{"id":3874,"date":"2017-01-20T13:02:45","date_gmt":"2017-01-20T13:02:45","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/HHS_Tokyo_Oral_Statement_on_DOH_2-19-2013_with_link_to_written_comments.pdf"},"modified":"2017-01-20T13:02:45","modified_gmt":"2017-01-20T13:02:45","slug":"hhs_tokyo_oral_statement_on_doh_2-19-2013_with_link_to_written_comments-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/es\/hhs_tokyo_oral_statement_on_doh_2-19-2013_with_link_to_written_comments-2\/","title":{"rendered":"HHS_Tokyo_Oral_Statement_on_DOH_2-19-2013_with_link_to_written_comments"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

HHS_Tokyo_Oral_Statement_on_DOH_2-19-2013_with_link_to_written_comments<\/a><\/p>\n

1
\nU.S. Department of Health and Human Services
\nPerspectives on the Revision of the Declaration of Helsinki
\nWorld Medical Association Expert Conference
\nTokyo, Japan
\nFebruary 28-March 1, 2013
\nOral Statement of James McCormick, U.S. Embassy Tokyo
\nGood afternoon. I am the Health and Scientific Affairs Officer at the U.S. Embassy Tokyo. I am
\npleased to be here on behalf of the U.S. Government to present the perspectives of the
\nDepartment of Health and Human Services (HHS) on the Declaration of Helsinki (DOH). HHS
\nhas the lead role in the development of our position on the DOH. Its broad health and human
\nservice mission is carried out through, among other HHS agencies, the Agency for Healthcare
\nResearch and Quality, the Centers for Disease Control and Prevention, the Food and Drug
\nAdministration, the National Institutes of Health, and the Office for Human Research
\nProtections.
\nA more detailed written statement prepared by HHS was submitted to the World Medical
\nAssociation (WMA) secretariat at the meeting in Cape Town. HHS has asked that this document
\nbe shared with the participants at this meeting as well.
\nHHS recognizes that the DOH has been an important source of ethical guidance in the conduct of
\nclinical research throughout the world for nearly half a century, and that it is highly regarded and
\nrespected for its reflection of fundamental principles and widely-held values. As the process to
\nrevise the 2008 version of the document begins, HHS wishes to commend the WMA for the
\nintegrity and transparency of its consultative and deliberative processes and for giving due
\nconsideration to the perspectives of all stakeholders and interested parties. In these remarks and
\nin its longer written comments, HHS provides its perspectives on the five main ethical topics that
\nare under consideration in this meeting as part of the revision process and raises several other
\nissues that relate to the content and structure of the current DOH.
\nBiobanks raise many important ethical issues, and they will likely play a role of growing
\nimportance in the world of research. However, the debate with regard to the ethical issues
\nsurrounding biobanks is ongoing, and there is as yet no consensus on the appropriate ethical
\ncourse to take. In HHS\u2019 view, it is premature to establish ethical requirements in areas where
\nsuch consensus has not been established.
\nRegarding insurance, compensation and protection, articulating the ethical principle that
\nresearch participants should not bear the cost of unforeseen harms related to their study
\nparticipation may be an appropriate addition to the DOH. However, given the different
\napproaches that nations take in addressing this issue, in HHS\u2019 view, it would be
\ncounterproductive to go further than this by attempting to identify a specific implementation
\nmechanism.
\n2
\nWith regard to the issue of post-study arrangements in resource poor settings, the current
\nDOH approach, as expressed in Paragraphs 33 and 14, warrants reconsideration and revision,
\nparticularly Paragraph 33. The expectation in Paragraph 33 that investigators will provide access
\nto interventions identified as beneficial or to other appropriate care or benefits is a standard that
\nmost investigators cannot meet. Certainly, researchers must be attentive to the ongoing health
\nneeds of research participants, but establishing a standard that is largely impossible to achieve
\ndoes not advance the ethical conduct of research. HHS urges WMA to consider a more
\nreasonable articulation of the investigator\u2019s obligations to the future well-being of the
\nparticipants enrolled in their studies. In HHS\u2019 view, the WMA should adopt a more measured
\nethical approach that would call upon researchers to consider the issue of post-trial access in the
\ncontext of local needs, the local healthcare infrastructure, national regulations and health care
\npolicies, and the availability of effective treatments and, where such access is possible, to
\ndescribe arrangements for access to interventions identified as beneficial in the study, such as
\ncontinued therapy with an investigational intervention or other appropriate care or benefits.
