Abstract
Access to and sharing of human biospecimens and associated data globally is critical to address important questions regarding complex diseases. In addition, such sharing is essential to ensure the diversity in biospecimen collections needed to develop treatments that will benefit all populations. Furthermore, access to biospecimens globally is essential for important research during public health emergencies. However, considerable challenges exist regarding accessing and sharing biospecimens, which can significantly impact research. Among these challenges are variations in regulations, both on a national and international level, the lack of a harmonized international framework for biospecimen and data sharing, and the secondary use of biospecimens for research.
In an article published in this month’s issue of Biopreservation and Biobanking, Isabel Baltzan 1 and her colleagues discuss the differences in the requirements in Canada for research on biospecimens from deceased individuals and the impact of these requirements on important public health research, such as studies on COVID-19 during the recent pandemic. The authors note that in Ontario, research ethics boards may waive consent if the conditions of the Tri-Council Policy Statement of 2022 have been met. 2 On the other hand, in Quebec, under the Civil Code of Quebec (CCQ), 3 researchers are required to seek consent from the next-of-kin or another appropriate decision maker if there is no explicit advance consent from the deceased individual. There is no option for a waiver under the CCQ. The authors note that the strict requirements for maintaining safety during the pandemic made obtaining consent from next-of-kin impracticable and was very resource-intensive. Furthermore, the authors point out that obtaining consent from the next-of-kin during public health emergencies such as COVID-19 may be burdensome to individuals who may be in mourning and may require disclosure of sensitive information regarding the deceased person’s death. Baltzan et al. advocate for clarification of the Quebec law to permit the use of biospecimens and data from deceased individuals without explicit consent in appropriate contexts, such as public health emergencies, and call for more streamlined access to biospecimens from deceased individuals for secondary research.
As Baltzan et al. point out, requirements for obtaining consent for the use of biospecimens from deceased individuals vary globally. The US Common Rule 4 does not require consent because research on deceased individuals’ biospecimens and data falls outside the Rule.
In Europe, individual countries have specific norms and regulations regarding the disposal of one’s body and postmortem tissues for the purposes of study, training, and scientific research. A European recommendation 5 (CM/Rec(2016)/6 regarding biological materials removed after death, indicates that they should only be removed from the body for storage for future research with consent or authorization provided for by law. The Committee of Ministries of the Council of Europe on research of human origins’ recommendation CM/Rec(2016) 5 permits research on biological materials from deceased individuals unless the person was known to have objected to it. The CM/Rec (2016)6 references sample use in research projects where the attempt to contact the person for consent proves unsuccessful. In such cases, the biological materials may only be used if an independent evaluation finds that evidence that (1) reasonable effort was used to contact the individual; (2) the research addresses an important scientific interest; (3) the research could not be reasonably achieved without use of these samples; and (4) there is no evidence the person has objected. In this context, an independent review by an ethics committee is also required to assess the research aim and verify the ethical acceptability.
In Italy, Law 2020N.10, 6 establishes modality for persons to express consent during their lifetime. An informed consent is required as outlined by Law n.219/2017. 7 Article 3 of Law 2020 N.10 permits a fiduciary to be nominated through an anticipated declaration of treatment, a “biotestament” introduced by the same law. Should a person that has given consent to biobank samples and data for future unknown research use but is deceased by the time of use, the informed consent is considered invalid unless the informed consent to biobank specifically contains a permission for postmortem use or they have also created a biotestament as indicated above.
The regulatory situation in New Zealand differs significantly from that of Canada, US, and Italy. In New Zealand the regulatory environment for the collection and use of human tissue is encompassed within the Human Tissue Act 2008 8 (the Act) and the National Ethics Advisory Committee 2019 National Ethical Standards for Health and Disability Research and Quality Improvement (NEAC Stds). 9 The Act legally defines human tissue and regulates the collection and use of human tissues from both living and deceased individuals, along with dictating penalties of imprisonment and monetary fines for breaches of law (Subpart 2). Both the Act and the NEAC Stds have autonomous consent at their core, with consent for research for deceased persons by next-of-kin or extended family/community. However, an ethical waiver is permitted where public good is best served. Both documents stress the requirements of cultural and spiritual sensitivity in the collection and use of human tissue and data throughout the research life cycle, including the consideration of both western bioethical principles and non-Western Te Ara Tika principles. 10 The Te Ara Tika ethical framework references Māori, the indigenous people of Aotearoa New Zealand’s protocols and practices requiring cultural consultation, cultural competency and partnership in research initiatives.
In New Zealand, the Code of Health and Disability Services Consumers’ Rights 1996 11 (Code of Rights) specifically addresses tissues obtained from a health care procedure (Right 7 [10]), which includes pathology specimens. Research use of clinical specimens is through informed consent or an ethical waiver. The NEAC Stds permit research biobanking with consent for future unspecified use of samples and data coupled with excellence in governance. An individual who consented to biobanking in this manner ensures continued use of their samples after death; alternatively, biobanking consent could signal intent to support future research thus facilitating an ethical waiver.
In summary, the requirements for the research use of biospecimens and associated data from the deceased vary significantly on a global level, as the examples discussed herein illustrate. In addition to regulations pertaining to biospecimens, privacy regulations, which we have not addressed here, must also be considered. While complete harmonization of regulations and policies globally related to the use of biospecimens and associated data may be unrealistic to achieve, a set of commonly accepted ethical principles for the use of biospecimens in research could help shape the making of policy and laws across national governments and achieve greater consistency. As called for in an editorial previously published in Biopreservation and Biobanking, 12 the research community must work towards establishing such principles. Promotion of these principles could facilitate important research using biospecimens and associated data, including from deceased individuals, while promoting the ethical conduct of such research and help establish and maintain trust with research participants, communities, and the public regarding research on human specimens and associated data.