Ethical and Policy Issues in Research Involving Human Participants, Vol. 2

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Ethical and

Policy Issues

in Research

Involving

Human

Participants

Volume II

Commissioned Papers

and Staff Analysis

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The National Bioethics Advisory Commission (NBAC) was established by Executive Order 12975, signed by President Clinton on October 3, 1995. NBAC’s functions are defined as follows:

a) NBAC shall provide advice and make recommendations to the National Science and Technology Council and to other appropriate government entities regarding the following matters:

1) the appropriateness of departmental, agency, or other governmental programs, policies, assignments, missions, guidelines, and regulations as they relate to bioethical issues arising from research on human biology and behavior; and

2) applications, including the clinical applications, of that research.

b) NBAC shall identify broad principles to govern the ethical conduct of research, citing specific projects only as illustrations for such principles.

c) NBAC shall not be responsible for the review and approval of specific projects.

d) In addition to responding to requests for advice and recommendations from the National Science and Technology Council, NBAC also may accept suggestions of issues for consideration from both the Congress and the public. NBAC also may identify other bioethical issues for the purpose of providing advice and recommendations, subject to the approval of the National Science and Technology Council.

National Bioethics Advisory Commission

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Ethical and

Policy Issues

in Research

Involving

Human

Participants

Volume II

Commissioned Papers

and Staff Analysis

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Patricia Backlar

Research Associate Professor of Bioethics Department of Philosophy

Portland State University Assistant Director

Center for Ethics in Health Care Oregon Health Sciences University Portland, Oregon

Arturo Brito, M.D.

Assistant Professor of Clinical Pediatrics University of Miami School of Medicine Miami, Florida

Alexander Morgan Capron, LL.B.

Henry W. Bruce Professor of Law

University Professor of Law and Medicine

Co-Director, Pacific Center for Health Policy and Ethics University of Southern California

Los Angeles, California

Eric J. Cassell, M.D., M.A.C.P.

Clinical Professor of Public Health

Weill Medical College of Cornell University New York, New York

R. Alta Charo, J.D.

Professor of Law and Bioethics Law School and Medical School University of Wisconsin Madison, Wisconsin

James F. Childress, Ph.D.

Kyle Professor of Religious Studies Professor of Medical Education Director, Institute for Practical Ethics Department of Religious Studies University of Virginia

Charlottesville, Virginia

David R. Cox, M.D., Ph.D.

Scientific Director Perlegen Sciences Santa Clara, California

Rhetaugh Graves Dumas, Ph.D., R.N.

Vice Provost Emerita, Dean Emerita, and

Laurie M. Flynn*

Senior Research and Policy Associate

Department of Child and Adolescent Psychiatry Columbia University

New York, New York

Carol W. Greider, Ph.D.

Professor of Molecular Biology and Genetics Department of Molecular Biology and Genetics Johns Hopkins University School of Medicine Baltimore, Maryland

Steven H. Holtzman

Chief Business Officer

Millennium Pharmaceuticals, Inc. Cambridge, Massachusetts

Bette O. Kramer

Founding President

Richmond Bioethics Consortium Richmond, Virginia

Bernard Lo, M.D.

Director

Program in Medical Ethics Professor of Medicine

University of California, San Francisco San Francisco, California

Lawrence H. Miike, M.D., J.D.

Kaneohe, Hawaii

Thomas H. Murray, Ph.D.

President

The Hastings Center Garrison, New York

William C. Oldaker, LL.B.

Senior Partner

Oldaker & Harris, L.L.P. Washington, D.C.

Co-Founder and General Counsel NeuralStem Biopharmaceuticals Ltd. College Park, Maryland

Diane Scott-Jones, Ph.D.

Professor

Psychology Department Boston College

National Bioethics Advisory Commission

Harold T. Shapiro, Ph.D., Chair

President Emeritus and Professor of Economics and Public Affairs The Woodrow Wilson School of Public and International Affairs Princeton University

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R

ESEARCH

E

THICS

IN

A

USTRALIA

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Preface

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ustralia has had a comparatively creditable record of ethical research involving humans. The litany of criticism about shoddy medical research documented in the epochal article by Professor Beecher (Beecher 1966, 1968; Levine 1986) has not occurred in this country. Comparatively fine as the Australian record may be, that record is not unblemished. A report commissioned by the Commonwealth Government in 1994 by Professor Margaret Allars into unsatisfactory aspects of the collection, manufacture, and injection of human growth hormone (Allars 1994) recommended that aspects of the research structure had to be reassessed. In particular, the Allars Report recommended a review of the National Health and Medical Research Council (NHMRC) Statement on Human Experimentation and the Supplementary Note on Reproductive Technology Procedures.Similarly, the Commonwealth Minister for Health (now called the Commonwealth

Minister for Health and Aged Care) referred ethical concerns about two postwar procedures and one multi-center clinical trial in the 1990s to the Australian Health Ethics Committee (AHEC). The two postwar procedures involved first, the inclusion of orphans and State wards in vaccine trials conducted in the postwar years and, second the experimental use of estrogen to reduce the height of “tall girls” in the 1950s. The multicenter trial involved the so-called “morning after pill” (RU486).

Research and experimentation has been a major issue, at least for the research community, in the last two decades in Australia. This “age of skepticism” (pace Eric Hobsbawn) has seen continuing demands for open government and greater public accountability, demands for expanded civil liberties, and demands for privacy protection rights. This wide debate has translated into debate about the protection of subjects in medical research (Laufer 1990; Darvall 1993), its major focus being the maintenance and improvement of ethical standards. This focus of concern is reflected in much of the work of the peak national health ethics body, the AHEC. In particular, the AHEC has conducted two series of National Workshops for Institutional Ethics Committees, a major review of the ethics review system in Australia (Chalmers 1996), and a major revision of the guidelines on research ethics published as the National Statement on Ethical Conduct in Research Involving Humansin mid 1999 (National Statement1999).

Ethical standards in human research and experimentation have not been static. The Australian research ethics community conducted a debate on improving and professionalizing the ethics review system during the late 1980s and 1990s. Researchers, institutions, trial sponsors, academic and professional critics, and changing attitudes to accountability have all contributed to an improvement in the practices and culture of research involving humans in this country.

The AHEC has come far since the Finn Report amalgamated the National Bioethics Consultative Committee (NBCC) and the Medical Research Advisory Committee to form the AHEC. Professor Finn stated in his report that “until the HEC (AHEC) concept is more fully developed and particularized, until the Council addresses more directly the burden of the ethics function...one cannot surmise with any confidence as to the extent to which those differences between the two bodies in their areas of mutual interest are likely to recede or be perpetuated” (Finn 1990 at 14). Considerable advances were made in the first three triennia toward this “evolutionary” change.

