Confidentiality Wording for Consent Form Template
The MSH REB confidentiality clause is based on the requirements introduced by the Personal Health Information Protection Act (PHIPA - Ontario) and focuses on the three basic aspects of the Act - Collection, Use and Disclosure of personal health information - as they apply to clinical research. The clause also incorporates requirements described by GCP guidelines, Health Canada regulations, and the Personal Information Protection and Electronic Documents Act (PIPEDA - Canada).
The information that is required in the Confidentiality section differs slightly for different types of study set ups. Basically, there are three factors to consider:
- Is the study sponsored, either by industry or by an agency? These studies require specific language to inform study subjects to whom their information will be disclosed outside the hospital and how it will be used by the sponsor.
- Does the study need to be registered with Health Canada (i.e., is it a Phase I, II, or III study, or involve the off-label use of a drug/device) or involve oversight by an international regulatory body? These studies need to identify Health Canada or another body as an entity that might look at the study records and also should specify the duration (25 years for Health Canada) that study data will be kept.
- Will the study be conducted solely at MSH? Multi-site studies need to identify who outside MSH will look at the study data. The storage period of study records also depends on where the study is run. Studies run solely at MSH require a 7 year storage period, whereas multi-site studies may be different.
Given these different requirements, the REB has constructed several Confidentiality sections which are aimed at addressing each specific study set up. Though not always the case, sponsored studies are also considered to be multi-site studies.
When constructing a consent form, please choose the Confidentiality section that best fits your study type:
- Sponsored, Health Canada registered study (28 KB Word)
- Sponsored study, not registered with Health Canada (28 KB Word)
- Non-sponsored, Health Canada registered, multi-site study (24 KB Word)
- Non-sponsored, Health Canada registered, MSH-only study (27 KB Word)
- Non-sponsored, multi-site study, not registered with Health Canada (27 KB Word)
- Non-sponsored, MSH-only study, not registered with Health Canada (27 KB Word)
The MSH REB recognizes that many sponsored or multi-site studies use template consent forms that include a non-MSH confidentiality section. While it is preferred that the MSH REB wording is used, other wordings will be considered as long as they incorporate the basic elements of the MSH wording and follow the general MSH consent preparation guidelines. In cases where disagreements arise, the MSH wording must prevail.
There may be other aspects of studies that require additional information or removal of some elements, but these will be considered on a case-by-case basis. For example, studies that link data to external databases or use audio or video recordings need specific wording to address the privacy/confidentiality concerns inherent with such methods.