Release of third report by the Bioethics Advisory Committee – Research Involving Human Subjects: Guidelines for IRBs

This Report of the Bioethics Advisory Committee (BAC) sets out guidelines for ethics governance of research involving human subjects.

The guidelines require all human biomedical research in Singapore, including research involving human tissue or medical information, to be subject to ethics governance.

Ethics governance is to be carried out by institutional review boards of all institutions involved in human biomedical research.

The guidelines set out:

• the constitution, accreditation and operation of institutional review boards; and

• the roles and responsibilities of institutions, institutional review boards and researchers.

The guidelines are built on current system of regulations for pharmaceutical trials and for human biomedical research conducted by hospitals, private clinics and other healthcare establishments under the supervision of the Ministry of Health.

BAC regards high standards of ethical governance for the protection of life, health, privacy and dignity of human subjects in biomedical research as vital to the progress of biomedical sciences in Singapore and to the reputation of Singapore as a global centre of excellence in biomedical research.

This Report is the culmination of an extensive research and consultation process, which began in April 2003 and follows upon earlier Reports of the BAC on Human Stem Cell Research and Cloning (June 2002) and on Human Tissue Research (November 2002).

Singapore’s Bioethics Advisory Committee (BAC) today announced the publication of its report on the ethics governance of research involving human subjects. Entitled "Research involving Human Subjects: Guidelines for IRBs", the Report seeks to clarify the roles and responsibilities of institutional review boards (IRBs), institutions and researchers in fostering a culture of good practice, transparency and accountability in the conduct of human biomedical research in Singapore. The guidelines set out in the Report encapsulate universally accepted principles on ethics governance for the protection of the life, health, privacy and dignity of human subjects in biomedical research.

Professor Lim Pin, Chairman of the BAC, says: “It is important for Singapore to establish clear and transparent standards and procedures for human biomedical research so that Singapore’s reputation as a global centre of excellence in biomedical research can be upheld and strengthened.”

The recommendations set out in the Report require all institutions (whether private or public) conducting human biomedical research in Singapore, including research involving human tissue or medical information, to establish IRBs to review and supervise such research. Where it is impracticable to set up an IRB (in the case of an individual researcher or a small group of researchers for instance), appropriate arrangements should be made with a hosting institution so that the research may be subject to ethics governance by an IRB. An IRB should be organised at, and integral to, the function of the highest administrative level of an institution. Associate Professor Terry Kaan, Chairman of BAC's Human Genetics Subcommittee, which led the work on this Report, says that: "We think it is important that IRBs should be staffed by an institution's most senior and most respected officers, researchers or consultants. The participation of an institution's top medical, scientific and administrative leadership would ensure that ethics governance is carried out by the best people with the appropriate knowledge, experience and training for the task. They would also set the tone in ensuring that the ethics governance process is independent, impartial and fair."

Under the current system, only pharmaceutical trials involving the testing of drugs on human subjects and human biomedical research conducted by hospitals, private clinics and healthcare establishments falling within the purview of the Ministry of Health (MOH), are required to undergo ethics review. The guidelines in this Report which are built on the basic framework of ethics governance issued by the NMEC (National Medical Ethics Committee) in 1997, expand the scope of ethics governance to include all human biomedical research conducted in Singapore, whether or not they are carried out in institutions under the purview of the Ministry of Health.

The new framework of ethics governance requires all biomedical research involving human subjects to undergo a formal process of ethics review. Such review may vary from a full formal process to an expedited process, depending on the potential and actual risks that the research under review poses to the human subjects. However, ethics review may be exempted in certain special cases which carry no risk to human subjects or in exceptional situations of national security or emergency health situations.

The Report also sets out the roles and responsibilities of institutions, IRBs and researchers (below). The fundamental responsibility of an IRB is to act as an ethics review gateway for all human biomedical research, with the primary objectives of the protection and assurance of the safety, health, dignity, welfare and well-being of human research subjects. Researchers share with IRBs and institutions a primary role in the ethics governance of human biomedical research but the ultimate responsibility for the ethical compliance of all aspects of the research rests with the researcher. Institutions have the overall responsibility of ensuring the proper conduct of human biomedical research carried out by their employees on their premises.