The Australian research ethics review system continues to evolve. The system could be described as a hybrid or intermediate system in contradistinction to entirely legislatively regulated systems or voluntary self-regulated models. There is no Australian equivalent of the National Research Act1974. However, there is greater

regula-tion of the system since the pre-1982 Australian voluntary system. Human Research Ethics Committees (HRECs), which conduct ethics review are notestablished by specific Commonwealth legislation, but they

are recognizedwithin the NHMRC Act 1992. In this major respect, research ethics review in Australia is not

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Comparisons between HRECs in Australia and Ethics Committees in the United States are misleading. Some HRECs in Australia may perform some of the functions of Ethics Committees, but the comparable institution in the United States is an Institutional Review Board (IRB). As well as the infamous Tuskegee Study (Furrow et al 1995 at 548–550), a number of questionable human experiments were disclosed before the U.S. Congress in the early 1970s. Disclosures were made particularly about dubious research conducted in prisons and mental hospitals and on human fetuses. Following these events, the National Research Act1974 was

introduced which required each institution conducting federally supported research involving human subjects to establish an IRB. These IRBs are required to review the ethical aspects of all research protocols within the institution. The general standards for the composition, operation, and responsibility of IRBs are contained in federal regulations (Code of Federal Regulations1992).

In order to fulfill the requirements of the federal regulations, each IRB is required to follow written proce-dures for the conduct of initial and continuing review of research and for reporting findings and actions to the investigator and the institution. An IRB determines which projects require review more often than annually and which projects need verification from sources other than the investigator. Changes in approved research may not be initiated without IRB review and approval, except where there are apparent immediate hazards to the human subjects. In addition to reporting to the IRB, there are other safeguards in the system. Both institutional officials and the Food and Drug Administration (FDA) must be told of any unanticipated problems involving risks to human subjects or others. Similarly, any instance of serious or continuing noncompliance with federal regulations or the decisions of the IRB (or any suspension or termination of IRB approval) must be reported to the institution or FDA. There are IRB procedural requirements aimed at ensuring proper consideration of the research. Except when an expedited review procedure is used, a research proposal must be reviewed by a majority of the members of the IRB. On review, at least one of the IRB members must be primarily concerned with nonscientific areas, and the proposal must receive the approval of a majority of those members present at the meeting.

American Ethics Committees continue to evolve and are not settled in their functions (Annas 1984;

In Re Quinlan1976; President’s Commission 1983). Ethics Committees in the USA include the following roles:

■ Advising doctors and family on decisions about withdrawing life support treatment;

■ Providing advice on withholding treatment from newborn infants with birth defects;

■ Making policy through drafting guidelines for hospital personnel on controversial areas of medical practice;

■ Providing education through the organization of seminars on areas of controversy; and

■ Providing advice on specific ethical dilemmas in the treatment of specific patients.

In effect, American Ethics Committees are patient care committees and are often referred to by this title. Some Australian hospital HRECs may perform some of the same functions as American Ethics Committees.

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The growth of ethics committees has followed diverse paths, and a number of other ethics committees have been established beyond the terms of the Department of Health Circular Guidelines (Rawbone 2000). Brazier particularly notes that a number of fertility units have established advisory committees to assist practitioners in making decisions about the admission of individual patients to the program (Brazier 1990).

This report presents background information on the ethics review system in this country, defines the current ethical system, and provides some background information on the new National Statement on Ethical Conduct in Research Involving Humans.This paper considers the current operation of the AHEC and the system of ethical

review of research involving humans by HRECs in Australia. The paper also addresses some specific questions posed by the National Bioethics Advisory Commission (NBAC), namely the following:

1. What are the strengths and weaknesses of nonregulatory systems of protection?

2. What features of these systems, if any, should be incorporated in the U.S. system?

3. What are the strengths and weaknesses of models that are comprehensive, those that encompass private and government sectors, and nonbiomedical and biomedical research?

1. Introduction

1. 1 Three Tiers: Researcher Ethics Committee and National Body

A three-tier system of ethics review operates within Australia:

■ The researcher

■ The HREC

■ The AHEC

At the first level, the researcher continues to carry ethical responsibilities toward research participants. The

National Statementbegins with a reference to the researcher and states that the “… guiding value for researchers

is integrity… ” (National Statement1999, Principle 1.1 at 11). The National Statement continues that “the

guid-ing ethical principle for researchers is respect for persons… ” (Principle 1.2) and that “… the ethical principle of beneficence is expressed in researchers’ responsibility to minimize risks of harm or discomfort to participants in research projects” (Principle 1.3). Researchers are also required to design their protocols to ensure respect for the dignity and well-being of the participants (Principle 1.4). Researchers should not discriminate in the distribution of benefits and burdens of participation in research or in the selection of research participants (Principle 1.5). Researchers have great responsibility in ensuring participant consent is obtained (Principles 1.7–1.12). Researchers must conduct research that has merit and balance the risks and likely benefits to be gained. Only people with the required experience, qualifications, and competence should conduct the research (Principles 1.13–1.15). These General Principles are bolstered throughout the National Statementwith specific

contextual duties of researchers to research participants in relation to the project. For example, in a clinical trial the researcher must declare any conflicts of interest through involvement in business or other similar association (Principle 12.5 at 36). It was a deliberate policy in drafting the National Statement to recognize and

reinforce the ethical responsibilities of researchers.

HRECs, which, until 1999 were referred to as Institutional Ethics Committees (IECs), conduct the second level of ethical review. The Australia HRECs compare closely with the U.S. IRBs established under federal regu-lations. Some HRECs were already operating before the system was formally established in 1982 by amend-ments to the Statement on Human Experimentation.The NHMRC issued the Statement on Human Experimentation,

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promulgated in 1999. The NHMRC was a nonstatutory body until 1992. In that year the NHMRC became a statutory authority when the Commonwealth Parliament passed the National Health and Medical Research Council Act, 1992 (Cth.). Although HRECs are not statutory bodies, institutions cannot receive research

fund-ing from public bodies unless consideration had been given to the research proposal by a properly constituted HREC. Originally, HRECs only considered medical and health research projects. Later, the Australian Research Council (ARC) (the major funding agency for nonmedical research) introduced a similar requirement that, in effect, expanded the jurisdiction of HRECs to allresearch involving humans.

