This guidance applies to clinical trials regulated by HSA:
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