Research using personal health information and biospecimens is central to the advancement of medicine. Electronic health records and clinical biobanks are rich data sources that can be used for secondary, research purposes. In Canada, academic researchers affiliated with institutions receiving federal funds must comply with the ethics standards articulated in the TriCouncil Policy Statement 2 (TCPS2) . Research using health information must also comply with provincial privacy statues .
Disclosure of health information initially collected in a clinical context is regulated by the Health Information Act (HIA) in Alberta and by similar statutes across Canada [2, 3]. The HIA permits disclosure of identifiable health information for research if certain conditions are met, including proposal review by a Research Ethics Board (REB) (s. 49) and consideration of the need for consent (s 50). Where consent is necessary, a number of conditions must be satisfied (s. 34). First, the consent must be provided in writing or electronically. The consent must also contain: an authorization for disclosure, the purpose of the disclosure, the identity of the person to whom it will be disclosed, an acknowledgement that the subject of the information is aware of why the information is needed, the risks and benefits associated with consent, the date on which the consent is effective, the date on which it expires (if any) and lastly, a statement that the consent may be revoked at any time. The HIA does not permit surrogates, such as family members or spouses, to provide consent unless a specific personal (research) directive is in place (s. 104).
In certain circumstances, the REB may determine that consent is not required (s. 50). For consent to be waived, the REB must find that the public interest outweighs the individual privacy interests, the researchers are qualified to carry out the research, privacy and confidentiality safeguards are in place and to obtain consent would be unreasonable, impractical or not feasible.
Characteristics of the research that might preclude consent include extremely large sample sizes, conditions with high mortality rates, or health information from a period in the past where it is likely most of the individuals would be lost to follow up in the present day. Finally, consent is not required where the information released is non-identifying (s 32(1)). Consistent with the law, TCPS2 emphasizes the importance of informed consent, but also identifies circumstances where non-consensual research may be permitted. The two standards differ with respect to the permissibility of surrogate consents and the form the consent must take.
Human biological materials, such as organ/tissue samples, bodily fluids or wastes, are also collected for clinical purposes, but may be accessed for secondary use as research materials. The removal of tissues is regulated in Alberta under the Hospitals Act . Under the Hospitals Act, surgically removed tissue must be submitted to a pathologist and then stored for specified periods. The provincial laboratory retains what it needs for clinical purposes but generally has excess amounts that are repurposed for research use.
In contrast to health information, there are no laws that govern the research use of human biological materials but ethics oversight in the form of REB review is required under the TCPS 2 (2014). Similar to health information, where biospecimens are de-identified, individual consents are not required for their use in research. If the materials are identifiable, researchers must seek an informed consent unless several, specific conditions are met .
While these provisions are clear, Canadian legal precedent has found that human tissue removed for medical tests becomes the property of the hospital where the procedure was performed, potentially limiting Canadians’ ability to decide what is done with their biological materials. This is consistent with the situation in the United States, where since the 1990’s patients are considered to have given up their rights to excised tissue. However, proposed new regulations may challenge this [5–7].
Both health information and biological specimens are valuable sources of research data. These resources can be sought on a study-by-study basis directly from individuals, or can be stored in data registries in the case of health information, or biobanks in the case of biological samples. Stewardship of the material then rests with custodians of the registries and biobanks. There has been much written on research use of health information and biospecimens [8–12]. Public opinion with respect to the use of health information and biospecimens is varied, with diversity of opinion reflected in beliefs about consent and related issues [8, 13–17]. Some prefer an opt-out approach where research use is assumed unless people state otherwise. Others prefer a broad, one time consent granting access to all future uses of their information and biosamples, while some prefer to provide consent each time their data are accessed [11, 13, 15, 18].
Considerations influencing individual consent preference include the nature of the data (i.e., health information or biospecimens), who is accessing the information, what the research is about and whether the information is identifiable or not [11, 15, 19, 20]. In addition, the public’s experience with health care and research are likely to influence perspectives as are sociodemographic characteristics including education, gender and age [15–17, 20, 21].
Where consent is required, evidence suggests that those consenting differ systematically from those who decline, biasing research results [9, 22, 23]. Such information is important as research ethics boards and data custodians continue to grapple with how best to balance public rights with individual interests arising from use of these research resources [10, 18]. Understanding public opinion as it reflects the considerations research ethics boards must make, particularly in the context of the Health Information Act and TCPS2 will assist these bodies in discharging their responsibilities. Specific patient groups bring unique perspectives to these considerations.
This survey sought to assess the opinions of patients with chronic kidney disease about the research use of health information and biospecimens.