The third level in the system is the AHEC. This body is established under § 35 and § 36 of the National Health and Medical Research Council Act1992 (Cth.). The AHEC is required to oversee the operation of the

HREC system and receives annual Compliance Reports from every registered HREC (National Statement 1999 Principles 2.46–2.48). In addition, the AHEC has the sole authority to publish medical research guidelines. In so doing, the AHEC is required to follow § 11–14 of the National Health and Medical Research Council Act1992,

which provides a unique procedure of two stages of public consultation before such guidelines may be issued.

1. 2 The

National Statement:

Changes in the Research Environment

The National Statement reflects a number of significant changes in the ethics of human research. First, the National Statementincludes a wider and more comprehensive view about research involving humans, going

beyond medical experimentation and extending to all research involving humans. The first Australian guide-lines in relation to research, the Statement on Human Experimentation, followed the Declaration of Helsinki and

applied ethical standards to medical research involving human subjects. Gradually, the Statement on Human Experimentationwas applied not only to medical research but other research involving humans particularly in

the social and behavioral sciences. The new National Statement recognizes this evolution.

Second, the National Statement recognizes the evolution of community and research community acceptance

that now “… all kinds of research involving or impacting upon humans should conform to the highest standards academic integrity and ethical practice” (National Statement1999 at 2).

Third, legislation is now more common place in the once self-regulated area of research ethics. Increasingly, Commonwealth and State legislation is impacting on and becoming more relevant to any consideration of research ethics. The regulation of Australian research is no longer a voluntary regulatory system of protection for research participants. Many Commonwealth and State Acts apply directly or indirectly to research. In particular, the NHMRC was brought under a statutory framework with the enactment of the National Health and Medical Research Council Actby the Commonwealth Parliament in 1992.

Fourth, in a number of countries there have been efforts to identify a better definitional understanding of what is meant by research. The National Statementnotes that:

There are many definitions of research. These include a systematic investigation to establish facts, principles or knowledge a study of some matter with the objective of obtaining and confirming knowledge. A defining feature of research is the validity of its results… .

An alternative approach to finding a definition of research is to list examples for what constitutes research, such as:

■ systematic prospective collection of information to test an hypothesis;

■ a planned study of existing practices with a view to changing/improving practice in light of the studies by findings/or to increase understanding;

or

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It is accepted that it is difficult to find an agreed-upon definition of research. The National Statementaccepts

that problems may arise from “… including activity that would not normally be included, like quality assurance activities or audits and excluding activity that probably should be included, such as research conducted as part of a course of education… [and]… omitting newly emerged genres of research, of which various kinds of multi-disciplinary research are examples” (National Statement1999 at 6). The definitional problem of research has

been considered seriously in Australia. The issue of the appropriate boundary between research and innovative therapy in practice arose in the inquiry conducted by Professor Margaret Allars in relation to innovative hormone treatment (Allars 1994; Giesen 1995).

Fifth, debates about the protection of subjects in research have expanded from concerns about physical protection to modern concerns about personal information privacy. Public concern about individual privacy is a major emerging challenge. Moves to store medical records on computer (rather than hard copy) have increased fears that privacy will be threatened. In respect of privacy, the federal Privacy Act 1988 (Cth.) was

a watershed. The Privacy Act, particularly § 95 dealing with privacy in public research and the Information Privacy Principles(NHMRC 2000) has had a significant impact on public health (Cth.). The Privacy

Commis-sioner has also extended the protections available to individuals in relation to their personal information held in the public sector under the Privacy Act1988 (Cth.) to the private sector with amendments to this Act.

Sixth, peer review and declining funding to research generally and medical research in particular cannot be discounted as an influence on changing research culture. It is far more difficult to obtain research funding. For example, the NHMRC funds only 20 percent approximately of research applications. Finally, moves to encourage private industry to contribute more funds to national research efforts, particularly in the area of genetics, has introduced increasing commercial considerations into the research environment.

All of these developments are leading to a more regulatory environment in Australia but still without specific legislation for the HRECs. Legislation, in the form of the National Health and Medical Research Council Act1992 (Cth.), establishes a national supervisory committee (the AHEC) and recognizes the HREC system. All

public research-funding bodies require ethics approval before research can be undertaken. The Commonwealth statutory authority, the Therapeutic Goods Administration (TGA), regulates clinical trials of drugs and devices in the same fashion as the FDA in the United States. Finally, although private institutions and organizations are

not obligedto follow NHMRC guidelines, there is a high degree of voluntary compliance on the part of private

research organizations.

2. A Brief Background to the Development of Ethical Review in Australia

A brief background is presented of the developments leading to the current system of ethical review in Australia. The primary purpose for the introduction of both codes of research practice and committees to review research has been and remains the protection of the welfare and rights of participants in research. It is axiomatic that the foundation of any system of ethical protection for the welfare and rights of participants depends on the integrity of the researchers themselves. The new Australian National Statementrecognizes the

centrality of the researcher as the first level of review. The National Statementstates that:

1. The guiding value for researchers is integrity, which is expressed in a commitment to the search for knowledge, to recognize principles of research conduct and the honest and ethical conduct of research and dissemination and communication of results.

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3. In research involving humans, the ethical principle of beneficence is expressed in researchers’ responsibility to minimize risks of harm or discomfort to participants in research projects (National Statement 1999 at 11).

Ethics review committees conduct the second level of review. These were gradually introduced during the 1970s and formally so in the 1980s. HRECs grant ethical approval to researchers for their research and, in so doing, aim to protect the welfare and rights of research participants. However, they are not funded to or capable of acting as a policing agency for the work of researchers (Chalmers and Pettit 1998). Finally, in the early 1990s Australia introduced a third level, with the establishment of a national bioethics committee, the AHEC.

2. 1 Toward National Ethical Standards in Research: The First Period— 1973–1982

Until 1965, the prime responsibility for ethical standards in human experimentation rested with the integrity of the individual researcher subject to the oversight of that researcher’s institution and colleagues. Australia ratified the Declaration of Helsinkiin 1965. This was an important symbolic act that was later realized by the

introduction of committees to review the ethical aspects of research experiments on humans. During the same decade, there was awareness of the concerns for ethical standards in the United States, but it is not clear how far this awareness influenced developments toward the establishment of ethics committees to review research (Editorial 1976). Some institutions in Australia already operated ethics committees in the 1960s, and these influenced the development of the ethics review system. These early ethics committees in Australia predated American developments and may account for differences in the ways in which the Australian system has devel-oped. Australia was essentially proactive in developing standards for ethical conduct in research rather than reactive to revelations or incidents of research impropriety.