In addition, the guidelines assist IRBs, institutions and researchers in the discharge of their respective responsibilities by addressing a variety of practical matters. They include conflicts of interest, multinational and multi-centre research projects, specific operating procedures such as those relating to fair review and documentation of decisions, deviations from and variations to research protocols that have been reviewed, the relationship between researchers and attending physicians of subject-patients, and the workload and protection of IRBs.

However, the guidelines do not apply to any human biomedical research in relation to genetically modified organisms, animals and their treatment, and economic, sociological and other studies in the disciplines of the humanities and social sciences.

The Report is the culmination of an extensive research process, which began in April 2003. On 16 September 2003, a consultation paper was distributed to 37 bodies concerned with the ethics governance of human biomedical research in Singapore. In addition, a dialogue session with the hospital ethics committees and IRBs was held on 7 November 2003. The consultation paper, the responses received in relation to the consultation paper and a summary of the dialogue session are included as annexes to the Report. The recommendations in the Report incorporate feedback received, including feedback from the BAC's International Panel of Experts and the International Advisory Council of the Biomedical Sciences Initiative.

These guidelines and recommendations have been presented to and accepted by the Life Sciences Ministerial Committee.

A copy of the Report is available on this website.

SUMMARY OF RECOMMENDATIONS

General

All Human Biomedical Research should be reviewed and approved by a properly constituted IRB before it is allowed to proceed. Some research, however, could qualify for Exempted Review or Expedited Review if it involves no risk or minimal risk to the safety, health, dignity and welfare of the research subjects and provided that the protection of the subjects’ privacy is strictly observed.

It is recommended that all IRBs be formally accredited by the MOH.

These Guidelines apply to all Human Biomedical Research wherever such research may be carried out in Singapore, whether or not such research is carried out in an institution under the direct jurisdiction of the MOH pursuant to the Private Hospitals and Medical Clinics Act.

IRBs

IRBs are accountable to their appointing institutions and they are responsible for:

• The ethics review and approval of proposed Human Biomedical Research programmes;

• The continuing review and supervision of the research programmes approved by them;

• Reporting to their respective institutions any unusual or unexpected events arising from the research;

• Providing feedback to and maintaining dialogue about applicable standards with their constituent researchers; and

• Receiving feedback from research subjects.

In the ethics review process, IRBs must be aware of any actual, potential or apparent conflict of interest and take reasonable steps to avoid or minimise such conflicts.

The scientific review of research proposals does not lie with the IRB. It is for the researchers to satisfy the IRB that an objective review of scientific merit has been carried out and to make these findings (whether positive or negative) available to the IRB.

In multi-centre research, a “lead” IRB should be designated from among the IRBs of participating institutions. The lead IRB will play the main role in conducting a full ethics review, in coordinating the research programme and in keeping other participating IRBs informed of any decisions and amendments made during the whole research period. The local portion of a multinational research programme should be subject to review by the local IRB.

Researchers

Researchers must comply with all the conditions laid down by the IRB that approved their project.

Researchers are also responsible for ensuring that their research complies with all relevant laws and other regulatory obligations and requirements.

Researchers are required to inform and seek approval from their IRBs for any proposed variations from the terms of approval of the projects before such variations can be implemented.

Researchers should submit annual (or more frequent) progress reports as required by their IRBs, as well as project completion reports and reports of adverse events.

Researchers should inform and discuss with the research subjects’ attending physicians if the research involves interfering with the subjects’ medical management.

Institutions

Institutions have the overall responsibility of ensuring the proper conduct of Human Biomedical Research carried out by their employees on their premises.

Every institution involved in Human Biomedical Research as defined in these Guidelines should establish and maintain an effective IRB. The institution must accept legal responsibility for the decisions of its IRB. IRBs may be shared by more than one institution. They could also be domain specific, providing more focused and specialised ethics review.

Each institution must set up clear policies for the establishment and operation of its IRB. The institution will determine the composition and constitution of the IRB, the specific operating procedures for ethics review and categories of research for Exempted Review and Expedited Review.

Institutions are responsible for providing their IRB members with full indemnity.

Institutions, in particular those with sizeable research programmes, should have in place programmes for the training and education of their IRB members.

Institutions should, in consultation with their IRBs, ensure that clear formal procedures are laid down for the release of all kinds of patients’ medical information.

Institutions should also ensure that there are adequate resources to enable their IRBs to discharge their duties and responsibilities in an effective and timely manner.

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