Bioethics Advisory Committee seeks community feedback on genetic testing and genetics research

Consultation Paper distributed to 114 community groups in Singapore , including religious, medical and patient interest groups, to seek their views

In the past year, the Bioethics Advisory Committee (BAC) examined a spectrum of ethical, legal and social issues arising from genetic testing in clinical practice and research. Studies were conducted on recent developments in both the local and global contexts and consultations with local and international experts were made. In addition, various policies and guidelines adopted in other leading jurisdictions and recommendations made by international organisations were carefully studied.

Following the extensive studies by the Human Genetics Subcommittee, a Consultation Paper entitled “Ethical, Legal and Social Issues in Genetic Testing and Genetics Research” was prepared. The Paper covers key ethical, legal and social issues in the following areas:

• Genetic testing and the application of gene technology in healthcare and research;

• Direct access to genetic testing, without the intermediation of a healthcare professional;

• Use and access to personal genetic information;

• Genetic testing and genetics research in vulnerable groups, including children, adolescents and the mentally impaired; and

• Standards for the provision of genetic testing services in the healthcare sector.

The Consultation Paper also proposes 24 recommendations related to the conduct of genetic testing in healthcare and research.

BAC Chairman, Professor Lim Pin, says: “Greater understanding of the human genome and advances in gene technology have provided the medical profession with improved tools in the diagnosis and management of patients. However, with the increasing availability and easy accessibility of genetic tests, ethical concerns arise. Guidelines are thus required for the conduct of genetic testing in both the clinical and research setting to ensure that tests are undertaken voluntarily, that the individual's privacy and confidentiality of the information so derived are protected and that the clinical applications of new technologies are not abused.”

Associate Professor Terry Kaan, Chairman of the Human Genetics Subcommittee adds, "As genetic information is unique because of its shared and predictive nature, issues related to genetic testing and the genetic information so derived are varied and complex with long-term ramifications. Like many other national ethics bodies and international organisations, the BAC is proposing guidelines to attend to these issues which may have imminent ethical, legal and social impact."

The consultation paper will be distributed to 114 organisations seeking their views on the issues discussed and the recommendations proposed. The BAC also welcomes comments from the public. Those interested in providing their views could obtain a copy of the consultation paper at www.bioethics-singapore.gov.sg and send their responses by 17 May 2005 to:

The Secretariat
Bioethics Advisory Committee
20 Biopolis Way
#08-01, Centros
Singapore 138668

All comments received will be carefully considered before the final recommendations are made to the Life Sciences Ministerial Committee.

Summary of Recommendations

Genetic Information

Recommendation 1
Genetic Information derived from Clinical Genetic Testing should be confined to a healthcare context, owing to its complex nature and need for professional input. Accordingly, it should be regarded as medical information and the highest ethical standard should be applied in its derivation, management and use.

General Ethical Considerations

Recommendation 2
Genetic Testing should be conducted in a manner that is respectful of the welfare, safety, religious and cultural perspectives and traditions of individuals.

Recommendation 3
Genetic Testing should be voluntary and conducted only after free and informed consent has been obtained. Consent must be based on sufficient information, which includes the nature, purpose, risks and implications of the test. Consent should also be obtained for future clinical and/or research use of tissue specimens.

Recommendation 4
An individual should be informed of the test result without undue delay unless he or she has clearly indicated the wish not to know. However, the test results of newborn babies and children for treatable conditions should be disclosed. In research involving Genetic Testing, researchers should inform the individual prior to participation in the research, whether the Genetic Information so derived will be disclosed to him or her.

Genetic Testing of Vulnerable Persons

Recommendation 5
We do not recommend the broad use of Genetic Testing on children and adolescents. Confirmatory Testing and Predictive Testing for genetic conditions where preventive intervention or treatment is available and beneficial in childhood are recommended. Carrier Testing should generally be deferred till the child is mature or when required to make reproductive decisions. Predictive Testing should generally be deferred where there is no preventive intervention or treatment, or where intervention or treatment is only available and beneficial during adulthood. However, in exceptional circumstances, parents and the physician should have the discretion to decide regarding Carrier and Predictive Testing, and genetic counselling should be an intrinsic part of the testing process.