A major response to the Declaration of Helsinkiwas the drafting of Australia’s first guidelines on human

experimentation, which were prepared by an ad hoc committee of the Medical Research Advisory Committee and adopted by the NHMRC. This first NHMRC Statement on Human Experimentationwas amended in 1973

and again in 1976. This latter amendment was important as it provided that applications to the NHMRC for research grants were required to be submitted to a medical ethics review committee for ethical approval, and that medical ethics research committees were required to be established by institutions conducting medical research and experimentation (Jonas 1969; Fletcher 1973; Gillespie 1988 at 3). Funding was therefore made conditional upon ethical approval. The intention was to ensure peer review. There was only one minimal stipulation in relation to the composition of these committees, namely that one person not connected with the institution was to be appointed.

This marked the first major step toward developing a systematic structure of ethical review by IECs, which in 1999 became known as HRECs in Australia. In an important sense this marked the end of the era of the self-regulation “closed shop.” This development was contemporaneous with demands for open government and greater public accountability, demands for expanded civil liberties, and demands for consumer rights. It was also in the mid-1970s that the public was beginning to hear reports of recombinant DNA research, genetic engineering, and the possibilities of IVF.

2. 2 Toward IECs and the Medical Research Ethics Committee of the NHMRC:

The Second Period— 1982–1989

The next significant steps in the development of ethical review were the revisions to the NHMRC Statement on Human Experimentationin 1982 and the establishment of the Medical Research Ethics Committee (MREC)

in 1983.

IECs were established formally in 1982. There were already many ethics committees in operation, particu-larly in the teaching hospitals before 1982. The NHMRC issued a new and substantially revised Statement on

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with the following specific topics: IECs; research on children, the mentally ill, those in dependent relationships (including unconscious patients); clinical trials; and IVF and embryo transfer). Supplementary Note 1provided

an expanded statement of the membership and functions of IECs, which were to be composed of men and women reflecting different age groups and including a person not associated with the institution. The mini-mum composition was a minister of religion; a lawyer; a medical graduate with research experience; and a lay woman and a lay man (NHMRC 1993b; McNeill 1993).

In broad terms, IECs were concerned with the approval of research activities. In this respect a primary concern was ensuring effective consent on the part of subjects in research projects. The IEC reviewed copies of relevant consent forms, the research protocol, relevant past research, the selection criteria for research partici-pants, the scientific method to be employed, the risks and benefits to subjects in the research program, and the perceived benefits of the research. The Supplementary Noteestablished the functions of the IECs that were, in

summary, to:

a) Consider ethical considerations of all proposed research projects;

b) Maintain surveillance of approved research;

c) Maintain a register of projects; and

d) Establish and maintain communication with the MREC.

In carrying out the functions defined in Supplementary Note 1, IECs were required to

■ Ensure the rights of the subjects of research take precedence over the expected benefits to human knowledge;

■ _{Ensure that the free and informed consent of the subjects will be obtained;}

■ Ensure that no member of the HREC adjudicates on projects in which they may be personally involved;

■ Ensure that research projects take into consideration local cultural and social attitudes;

■ _{Give their own consideration to projects that involve research in more than one institution;}

■ Require the principal investigator to disclose any previous decisions regarding the project made by another IEC and whether the protocol is presently before another IEC; and

■ Determine the method of monitoring appropriate to each project, with monitoring of research to continue until projects are completed (this monitoring requirement was not introduced until 1992 by amendment to the Statement on Human Experimentation).

The MREC, which replaced the Medical Research Advisory Council, was established as one of the standing advisory committees to the NHMRC. It was commissioned to keep under review and make recommendations to the council on ethical principles in relation to human experimentation. In addition, the MREC was required to keep under review the work of IECs. The MREC thus created a third level of ethical consideration, and it was directly related to the systematic development of IECs in Australia.

In 1984 it was decided that the MREC should review the operation of IECs throughout Australia and, in particular, consider the performance and effectiveness of the Supplementary Noteon IECs in relation to their

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2. 3 Toward a National Ethics Committee: The Third Period— 1988 to the Present

2. 3. 1 MREC

The MREC of the NHMRC was a major step in the evolution toward a national ethics body. The original remit of the committee was to make recommendations to the council on ethical principles in relation to human experimentation, and this the committee did with distinction during the 1980s. For example, the MREC updated the Statement on Human Experimentation in 1982 and included notes on IECs, research in children,

the mentally ill, and those in dependant relationships or comparable situations; therapeutic trials; and IVF and embryo transfer (ET). In 1983 the NHMRC produced Ethics in Medical Research Involving the Human Fetus and Human Fetal Tissuewhich became Supplementary Note 5 to the Statement of Human Experimentation, and, in

1985 the NHMRC produced the Report on Ethics and Epidemiological Research, which was added as a new Supplementary Note 6.

At the same time as the revisions to the NHMRC Statement on Human Experimentationin 1982 and the

establishment of the MREC, the controversial area of reproductive technology was considered by the NHMRC.

Supplementary Note 4 – In-vitro Fertilisation and Embryo Transfer, adopted by the NHMRC at its 94th session

in October 1982, was the “first official, Government-approved regulatory code for the practice of in-vitro fertilisation in this country (or, for that matter, anywhere)...” (Scott 1984 at 3). This Notedescribed IVF as a

“justifiable means of treating infertility” (NHMRC 1992 at 14). The note went on to say, however, that “… much research remains to be done and the NHMRC Statement on Human Experimentation and Supplementary Notes

should continue to apply to all work in this field.” Accordingly, any institution offering IVF was required to have all aspects of its program approved by an IEC with a register being kept detailing parentage, treatment cycles, and records of success. The programs were to “normally involve” the ova and sperm of married partners (NHMRC 1992 at 14). Research remained “... inseparable from the development of safe and effective IVF and ET” and so embryonic development “...beyond the stage at which implantation would normally occur is not acceptable” (NHMRC: 1992 at 15). Finally, with some prescience, cloning experiments were declared ethically unacceptable (NHMRC 1984).

2. 3. 2 The Short-Lived National Bioethics Committee

An avalanche of Australian government reports followed this NHMRC Supplementary Noteon IVF and embryo

transfer (Waller 1982–1984; Demack 1984; Chalmers 1985; Cornwall 1984; Michael 1986; NSW Law Reform Commission 1980–1989; Family Law Council 1985; Senate Select Committee 1986). Reports on artificial conception from some States recommended State regulatory bodies; other States recommended that voluntary adherence to NHMRC guidelines was adequate without the need to introduce further regulatory schemes.

