HHS_Tokyo_Oral_Statement_on_DOH_2-19-2013_with_link_to_written_comments

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U.S. Department of Health and Human Services
Perspectives on the Revision of the Declaration of Helsinki
World Medical Association Expert Conference
Tokyo, Japan
February 28-March 1, 2013
Oral Statement of James McCormick, U.S. Embassy Tokyo
Good afternoon. I am the Health and Scientific Affairs Officer at the U.S. Embassy Tokyo. I am
pleased to be here on behalf of the U.S. Government to present the perspectives of the
Department of Health and Human Services (HHS) on the Declaration of Helsinki (DOH). HHS
has the lead role in the development of our position on the DOH. Its broad health and human
service mission is carried out through, among other HHS agencies, the Agency for Healthcare
Research and Quality, the Centers for Disease Control and Prevention, the Food and Drug
Administration, the National Institutes of Health, and the Office for Human Research
Protections.
A more detailed written statement prepared by HHS was submitted to the World Medical
Association (WMA) secretariat at the meeting in Cape Town. HHS has asked that this document
be shared with the participants at this meeting as well.
HHS recognizes that the DOH has been an important source of ethical guidance in the conduct of
clinical research throughout the world for nearly half a century, and that it is highly regarded and
respected for its reflection of fundamental principles and widely-held values. As the process to
revise the 2008 version of the document begins, HHS wishes to commend the WMA for the
integrity and transparency of its consultative and deliberative processes and for giving due
consideration to the perspectives of all stakeholders and interested parties. In these remarks and
in its longer written comments, HHS provides its perspectives on the five main ethical topics that
are under consideration in this meeting as part of the revision process and raises several other
issues that relate to the content and structure of the current DOH.
Biobanks raise many important ethical issues, and they will likely play a role of growing
importance in the world of research. However, the debate with regard to the ethical issues
surrounding biobanks is ongoing, and there is as yet no consensus on the appropriate ethical
course to take. In HHS’ view, it is premature to establish ethical requirements in areas where
such consensus has not been established.
Regarding insurance, compensation and protection, articulating the ethical principle that
research participants should not bear the cost of unforeseen harms related to their study
participation may be an appropriate addition to the DOH. However, given the different
approaches that nations take in addressing this issue, in HHS’ view, it would be
counterproductive to go further than this by attempting to identify a specific implementation
mechanism.
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With regard to the issue of post-study arrangements in resource poor settings, the current
DOH approach, as expressed in Paragraphs 33 and 14, warrants reconsideration and revision,
particularly Paragraph 33. The expectation in Paragraph 33 that investigators will provide access
to interventions identified as beneficial or to other appropriate care or benefits is a standard that
most investigators cannot meet. Certainly, researchers must be attentive to the ongoing health
needs of research participants, but establishing a standard that is largely impossible to achieve
does not advance the ethical conduct of research. HHS urges WMA to consider a more
reasonable articulation of the investigator’s obligations to the future well-being of the
participants enrolled in their studies. In HHS’ view, the WMA should adopt a more measured
ethical approach that would call upon researchers to consider the issue of post-trial access in the
context of local needs, the local healthcare infrastructure, national regulations and health care
policies, and the availability of effective treatments and, where such access is possible, to
describe arrangements for access to interventions identified as beneficial in the study, such as
continued therapy with an investigational intervention or other appropriate care or benefits.
Concerning vulnerable groups, HHS recommends that the reference to disadvantaged
populations in Paragraph 17 be deleted. Its inclusion inappropriately characterizes every
disadvantaged population or community as incapable of giving or refusing consent for
themselves or as vulnerable to coercion or undue influence. Paragraph 17 should also make the
point that research participation in itself can be beneficial to a population or community, not just
the research results.
Regarding ethics committees, from HHS’ standpoint the current DOH content is appropriate
and, with one exception, sufficient. The one addition that HHS recommends is to specify in
Paragraph 15 that Ethics Review Committees should be comprised of members with the
appropriate expertise to review the research protocols that are submitted to them.
Additionally, although broad consent is not an agenda topic for this meeting, as it was in Cape
Town, HHS supports WMA’s consideration of the concept of broad consent. The ethical
acceptability of the use of broad consent in certain types of research is an important and timely
issue. HHS is currently considering changes in its regulations to allow the use of broad consent
for research involving biospecimens and data. Such a change will facilitate important research
and, if properly designed and implemented, would be in keeping with applicable ethical
principles.
I also want to take this opportunity to highlight two areas of the 2008 DOH that HHS views as
problematic or in need of clarification.
 First, HHS is concerned that while much of the DOH appropriately remains at the level of
broad principles, there are a number of paragraphs that include requirements that, in their
specificity, are at odds with national laws and/or regulatory requirements. Excessive
specificity undermines the value of DOH as a source of basic ethical guidance and leads
to unnecessary conflicts with national approaches that are based on the same fundamental
ethical principles. This problem is exacerbated because of language in the DOH that
claims moral supremacy over national requirements and standards. As such, HHS urges
WMA to modify Paragraphs 10 and 15 which inappropriately call on researchers to
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disregard their obligations to follow their national laws and regulations when they
conflict with the provisions of the DOH.
 Second, the DOH draws an artificial and confusing distinction between “Medical
Research” in Part B and “Medical Research Combined with Medical Care” in Part C.
Since it is difficult to find conceptual differences that warrant separate ethical guidance,
HHS recommends that the additional principles in Paragraphs 32-35 of Part C be
incorporated into Parts A or B and that Paragraph 31 be deleted. In its written statement,
HHS makes specific suggestions about where to place those paragraphs.
Finally, HHS also wishes to comment on the topic of placebo controls in clinical research. The
consensus achieved in 2008 on Paragraph 32 provides appropriate ethical guidance. It allows for
the use of placebos when a proven intervention exists if the study has scientific merit and clinical
value and does not pose risks of serious or irreversible harm to the study subjects. HHS urges
the WMA to preserve the current wording on the use of placebos in medical research.
HHS has elaborated on these topics in written comments that are available to you. The written
comments also contain some suggestions on how to improve the readability of the DOH.
I appreciate the opportunity to present HHS’ perspectives on the DOH, and want you to know
that HHS looks forward to providing further perspectives, as well as more specific comments,
during the next phase of the revision process. If you have any questions about the HHS position,
I would point you to HHS’ written comments which have been posted on the WMA website at:
https://www.wma.net/en/50events/20otherevents/40doh2012_1/HHS_Comments_on_DO
H_for_Cape_Town_Conference_12-5-7-2012.pdf
In addition, I would be glad to provide a point of contact at HHS for clarification about the
comments or if you have any other questions.