The RCWIH BioBank adheres to the highest ethical standards in all of its operations and is fully approved by the Mount Sinai Hospital Research Ethics Board (MSH REB), which operates in accordance with the Tri-Council Policy Statement: Guidelines on Research Involving Human Subjects, ICH-GCP Guidelines, the Ontario Personal Health Information Protection Act, 2004 and Part C, and Division 5 of the Food and Drug Regulations of Health Canada.
By coordinating with the clinical care staff of Mount Sinai Hospital, RCWIH BioBank Clinical Research Personnel ensure that all clinical materials collected do not interfere in any way with the care of patients and their babies, or with any personal banking a patient may wish to have of their child’s umbilical cord blood following delivery.
All participants in the RCWIH BioBank program are protected by legal Informed Consent Documents, which clearly state that any donated specimens will be used for research purposes only. The possible benefits to research discovery programs and community healthcare, as well as any risks associated with participation, are discussed prior to the provision of consent.
The RCWIH BioBank has adopted stringent policies, such as coding procedures to ensure that all specimens and personal health information are fully de-identified prior to their distribution to investigators, and can only be linked to the donors by RCWIH BioBank personnel. All clinical information that is collected for the purpose of research is stored on secure servers and protected by several levels of password encryption.
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