There were essentially inconsistent recommendations in relation to regulation of embryo experimentation. Then the Commonwealth Senate set up a Select Committee that presented a report on Human Embryo Experimentation in Australiain 1985 (Senate Select Committee 1986). The report made recommendations on

the regulation of embryo experimentation. The committee recommended that voluntary adherence to nation-ally promulgated guidelines monitored by IECs was not adequate (Senate Select Committee 1986, Chapter 4, para. 4.17). Instead, the Select Committee envisaged a national body, issuing research protocols and research

licenses that should be required before experimentation of any kind was undertaken on human embryos. The license was to be for a limited time and subject to conditions (Senate Select Committee 1986, Chapter 4, para. 4.25). The committee recommended that a Commonwealth Statute, preferably in company with the States and the Northern Territory, should set down a broad declaration of the principle banning nontherapeutic embryo experimentation that frustrated the development of the embryo and should establish a licensing scheme.

Importantly, in relation to the development of a national ethics committee, the report recommended the

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powers or where the body acted in any way outside its charter. This national bodywould report to Parliament

(Senate Select Committee 1986, Chapter 4, para 4.42), consult with the public (Senate Select Committee 1986, Chapter 4, para 4.43), and

Formulate guidelines, consider research protocols, and monitor research procedures...and initiate prosecution or injunction against those carrying out prohibited experimenting. Such a body would supersede the NHMRC with its MREC (Senate Select Committee 1986, Chapter 4, para 4.46).

The report by the Family Law Council (a statutory council set up under the Commonwealth Family Law Act1975 to advise on the development of federal family law) also recommended establishing a National Body

(Family Law Council 1985). This report recommended a National Council on Reproductive Technology, which was to take a national approach to research and practice in reproductive technology in Australia (Family Law Council 1985, recommendations 30, 31).

Both the report of the Senate Select Committee and the Report of the Family Law Council echoed the call in 1982 by Justice Michael Kirby, who had promoted some form of institution to tackle questions of ethics and experimentation, particularly in the area of IVF:

Otherwise, it will be the judgment of history that the scientists of our generation brought forth most remarkable development of human ingenuity— but the lawyers, philosophers, theologians and law-makers proved incompetent to keep pace (Kirby 1983 at 12).

Following the publication of the Senate’s Select Committee Report, the federal government decided to establish the NBCC. In 1988 the Federal Minister for Health in conjunction with the other Australian State Health Ministers announced that, in view of rapid advances in biotechnology creating bioethical issues, a new body would be established. The NBCC was established by the Health Ministers of Australia (with approval of the States’ Attorneys-General), but it was not invested with executive functions and only had advisory powers. The

NBCC was limited to issues of artificial conception and was requested to consider and made recommendations in the area of human embryo experimentation.

The committee was multidisciplinary, with representatives in areas of philosophy, moral theology, social science, women’s health, law, medical research, nursing, and gynecology. It was effectively and ably led by Ms. Robyn Layton QC of the South Australian Bar. The aim of the NBCC was to search for a

more coordinated, national approach to this issue [reproductive technology]...and the National Bioethics Consultative Committee will play an important part in formulating such an approach“ (Senate Select Committee 1986).

The NBCC met for the first time in August 1988. During its brief and at times turbulent period, the NBCC produced a number of major reports including the following:

■ Donor Gametes, Record Keeping and Access to Information,June 1988;

■ Access to Information: An Analogy Between Adoption and the Use of Gamete Donation,December 1988;

■ Surrogacy Report No. 1,April 1990;

■ Discussion Paper on Surrogacy 2 – Implementation,October 1990;

■ Human Embryo Experimentation: Background Paper and Select Bibliography,November 1990; and

■ Reproductive Technology Counselling, Final Report,March 1991.

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2. 3. 3 The AHEC Established

Before the introduction of the National Health and Medical Research Council Act,1992 (Cth.), in 1991 formal

discussions began between the Chair of the NBCC, Robyn Layton QC of the South Australian Bar, and the Chair of the NHMRC, Dr. Di Horvath, with a view to amalgamating the MREC and the NBCC. The then Minister for Community Services and Health, The Hon. Mr. Brian Howe MHR, had commissioned a report on the advisability of concentrating advice to government on health ethics matters within a principal committee of the NHMRC (Finn 1990). The NBCC was established to handle specific references from the Australian Health Ministers Advisory Committee (AHMAC). As such, the NBCC could never have been a permanent standing committee. By the time of the publication of itsReport on Surrogacy(NBCC 1990), the NBCC had completed

the review of the key issues in reproductive technology. In a similar vein, the MREC was not the sole repository of ethical advice within the NHMRC.

The Minister for Community Services and Health decided to establish a new committee within the NHMRC to advise on health ethics. The new committee was to take up many of the responsibilities of the NBCC and the MREC as well as the ethical advice, which could flow, from the other principal committees of the NHMRC. In early 1991 it was decided that the new committee would be a principal committee of the NHMRC and was to be tentatively called the Health Ethics Committee (HEC). At early meetings, the broad terms of reference and focus of the new amalgamated HEC were established. These were:

1. To focus upon the social, legal, and ethical dilemmas arising from the fields of medical research, health care practice, and public health;

2. To pursue an agenda within the broad priorities of NHMRC;

3. To provide advice on particular ethical situations by linking people within the networks of the NHMRC; and

4. To respond to issues identified by the principal committees of the NHMRC.

The issue of the continued independence of the proposed HEC was the subject in some of these earlier discussions. It should be noted that the early Terms of Reference specified that the HEC was neither to have the role of providing an ad hoc ethics advisory service to the NHMRC nor to be used as a clearinghouse for reports from other principal committees of the NHMRC. Early discussions conceived of a committee of ten people covering many disciplines, with a national representation and balanced gender mix. It was agreed that the expertise of the NBCC could be broadened with the possible inclusion of a further clinician, health econo-mist, and epidemiologist. Most importantly the expertise of the NBCC had to be supplemented with expertise from the MREC, particularly in relation to the operation of IECs. The success of these negotiations were quickly realized with the presentation of a work program to the June 1991 Council Meeting of the NHMRC.

The processes of the new HEC were discussed in some detail. The new principal committee was to enjoy a fair degree of independence within the structure of the NHMRC with power to set its own priorities. Matters could be referred by the NHMRC, other principal committees of the NHMRC, or from Commonwealth and State ministers. In addition, the new committee:

■ Did not expect the NHMRC to edit or change the contents of its reports, but merely to have the power to refer back for further consideration.

■ Was to carry on work previously undertaken by the MREC.

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■ Was to consider its relationship with State governments and other related organizations.

■ Was to have parity with all other principal committees with its level of NBCC budget maintained.

Finally, it was felt that the NBCC had achieved a high international profile and a style and quality of consultation that was important to maintain. For this reason the title “Australian” was to be added to the original suggested title of HEC to form the new AHEC.

