Ethical guidance for the management of conflicts of interest for researchers, engineers and clinicians engaged in the development of therapeutic deep brain stimulation
Identifieur interne : 001364 ( Istex/Corpus ); précédent : 001363; suivant : 001365Ethical guidance for the management of conflicts of interest for researchers, engineers and clinicians engaged in the development of therapeutic deep brain stimulation
Auteurs : Joseph J. Fins ; Thomas E. Schlaepfer ; Bart Nuttin ; Cynthia S. Kubu ; Thorsten Galert ; Volker Sturm ; Reinhard Merkel ; Helen S. MaybergSource :
- Journal of Neural Engineering [ 1741-2560 ] ; 2011.
Abstract
The clinical promise of deep brain stimulation (DBS) for neuropsychiatric conditions is coupled with the potential for ethical conflicts of interest because the work is so heavily reliant upon collaborations between academia, industry and the clinic. To foster transparency and public trust, we offer ethical guidance for the management of conflicts of interest in the conduct of DBS research and practice so that this nascent field can better balance competing goods and engineer new and better strategies for the amelioration of human suffering. We also hope that our ethical analysis will be of relevance to those working with other related neuroprosthetic devices, such brain-computer interfaces and neural arrays, which naturally share many of the same concerns.
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DOI: 10.1088/1741-2560/8/3/033001
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<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Ethical guidance for the management of conflicts of interest for researchers, engineers and clinicians engaged in the development of therapeutic deep brain stimulation</title><author><name sortKey="Fins, Joseph J" sort="Fins, Joseph J" uniqKey="Fins J" first="Joseph J" last="Fins">Joseph J. Fins</name><affiliation><mods:affiliation>Division of Medical Ethics, New York Presbyterian-Weill Cornell Medical Center, 435 East 70th Street, Suite 4-J, New York, NY 10021, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>E-mail: jjfins@med.cornell.edu</mods:affiliation></affiliation></author><author><name sortKey="Schlaepfer, Thomas E" sort="Schlaepfer, Thomas E" uniqKey="Schlaepfer T" first="Thomas E" last="Schlaepfer">Thomas E. Schlaepfer</name><affiliation><mods:affiliation>University of Bonn, Germany</mods:affiliation></affiliation></author><author><name sortKey="Nuttin, Bart" sort="Nuttin, Bart" uniqKey="Nuttin B" first="Bart" last="Nuttin">Bart Nuttin</name><affiliation><mods:affiliation>University Hospitals, Leuven, Belgium</mods:affiliation></affiliation></author><author><name sortKey="Kubu, Cynthia S" sort="Kubu, Cynthia S" uniqKey="Kubu C" first="Cynthia S" last="Kubu">Cynthia S. Kubu</name><affiliation><mods:affiliation>The Cleveland Clinic, Cleveland, OH, USA</mods:affiliation></affiliation></author><author><name sortKey="Galert, Thorsten" sort="Galert, Thorsten" uniqKey="Galert T" first="Thorsten" last="Galert">Thorsten Galert</name><affiliation><mods:affiliation>Europische Akademie, Bad Neuenahr-Ahrweiler, Germany</mods:affiliation></affiliation></author><author><name sortKey="Sturm, Volker" sort="Sturm, Volker" uniqKey="Sturm V" first="Volker" last="Sturm">Volker Sturm</name><affiliation><mods:affiliation>University of Cologne, Germany</mods:affiliation></affiliation></author><author><name sortKey="Merkel, Reinhard" sort="Merkel, Reinhard" uniqKey="Merkel R" first="Reinhard" last="Merkel">Reinhard Merkel</name><affiliation><mods:affiliation>University of Hamburg School of Law, Germany</mods:affiliation></affiliation></author><author><name sortKey="Mayberg, Helen S" sort="Mayberg, Helen S" uniqKey="Mayberg H" first="Helen S" last="Mayberg">Helen S. 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Fins</name><affiliation><mods:affiliation>Division of Medical Ethics, New York Presbyterian-Weill Cornell Medical Center, 435 East 70th Street, Suite 4-J, New York, NY 10021, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>E-mail: jjfins@med.cornell.edu</mods:affiliation></affiliation></author><author><name sortKey="Schlaepfer, Thomas E" sort="Schlaepfer, Thomas E" uniqKey="Schlaepfer T" first="Thomas E" last="Schlaepfer">Thomas E. Schlaepfer</name><affiliation><mods:affiliation>University of Bonn, Germany</mods:affiliation></affiliation></author><author><name sortKey="Nuttin, Bart" sort="Nuttin, Bart" uniqKey="Nuttin B" first="Bart" last="Nuttin">Bart Nuttin</name><affiliation><mods:affiliation>University Hospitals, Leuven, Belgium</mods:affiliation></affiliation></author><author><name sortKey="Kubu, Cynthia S" sort="Kubu, Cynthia S" uniqKey="Kubu C" first="Cynthia S" last="Kubu">Cynthia