Scope
Note: This Procedure is consistent with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (“TCPS 2 (2022)”), Chapter 12 – Human Biological Materials Including Materials Related to Human Reproduction, and Chapter 13 – Human Genetic Research.
This procedure forms part of JIBC’s Research Involving Human Participants Ethics Policy (the “Policy”) and should be followed and applied in relation to the free and informed consent of participants in research at JIBC under the Policy. Terms not otherwise defined in this procedure are as defined in the Policy.
Purpose
This procedure addresses ethical considerations raised by research involving human biological materials centred on acceptable access to, and use of, the materials, potential privacy concerns arising from the handling of information derived from such materials, and the special status some individuals and groups accord to the human body and its parts.
Procedural Guiding Principles
Human genetic research involves the study of genetic factors responsible for human traits and the interaction of those factors with each other, and with the environment.
For the purposes of this Procedure, human biological materials include tissues, organs, blood, plasma, skin, serum, DNA, RNA, proteins, cells, hair, nail clippings, urine, saliva and other body fluids.
Research in human genetics includes the identification of genes that comprise: the human genome; functions of genes; the characterization of normal and disease conditions in individuals, biological relatives, families, communities and groups; and studies involving gene therapy.
Collection of Human Biological Materials (TCPS 2 (2022), Chapter 12, Articles 12.1 and 12.2)
Research involving collection and use of human biological materials requires Research Ethics Board (“REB”) review and:
- consent of the participant who will donate biological materials; or
- consent of an authorized third party on behalf of a participant who lacks decision-making capacity, taking into account any research directive that applies to the participant; or
- consent of a deceased participant through a donation decision made prior to death, or by an authorized third party.
To seek consent for use of human biological materials in research, researchers shall provide prospective participants or authorized third parties with applicable information as set out in Article 3.2 as well as the following details:
- the type and amount of biological materials to be taken;
- the manner in which biological materials will be taken, and the safety and invasiveness of the procedures for acquisition;
- the intended uses of the biological materials, including any commercial use;
- the measures employed to protect the privacy of and minimize risks to participants;
- the length of time the biological materials will be kept, how they will be preserved, the location of storage (e.g., in Canada, outside Canada), and the process for disposal, if applicable;
- any anticipated linkage of biological materials with information about the participant; and
- the researchers’ plan for handling results and findings, including clinically relevant information and incidental findings.
Consent and Secondary Use of Human Biological Materials for Research Purposes (TCPS 2 (2022), Articles 12.3a, 12.3b, and 12.4)
Researchers who have not obtained consent from participants for secondary use of identifiable human biological materials shall only use such material for these purposes if they have satisfied the REB that:
- identifiable human biological materials are essential to the research;
- the use of identifiable human biological materials without the participant’s consent is unlikely to adversely affect the welfare of individuals from whom the materials were collected;
- the researchers will take appropriate measures to protect the privacy of individuals and to safeguard the identifiable human biological materials;
- the researchers will comply with any known preferences previously expressed by individuals about any use of their biological materials;
- it is impossible or impracticable to seek consent from individuals from whom the materials were collected; and
- the researchers have obtained any other necessary permission for secondary use of human biological materials for research purposes.
If these conditions are met, the REB may approve the research without requiring consent from the individuals from whom the biological materials were collected.
Researchers shall seek REB review, but are not required to seek participant consent, for research that relies exclusively on the secondary use of non-identifiable human biological materials.
When secondary use of identifiable human biological materials without the requirement to seek consent has been approved, researchers who propose to contact individuals for additional biological materials or information or for reasons related to the welfare of the participant shall, prior to contact, seek REB approval of the plan for making contact.
Application of Core Principles to Genetic Research (TCPS 2 (2022), Article 13.1)
Guidance regarding a proportionate approach to research ethics review, consent, privacy, confidentiality, research with human biological materials and other ethical guidance described in earlier chapters of this Policy apply equally to human genetic research.
Plans for Managing Information Revealed through Genetic Research (TCPS 2 (2022), Articles 13.2 and 13.3)
Researchers conducting genetic research shall:
- in their research proposals, develop a plan for managing information that may be revealed through their genetic research;
- submit their plan to the REB; and
- advise prospective participants of the plan for managing information revealed through the research.
Where researchers plan to share findings with individuals, researchers shall provide participants with an opportunity to:
- make informed choices about whether they wish to receive information about themselves; and
- express preferences about whether information will be shared with biological relatives, or others with whom the participants have a family, community or group relationship.