3. The Commonwealth Review of Ethics Committees 1995–1996

3. 1 Background to the Ministerial Review

Under the National Health and Medical Research Council Act 1992 (Cth.), the AHEC was made responsible for

the administration of the national system of HRECs. While the system was generally recognized as working well during the 1990s, a number of areas of improvement were frequently mentioned in correspondence to AHEC, in the Medical Journal of Australia,and at public seminars, particularly the AHEC sponsored workshops

in 1993 and 1995. Some of those included:

■ Managing the increasing workload pressure on HRECs;

■ Lack of scientific expertise in some areas;

■ _{Absence of formal training programs;}

■ Legal liability and indemnity issues;

■ Problems in relation to noncommercial or nonpharmaceutical company-sponsored research;

■ Duplication of effort among the various layers;

■ Need for a clinical trials register;

■ Benefits of expedited review; and

■ Concerns regarding multicenter trials and monitoring of research.

In 1995, the Commonwealth Minister for Health, the Hon. Dr. Carmen Lawrence MHR, announced an inquiry into the ethics review system. The review was requested in the context of two events. First, there was the controversy surrounding Family Planning Australia trials of the abortifacient RU486 in 1994. Second, in the same year, the Report of the Inquiry into the Use of Pituitary Derived Hormones in Australia and Creutzfeldt-Jakob Diseaseby Professor Margaret Allars (hereafter referred to as the Allars Report) (Allars 1994) was released.

The Ministerial Review Committee was to inquire into the operation of HRECs with particular reference to the problems which have been identified following the Allars Report (Allars 1994) and the RU486 trials. RU486 was the so-called Morning After Pill which was counter-trialed in both Sydney and Melbourne. These trials formed part of an international multicenter study to determine the effectiveness of various doses of the drug and were sponsored by the World Health Organization (WHO). Although much of the controversy surround-ing the trials related to ideological differences and concerns as to the appropriateness of the drug importation procedures, issues regarding the adequacy of the ethics committee review process were also raised. A separate and independent review on the RU486 trials (chaired by Professor John Funder) was conducted. That commit-tee reported that ethics commitcommit-tee review had been adequate and recommended, following some modifications to the consent forms, that the trials recommence.

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procedures (including issues of membership and decisionmaking). The Allars Report (Allars 1994) also raised fundamental issues relevant to the Ministerial Review relating to monitoring of ongoing research, the distinction between treatment and research, and the importance of consent by, and the duty to warn, research participants. The pituitary hormones program, which was the subject of the Allars Report, had been initiated at a time before the establishment of the ethics review system. In addition, the use of these hormones was considered to be treatment that had already been tested and adopted overseas. Many of the issues raised in the Allars Report concerned poor practice in relation to the collection and use of damaged pituitaries and were beyond the scope of the Ministerial Review. The Review’s Terms of Reference required that it have “special regard to issues of concern to women particularly in trials relating to reproductive technology” and to “examine and report on recommendation 10 of the Allars Report” which stated:

10. That the NHMRC

■ review the Statement on Human Experimentation to ensure that

■ it provides guidance with regard to decisions as to whether treatment in a therapeutic setting constitutes an experiment;

■ a procedure is developed by which such decisions are scrutinized and not left entirely to the treating medical practitioner.

■ issue a Supplementary Note on Reproductive Technology Procedures which ensures that new procedures, including the use of drugs in new treatment regimes, are:

■ registered with the Health Ethics Committee of the NHMRC; and

■ approved by the institutional ethics committee of the institution in which the procedure is carried out; and

■ consent is made in on the basis of full information regarding risks and outcomes as defined in the Supplementary Note 2 on Research on Children, the Mentally Ill and Those in Dependent Relationships or Comparable Situations” (Allars 1994).

3. 2 Matters Addressed by the Ministerial Review

A number of issues, summarized below, were addressed in the Ministerial Review and presented in the Report of the Review on the Role and Functions of Institutional Ethics Committees (Report on IECs)(Chalmers 1996). These

issues provide a background to the consultation and led to the publication of the revised National Statement on Ethical Conduct in Research Involving Humans.A list of the actual recommendations is included in Schedule 1.

The Report on IECsnoted the heavy and increasing workload of IECs, their lack of resources, their limited

expertise in dealing with some types of research, difficulties with monitoring and with multicenter trials, and the dominance of scientists on the committees. The following are some of the main areas addressed.

Multicenter Research.There was no system of formal regional or national ethics review. Each IEC gave

approval to research conducted in the institution. The practice had developed for individual IECs to commu-nicate and exchange views with other IECs, particularly in relation to research projects carried out at different centers. The AHEC received numerous requests urging the establishment of a single national research ethics committee to consider multicenter trials involving humans. Researchers raised difficulties experienced in conducting multicenter trials where ethics approval must be obtained from a number of different IECs which may reach different conclusions in relation to the ethical acceptability of the trial. Different procedures, differ-ent meeting times, and differdiffer-ent IEC membership often resulted in considerable delay in mounting a trial.

The Report on IECsproposed that it was appropriate for one Australian IEC to accept the scientific assessment

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Multicenter Clinical Trials.Until 1991 all pharmaceutical and device trials were conducted under the

auspices of the centralized Commonwealth TGA. Following the Baume Report(Baume 1991) a deregulated

Clinical Trials Notification Scheme (CTN) was introduced which allowed IRCs to participate in organized clinical trials of pharmaceutical drugs and devices by notification only to the TGA (AHEC 1992). As a result of the CTN scheme, only a self-selecting group of IECs (now known as HRECs), with appropriate infrastructure support, mainly based in major teaching hospitals, participates in this scheme. This issue is dealt with in Section 6 of this report.

Adequacy of Compensation and Insurance Arrangements.The AHEC considered the issues of

compensa-tion, indemnity, and insurance in relation to the introduction of the deregulated CTN scheme for clinical trials of drugs and devices. The concerns of IECs were twofold. First, IECs were concerned that the individual members of the committee might have attracted legal liability from the decisions giving ethical approval to a CTN application (Capron 1985). Second, there were concerns that the institutional arrangements for insurance cover for participants in a clinical trial might not have been clear in relation to existing institutional insurance arrangements.

In relation to the first concern, a number of legal decisions were widely discussed causing concern in the Australian research ethics community. The High Court of Australia decision in Rogers v W hitaker established

that a medical practitioner has not only a duty to exercise reasonable care in the diagnosis and treatment of a patient’s condition, but also a duty to disclose material risks inherent in any proposed treatment. A risk is material if in the circumstances a reasonable person is likely to attach significance to it, and the medical practi-tioner knows or should know that the particular patient is likely to attach significance if warned of the risk (this is consistent with U.S. and Canadian case law Canterbury v Spence and Reibl v Hughes). In this respect there

is a higher duty of disclosure in the case of research projects: Halushka v University of Saskatchewan. There is

further direct authority on the liability for nondisclosure of risks to research participants in the Canadian deci-sion in Weiss v Solomon. This case also excited much critical comment (Freedman and Glass 1990). A number

of other American cases have established the liability of hospitals in relation to decisions by Ethics Committees (see, for example, Davis v Rodman; Bouvia v Glenchur;Merritt 1987 at 1250–1252).

