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:
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Genetic testing and the application of gene technology in healthcare and research;
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Direct access to genetic testing, without the intermediation of a healthcare professional;
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Use and access to personal genetic information;
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Genetic testing and genetics research in vulnerable groups, including children, adolescents and the mentally impaired; and
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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.
About the BAC
The BAC was established by the Government in December 2000 to address the ethical, legal and social issues arising from human biomedical research and its applications. It develops and recommends policies on these issues, with the aim of protecting the rights and welfare of individuals, while allowing the biomedical sciences to develop and realise its full potential for the benefit of mankind.
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