\nConcerning vulnerable groups, HHS recommends that the reference to disadvantaged
\npopulations in Paragraph 17 be deleted. Its inclusion inappropriately characterizes every
\ndisadvantaged population or community as incapable of giving or refusing consent for
\nthemselves or as vulnerable to coercion or undue influence. Paragraph 17 should also make the
\npoint that research participation in itself can be beneficial to a population or community, not just
\nthe research results.
\nRegarding ethics committees, from HHS\u2019 standpoint the current DOH content is appropriate
\nand, with one exception, sufficient. The one addition that HHS recommends is to specify in
\nParagraph 15 that Ethics Review Committees should be comprised of members with the
\nappropriate expertise to review the research protocols that are submitted to them.
\nAdditionally, although broad consent is not an agenda topic for this meeting, as it was in Cape
\nTown, HHS supports WMA\u2019s consideration of the concept of broad consent. The ethical
\nacceptability of the use of broad consent in certain types of research is an important and timely
\nissue. HHS is currently considering changes in its regulations to allow the use of broad consent
\nfor research involving biospecimens and data. Such a change will facilitate important research
\nand, if properly designed and implemented, would be in keeping with applicable ethical
\nprinciples.
\nI also want to take this opportunity to highlight two areas of the 2008 DOH that HHS views as
\nproblematic or in need of clarification.
\n\uf0b7 First, HHS is concerned that while much of the DOH appropriately remains at the level of
\nbroad principles, there are a number of paragraphs that include requirements that, in their
\nspecificity, are at odds with national laws and\/or regulatory requirements. Excessive
\nspecificity undermines the value of DOH as a source of basic ethical guidance and leads
\nto unnecessary conflicts with national approaches that are based on the same fundamental
\nethical principles. This problem is exacerbated because of language in the DOH that
\nclaims moral supremacy over national requirements and standards. As such, HHS urges
\nWMA to modify Paragraphs 10 and 15 which inappropriately call on researchers to
\n3
\ndisregard their obligations to follow their national laws and regulations when they
\nconflict with the provisions of the DOH.
\n\uf0b7 Second, the DOH draws an artificial and confusing distinction between \u201cMedical
\nResearch\u201d in Part B and \u201cMedical Research Combined with Medical Care\u201d in Part C.
\nSince it is difficult to find conceptual differences that warrant separate ethical guidance,
\nHHS recommends that the additional principles in Paragraphs 32-35 of Part C be
\nincorporated into Parts A or B and that Paragraph 31 be deleted. In its written statement,
\nHHS makes specific suggestions about where to place those paragraphs.
\nFinally, HHS also wishes to comment on the topic of placebo controls in clinical research. The
\nconsensus achieved in 2008 on Paragraph 32 provides appropriate ethical guidance. It allows for
\nthe use of placebos when a proven intervention exists if the study has scientific merit and clinical
\nvalue and does not pose risks of serious or irreversible harm to the study subjects. HHS urges
\nthe WMA to preserve the current wording on the use of placebos in medical research.
\nHHS has elaborated on these topics in written comments that are available to you. The written
\ncomments also contain some suggestions on how to improve the readability of the DOH.
\nI appreciate the opportunity to present HHS\u2019 perspectives on the DOH, and want you to know
\nthat HHS looks forward to providing further perspectives, as well as more specific comments,
\nduring the next phase of the revision process. If you have any questions about the HHS position,
\nI would point you to HHS\u2019 written comments which have been posted on the WMA website at:
\nhttps:\/\/www.wma.net\/en\/50events\/20otherevents\/40doh2012_1\/HHS_Comments_on_DO
\nH_for_Cape_Town_Conference_12-5-7-2012.pdf
\nIn addition, I would be glad to provide a point of contact at HHS for clarification about the
\ncomments or if you have any other questions.<\/p>\n"},"caption":{"rendered":"

HHS_Tokyo_Oral_Statement_on_DOH_2-19-2013_with_link_to_written_comments 1 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 […]<\/p>\n"},"alt_text":"","media_type":"file","mime_type":"application\/pdf","media_details":{},"post":null,"source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/HHS_Tokyo_Oral_Statement_on_DOH_2-19-2013_with_link_to_written_comments.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media\/3874"}],"collection":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media"}],"about":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/types\/attachment"}],"author":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/comments?post=3874"}]}}