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1. Law BEC Guidance BACKGROUND On July 9, 2010, the Government of Malaysia approved the establishment of the first National Bioethics Council of Malaysia (Majlis Bioetika Negara). As the name implies, this council acts as an advisory body on bioethics issues that may have an impact on the environment, health, culture, laws, religions and society in general. The appointed members are experts from various disciplines related to bioethics as well as representatives from related Ministries and NGOs. Research Ethics System Ethics Committee Ethics Committee Ethics Committee INTRODUCTION Malaysia joins international good practice. By establishing a National Bioethics Council of Malaysia (BEC), the Government of Malaysia joins international good practice of examining, reporting and advising on issues in bioethics.  The Bioethics Council is well placed to learn from what similar bodies have undertaken in other countries, and apply this in the Malaysian context. In the UK, the preeminent advisory body is the Nuffield Council on Bioethics (NCB). Making guidance effective requires structures for enactment. For the careful thought and advice of the BEC to make a real difference to health research in Malaysia, it must be communicated and supported in a standardised and authoritative way. In the UK, one of the avenues for this dissemination and enforcement is a well-structured system of ethical review, established by the UK Department of Health. Research Research Research Research Research Research Research Research Research Research Research PROPOSAL Build on established practice. The BEC of Malaysia has the opportunity to pull together current bioethics guidance in the country, deepen it, and develop structures for its dissemination and implementation. Based again on UK experience, we propose that the BEC focus on governance of bioethics research through a system of ethics committees. The National Bioethics Council of Malaysia: The Promise of Health Research GovernanceMohammad Firdaus Abdul Aziz Dphilcandidate (firdaus.aziz@dph.ox.ac.uk) Dr. Karen MelhamNIHR Biomedical Research Centre Oxford, Researcher in Ethics (karen.melham@dph.ox.ac.uk) HeLEX – Centre for Health, Law and Emerging TechnologiesDepartment of Public Health, University of Oxford, United Kingdom National Research Ethics Service Dual mission: To protect the rights, safety, dignity and well-being of research participants; and To facilitate and promote ethical research that  is of potential benefit to participants, science and society.  Consists of committees of volunteers, support staff. and a National Research Ethics Advisors’ Panel. THE NHS RECs An entirely independent body from research sponsors to avoid bias and ensure research integrity. Consist of 7-18 volunteer members. Open to lay members, including those whose personal or professional interest is not in a research area and who have not been involved except as a participant. Provide overview to compliance with relevant UK law (Clinical Trials, Mental, Capacity, Data Protection, Human Tissue) Research in specific areas such as Gene therapy and Xenotransplantation are reviewed respectively by the Gene Therapy Advisory Committee (GTAC) and the UK Xenotransplantation Interim Regulatory Authority (UKXIRA). Controversial research such as embryo research, needs to refer to relevant law. Established in response to concerns about the lack of a national advisory body to examine and provide advice on ethical issues raised by developing bio technologies and medicine. Established in 1991 by the Nuffield Foundation, a UK-based independent charitable body– not government-appointed body. Plays  a vital role  in promoting bioethics through awareness activities, publication, advocacy, publicity of relevant information, and organising workshops conducted by appointed committee(s) or working parties. Meets with regulatory bodies (i.e Department of Health) annually to exchange information. WHAT CAN BE LEARNED FROM THE UK EXPERIENCE ? Nationally Networked System. DoH is given a mandate to govern and integrate health and research system through its appointed RECs, which need to be recognised by the UKECA and accountable to the UKECA or NRES (appointed body in England by the UKECA). Independent advisory body. NHS RECs are entirely independent from any organisations that provide funding for research activities to ensure transparency and to maintain trust from the public. Harmonised and standardised ethical standards. The same high ethical standards are being used as a reference by NHS RECs throughout the UK. Specialised ethics committees. Specialised ethics committees provide competent ethical review for very specific research areas. Diverse membership. Memberships not only exclusive to professionals of bio-medicines and bio-technologies, but also involves members from various backgrounds (i.e. public/lay persons, experts in law, and ethics). This is to ensure a fair and transparent review. Experts training. The REC members are given appropriate training to ensure all members can provide a competent evaluation and ethical review of research proposed. UK ETHICS COMMITTEES: BRIEF CHRONOLOGY Mid-1960s RECs first established in the UK National Health System (NHS) by the Department of Health (DoH) 1991(England & Wales), 1992(Scotland) Establishment of Local Research Ethics Committees (LRECs) 1997 Establishment of Multi-centre Research Ethics Committees (MRECs) 2004 Establishment of Central Office for Research Ethics Committees (COREC) in England The implementation of EU Clinical Trials Directive 2001/20/EC – leads to the creation of UK Ethics Committee Authority (UKECA) 2007 The establishment of National Research Ethics Service (NRES), incorporates COREC and NHS RECs (in England) References: The UK Nuffield Council on Bioethics website at http://www.nuffieldbioethics.org/about accessed on May 9, 2012. The UK National Research Ethics Service website at http://www.nres.nhs.uk/about-the-national-research-ethics-service/about-nres/ accessed on May 9, 2012. *Refer to this website for a complete chronology up to 2011. The UK Health Research Authority website at http://www.hra.nhs.uk/ accessed on May 9, 2012. ‘Supplementary Operational Procedures for the Gene Therapy Advisory Committee: Transfer of applications under the Clinical Trials Amendment Regulations 2008’ at http://www.advisorybodies.doh.gov.uk/genetics/gtac/gtacsop-transferapps.pdf accessed on May 10, 2012. ‘Directive 2001/20/EC of the European Parliament and of the Council’, Official Journal of the European Communities, 1.5.2001. Privacy in Research Ethics and Law at http://www.privireal.org/content/rec/uk2.php accessed on May 13, 2012.