In relation to the concerns some institutions questioned the compensation limits, which were included in the documentation supporting some protocols for multicenter clinical trials. The AHEC reviewed a number of research compensation arrangements, which included limits on the amount of any claim for compensation by a research subject in a trial. These limits were clearly inadequate in comparison with Australian insurance payouts for injuries. The AHEC had addressed these concerns earlier in a report that required institutions to review their compensation indemnity and insurance arrangements with their insurer and to put in place appro-priate compensation cover for research participants (NHMRC 1994). A major national insurer introduced a specific no-fault liability cover for clinical trials, which was taken up by a number of institutions participating in multicenter clinical trials.

Workload and Resource Support for IECs.This issue was clearly identified through the 1993 Survey of

IECs and the Workshops for IECs (AHEC 1993). There was an expansion in workload because of a failure to sufficiently define the distinction between clinical practice and human experimentation. The result was that additional projects were referred to IECs, which would be more properly described as clinical practice and not experimentation. The other major growth in workload arose from referrals of health related and social science research projects to IECs.

Monitoring of Projects.Under the NHMRC Guidelines (NHMRC 1992), IECs were required to monitor

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Composition.There were concerns that the decisionmaking process was influenced too heavily by those

with research interests. The original idea of an IEC was that it should have a majority of outside members. Surveys confirmed that clinicians and medical researchers dominated most IECs in Australia. The NHMRC

Statement on Human Experimentationprovided a minimum membership (NHMRC 1992). In fact, the majority

of IECs were in the range of 10 to 15 members (16 or more members – 5 percent; 10 to 15 – 55 percent; 10 or fewer – 40 percent) with the majority represented by researchers. Paul McNeill has been a strident critic of this (McNeill 1993). Much of this diversity was due not only to the purpose of the institution and the nature of the research, but particularly to the authority, power, and responsibility given to, or accepted by, or assumed by IECs. In some institutions, the IECs had a broader function providing an advisory, policy and educational role relating to matters of clinical practice and management. Such committees may only rarely consider research proposals.

Procedures.Many of the IECs reported that they were not well resourced. This had the consequence, in

some cases, of inadequate official record keeping. IECs make decisions that can have a direct effect on the reputation or standing of the researcher, the rights of the research subject, and the interests of the institution. The question which arises is whether these decisions ought to conform with the accepted standards of good administrative practice requiring that decisions are recorded and that reasons should generally be given. There is some authority for the proposition that an IEC’s decisions are reviewable (R v Ethical Committee of St Mary’s Hospital ex-parte Harriott), and it is probable that professional members in an IEC are answerable to the

disciplinary authorities of their profession.

3. 3 Comment

The Report on IECs(Chalmers 1996) was accepted by the Council of the NHMRC during 1996, and its various

recommendations were steadily introduced culminating in the introduction of the National Statement on Ethical Conduct in Research Involving Humansin 1999. The report recommended that the original NHMRC Statement on Human Experimentation(NHMRC 1992) required a thorough revision taking into account parliamentary

references to the AHEC, issues of public interest, and new ethical questions raised by technological advances. It is interesting to note the similarities between this Australian Report and a review in the United States by the Office of the Inspector General of the Department of Health and Human Services. This review noted concerns that the IRBs in the United States have generally been doing “too much, too quickly with too little expertise.” The steady move toward more formal, regulated, and professional processes of ethics review of research is, no doubt, a common theme in most countries.

4. The Current System of Ethical Review in Australia

4. 1 The National Health and Medical Research Council of Australia

Since its creation in 1937, the National Health and Medical Research Council has been the peak Australian funding body for health and medical research. One of the original aims of the NHMRC was to promote consis-tency in the health and public health policies of the individual State governments within the federal system. The NHMRC, having been established by Order-in-Council in 1937, was placed under a new statutory frame-work with the passage of the National Health and Medical Research Council Act1992. The NHMRC remains the

principal independent advisory body on health under the Act. Importantly, it is the principal national body for the provision of advice on matters of health ethics. Under the National Health and Medical Research Council Act,

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The Act confers four obligations on the NHMRC:

■ To raise the standard of individual and public health throughout Australia;

■ To foster the development of consistent health standards between the various States and Territories;

■ To foster medical research and training and public health research training throughout Australia; and

■ To foster consideration of ethical issues relating to health.

4. 2 The AHEC Function and Relationship with the Commonwealth Parliament

The ethics advisory function is carried out by the AHEC, a principal committee of the NHMRC.

The AHEC was established under the National Health and Medical Research Council Act 1992 (Cth.) (see

particularly § 35 and § 36). It is a multidisciplinary committee which, under the Act has the following Terms of Reference:

1. To advise the Council on ethical issues relating to health.

2. To develop and give the Council guidelines for the conduct of medical research involving humans.

3. Such other functions as the Minister from time to time determines.

The Minister made such a determination at the time of the Act and conferred further functions on the AHEC as follows:

3.1 To develop and give the Council guidelines for ethical conduct in the health field, additional to those required for function 2 above, and for the purposes of the Privacy Act 1988;

3.2 To promote community debate and consult with individuals, community organizations, health professions and governments, on health and ethical issues;

3.3 To monitor and advise on the workings of institutional ethics committees (now HRECs);

3.4 To monitor international developments in relation to health ethical issues and files with relevant international organizations and individuals.

The NHMRC had some initial challenges in becoming fully acquainted with the expectations of the Senate-initiated AHEC that replaced the MREC (Commonwealth Parliamentary Debates: 1991 at 1089–1092). A short time after the passage of the National Health and Medical Research Council Act,it was decided that there should

be an external review of the NHMRC. A Canadian academic was commissioned, and a report was presented in December 1993 (Bienenstock 1993). This report recommended that the NHMRC improve its planning processes for developing and setting priorities and strategies; improving the advisory processes of the NHMRC Committees; improving and simplifying the research funding allocation processes; and, finally, recommending substantial changes to the administrative support of the NHMRC.

AHEC was the subject of specific comment in the Bienenstock Report, which is worth quoting at length:

AHEC is the most recently established of the Principal Committees of the NHMRC, having been in operation for two and a half years at the time of this review. It evolved from the former Medical Research Ethics Committee of NHMRC and the National Bioethics Consultative Committee (NBCC) of the Australian Health Ministers’ Conference.