S. Kubu</name><affiliation><mods:affiliation>The Cleveland Clinic, Cleveland, OH, USA</mods:affiliation></affiliation></author><author><name sortKey="Galert, Thorsten" sort="Galert, Thorsten" uniqKey="Galert T" first="Thorsten" last="Galert">Thorsten Galert</name><affiliation><mods:affiliation>Europische Akademie, Bad Neuenahr-Ahrweiler, Germany</mods:affiliation></affiliation></author><author><name sortKey="Sturm, Volker" sort="Sturm, Volker" uniqKey="Sturm V" first="Volker" last="Sturm">Volker Sturm</name><affiliation><mods:affiliation>University of Cologne, Germany</mods:affiliation></affiliation></author><author><name sortKey="Merkel, Reinhard" sort="Merkel, Reinhard" uniqKey="Merkel R" first="Reinhard" last="Merkel">Reinhard Merkel</name><affiliation><mods:affiliation>University of Hamburg School of Law, Germany</mods:affiliation></affiliation></author><author><name sortKey="Mayberg, Helen S" sort="Mayberg, Helen S" uniqKey="Mayberg H" first="Helen S" last="Mayberg">Helen S. Mayberg</name><affiliation><mods:affiliation>Emory University School of Medicine, Atlanta, GA, USA</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Journal of Neural Engineering</title><title level="j" type="abbrev">J. Neural Eng.</title><idno type="ISSN">1741-2560</idno><imprint><publisher>IOP Publishing</publisher><date type="published" when="2011">2011</date><biblScope unit="volume">8</biblScope><biblScope unit="issue">3</biblScope><biblScope unit="page" from="1">1</biblScope><biblScope unit="page" to="6">6</biblScope><biblScope unit="production">Printed in the UK</biblScope></imprint><idno type="ISSN">1741-2560</idno></series><idno type="istex">D964DED97D4846E61F366CEB29BF4617B8A58DD4</idno><idno type="DOI">10.1088/1741-2560/8/3/033001</idno><idno type="PII">S1741-2560(11)82782-5</idno><idno type="articleID">382782</idno><idno type="articleNumber">033001</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">1741-2560</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">The clinical promise of deep brain stimulation (DBS) for neuropsychiatric conditions is coupled with the potential for ethical conflicts of interest because the work is so heavily reliant upon collaborations between academia, industry and the clinic. To foster transparency and public trust, we offer ethical guidance for the management of conflicts of interest in the conduct of DBS research and practice so that this nascent field can better balance competing goods and engineer new and better strategies for the amelioration of human suffering. We also hope that our ethical analysis will be of relevance to those working with other related neuroprosthetic devices, such brain-computer interfaces and neural arrays, which naturally share many of the same concerns.</div></front></TEI><istex><corpusName>iop</corpusName><author><json:item><name>Joseph J Fins</name><affiliations><json:string>Division of Medical Ethics, New York Presbyterian-Weill Cornell Medical Center, 435 East 70th Street, Suite 4-J, New York, NY 10021, USA</json:string><json:string>E-mail: jjfins@med.cornell.edu</json:string></affiliations></json:item><json:item><name>Thomas E Schlaepfer</name><affiliations><json:string>University of Bonn, Germany</json:string></affiliations></json:item><json:item><name>Bart Nuttin</name><affiliations><json:string>University Hospitals, Leuven, Belgium</json:string></affiliations></json:item><json:item><name>Cynthia S Kubu</name><affiliations><json:string>The Cleveland Clinic, Cleveland, OH, USA</json:string></affiliations></json:item><json:item><name>Thorsten Galert</name><affiliations><json:string>Europische Akademie, Bad Neuenahr-Ahrweiler, Germany</json:string></affiliations></json:item><json:item><name>Volker Sturm</name><affiliations><json:string>University of Cologne, Germany</json:string></affiliations></json:item><json:item><name>Reinhard Merkel</name><affiliations><json:string>University of Hamburg School of Law, Germany</json:string></affiliations></json:item><json:item><name>Helen S Mayberg</name><affiliations><json:string>Emory University School of Medicine, Atlanta, GA, USA</json:string></affiliations></json:item></author><language><json:string>eng</json:string></language><originalGenre><json:string>review</json:string><json:string>review</json:string></originalGenre><abstract>The clinical promise of deep brain stimulation (DBS) for neuropsychiatric conditions is coupled with the potential for ethical conflicts of interest because the work is so heavily reliant upon collaborations between academia, industry and the clinic. To foster transparency and public trust, we offer ethical guidance for the management of conflicts of interest in the conduct of DBS research and practice so that this nascent field can better balance competing goods and engineer new and better strategies for the amelioration of human suffering. 