Transcript 5th Biomedical Sciences International Advisory Council

Conference on International Collaborative
Research and Health Ethics
29 November 2005
Jakarta, Indonesia
Research Ethics Review:
The Regulatory Framework in Singapore
Terry Sheung-Hung KAAN
Faculty of Law, National University of Singapore
Bioethics Advisory Committee, Singapore
[email protected]
Regulatory Policy


Regulations, regulations, regulations, and the
letter of the law – but contrary to expectations …
Basic scheme similar to that of UK, multipronged approach with checks and balances at
many points through:




Statutory law providing general framework, most often
concerned establishing regulatory jurisdiction, powers
Assumption of dynamic common law filling interstices
Professional, and institutional self-regulation
Subsidiary legislation, Executive directives, policy
statements, professional codes, ethical codes and
practice guidelines – quasi-law, because statutes
require compliance with professional standards
2
The General Regulatory Framework



Ministry of Health (MoH) has general oversight
of medical profession, tissue banks, hospitals,
“clinics” (defined broadly), stem cell research
(e.g. Private Hospitals and Medical Clinics Act,
Medical Registration Act, Medicines Act, the
Human Cloning & Other Prohibited Practices Act)
Health Sciences Authority (HSA) has general
oversight of pharmaceutical / clinical trials, issues
clinical trial licences (Medicines (Clinical Trials)
Regulations / Singapore Guideline for Good
Clinical Practice)
Singapore Medical Council (SMC) has general
oversight of medical profession (Medical
Registration Act) – applies professional
standards
3

Statutory law provides general regulatory framework,
confers regulatory jurisdiction and enforcement teeth

Common law principles & precedents provide further
underpinnings (but does it?) – “seamless” body of
law?
Leaving particular and interstitial details and
implementation to institutional and professional selfregulation


Role of IRBs and statutory professional bodies
Role of bodies such as the National Medical Ethics
Committee (NMEC), and the Bioethics Advisory
Committee (BAC)
4

Clear preference for professional self-regulation
and institutional self-regulation where practical –
has worked well in past

General public acceptance, also preferred by
professions

Leaves Government in high-level “gatekeeper”
supervisory role through audit / accreditation /
licensing (may prescribe licensing conditions),
without getting involved in micro-management
5

Argument that in fields where state of ethical debate
(let alone agreement on law) barely keeps pace with
the state of the science, constantly evolving policy
statements and practice directions crafted in
consultation with public, community and professional
groups often more realistic, flexible and substantively
responsive than hard statutory law

Spirit as opposed to letter of the law: when in doubt,
ask! consult! (Government, IRBs, professions)

Not reinventing the wheel: in absence of local
direction, general assumption that starting point is
best practice in major scientific jurisdictions (but if
best practices differ?) Ditto policy and legislation
6
The System in Action

Since establishment in 2000, four Reports issued by the
Bioethics Advisory Committee (BAC):





Ethical, Legal and Social Issues in Human Stem Cell
Research, Reproductive and Therapeutic Cloning (“The
Stem Cell Report”, June 2002)
Human Tissue Research (November 2002)
Research Involving Human Subjects: Guidelines for
IRBs (November 2004)
Genetic Testing and Genetic Research (November,
2005)
Full text of all Reports downloadable from
http://www.bioethics-singapore.org
7

General starting point: the public Consultation Paper
(“White Paper”)

First used by the National Medical Ethics Committee in
1994 for the proposals leading to the Advance Medical
Directive Act (living wills)

Extensive consultation with professional, civic,
community, patient interests, religious groups

Aim is to come up with a set of recommendations /
guidelines that takes into account as far as possible the
views of all in the community, and not just professional
groups

Groups and public are invited to submit written
representations – all become part of the record when
Reports are published
8

Record of representations offer valuable insights and a
permanent record of perspectives and views of sections
of the community, particularly where there is
fundamental disagreement e.g. human embryonic stem
cell research, pre-implantation genetic diagnosis

Of particular interest to ethicists looking for sources on
Asian cultural and religious perspectives – Singapore is
a plural society

Religious, professional views predominate

When concerns are crystallised into words and
positions, easier to work out agreement and
compromise instead of working on assumptions
9

After the Consultation:

If Report accepted by Government, recommendations (if
in form of normative guidelines) have force as ethical
guidelines to be applied as the considered and accepted
practice and professional norms / best practice by
professional groups, institutions, IRBs