Recommendation 6
Genetic Testing involving vulnerable persons should be conducted only if appropriate free and informed consent has been obtained. In the case of persons in special relationships, extra care should be taken to ensure that the consent is freely given.Clinical Genetic Testing should only be conducted if it is medically beneficial. Genetic Testing for research should only be conducted ifthe research is considered of sufficient importance and there is no appropriate alternative test population.

Privacy and Public Access to Genetic Testing

Recommendation 7
Genetic test results should not be disclosed to third parties, including employers and insurers, without the free and informed consent of the individual.

Recommendation 8
Genetic Testing should be conducted through the intermediation of a qualified healthcare professional. Accordingly, the advertising of genetic tests by manufacturers or suppliers to the public is strongly discouraged. A comprehensive regulatory framework should be established for access to Genetic Testing services. Genetic tests that provide predictive health information should not be directly offered to the public.

Recommendation 9
The non-consensual or deceitful obtaining of body samples for the purpose of Genetic Testing should be legally prohibited.

Preimplantation Genetic Testing

Recommendation 10
Preimplantation genetic diagnosis is permissible provided that it is subject to control by a relevant authority and limited to serious medical conditions. The relevant authority should license, monitor and assess preimplantation genetic diagnosis to ensure that it is employed within legal and ethical limits.

Recommendation 11
Use of preimplantation genetic diagnosis for sex selection and the selection of certain desired traits for non-medical reasons should be prohibited.

Recommendation 12
Preimplantation tissue typing, whether as the sole objective or in conjunction with preimplantation genetic diagnosis to avoid a serious genetic disorder, is permissible but should be licensed and evaluated on a case-by-case basis.

Germline Genetic Modification

Recommendation 13
Clinical practice of germline genetic modification should not be allowed at this time.

Prenatal Genetic Diagnosis

Recommendation 14
Prenatal genetic diagnosis should be voluntary, conducted with informed consent and with appropriate pre- and post-test counselling. The prospective parents’ choice of whether a genetic disorder warrants a prenatal genetic diagnosis or termination of the pregnancy should be respected.

Recommendation 15
Prenatal genetic diagnosis should be limited to serious genetic diseases. The use of prenatal genetic diagnosis for gender selection, apart from sex-linked disorders is unacceptable. Similarly, it is unacceptable to use prenatal genetic diagnosis for the selection of any physical, social or psychological characteristics or normal physical variations.

Recommendation 16
The appropriate professional bodies should prescribe detailed ethical guidelines on the practice of prenatal genetic diagnosis for their members.

Predictive Testing

Recommendation 17
Presymptomatic testing should be available for adults at risk who request it, even in the absence of treatment, after proper counselling and informed consent.

Recommendation 18
Susceptibility testing should not be applied clinically unless there is unequivocal empirical evidence of validity and utility.

Genetic Screening

Recommendation 19
In genetic screening programmes, the appropriate free and informed consent should be obtained from the individual to be tested or parents (or legally designated persons) as the case may be. A confirmatory diagnostic test should be performed as soon as possible after a positive screening test, so as to minimise unnecessary anxiety or to enable measures for the prevention or treatment of the condition to be instituted without delay.

Standards of Genetic Test Providers

Recommendation 20
All laboratories conducting Clinical Genetic Tests should be accredited by an accreditation body designated by the relevant authority, based on standards it considers appropriate.

Recommendation 21
Interpretation of genetic test results should only be performed by healthcare professionals who are appropriately qualified or have sufficient experience. Genetic counselling should immediately follow the disclosure of the test result, particularly if the test result is not favourable.

Genetic Counselling

Recommendation 22
Genetic counselling should be offered to all individuals prior to and after they undergo Genetic Testing.

Recommendation 23
Genetic counselling should generally be conducted in a non-directive manner, and should provide sufficient information and appropriate support to the individual and his or her family members.

Professional Development

Recommendation 24
Individuals involved in genetic counselling should possess up-to-date knowledge of medical genetics and should be appropriately trained in both medical genetics and counselling.

For media enquiries, please contact the BAC Secretariat:

Dr Sylvia Lim
DID: (65) 6826 6258
sylvia_lim@bioethics-singapore.gov.sg

Ms Linda Tan
DID: (65) 6826 6263
linda_tan@bioethics-singapore.gov.sg

Ms Jessy Chen
DID: (65) 6826 6264
Jessy_Chen@bioethics-singapore.gov.sg