Presentation_Emanuel

The Eighth Revision of the
Declaration of Helsinki:
What Should be Done?
Ezekiel J. Emanuel, M.D., Ph.D.
Vice Provost, Global Initiatives
Chair, Department of Medical Ethics & Health Policy
University of Pennsylvania
Thanks
• I have been a critic of the Declaration.
• Inviting me to address the WMA during
this revision process displays a deep
commitment to openness and to
considering views of critics.
• You are to be admired and thanked.
Outline
• Status of the Declaration
• Problems with the Current Version of
the Declaration
• Recommendations for the Revised
Declaration
Status of the Declaration
• Declaration of Helsinki stands as an
honored guidance document on human
subjects research.
• In 1964, it was pre-eminent.
• In 2012, it is not alone but in a crowded
field.
Status of the Declaration
• A revision of the Declaration needs to
accomplish two things:
 Distinguish itself from other guidance
documents.
 Justify why it should be followed relative to
other documents.
Status of Declaration
• Unlike other guidance documents,
Declaration is short—35 paragraphs
and just over 2000 words.
• The aim is to keep it as a short
document— i.e. to be read in under 15
minutes.
Status of Declaration
• As a short document, the Declaration
must be a statement of broad principles
that guide reasoning about the ethics of
human subjects research.
 A broad Constitution requiring
elucidation and interpretation.
 Not detailed legislation or regulation.
Status of Declaration
• Consequently, the revision must be
scrutinized to remove
 Provisions that do not relate to human
subjects research—e.g. animal research,
impact of environment, and unproven
interventions.
 Detailed specifications of requirements—e.g.
what should go into protocols, operations of
REC, who is and is not vulnerable.
Status of Declaration
• Consequently, the revision must
 Address everyone who is engaged in the
research endeavor not just physicians. As a
broad statement of principle it applies to all
who participate in research.
 Adopt broad language— “Separation of
Church and State” “Equal Protection under
the Law”
Problems with the Declaration
• The Declaration has grown from 11
provisions to 35 provisions.
• The provisions never reflected a
coherent view of the ethics of research.
It has always been an apparent random
collection of provisions rather than a
coherent framework.
Problems with the Declaration
• Past revisions of the Declaration have
significantly changed the document and
then changed it back.
• Seems as if there is no limit on the
changes. If a Constitution, should aim
for carefully worded document—not
one that changes with the times.
Problems with the Declaration
• At least 6 major problems:
 Confuses patient care and research
 Disorganized bordering on incoherent.
 Repetitive provisions
 Contradictory provisions.
 Contains vacuous statements
 Makes ethical judgments that appear to
lack justification.
Problems with the Declaration
• The introduction –especially provisions
3, 4, and 35—confuse patient care and
research.
• Research subjects are not patients and
do not have the same ethical
entitlements.
Problems with the Declaration
• One consequence of the confusion is
narrowing the audience for the
Declaration to physicians and then
stating that “other participants” are
encouraged to adopt these principles.
• Also sanctions some types of non-
research clinical interventions.
Problems with the Declaration
• Disorganization:
 No coherent framework. Having a coherent
framework does not mean Declaration has
to adopt either a utilitarian or deontological
philosophy, but it must have a view that it is
articulating.
 No clear rationale or logical flow informing
the order of the provisions and how they
connect.
Problems with the Declaration
 Risks-Benefits– provisions 8, 18, 20, 21, 27
 Informed consent—22, 24, 25, 26, 27, 28,
29 with three provisions—27-29— related to
incompetent patients
 Why animals or environment or advice to
editors?
 Why providing access to research for
under-represented populations in the
introduction?
Problems with the Declaration
 Why does registering a trial occur in the
midst of provisions about risk and benefits?
 No clear specification of who has an
obligation for fulfilling various provisions—
eg providing post-trial access.
Problems with the Declaration
• Repetitive provisions
 Voluntary consent in provision 22 and then
again in 24 and maybe 34.
 Relationship between value of research
and risk in provisions 21 and 31.
Problems with the Declaration
• Contradictions
 Addressed to physicians but then has
provision addressed to authors, editors
and publishers as well as to “other
healthcare professional”.
