WMA_Cape_town-_Feinholz

EXPERT CONFERENCE ON THE
REVISION OF THE DECLARATION OF
HELSINKI
CAPE TOWN, SOUTH AFRICA.
06/12/2012
DAFNA FEINHOLZ
CHIEF OF BIOETHICS SECTION
UNESCO AND DoH
Declaration of Helsinki
Recognized by UNESCO as one of the leading
international guidelines.
Important for UNESCO to participate in the debates
to collaborate in the efforts to ensure DoH remains
relevant and with a prominent role.
For Whom?
 From and for Physicians, yes but….
 Aspiration: should be good to anybody!
 The principles are relevant for other researchers and
other actors (funders, publishers)
 DoH in fact, invites others.
 De facto, it is a reference for non physicians and for
many engage in research with human research.
 Its a responsibility also to assume the relevance it
has gained. Integrated in some countries
legislation.
Some of the challenges
 Maintaining the specificity, and readable in 15
minutes, should not exclude to keep relevant in a the
wider (including dissemination of knowledge),
changing and increasingly complex context in
which research takes place.
 I will refer basically to post trial
arrangements/benefit sharing and ethics
committees.
Relevant principles of Universal Declaration
of Bioethics and Human Rights
15. Sharing of benefits
Related to Articles 4: Benefit and harm: In applying
and advancing scientific knowledge, medical
practice and associated technologies, direct and
indirect benefits to patients, research participants
and other affected individuals should be
maximized….”
Art 13 Solidarity and Cooperation
Art 21: “ Transnational health research Research
should be responsive to the needs of host
countries….”
Relevant principles of Universal Declaration
of Bioethics and Human Rights
Art. 10: Equality, justice and Equity
Human rights framework of UN and the Declaration:
International Covenant on Economic, Social and
Cultural Rights:
“Enjoy the benefits of science and technology and its
applications.”
Relevant principles of Universal Declaration
of Bioethics and Human Rights
15. Sharing of benefits
1. Benefits resulting from any scientific research and
its applications should be shared with society as a
whole and within the international community, in
particular with developing countries.
In given effect to this principle, benefits may take any
of the following forms:
a) Provision of new diagnostic and therapeutic modalities or
products steaming from research
b) Access to quality health care
c) Access to scientific and technological knowledge
d) Support for health services
e) Capacity-building facilities for research purposes.
Relevant principles of Universal Declaration
of Bioethics and Human Rights
Art 14. …..”Description of arrangements for post-study
access by study subjects to interventions identified
as beneficial in the study or access to other
appropriate care of benefit.”
Positive:
Call for a description in the protocol, which should
imply prior negotiation
Caution:
Post study (access to successfully tested ..) and other
benefits (health care during the research, etc)
together. Does not mean choosing, but differently as
appropriate.
Relevant principles of Universal Declaration
of Bioethics and Human Rights
Negative:
No specification of whose obligation it is to discharge post study obligations.
How will ethics committees will evaluate and promote compliance with
these obligations?
Article: 33. “At the conclusion of the study, patients entered into the study
are entitled to be informed about the outcome of the study and to
share any benefits that result from it, for example access to
interventions identified as beneficial or to other appropriate care or
benefit.
But…..
• What about other benefits during the research? Access to health care,
etc.
• Of course it could elicit the problem of undue inducement, but that
would also need to be sorted out.
Relevant principles of Universal Declaration
of Bioethics and Human Rights
• Compared to : …..”every patient entered into the study
should be assured of access”
• “are entitled” vs. should be assured…. and not clearly by
whom…….
• Different stakeholders, different type of research,
participants (not only patients), but there is a need to:
• define who will be responsible particularly in ensuring
access to successful outcome or other benefits,
• When this will be decided (before the trial starts)
• What are the benefits
• Who are the beneficiaries
Relevant principles of Universal Declaration
of Bioethics and Human Rights
• As different stakeholders are involved and had
different obligations, there is a need to identify
potential responsible and indicate the need for a
mechanism to agree.
• Some countries like Brazil have local legislation in
order to assure “access to medicine being tested”…
Relevant principles of Universal Declaration
of Bioethics and Human Rights
21. Transnational Practices
2. When a research is undertaken or otherwise
pursued in one or more States (the hosts State(s)
and funded by a source in another State, such
research should be the object of an appropriate
level of ethical review in the host State(s) and the
State in which the funder is located. (Dual review)
4.When negotiating a research agreement, terms for
collaboration and agreements on the benefits of
research should be established with equal
participation by those party to the negotiation
(taking into account power and minimum basis)
Relevant principles of Universal Declaration
of Bioethics and Human Rights
 Indicate the role of ethics committee in reviewing
and ensuring appropriate post study access and
benefit sharing arrangements and who will be
responsible.
 Indicate the need for host country committee to
fully participate in the review of the protocol in
international research.
 Previous version included reporting sources of
funding, sponsors and other sources of conflict of
interest to Ethics Committees, and is lacking here,
…..they are mentioned in the information to the
research participant.