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Neural Eng.</title><idno type="pISSN">1741-2560</idno><imprint><publisher>IOP Publishing</publisher><date type="published" when="2011"></date><biblScope unit="volume">8</biblScope><biblScope unit="issue">3</biblScope><biblScope unit="page" from="1">1</biblScope><biblScope unit="page" to="6">6</biblScope><biblScope unit="production">Printed in the UK</biblScope></imprint></monogr><idno type="istex">D964DED97D4846E61F366CEB29BF4617B8A58DD4</idno><idno type="DOI">10.1088/1741-2560/8/3/033001</idno><idno type="PII">S1741-2560(11)82782-5</idno><idno type="articleID">382782</idno><idno type="articleNumber">033001</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2011</date></creation><langUsage><language ident="en">en</language></langUsage><abstract><p>The clinical promise of deep brain stimulation (DBS) for neuropsychiatric conditions is coupled with the potential for ethical conflicts of interest because the work is so heavily reliant upon collaborations between academia, industry and the clinic. To foster transparency and public trust, we offer ethical guidance for the management of conflicts of interest in the conduct of DBS research and practice so that this nascent field can better balance competing goods and engineer new and better strategies for the amelioration of human suffering. We also hope that our ethical analysis will be of relevance to those working with other related neuroprosthetic devices, such brain-computer interfaces and neural arrays, which naturally share many of the same concerns.</p></abstract></profileDesc><revisionDesc><change when="2011">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/D964DED97D4846E61F366CEB29BF4617B8A58DD4/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="corpus iop not found" wicri:toSee="no header"><istex:xmlDeclaration>version="1.0" encoding="ISO-8859-1" </istex:xmlDeclaration><istex:docType SYSTEM="http://ej.iop.org/dtd/iopv1_5_2.dtd" name="istex:docType"></istex:docType><istex:document><article artid="jne382782"><article-metadata><jnl-data jnlid="jne"><jnl-fullname>Journal of Neural Engineering</jnl-fullname><jnl-abbreviation>J. Neural Eng.</jnl-abbreviation><jnl-shortname>JNE</jnl-shortname><jnl-issn>1741-2560</jnl-issn><jnl-coden>JNEIEZ</jnl-coden><jnl-imprint>IOP Publishing</jnl-imprint><jnl-web-address>stacks.iop.org/JNE</jnl-web-address></jnl-data><volume-data><year-publication>2011</year-publication><volume-number>8</volume-number></volume-data><issue-data><issue-number>3</issue-number><coverdate>June 2011</coverdate></issue-data><article-data><article-type type="review" sort="regular">PERSPECTIVE</article-type><type-number numbering="article" type="review" artnum="033001">033001</type-number><article-number>382782</article-number><first-page>1</first-page><last-page>6</last-page><length>6</length><pii>S1741-2560(11)82782-5</pii><doi>10.1088/1741-2560/8/3/033001</doi><copyright>2011 IOP Publishing Ltd</copyright><ccc>1741-2560/11/033001+06$33.00</ccc><printed>Printed in the UK</printed><features colour="none" mmedia="no" suppdata="no"></features></article-data></article-metadata><header><title-group><title>Ethical guidance for the management of conflicts of interest for researchers, engineers and clinicians engaged in the development of therapeutic deep brain stimulation</title><short-title>Perspective</short-title><ej-title>Perspective</ej-title></title-group><author-group><author address="jne382782ad1" email="jne382782ea1"><first-names>Joseph J</first-names><second-name>Fins</second-name></author><author address="jne382782ad2"><first-names>Thomas E</first-names><second-name>Schlaepfer</second-name></author><author address="jne382782ad3"><first-names>Bart</first-names><second-name>Nuttin</second-name></author><author address="jne382782ad4"><first-names>Cynthia S</first-names><second-name>Kubu</second-name></author><author address="jne382782ad5"><first-names>Thorsten</first-names><second-name>Galert</second-name></author><author address="jne382782ad6"><first-names>Volker</first-names><second-name>Sturm</second-name></author><author address="jne382782ad7"><first-names>Reinhard</first-names><second-name>Merkel</second-name></author><author address="jne382782ad8"><first-names>Helen S</first-names><second-name>Mayberg</second-name></author></author-group><address-group><address id="jne382782ad1"><orgname>Division of Medical Ethics, New York Presbyterian-Weill Cornell Medical Center</orgname>, 435 East 70th Street, Suite 4-J, New York, NY 10021, <country>USA</country></address><address id="jne382782ad2"><orgname>University of