Presentation_on_DoH-_Mfutso-Bengo
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Prof. J. Mfutso-Bengo, PhD
Center of Bioethics (CEBESA)
University of Malawi College of Medicine
CapeTown – South Africa
December 2012
www.medcol.mw
Joseph-matthew@gmx.net
Revisions on the Declaration of
Helsinki
Introduction
TheWorld Medical Association (WMA)was
established after theWW2 in reaction to the
atrocities committed by physicians
It was meant to be a global representative body for
physicians
Currently, there are 48 National Medical
Associations and approximately 7 million physicians
WMA adopted the Declaration of Helsinki (DoH) in
1964
The Roles of the WMA in Biomedical
Research
Establishment of high-level global ethical
standards for biomedical research
Bridge between physicians and researchers
Advocate for patients serving as human
subjects
Participant in capacity-building initiatives
Brief History of DoH
First adopted in 1964
Significant additions in 1975
Minor amendments in 1983, 1989 and 1996
Major revision and reorganization 2000
Notes of clarification in 2002 and 2004
Another revision in 2008
Influence of DoH
CIOMS guidelines follow the DoH quite closely
ICH-GCP guidelines require adherence to “principles
that have their origin in the DoH”
The UNESCO Declaration on Bioethics and Human Rights
cites the DoH
The EC Directive on ClinicalTrials and the US FDA
require adherence to the principles of DoH
DoH is the most cited research ethics document by
research ethics committees
Proposed Amendments in the 2012
Consultation Draft
Paragraph 11: It should be revised to read;“It is the duty of
the researcher in medical research to protect the life,
health, privacy, confidentiality and dignity of the
human subject”
Paragraph 12: It should be revised to read;“Appropriate
caution must be exercised in the conduct of research which
may affect the environment, and the welfare of human
subjects and animals used for research must be respected.”
Proposed Amendments in the 2012
Consultation Draft
Article 14 the ethics committee should provide the
researchers with a checklists of documentation and
requirements for independent scientific and ethical review
process
The researcher should also submit to the committee, for
review, information regarding funding, sponsors, institutional
Affiliations, other potential conflicts of interest and
incentives for subjects. I propose to add “Post trial access
plan if appropriate and community engagement
plan.”
Proposed Amendments in the 2012
Consultation Draft cont’d
Paragraph 28: It should be revised to read:“
When a subject deemed legally incompetent,
such as a minor child, is able to give assent to
decisions about participation in research, the
investigator must obtain that assent in addition to
the consent of the legally authorized
representative. However, emancipated
minors should be allowed to give their
own informed consent.” e.g., minors who
are mothers.
Proposed Amendments in the 2012
Consultation Draft cont’d
Paragraph 31: It should be revised to read;“The physician
should fully inform the patient which aspects of the care
are related to the research.The refusal of a patient to
participate in a study must never interfere with the
patient-physician relationship. And if a conflict of
interest (CoI) exists between a physician cum
researcher and a patient, the physician must
disclose the CoI to the patient and recuse
him/herself from recruiting the patient as a
human subject.”
Proposed additional principle
Paragraph : “Human subjects who
participate in clinical trials involving
investigational products whose safety
profiles are unknown should be
provided with clinical trials
insurance”
Exportation and importation of clinical
and research samples
There is growing trend of exporting human tissues from developing countries to laboratories in
developed countries for clinical diagnosis or clinical research. Especially for clinical samples have
the potential for abuse and lack of accountability
There is need to create safeguards to avoid the abuse of those human tissues.
Hence we propose that there is a need to have a material transfer agreement(MTA).
The MTA agreement form should have a clear description of namely:
1. The destination
2. Ownership
3. The intention of export/import
4. Access and control of the samples
5. Safety and security of the samples
6. Capacity building issues
7. Justification
8. Permission
9. Signatures
How to resolve conflicting decisions
between ethics committees in multi-
centered clinical trial
Incase of conflict between a remote and a local ethics
committee.The voice of the local ethics committee ought to be
taken into consideration
The scientific and ethical justification should not be ignored
Conditions for supporting local ethical
jurisdictions
1. Members of the local population and, in this situation, the local ethical
committee is the best judge of what is appropriate
2. Exception: local review is sufficient only if the host country/institution
has a system of substantive protections that are equivalent to international
acceptable standards.
3. The basis of this argument is the principle of justice: that equals should be
treated equally. Local ethical committees should be allowed to adjudicate
conflicts between remote and local committees, One approach to
resolving the impasse could be to distinguish between fundamental,
qualitative and non-arguable principles and more relative, quantitative and
circumstantial applications.
(6) Ethical principles cannot be universal without being contextual
Conditions for supporting local ethical
jurisdictions
(1)The local committee must be constituted and its deliberations
executed according to internationally recognized ethical standards
(e.g.TheWorld MedicalAssociation’s Declaration of Helsinki;The
Belmont Report: Ethical Principles*).
A clear SOPs of decision-making process
Conclusion
Developing countries are vulnerable to
unscrupulous researchers
Collective responsibility in protecting the rights,
safety, and welfare of human subjects is critical.
This calls for fair and objective regulations and
guidelines that aim at promoting research and
development while at the same time not
compromising the protection of human subjects