HUMAN RESEARCH ETHICS

Introduction to Research Ethics: Issues, Guidelines, Principles and Values

PART A: Human Research Ethics and the National Statement: A History

Human research ethics: the current situation

In Australia and in many countries, human research ethics comprises a set of standards, usually in the form of guidelines that are used by ethics committees established in research institutions to conduct reviews of proposed research projects that involve human participants. In many countries there is also some form of national oversight. A report by Rand Europe contains a useful overview of the pattern of human research ethics practice.

Standards

These are typically national but there are some important international versions. Of the national standards, well established examples are those of Australia, New Zealand and Canada. These take the form of guidelines issued by government agencies and depend for their effectiveness on being conditions of public research funding contracts. These standards are designed to apply to all human research, from every discipline. The national standards for the United States of America, although contained in regulations made under federal legislation, are limited by the scope of that legislation.

There are important international standards of which the Declaration of Helsinki issued by the World Medical Association and the International Ethical Guidelines for Biomedical Research Involving Human Subjects issued by the Council for International Organizations of Medical Sciences Committees are the best known.

Committees

The name, size and specified membership of these committees varies from country to country. In Australia, they are human research ethics committees (HRECs), in Canada, research ethics boards (REBs), in the United States, institutional review boards (IRBs). It is common to require that members include those with knowledge of the relevant research disciplines and also members who reflect the opinions and interests of the community. The functions of committees are broadly the same, namely, to review proposed research projects in order to protect the welfare of the human participants and to be satisfied that the projects will meet the relevant ethical standards.

National oversight

The extent and structure of national oversight varies widely.

In Australia, the National Health and Medical Research Council (NHMRC) operates a voluntary registration system for HRECs and requires those registered to provide an annual report of their compliance with key requirements and of their activities. Under relevant Commonwealth legislation, HRECs need to be registered in order to review research involing unregistered therapeutic goods and to conform to privacy regulation.

Read more about other national structures...

In the United States, the Office for Human Research Protections (OHRP) operates a two-step process:
1. institutions that conduct research involving human subjects that is funded by a federal agency must submit an assurance of compliance with the regulations and
2. That assurance must include on approval from an IRB that is registered with the OHRP.

In New Zealand, ethics committees need to be accredited by the Health Research Council in order to attract statutory insurance cover for research or to conduct research using certain health information or to conform with privacy regulation.

In the United Kingdom, the National Research Ethics Service operates a system of appraisal and accreditation of research ethics committees that review research within the National Health Service.

The reasons for the current systems

The present systems have emerged to express some enduring principles of ethics and in response to some important historical events.

Emergence of principles

The ethics of the conduct of research involving humans has been recognised as a matter of importance both by researchers, especially in medical research, and by moral philosophers, from the early decades of the nineteenth century. At about that time, some medical researchers, including Claude Bernard and William Osler, recognised the ethical differences in their relationships with patients from their relationships with research subjects, building on early statements of medical ethics, such as that by Thomas Percival.

However, the practice of human research during the nineteenth century and the first half of the twentieth century did not address the early recognition of the ethical significance of human involvement.

It was the exposure of the brutal and inhuman experiments conducted in German concentration camps between 1940 and 1945 in the Nuremberg doctors trial that is generally regarded as the beginning of the modern focus on human research ethics. The Nuremberg Code is a statement of ten principles first presented in 1946 as part of the judgment of the Military Tribunal that tried and convicted a number of doctors for their treatment of prisoners and concentration camp inmates.

In 1964, the World Medical Association issued the first version of the Declaration of Helsinki that is widely recognised as an international standard for the ethics of human medical research. The Declaration has been amended on number of occasions.

Read more about the emergence of principles...

For a list of other key historical documentary sources of the development of human research principles and review processes in the United States of America, see the sources accessible at http://history.nih.gov/about/timelines_laws_human.html. The international documents listed there are relevant to Australian practice, while the Belmont Report 1979, has been influential.

These statements of principles have much in common with the Australian National Statement and show that it continues a well established tradition of values and principles. (The extent of common ground has been well demonstrated in "What Makes Clinical Research Ethical?", Ezekiel J Emanuel, David Wendler, Christine Grady, JAMA;2000:283: 2701-2711) At a deeper level, these have a foundation in the ideas of moral philosophy that have a longer history. The link below will take you to an extract from some reading on the philosophical and ethical foundations of human research ethics.

Experimenting on Human Subjects: Philosophical perspectives, Macklin, R and Sherwin, S" 25 Case Western Reserve Law Review, p. 434, 1974-1975 © Case Western Reserve University

Emergence of review processes

Although the Declaration of Helsinki in 1964 referred to the review of proposed research by a special independent committee, it was not until the disclosure of the infamous Tuskegee syphilis study in the United States of America that the practice of requiring a prior ethical review of proposed research - rather than the scientific review that the Declaration of Helsinki appeared to require - became established.

The United States legislated for the prior review of proposed research by institutional review boards (IRBs), a regulation referred tom as the common rule.

Since then, reliance on the prior review by a specially constituted ethics committee has become a common element in national research ethics systems.

Human research ethics in Australia

For a brief account of the history of human research ethics in Australia, read the material at the following link: http://www.nhmrc.gov.au/health_ethics/history.htm

Human research ethics and the National Statement on Ethical Conduct in Human Research

Read the Preamble, the Purpose. Scope and Limits of This Document of the National Statement at:
http://www.nhmrc.gov.au/guidelines/publications/e72