Ethics Forms

The following categories, provide guidance for assessing the extent to which human biological materials could be used to identify an individual:

1. Identified human biological materials – the materials are labelled with a direct identifier (e.g., name, personal health number). Materials and any associated information are directly traceable back to a specific individual.

2. Coded human biological materials – direct identifiers are removed from the materials and replaced with a code. Depending on access to the code, it may be possible to re-identify specific individuals (e.g., a principal investigator retains a key that links the coded material with a specific individual if re-linkage is necessary).

3. Anonymized human biological materials – the materials are irrevocably stripped of direct identifiers, a code is not kept to allow future re-linkage, and risk of re-identification of individuals from remaining indirect identifiers is low or very low.

4. Anonymous human biological materials – the materials never had identifiers attached to them, and risk of identification of individuals is low or very low. *Category D is exempt for REB review.

_{*Rapid technological advances facilitate identification of information and make it harder to achieve anonymity. These activities may heighten risks of identification and possible stigmatization where a data set contains information about or human biological materials from a population in a small geographical area, or information about individuals with unique characteristics (e.g., uncommon field of occupational specialization, diagnosis with a very rare disease). Where the researcher seeks data linkage of two or more anonymous sets of information or human biological materials and there is a reasonable prospect that this could generate identifiable information, then REB review is required.}