Sometimes, however, statutory teeth is required –
translation into law: e.g. the Human Cloning and Other
Prohibited Practices Act

Public consultation before legislation approach also now
widely used by Government in other areas, especially
through the internet
10
Research Ethics Review

If pharmaceutical / clinical trial, regulated by the Health
Sciences Authority (HSA) under the Medicines (Clinical
Trials) Regulations: clinical trial licence, full ethics review
required, full process described in the Research Involving
Human Subjects Report

HSA also regulates medical devices, therapeutic use of
experimental drugs

Human embryonic research, stem cell research
regulated directly by MoH under Human Cloning and
Other Prohibited Practices Act
11

Tissue banking (and indirectly research access to stored
human tissue) by MoH regulatory jurisdiction over tissue
banks under the Private Hospitals and Medical Clinics Act

Other kinds of biomedical research involving human
subjects:



If by physicians (majority of biomedical researchers
are), MoH under the Medical Registration Act
If carried out in or under auspices of hospitals and
medical institutions (most trials), MoH under the Private
Hospitals and Medical Clinics Act
If involving administration of drugs (but not
pharmaceutical trials), MoH under the Medicines Act
and the Medical Registration Act
12

Since 1998, all hospitals required to have IRBs
(generally separate clinical ethics committees and
research IRBs)

Most IRBs institutional, some organised along domain
lines, some shared

No uniform guidelines for structure / constitution of
IRBs until 2004 BAC Report

IRB approval required for all research involving human
subjects (long required by principal funders) –
separation into scientific review, then ethics review

Provision for exempted review (pre-approved
categories of “routine” investigations involving minimal
or remote risks
13

Provision for expedited review – similar to exempted
review for low-risk, accepted categories (e.g. annual
reviews of previously approved research in which there
has been little or no change in on-going research)

IRBs and institutions must have clearly defined
guidelines for exempted and expedited review
categories e.g. writing up clinical results, review of
clinical program, research using commercially available
cell lines or commercially available anonymous DNAs,
RNAs, fixed tissues)
Responsibilities of IRBs:
 Ethics review
 Continuing Review and Supervision
 Reporting and Feedback
14

“Lead IRB” concept for multinational, multi-loci / centre
research projects – concept of “lead IRBs” for primary
review, but each institution responsible for making final
decision

Guidelines for SOPs, consent requirements, conflicts of
interests, impartiality and independence of IRB members,
fair review and documentation of decisions – but
institution vary greatly in amount of research they
undertake

IRBs as gateway control for access to research subjects,
facilities, research material, collaboration, publication –
efficacy?
15

Responsibilities of Researchers:

Researchers have a “primary and central role
in ethics governance” – to not treat IRB
approval as transfer of ethical and legal
responsibilities, which are non-delegable

Researchers “primarily and ultimately
responsible for making the first judgment” as
to whether research is ethical – submission to
IRB is assertion that it is

Continuing responsibilities, deviation and
variation. Adverse events.
16

Researchers and attending physicians: should
physicians have veto power over recruitment for
trials? Or merely kept informed, if at all?

Responsibilities of appointing institutions – IRB
reporting to top management, protected time,
administrative support

Legal relationship between appointing
institutions and IRBs – recommendation for
statutory legal indemnity obligation

Accreditation of IRBs (MoH licensing
requirements)
17
The Future






More research being carried outside of traditional
setting – shifting paradigms
Limits of self-regulation > public trust, statutory
teeth
Different institutions, different challenges
New laws needed to plug the gap – a omnibus
Regulation of Biomedical Research Bill was
proposed and public feedback sought in 2003,
but Human Cloning Act hived out of it for early
enactment
Health, or research?
A cautionary tale? But perhaps better
evolutionary than revolutionary. Stay tuned …
18
Resources

Full text of Singapore Statutes:
 http://www.statutes.agc.gov.sg or
 http://www.agc.gov.sg > click on “Statutes Online”

Full text of all Bioethics Advisory Committee Reports
and Consultation Papers (including written
representations):
 http://www.bioethics-singapore.org

Other biomedical research information:
 The Ministry of Health: http://www.moh.gov.sg
 Singapore Government portal: http://.www.gov.sg
19
Conference on International Collaborative
Research and Health Ethics
29 November 2005
Jakarta, Indonesia
Research Ethics Review:
The Regulatory Framework in Singapore
Terry Sheung-Hung KAAN
Faculty of Law, National University of Singapore
Bioethics Advisory Committee, Singapore
[email protected]