Problems with the Declaration
 Well-being takes precedence over all other
interests (provision 6), but in other places
other interests—privacy, self-
determination, benefits to communities—
must be considered with no ordering of the
interests—provision 11.
Problems with the Declaration
• Vacuous provisions
 “most interventions involve risks and
benefits.”
 “It is the duty of physicians who participate
in research to protect the life, health,
dignity, integrity, right to self-
determination, privacy and confidentiality
of personal information of research
information of research subjects.”
Problems with the Declaration
• There are many provisions that seem to
lack ethical justification:
 Why require such extensive disclosure of
conflict of interest but not prohibit conflicts of
interest or require they be managed?
 Why require the research with unconscious
patients be done only if the condition that
prevents consent is the one being
researched—unconsciousness post MI?
Fixing the Declaration
• Need careful and consistent wording of
broad principles—avoiding elaboration
of details
• Need to address all those engaged in
research
• Need coherent framework
• Need to try to develop an enduring
document.
How to Fix the Declaration
1) Begin with necessity for and purpose of
medical research—provisions 5 and 7.
2) Emphasize the purpose of an ethical
code on human subjects research—to
protect subjects from exploitation and
harm to their interests—health, well-
being, self-determination, privacy—
Combine provision 6, with relevant
parts of 9 and 11.
How to Fix the Declaration
3) State to whom the ethical principles
apply—e.g. everyone engaged in
research.
4) State that broad ethical principles
require interpretation and application
and that this will occur in individual
country research regulations. This
clarifies relation of Declaration to
individual country laws.
How to Fix the Declaration
5) State that research must be informed by
science and conducted rigorously to
produce valid and reliable data. Expand
provision 12.
6) State that research needs to enroll
people fairly—include under-
represented, not target vulnerable, etc.
Combine provisions 5, 17, 29, maybe 35
How to Fix the Declaration
7) Discuss the need to assess likelihood
and magnitude of risks and benefits in
quantitative manner and how to weigh
risks and benefits of research. Refine
provisions 8, 18, 20, 21,
8) Require elaboration of research
protocol. Provision 14. Maybe less
detail.
How to Fix the Declaration
9) Require independent review by
research ethics committee. State when
expedited review is permissible and
when comprehensive review is
appropriate. Revise provision 15.
How to Fix the Declaration
10)State qualifications and obligations of
researchers—eg not only physicians,
etc. Specify the requirements on
conflict of interest—e.g. no conflict of
interest or managed. Provision 16 and
more. Consider shortening to
principles rather than shopping list.
How to Fix the Declaration
11) Informed consent— divided into four
provisions:
 Mentally competent
 Mentally incompetent
 Emergency research
 Human material and data.
Specify what it requires in terms of information,
voluntariness (avoidance of coercion, etc).
9) ,
How to Fix the Declaration
12) Specify researchers’ ethical
obligations including
 Protecting enrolled subjects of research
 Data security and maintaining
confidentiality of data,
 Informing research subjects of results.
13) Compensation for research related
injuries.
How to Fix the Declaration
14) Registration of research—might limit
this to clinical research with greater
than minimal risk
15) Public dissemination of results
16) Post-trial access to interventions.
Conclusion
• Declaration of Helsinki has a special
place as guidance document.
• While in 1964 the Declaration was
alone and preeminent, today it has
significant competition from other
documents.
• There is a need to clarify and specify its
special role.
Conclusion
• The Declaration is to remain relevant
and to remain a short document, then
 It must become a broad statement of
principles much like a Constitution.
 This means it will be interpreted and
specified by particular laws and
regulations in countries.
• Thus the Declaration is “Constitution-
like” and its form should reflect this.
Conclusion
• Currently Declaration does not reflect
this role.
• Declaration has serious problems that
have been compounded by revisions—
incoherent structure, contradictions,
unjustified provisions, too much detail
to be a broad statement of principles.
Conclusion
• Reformat and refocus the Declaration.
• Given you an initial attempt at that
reformulation.
• Careful, statement of principles is
needed.