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advice and speakers on request. AHEC has also developed the broader ethics role, conducting some preliminary work into the ethics of health resource allocation, guidelines to promote ethical conduct in the health field, and issued various discussion papers on health ethics issues....

It is apparent that AHEC has had some difficulty in coming to grips with its role and function in what is undoubtedly a complex and extraordinarily wide ranging area. It has attracted considerable criticism from some quarters for failing to provide concrete advice on practical issues relating to research, particularly those relating to the operations of Institutional Ethics Committees (IECs), though some progress appears to have occurred in this area at the most recent Council meeting. It is seen by some people as being dominated by the members of the former NBCC, which was concerned with broader ethical, social and legal aspects of health care, and as having insufficient expertise and involvement by practicing researchers to deal with concrete ethical problems relating to research. On the other hand, some members of AHEC have felt that the Committee has been too occupied with the agendas of subcommittees, particularly the IEC Subcommittee, to be able to define its broader role and activities.

Consideration of the legal and ethical aspects of health will grow in importance in the future. The NHMRC will play a vital part in this development. A balanced approach to this issue must involve recognition by health practitioners that ethical considerations are crucial in their work, and by the NHMRC that health practitioners and researchers must be an integral part of the development of appropriate guidelines. To separate ethical considerations from the practice of health and research is to invite irrelevance rather than independence” (Bienenstock 1993 at 23–24).

Professor Bienenstock recommended that AHEC should integrate its activities and priorities with those of the NHMRC as a whole, focus its energies on issues of highest practical and immediate priority, and be accountable to Council for its work. In so doing AHEC was to be restructured to more fully integrated activities with the principal committees of NHMRC (Bienenstock 1993, Recommendation 11). AHEC was to operate as any other principal committee of the NHMRC, but with the unique guideline development function under § 8 of the Act.

4. 3 The AHEC Composition and Role

Only two of the principal committees of the NHMRC, namely the Research Committee and the AHEC, were specifically mentioned within the terms of the National Health and Medical Research Council Act 1992. By § 35

of the Act, the Minister must establish principal committees called the Medical Research Committee (now the Research Committee) and the AHEC. During the parliamentary debate and particularly those in the Senate, the composition and independent role of the AHEC was established.

■ § 36 of the National Health and Medical Research Council Act1992 provides that AHEC is to have the

following membership:

■ the Chairperson;

■ a person with knowledge of the ethics of medical research;

■ a person who has expertise in law;

■ a person who has expertise in philosophy;

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■ a person who has experience in medical research;

■ a person who has experience in public health research;

■ a person who has experience in social science research;

■ a person who has experience in clinical medical practice;

■ a person who has experience in nursing or allied health practices;

■ a person with knowledge of the regulation of the medical profession;

■ a person with understanding of health consumer issues;

■ a person with understanding of the concerns of people with a disability; and

■ no more than two other persons with expertise relevant to the functions of the Committee.

■ The Act specifies a nomination system that must take place from among peak bodies in relation to these areas of expertise. In an apparent effort to limit the power of the Minister to his/her own appointees, the Act includes a requirement that for most categories peak professional bodies must be consulted. For example, the person with expertise in law should be appointed from persons nominated by the State and Territory Law Societies or the Commonwealth Law Council. Similarly, the senior representative bodies of the officially recognized religions nominate the person with expertise in religion.

■ AHEC must not have more than one member of the Research Committee of the NHMRC and its Chair must be a person who is not a member of the Research Committee (§ 35(6) of the Act).

■ _{Matters could be referred by the NHMRC, other principal committees of the NHMRC or from}

Commonwealth and State ministers. For example, the reference to the AHEC to prepare a Report on the Scientific, Ethical, and Legal Considerations Relevant to Human Cloningwas a reference from the

Commonwealth Minister for Health and Aged Care.

■ The NHMRC cannot edit or change (§ 8(2) of the Act) the contents of AHEC reports, but may refer the guidelines back for further consideration.

■ Community consultation is a requirement under § 11–14 of the Act. A two-stage public consultation process is specified.

The organizational and structural changes recommended by the Bienenstock Report (Bienenstock 1993) were put into place during the first half of the 1990s. By the second triennium of the AHEC (1993–1996) the Council of the NHMRC had a clear appreciation of the role and function of the AHEC. In particular, the Council recognized that the guideline development function of the AHEC was neither an advisory role nor a role which could be interfered with by the Council.

4. 4 Guidelines of AHEC and Consultation

The AHEC, in its role as one of the principal committees of the NHMRC, is responsible for developing guide-lines for the conduct of medical research involving humans, other advice relating to health, and for providing assistance to HRECs.

The guideline development function of AHEC is critical. Under § 8 of the National Health and Medical Research Council Act1992 (Cth.), the NHMRC issues guidelines for the conduct of medical research involving

humans. However, the guidelines for the conduct of medical research are developed by the AHEC and must be issued by the NHMRC precisely as developed by the AHEC(§ 8(2)). It should be noted that guidelines

Ethical and Policy Issues in Research Involving Human Participants, Vol. 2

Ethical and

Policy Issues

in Research

Involving

Human

Participants

Volume II

Commissioned Papers

and Staff Analysis

Ethical and

Policy Issues

in Research

Involving

Human

Participants

Volume II

Commissioned Papers

and Staff Analysis

National Bioethics Advisory Commission

CONTENTS

R

ESEARCH

E

THICS

IN

A

USTRALIA

Preface

A

1. Introduction

1. 1 Three Tiers: Researcher Ethics Committee and National Body

1. 2 The

National Statement:

Changes in the Research Environment

2. A Brief Background to the Development of Ethical Review in Australia

2. 1 Toward National Ethical Standards in Research: The First Period— 1973–1982

2. 2 Toward IECs and the Medical Research Ethics Committee of the NHMRC:

The Second Period— 1982–1989

2. 3 Toward a National Ethics Committee: The Third Period— 1988 to the Present

2. 3. 1 MREC

2. 3. 2 The Short-Lived National Bioethics Committee

2. 3. 3 The AHEC Established

3. The Commonwealth Review of Ethics Committees 1995–1996

3. 1 Background to the Ministerial Review

3. 2 Matters Addressed by the Ministerial Review

3. 3 Comment

4. The Current System of Ethical Review in Australia

4. 1 The National Health and Medical Research Council of Australia

4. 2 The AHEC Function and Relationship with the Commonwealth Parliament

4. 3 The AHEC Composition and Role

4. 4 Guidelines of AHEC and Consultation