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Stored Biological Materials

This guideline has been developed to address ethical issues pertaining to the collection, storage and use of human biological materials for research purposes. It will aid researchers and CHIPER in the application of principles outlined in the Tri-Council Policy Statement 2: Ethical Conduct for Research Involving Humans. 

Definitions 

Anonymized information/samples: information which has been irrevocably stripped of direct identifiers, no code is retained to allow future re-linkage, and the risk of re-identifying individuals from the remaining indirect identifiers is low or very low. 

Anonymous information/samples: information which never had identifiers associated with it (e.g., anonymous surveys) and risk of identification of individuals is low or very low. 

Authorized third party (also known as “authorized third party decision makers”, “legally acceptable representative” or “substitute decision-maker”): any person with the necessary legal authority to make decisions on behalf of an individual who lacks the capacity to decide whether to participate or to continue to participate in a particular research project. 

Coded information/samples: information from which direct identifiers have been removed and replaced with a code. Depending on access to the code, it may be possible to re-identify specific participants (e.g., the Researcher retains a list that links the participant’s code name with their actual name so data can be re-linked if necessary). 

Directly identifying information/samples: information which identifies a specific individual through direct identifiers (e.g., name, social insurance number, personal health number). Identified biological material and any associated information are directly traceable back to a specific individual.

Human genetic research: the study of genetic factors responsible for human traits and the interaction of those factors with each other, and with the environment. 

Indirectly identifying information: information which can reasonably be expected to identify an individual through a combination of indirect identifiers (e.g., date of birth, place of residence, or unique personal characteristic).

Collection of Biological Material for Research 

The collection, storage, and use of human biological materials (e.g., human tissue, such as bone, muscle, skin, connective tissue, organ tissue, and hair, blood, body fluids, feces, DNA, etc.) for research must be undertaken with the free and informed consent of competent participants. In the case of incompetent participants, free and informed consent must be obtained from an authorized third party. In the case of deceased individuals, free and informed consent must have been expressed in a prior directive or free and informed consent must be obtained from an authorized third party. (TCPS 2, Article 12.1). 

Informed Consent for Collection of Biological Material for Research 

The general principles for informed consent should be applied in addition to the following issues specific to the collection of biological material: 

  • The purpose of the research for which biological samples are being collected (TCPS 2, Article 12.2). 
  • The type and amount of biological samples to be taken; the manner in which samples will be taken; and the safety and invasiveness of acquisition (TCPS 2, Article 12.2). 
  • The potential uses for the samples, including any commercial uses (TCPS 2, Article 12.2).  
  • Use for genetic research must be specified. Generalized descriptions of the potential uses are only acceptable if the samples are anonymized. 
  • Potential benefits and harms from the research (including, where appropriate, benefits and harms to families, groups, or communities). 
  • Specify how long the samples will be stored (TCPS 2, Article 12.2). Storage for an indefinite period is only acceptable if the samples are anonymized. 
  • Specify where the tissue will be stored; and, if applicable, who will be responsible for distributing the tissue for future research. 
  • The informed consent form may be designed with yes/no checkboxes giving participants the opportunity to consent to or refuse certain categories of research. Examples include: 
  • Future use of identifiable samples for any project relating to the condition for which the sample was originally collected; 
  • Future use of anonymized samples for any project relating to the condition for which the sample was originally collected; 
  • Future use of anonymized samples for projects that are unrelated to the condition for which the sample was originally collected; 
  • Use of samples for one particular project; and 
  • Future contact permitted to ask for consent to do further projects; etc. 
  • Describe the safeguards to protect the individual’s privacy and confidentiality. 
  • Describe any identifying information attached to specific samples, links to personal information, and potential for traceability (TCPS 2, Article 12.2). 

When the informed consent is obtained in a clinical setting, it should be clear that refusal to consent to research use of biological materials will in no way affect the quality of the patients’ clinical care. 

The participant should be told whether they will be provided with the results of the testing. In the case of anonymized samples, where appropriate, participants may be given the overall results of the project. The results should be disclosed when they signify a clinical problem and methods to improve or treat the condition are available. If the results will not be disclosed, reasons for this should be provided. 

Where the samples are identifiable, the participants should be able to request that their sample be destroyed. Exercising the right to withdrawal is not possible in the case of anonymized samples and the participant should be informed of this in the informed consent form. 

Where appropriate, the researcher should inform the participant at the time of consent that the participant is not entitled to any financial or commercial benefits arising from the research. 

If the biological samples or data derived from the research are to be sent to other researchers or institutions, the participant should be informed at the time of consent and given the opportunity to decline. The recipient researcher’s/institution’s policies governing storage and access to stored samples should be included in the Harmony application. 

 

Secondary Use of Previously Collected Biological Materials 

Research involving the use of previously collected biological samples (samples that were either collected for another research project or samples from pathological examinations) must be submitted to RITHIM for review and approval. 

When identification is possible, researchers shall seek to obtain free and informed consent from the participants, or from their authorized third parties, for the use of previously collected biological material (TCPS 2, Article 12.3A). If obtaining informed consent is not feasible, approval must be sought from RITHIM prior to use of the samples. 

If informed consent was previously obtained at the time of sample collection, a copy of the informed consent form must be provided in Harmony with the new project application. For identifiable samples, the original informed consent forms will be reviewed to determine whether the participants agreed to participate in the type of research proposed. If the informed consent forms are inadequate, the researcher must either obtain consent from the participants for the current research or, if appropriate, anonymize the samples. 

When biological material has been provided by persons who are not individually identifiable (Anonymous and Anonymized information/samples – see definitions above), and when there are no potential harms to them, there is no need to seek the donor’s permission to use their biological material for research purposes (TCPS 2, Article 12.3B). 

Storage of Biological Materials for Research 

The researcher should control access to stored biological materials. The researcher should outline plans for the transfer of responsibilities regarding the samples and research data, in the event of their departure from the institution, prolonged absence or death. 

The project protocol and Harmony application must describe the storage procedures in detail, for example: where will the samples be stored; how will they be stored to protect the participants’ privacy and confidentiality; and who will have access to identifiable information.  

When transferring genetic material and information between researchers, only coded or anonymized information should be transmitted. 

Ethical Issues for CHIPER to Consider 

Rendering samples anonymous has the advantage of increasing confidentiality, however, it has the disadvantage of making it impossible to offer potential benefits of the research to participants and their families. This is important when research may disclose previously undiagnosed conditions, such as an inherited predisposition to breast cancer (TCPS 2, Articles 3.4 and 13.2). 

In addition to the privacy and confidentiality of the individual participants, CHIPER will consider implications of the research to biological relatives of the participants or related communities. When harms to the individual or associated groups can be anticipated, researchers should, to the extent possible, plan their research so as to minimize such harms and should consult, when appropriate, representatives of the relevant groups regarding the project design.