Consent revisited: points to consider.

• Author: Knoppers, Bartha Maria
• Position: Canada - Special Issue: Canadian Governance for Ethical Research Involving Humans

Obtaining informed consent for research involving tissue samples and data is the Damoclean sword for both researchers and participants. It has become the focal point of research ethics review. Over time, and strongly influenced by models of consent from clinical drug trials, core elements have been developed that form the template for most research

in Canada (Box A). Protection of the interests and inclusion of children, minors and incompetent adults find expression in the clarification of the role of legal representatives and of assent mechanisms but the ambit and mechanisms involved in ratification remain unclear (Box B). Whether research is retrospective or prospective, the juxtaposition of informatics and genomics, together with the need for access to normal and affected tissues and to ongoing data (medical, phenotypic, environmental, epidemiological ...) (Box C), are posing new challenges. Issues are emerging that were not foreseen in the current guidelines governing research. (1)

Indeed, the twin ethical and legal principles of autonomy and privacy are being challenged by: (1) requests for access to tissues/data collected from now deceased persons; (2) the creation of biobanks (including registries and longitudinal studies as well as surveillance for public health); (3) the need for withdrawal mechanisms; (4) an expectation that individual results should be returned to participants; and (5) benefit-sharing issues. These challenges require a rethinking of consent to research and the accompanying provisions for confidentiality.

1. Tissue and Data Collected from Deceased Persons

   Are access requests to use samples and data from deceased individuals subject to health information and privacy laws? Currently, such legislation applies only to identifiable living persons. (2) Often the general consents signed upon admission to a hospital contain provisions concerning the use of archived samples removed during routine medical care for quality assurance programs or for "in-house" research in university hospitals with appropriate confidentiality protections. Moreover, until recently little thought was given to access to such samples and data by other researchers whether from the public or private sector. But, in the absence of explicitly "giving" one's body for research upon death, prior, free and informed directives by patients for end-of-life decisions usually do not contain specific instructions for research purposes. In the case of incompetent adults and children, those legally mandated to provide proxy consent for medical care or for research may not have authority for the research use of samples after death. Prospective studies can obtain such prior authorization but in the absence of anonymization or a legislative provision concerning the powers of family members or authorized medical personnel in the context of research, (3) this area is an ethical and legal minefield with no apparent resolution or harmonization of practice across Canada. It would be strange indeed if incineration of samples and destruction of data were to be, due to lack of clarity, the legally and ethically expedient solution rather than either double coding (see infra 7) or anonymization of the data with REB oversight.

2. Biobanks/Repositories as Resources for Future Research

   Contrary to the usual trajectory of single or multicentre research protocols, or even of individual collections of samples and data that simply grow in size and purpose over time or are merged with others to create a larger cohort to answer a specific research question, modern biobanks are created as research resources. They are usually longitudinal in nature, have specific governance structures and may serve one or more large projects comparing phenotypic and genotypic information over time as well as receive requests for access for individual research projects.

   Biobanks are the focal point of many of the challenges mentioned earlier. (4) Moreover, as just mentioned, these banks often require broad consent from donor participants to facilitate research involving their samples and data over time (see infra 6). (5) Subject to ethics review and requiring procedural and independent governance of a more centralized nature, additional unique features of these banks also include the potential...