Ethical standards for research

Any research involving the use of human subjects or human biological materials for the purpose of genetic research raises many complicated ethical issues. ChemGenex Pharmaceuticals is very sensitive to the ethical issues surrounding such genetic research and is committed to conducting its human genetic research programs in accordance with the highest ethical standards. Consequently, ChemGenex Pharmaceuticals has consulted experts in the field of bioethics in order to establish ethics policies for its human genetic research projects to ensure that they comply with the requirements for justice, beneficence, and respect for the subjects of the research as outlined in the Belmont Report on Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1978)(1).

ChemGenex Pharmaceuticals has established the following ethics policy for genetic research.

Ethical standard for genetics research involving human biological materials

One of the major concerns regarding the use of human tissue for biomedical research is the harm that the results may cause individuals or collectives participating in the research such as the revelation of private information about their present or future health status. This is particularly relevant in research where tissue is used for genetic studies into the identification of new genes that can predispose to disease, as the participants may not have been aware that they were at risk. Such revelations would also impact on family members and could affect an individual's status in the community or the ability of certain persons to obtain particular types of insurance. In this regard any type of genetic research involving humans should abide by the three basic ethical principles of research as identified by the Belmont Report (1978)(1) and adapted by the Australian Health Ethics Committee (AHEC) for the National Health and Medical Research Council of Australia(2). These basic principles are:

• Respect - for all persons involved in the research;
• Beneficence - to maximize possible benefits and minimize any possible harm; and
• Justice - to determine who ought to receive the benefits of research and bear its burdens.

Another essential value for research is that of the integrity of the researchers involved. This includes a commitment to the research and its contribution to knowledge, a commitment to using appropriate and honest research methods and the accountability of the researchers to both the general community and to specific groups or collectives for the consequences of the research.

ChemGenex Pharmaceuticals is dedicated to carrying out biomedical research for the purpose of increasing our understanding of the causes of some of the world's most prevalent illnesses and trying to develop new methods for the treatment or prevention of these diseases. To achieve this ChemGenex Pharmaceuticals is committed to applying the highest ethical standards to its research programs including those that involve the collection of human tissue samples and health data related to disease. In accordance with the recommendations of the NHMRC's National Statement on Ethical Conduct in Research involving Humans, ChemGenex Pharmaceuticals proposes to abide by the following general methods for the collection of human tissue samples and data and for the use of this information for research purposes.

A. Ethics Approval

Ethics approval for any projects will be obtained through a recognised Human Ethics Committee in Australia and a Human Ethics Committee in any country from which samples are to be collected. This will allow ChemGenex Pharmaceuticals to establish rigorous guidelines for individual projects and ensure that the highest ethical standards are upheld. ChemGenex Pharmaceuticals will regularly consult with these committees for advice and solutions to any ethical problems that may arise during the course of such programs.

B. Respect for Individuals

All patients or potential donors will be provided with information at their level of comprehension about the purpose, methods, demands, risks, inconveniences, discomforts, and possible outcomes of the research (including the likelihood and form of publication of research results).

Patients can make a voluntary choice about whether or not they wish to participate in the research without any consequences to their treatment. Informed consent will be obtained from all individuals who agree to participate. The welfare, rights, beliefs, perceptions, customs and cultural heritage of individuals and collectives participating in the research will be respected.

Participants may elect how their samples and data can be used (e.g. for research on a variety of diseases or a defined few). Samples will be securely stored and will be discarded once the original purpose for which they were collected has been achieved or at the donors request. All information provided by participants about family members will be kept confidential. Any information used by ChemGenex Pharmaceuticals for the purposes of research will be encrypted and the anonymity of the individual will be ensured as the donors will not be able to be re-identified.

C. Beneficence

ChemGenex Pharmaceuticals is committed to using any samples and information collected in these projects for the sole purpose of improving the diagnosis, prevention and treatment of human diseases. Donor privacy and protection from any form of harm (psychological or emotional distress, discomfort and economic or social disadvantage) is a priority.

D. Justice

Benefits from this type of research include:

• ChemGenex Pharmaceuticals will fund the establishment of any research facilities or personnel required for the projects. This could potentially provide a number of jobs in the regions where the research is being conducted including a number of jobs for scientists.
• Any health databases developed by ChemGenex Pharmaceuticals will be freely available to be used for the benefit of the people involved. The data will provide valuable information on disease prevalence and could potentially be used to develop new health initiatives and Public health policies. All data will be encrypted when it is entered into the database so as to ensure the privacy of the donors.
• Where ChemGenex Pharmaceuticals enters an agreement with particular Nations or Groups for rights to samples and information, these Nations/Groups will receive benefits such as royalties or profits arising from new therapeutics at a rate that is in accordance with the Human Genome Organization Ethics Committee's(3) recommendations for benefit sharing. In addition any new therapeutics developed from the research will be provided free of charge to such Nations/Groups.

In addition

ChemGenex Pharmaceuticals and/or its commercial partners will be responsible for funding all of the research and development costs related to the development of new therapeutics.

Any new therapeutics will benefit people worldwide suffering from similar diseases.

ChemGenex Pharmaceuticals firmly believes that research involving human tissue samples and health data can be conducted in an ethical manner. ChemGenex Pharmaceuticals is committed to conducting honest and ethical research and understands that they are accountable for the consequences of such research.

(1) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, The National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research, Department of Health, Education and Welfare Publication No (OS) 78-0012, US Government Printing Office, Washington, 1978.

(2) National Statement on Ethical Conduct in Research involving Humans, (1999) Issued by the National Health and Medical research Council (NHMRC) of Australia in accordance with the NHMRC Act, 1992 (Cth).

(3) HUGO Ethics Committee, Statement on Benefit-Sharing (http://www.gene.ucl.ac.uk/hugo/benefit.html).