Features Practice Technique
An issue of ethics: Summer 2003

The second in a 3-part series on the topic of research ethics, this article focuses specifically on the purpose of research ethics boards, the role of the National Council on Ethics in Human Research and defines some common terms and concepts utilized in research ethics.

Institutional research ethics committees made their appearance in North American university medical centres approximately 25 years ago. The committees, or as they are known in Canada, Research Ethics Boards (REBs), are generally responsible for reviewing the ethical aspects of medical research proposals before the research is undertaken or funded.

More specifically, REBs are responsible for reviewing research proposals, waiving the requirements for ethics review, approving proposals meeting ethical requirements, advising researchers about measures that can be taken to ensure their project is ethically acceptable, initiating education on research ethics, rejecting proposals and, terminating any ongoing research that ceases to meet ethical standards.

Local institutional research ethics boards must comply with national ethical guidelines. These guidelines provide criteria which are to apply to the function of local research ethics boards and the evaluation of
individual medical research proposals.

The national body that provides direction and support for compliance with these guidelines is called the National Council on Ethics in Human Research (NCEHR).

To extend protection of subjects of research beyond Medical Research Council (MRC) funded projects, the NCEHR includes representatives from key organizations in clinical research and from the public.

In 1995, the Co-ordinating Committee for NCEHR was established. The committee’s purpose is to serve as a forum for discussion and collaboration of institutional research ethics, and provide financial and intellectual support to NCEHR so as to facilitate the discharge of its important responsibilities and the fulfillment of its mission.

The mission of the National Council on Ethics in Human Research is to advance the protection and promotion of the well-being of human participants in research; and to foster high ethical standards for the conduct of research involving humans.

The role of the National Council on Ethics in Human Research is to:

• Assist Research Ethics Boards (REBs) in interpreting and implementing guidelines for the ethics of research involving human participants;
• Assist REBs in resolving contentious issues;
• Provide assistance to REBs in establishing and
• implementing procedures for evaluating and monitoring the performance of research involving human subjects;
• Establish an ongoing mechanism to assess the functions of REBs;
• Foster education, dialogue and understanding in and among institutions, REBs, researchers, professional personnel, organizations that fund research and the public, on the ethical aspects of research involving human subjects and the implementation of appropriate guidelines;
• Work with the ethics committees or divisions of the various Research Councils, Royal College of Physicians and Surgeons of Canada, and Health Canada, to ensure that human research ethics guidelines or pronouncements meet the needs of research involving human subjects in Canada;
• Assist the REBs, institutions and organizations that fund research in maintaining and developing expertise concerning the evolution of ethical perspectives on all aspects of research involving human subjects.

Such expertise will involve traditional areas of research, those of newer science and technology, and particularly those relating to human cultural diversity in Canada.

Members: Until 1995, members of Council were appointed by the Royal College of Physicians and Surgeons of Canada. Many of these individuals were representatives of health care organizations.

Two persons from specific disciplines provided expertise in law and ethics as related to health science research; and three others were community members who brought a public perspective to Council’s work.

Currently, Council appoints its own members after consultation with the Co-ordinating Committee. The membership has increased in number and in its range of representation to include individuals with an interest in research ethics as reflecting the constituencies represented by the membership of the Co-ordinating Committee.

In addition to these individuals, Council includes persons with a specific disciplinary expertise in ethics and law, as well as community members.

Renewal or new appointments are made on a staggered basis through Council’s nominating process.

Accountability: The National Council on Ethics in Human Research reports annually to Health Canada, the Medical Research Council of Canada, the Natural Sciences and Engineering Research Council of Canada, the Royal College of Physicians and Surgeons Council, and the Social Sciences and Humanities Research Council of Canada, as well as the boards of various participating organizations.

The National Council on Ethics in Human Research reaffirms its dedication to the highest possible ethical standards in research with a current focus on health and biomedical issues. In order to participate in ethics review for applicable massage therapy research proposals massage therapists must be knowledgeable in and be able to utilize the language of research.

The following list provides definitions of common terms and distinctions used in research ethics review.

Human Participant: A human participant is any person who is a source of primary data and who is not acting as, assisting, or collaborating with the principal researcher.

Researcher: A researcher is anyone who carries out research. The primary researcher is the person who has primary responsibility for a given research project.

He or she plans and co-ordinates the research, and typically analyzes the data and reports the results. The researcher is responsible for submitting the project for review to the Research Ethics Board (REB).

Minimal Risk: When conducting a particular research study which involves risk for the participant, the probability and extent of risk must be no greater than that of those risks involved in normal day-to-day activities. Risk, above and beyond that involved in normal daily activities, is unacceptable and violates research ethics requirements.

Non-minimal Risk:
a. When the research involves sensitive issues, the risk does not qualify as minimal. Sensitive issues include the following: sexuality, mental and physical illness, physical and sexual abuse, substance abuse, death, illegal activities and all issues involving children or the incompetent as research subjects;
b. When the research involves any deception or partial disclosure, the risk does not qualify as minimal.

Free and informed consent:
a. Free consent is voluntarily given, without manipulation, undue influence or coercion;
b. Persons sufficiently aware of the risks and benefits to make a reasonable choice give informed consent.

Deception: Deception occurs whenever information is withheld and/or participants are misled about procedures and purposes of research.

Part three of this series will focus on the requirements of informed consent and will provide specific and detailed information on requirements for research ethics forms