Professional responsibility and the protection of human subjects of research in Canada.

• Author: Dinsdale, Henry
• Position: Special Issue: Canadian Governance for Ethical Research Involving Humans

Introduction

Protection of human subjects of research involves governments, research funding agencies, professional organizations, institutions, individual researchers and research participants. (1) This paper reviews the responsibilities and roles of professionals and their organizations, including the development of appropriate assurance mechanisms for such protection.

What Does it Mean to Be a Professional?

A profession is more than "an occupation, especially one that involves prolonged training and a formal qualification." (2) An important omission in that definition is the contract with society on which professionalism is based. That contract requires public trust, which in turn depends upon the integrity of individual professionals and their organizations.

Fundamental principles that characterize medicine's social contract are primacy of the patient's welfare, patient autonomy and social justice. (3) Professions become de facto trustees of the public interest if those principles are maintained in the face of pressures from the state or the marketplace. Professions must protect not only vulnerable persons but also vulnerable social values. If professions do not meet their responsibility, public criticism ensues and, in the case of medicine, characterizes physicians as servants of the state or tools of business.

Self-Regulation

Self-regulation is a responsibility and privilege permitted professions through legislation. An important component of self-regulation is defining and organizing educational and standard-setting processes for current and future members of the profession. Professional organizations do much to ensure quality assurance by establishing standards and confirming their implementation by accreditation, certification and continuing education. For example, the Quebec Professional Code lists five elements to be considered when designating a professional order, including, "the special gravity of the prejudice that might be sustained by those who have recourse to the services of such persons because their competence or integrity was not supervised by the order." (4)

The setting for self-regulation involves legislation, regulation, accreditation, certification and licensure; they are complementary mechanisms, each has strengths and limitations.

Legislation is the law, considered collectively. Laws are the system of values that, in a particular country or community, regulate the actions of its members and which may be enforced by the imposition of penalties. Elected representatives pass laws in a democracy.

Regulations are the rules or directives made and maintained by an authority. They are the mechanism by which government bureaucracy implements legislation. For example, The Canadian Food and Drug Act provides regulations with regard to the safety and marketing of drugs. Regulations may cite guidelines produced by non-governmental organizations.

Accreditation is a non-governmental, self-assessment and external peer assessment process used by professional organizations to accurately assess levels of performance in relation to established standards and to implement ways to continuously improve. (5) It is neither an audit nor an inspection. Existing federal and provincial regulations and policies may be used as a starting point in developing the purpose and scope of accreditation standards but accreditation moves beyond the minimal standards set by regulations. Accreditation is a more flexible process than regulation. It is a process that can be applied internationally.

A successful accreditation program is voluntary (a frequently misunderstood and underestimated element), involves peers, incorporates lay persons, is educational, rigorously evaluative, has buy-in by major stakeholders and is accountable to the public and adheres to internationally agreed methods of accreditation. It is done by an organization at arm's length from the program/organization being accredited.

An important benefit of accreditation is the synergy created among stakeholders in the process of developing standards. It contrasts with the top-down process of government regulators who lack a tradition of interaction with professionals in the field. Accreditation bodies adhere to internationally agreed upon methods of accreditation.

Critics of accreditation (6) appear not to appreciate the value of stakeholder involvement in the development of standards, the ongoing identification with accreditation by professionals, its powerful educational component, authority, and the significant...