U.S. and Canadian regulations may be becoming more consistent with regard to research that involves the use of biospecimens. Recent changes proposed to the regulations governing research in Canada may provide a mechanism similar to the Broad Consent provision of the new Common Rule in the U.S.
Biospecimen Regulation in Canada
In Canada, researchers funded by any of the three federal agencies must comply with the Tri-Council Policy Statement: Ethical Conduct for Research involving Humans. This document promotes the ethical conduct of research involving humans by appealing to the ethical principles of justice, concern for welfare and respect for persons. “Respect for persons” refers to the autonomy of research participants. The obtaining of informed consent to participate in a research study is the chosen mechanism by which to acknowledge and respect participant autonomy.1 The application of informed consent to specimens requires, that subjects enter into research voluntarily and with sufficient information about the research activity to make a decision about participation.2 Yet the storage and broad sharing of biospecimens and data make it impossible to foresee all of the future research for which they might be used at the time they were collected.3 Given that technology advances at a rapid pace, the future risks associated with using biospecimens and data are seen as being unpredictable.4 Even though it is difficult to meet all the legal and ethical requirements of informed consent McGuire and Beskow argue that stored specimens and data are a valuable resource and should be used to advance research if appropriate protections are in place.5
Research Ethics Boards (REBs) of institutions in Canada that host researchers funded by federal agencies have been given the mandate to review the “ethical acceptability” of a research project involving humans.6 Research projects involving living human participants, and research involving human biological materials obtained from “living and deceased individuals” require ethics review by an REB before the research starts.7 Thus, both categories are considered “research involving humans.”
However, when a project involves “secondary use of non-identifiable human biological materials” researchers remain obligated to submit to an REB ethics review, although they are not presently required to obtain the consent of participants.8
The definition of identifiable biological specimens in Canada is dependent upon the framework of a specific project. It is understood that the REB in its ethics review account for the expectation that technological developments will increase the chance of re-identification. Such re-identification would violate the abiding concern for the welfare of participants and subsequent agreement to uphold a participant’s right to privacy and the confidentiality of their information.9
Current proposed revisions of the TCPS2 (2014) consider the ethical revision of “research involving non-identifiable human cells whose ethical provenance has already been established” (the confidence that informed consent has been properly obtained and that biological samples are managed in accord with the regulations) may introduce obstacles to research while not adding protection to research participants.10 This proposal would end the need for an REB review of research projects involving the use of non-identifiable human cells from sources showing evidence of consent, aiming in particular at the use of such material from biobanks.11 Public comments on the proposed changes to TCPS2 (2014) highlight a number of outstanding issues, such as the need to define “identifiable information” in the current technological context for individuals and groups including the risk of increasing stigma, and biobank certification, among other concerns.12
The proposed changes to TCPS2 in Canada are aimed at streamlining REB oversight in order to facilitate research without decreasing the level of protection for participants.
Biospecimen Regulation in the U.S.
The U.S. new Common Rule, on the other hand, includes additional safeguards for research involving human subjects.
For identified biospecimens, the U.S. new Common Rule now has a provision requiring regular review of what constitutes identifiability, raising the realistic possibility that biospecimens containing genomic information may be considered identifiable in the future.13 Additional safeguards in the revised rule:
- Consent requirements have been revised to require disclosure if biospecimens, even those lacking external identifiers, will be subject to whole genomic sequencing, anticipating that such procedures already blur the line between identifiable and non-identifiable material.14
- Waiver requirements have been strengthened by the addition of a requirement that identified biospecimens may only be used under a waiver if the research could not practically be done without identifiers.15
- The introduction of a Broad Consent provision allows identified biospecimens to be used without a specific description of the future research that will be done.16
Contrast this with Canada, where research using biospecimens is already considered human subject research, whether or not those biospecimens are identified, and proposed changes to TCPS2 may provide a mechanism similar to Broad Consent. If non-identifiable biospecimens can be linked back to an initial consent for collection or secondary use, such a link may be sufficient to allow research without additional ethical review.
The proposed changes to TCPS2 further underscore the ongoing challenge to achieve balance between the autonomy of participants and the social good of increased scientific knowledge.
1 Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2-2014), Chapter 3, Article 3.2.
3 McGuire, Amy L, Beskow, Laura L. Informed Consent in Genomics and Genetic Research. Annu Rev Genomics Hum Genet. 2010 September 22:11:361-362.
6 TCPS-2 2014. Chapter 6.
7 TCPS-2 2014. Chapter 2, Article 2.1.
8 TCPS-2 2014. Chapter 12 Article 12.3B
9 TCPS-2 2014. Chapter 5
10 TCPS-2 2014. Chapter 2, Section A, at the end of subsection entitled ‘Research Exempt from REB Review’ -after Article 2.4 which will become Article 2.4A) and the addition of Article 2.4B.
11 TCPS 2 2014. Proposed Changes to Chapter 12, Section D, at the beginning of the subsection entitled ‘Storage and Banking of Human Biological Materials’ (after Article 12.4): Addition of Article 12.5A. and of Article 12.5B; Change on Article 12.10
12 Link to TCPS -2 Proposed Changes Public Forum http://www.pre.ethics.gc.ca/eng/consultations/2017/comment-commentaire/
13 The Final Rule. Article 46.102 (e) (5) and (6), 102(e)(6) and (7), Article 46.103
14 The Final Rule. Article 46. 116(d)(1) and 116(c) (9) – –
15 The Final Rule. General Requirements for Informed Consent 46.116(f)(3)
16 – Ibid.