Bioethics Advisory Committee seeks public feedback on the use of personal information in biomedical research

Consultation Paper distributed to 70 religious, professional and scientific organisations, and healthcare and research institutions in Singapore to seek their views

Over the past two years, the Bioethics Advisory Committee (BAC) has thoroughly examined the ethical, legal and social issues arising from the use of personal information in biomedical research. This was achieved by studying various policies and guidelines adopted in other leading jurisdictions and recommendations made by national and international organisations. Local and international experts were also consulted.

The BAC has prepared a Consultation Paper entitled “The Use of Personal Information in Biomedical Research”. Key ethical, legal and social issues covered in this paper are:

• Legal protection of personal information in biomedical research;

• Obtaining informed consent for biomedical research;

• Ethical considerations provided by the BAC include:

• Privacy and confidentiality considerations; and

• Access to personal information by third parties such as employers and insurers.

The Consultation Paper proposes 13 recommendations to address these issues.

Associate Professor Terry Kaan, Chairman of the Human Genetics Subcommittee says: “For biomedical research to develop in Singapore, it is essential for researchers to have access to medical information and other kinds of personal information. I think most people are supportive of research. Having clear rules about how such information may be used, and ensuring that there are appropriate safeguards in place for the protection of such information will encourage people to participate and help in such research in the confidence that their privacy and the confidentiality of their private information will be protected. I think we also need to consider establishing laws to support the work of disease registries, which are crucial in national health care planning and policy, and in advancing treatment for the diseases that affect us most here in Singapore. The development of a legal privacy protection regime will help reinforce public confidence in privacy safeguards, and allow registries to function properly. This will bring us in line with the personal information protection regimes of most major scientific jurisdictions.”

BAC Chairman, Professor Lim Pin agrees with Associate Professor Kaan, adding: “It should be stressed that a legal privacy protection regime is to facilitate biomedical research, and not to impede its progress. A legal privacy protection regime will help prevent possible ethical lapses regarding privacy and confidentiality from occurring and thus safeguard and promote Singapore’s reputation as a responsible and safe country for carrying out biomedical research. This will bring about multiple benefits such as the possibility of collaboration with other countries for biomedical research.”

The Consultation Paper will be distributed to 70 organisations and institutions 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 should send their responses by 31 July 2006 to:

Email: contactus@bioethics-singapore.gov.sg

All comments received will be carefully considered before the final recommendations are made to the Steering Committee on Life Sciences. The BAC plans to publish all written responses received, unless it receives a request to consider responses confidential.

List of Recommendations

The Legal Protection of Personal Information

Recommendation 1
We recommend that the relevant authorities consider establishing a legal framework for the use of personal information in biomedical research.

Informed Consent

Recommendation 2
Specific consent should be obtained when research involves identifiable personal information or tissue samples. General consent may be obtained for subsequent research involving the use of de-identified information or remnant tissue. The information to be provided to the individual when taking consent should depend on the sensitivity of the information and the risk of harm.

Epidemiological Research and Public Health Research

Recommendation 3
We recommend that the relevant authorities clarify the legal basis for the disclosure of medical information to disease registries by health care institutions and physicians; and establish mechanisms enabling the registries and healthcare institutions to increase the accessibility of personal information for research that can significantly advance public welfare, while safeguarding privacy concerns.

Recommendation 4
We recommend that the relevant authorities consider establishing legal mechanisms to facilitate the use of personal information in registries, databases, and medical records for epidemiological research and public health research. These mechanisms should also ensure that there is minimal risk to individual privacy and confidentiality.

Clinical Audit

Recommendation 5
We recommend that the relevant authorities consider legal provisions necessary to ensure that the potentially increased scope of clinical audits does not violate medical confidentiality and to assure the public that privacy and confidentiality interests in personal information will be safeguarded.

Additional Considerations about Consent

Recommendation 6
We recommend that IRBs, when reviewing research, ensure that any concerns in regard to vulnerable persons are appropriately addressed.

Recommendation 7
Research participants should be allowed to withdraw their consent to participate in a research at any time without explanation and without prejudice. They should be assured that upon withdrawal their personal information and/or tissue samples will either be destroyed or irreversibly de-identified.

Privacy and Confidentiality

Recommendation 8
Personal information should be de-identified as far and as early as possible and should be stored or transferred as de-identified information.

Recommendation 9
Researchers should not attempt to identify an individual from de-identified information as it is a serious breach of ethics to do so.

Recommendation 10
Irreversibly de-identified personal information generally need not be subject to privacy and confidentiality requirements.

Recommendation 11
When reversibly de-identified information is used for research, IRBs should consider the adequacy of the extent and means of the de-identification in proportion to the risk. Should a person be identified from de-identified information, the person should still enjoy confidentiality and privacy entitlements.

Recommendation 12
The ethical principle of confidentiality should apply to the use of personal information from medical or public registries. Confidentiality safeguards should be commensurate with the potential risk of harm from inadvertent disclosure.

Access to Medical Information by Employers and Insurers

Recommendation 13
We recommend that the government consider implementing a moratorium on the use of predictive genetic information for insurance purposes and appoint an authority to consider long-term implications of the accessibility of predictive genetic test results by employers and the insurance industry and to monitor developments in this area.

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:

Mr Calvin Ho
DID: (65) 6826 6382
calvin_ho@bioethics-singapore.gov.sg

Mr Alvin Chew
DID: (65) 6826 6291