Research participants' rights to access information about themselves held by public research institutions.

• Author: Ries, Nola M.

Introduction

The growth in longitudinal studies that involve collection and banking of personal information and biological samples from research participants over many years has generated wide-ranging analysis of associated ethical, legal and social aspects, especially issues of consent, privacy and confidentiality, handling of research findings, and benefit sharing. (1) One issue, however, that has received relatively little attention in the discussion of research databanks is the right of participants to request access to information about themselves held by researchers. Over the course of a long-term study, much information about participants will be collected and recorded, including participant responses to study questionnaires and other instruments, records of physical measures, and results from analyses of blood or other biological samples that may be conducted for some studies.

As discussed below, a key fair information principle is that individuals ought to be able to know about and access personal information about themselves, especially information held by public institutions. Indeed, freedom of information laws across Canada codify a right to access information held by public bodies, subject only to specified exceptions. (2) What is the scope of a research participants' right to obtain access to information about themselves held by researchers in public institutions, such as universities? How does legislation apply to records created for research purposes? What factors should researchers consider in developing policies to handle access requests?

To address these and related questions, this paper discusses the development of Canadian legal principles concerning access to personal information, focusing particularly on health information. It begins with a brief overview of Canadian common law principles about access to health care records, then turns to the development of statutory access to information rules. Legislative provisions that apply to records obtained or created for research purposes are summarised and practical considerations for developing access to information policies are discussed.

Canadian Common Law: McInerney v. MacDonald

To open the discussion of information access rights, it is worth looking back to the 1992 Supreme Court of Canada decision in McInerney v. MacDonald. (3) This litigation concerned the common law right of a patient to access records held by her physician. Dr. McInerney provided copies of records she had created, but refused to release copies of reports she had received from other physicians. In her view, those documents were the property of the other physicians and Ms. McInerney should contact them directly to request access.

Ruling in the patient's favour, the Supreme Court of Canada held that a patient has a right to access their health care records and that a physician should provide access to all records that informed the patient's treatment, including records obtained from other health care providers. The Court based this access right on the fiduciary relationship between the physician and the patient and noted that "a patient has a vital interest in the information contained in his or her medical records." (4) While the relationship between researcher and participant may arguably be characterised as fiduciary in limited circumstances, such as the relationship between a physician-researcher and a patient-participant in a clinical trial, (5) the McInerney case is nonetheless notable in emphasising the importance of access to information about oneself. The nature of the information contained in research records is similar to the Supreme Court's description of information contained in medical records: "at least in part, medical records contain information about the patient revealed by the patient ... Of primary significance is the fact that the records consist of information that is highly private and personal to the individual. It is information that goes to the personal integrity and autonomy of the patient." (6)

Moreover, the Court noted that access to records about oneself may be necessary for a patient to ascertain that a health care provider has, in fact, discharged their duty to act in the patient's best interests: "it is important that the patient have access to the records ... to ensure the proper functioning of the doctor-patient relationship and to protect the well-being of the patient. If there has been improper conduct in the doctor's dealings with his or her patient, it ought to be revealed." (7) This same reasoning may apply to a research participant's interest in obtaining access to personal information held in research records, especially if access to the information may be relevant to the individual's ongoing, informed consent to participate. For instance, a person who became a research participant as a child may, upon developing capacity to give their own consent to continued participation, request access to information collected about them earlier in their life. (8)

While these are points of analogy between access to health care records and access to records compiled for research, it must be noted that the Supreme Court in McInerney limited the direct scope of its decision by stating it "does not extend to information arising outside the doctor-patient relationship." (9) Yet, when the case was before the New Brunswick Court of Appeal, the majority observed presciently "that a noticeable trend has developed favouring an individual's right of access to personal information." (10) Indeed, that trend began to emerge in the latter decades of the 20th century and culminated, in Canada, with enactment of provincial and federal statutes that codify information access rights. (11)

The Trend to a Right of Access to Information about Oneself

Fair information principles

In the 1970s, several influential American and European governmental commissions examined the growing technological capacity to store vast amounts of computerised data about citizens and began to formulate fair information practices. (12) The principle of individual access was common among recommendations for fair information handling practices; as a U.S. report stated: "There must be a way for an individual to find out what information about him is in a record and how it is used." (13) In 1980, the Organization for Economic Cooperation and Development (OECD) adopted guidelines for the protection of personal information. (14) These guidelines included an "individual participation" principle which states that an individual should have a right to access information about themselves. The OECD guidelines influenced development of fair information principles in other jurisdictions, including the Canadian Standards Association (CSA) Model Code for the Protection of Personal Information. (15) Principle 9 of the CSA Model Code states: "Upon request, an individual shall be informed of the existence, use, and disclosure of his or her personal information, and shall be given access to that information." (16) This Model Code was subsequently adopted into law to form the core principles of the federal Personal Information Protection and Electronic Documents Act. (17)

Development of statutory access rights

At the time of the Supreme Court's decision in McInerney v. MacDonald, there was no consistent legislative approach to access to information across Canada. The legal situation is markedly different today as access to information legislation currently exists in all Canadian jurisdictions. (18) The legislation varies, however, in its application to different types of organisations, with separate statutes typically regulating public and private sector bodies. Researchers should be aware of legislation that will apply to the organisation that acts as a data repository for long-term studies. This paper focuses on research led by university-based investigators where databanks are held by these public institutions. Thus, the discussion addresses provincial statutes...