Bonn</orgname>, <country>Germany</country></address><address id="jne382782ad3"><orgname>University Hospitals, Leuven</orgname>, <country>Belgium</country></address><address id="jne382782ad4"><orgname>The Cleveland Clinic, Cleveland, OH</orgname>, <country>USA</country></address><address id="jne382782ad5"><orgname>Europäische Akademie, Bad Neuenahr-Ahrweiler</orgname>, <country>Germany</country></address><address id="jne382782ad6"><orgname>University of Cologne</orgname>, <country>Germany</country></address><address id="jne382782ad7"><orgname>University of Hamburg School of Law</orgname>, <country>Germany</country></address><address id="jne382782ad8"><orgname>Emory University School of Medicine, Atlanta, GA</orgname>, <country>USA</country></address><e-address id="jne382782ea1"><email mailto="jjfins@med.cornell.edu">jjfins@med.cornell.edu</email></e-address></address-group><history received="27 January 2011" accepted="15 March 2011" online="10 May 2011"></history><abstract-group><abstract><heading>Abstract</heading><p indent="no">The clinical promise of deep brain stimulation (DBS) for neuropsychiatric conditions is coupled with the potential for ethical conflicts of interest because the work is so heavily reliant upon collaborations between academia, industry and the clinic. To foster transparency and public trust, we offer ethical guidance for the management of conflicts of interest in the conduct of DBS research and practice so that this nascent field can better balance competing goods and engineer new and better strategies for the amelioration of human suffering. We also hope that our ethical analysis will be of relevance to those working with other related neuroprosthetic devices, such brain-computer interfaces and neural arrays, which naturally share many of the same concerns.</p></abstract></abstract-group></header><body numbering="bysection"><sec-level1 id="jne382782s1" label="1"><heading>Preamble: rationale for ethical guidance</heading><p indent="no">Deep brain stimulation (DBS) is a method used to reversibly modulate brain dysfunction. It has been systematically researched and developed for clinical application in neurology and psychiatry; indeed, it is the method of choice for various kinds of tremor and for intractable dopamine sensitive Parkinson's disease [<cite linkend="jne382782bib01">1</cite>]. Its putative application for psychiatric disorders, such as treatment resistant obsessive–compulsive disorders [<cite linkend="jne382782bib02">2</cite>, <cite linkend="jne382782bib03">3</cite>] and major depression [<cite linkend="jne382782bib04" range="jne382782bib04,jne382782bib05,jne382782bib06">4–6</cite>], has come into investigative focus more recently. We believe that the application of DBS for psychiatric disorders has the potential to improve the condition of patients for whom conventional treatments have been ineffective.</p><p>This clinical promise is coupled with the potential for ethical conflicts of interest because the work is so heavily reliant upon collaborations between academia, industry and clinics [<cite linkend="jne382782bib07">7</cite>]. This dynamic, coupled with the contentious antecedent history of psychosurgery [<cite linkend="jne382782bib08">8</cite>, <cite linkend="jne382782bib09">9</cite>], increased government scrutiny, and remaining ethical and social challenges [<cite linkend="jne382782bib10">10</cite>] makes transparency especially critical if public trust and confidence in this research is to be sustained.</p><p>To this end, we offer ethical guidance for the management of conflicts of interest in the conduct of DBS research and practice so that this nascent field can better balance competing goods, and engineer new and better strategies for the amelioration of human suffering. We also hope that our ethical analysis will be of relevance to those working with related neuroprosthetic devices, such as brain–computer interfaces and neural arrays, which would naturally share many of these same concerns.</p><p>Our concerns have come into focus through on-going deliberations as a multinational interdisciplinary group looking at ethical and policy issues related to DBS in neuropsychiatric disorders. Some of us are engaged in DBS research and others have been commentators on ethical and policy issues. Through these efforts, we have had to collaborate with industry and make judgments about the ethical propriety of these relationships. Collectively, we have learned that the process of editorial and institutional discernment about conflicts of interest can be arbitrary and idiosyncratic at best and sometimes ideological at worst. For example, in our efforts to publish our collective work-–some of which has been critical of some relationships with corporate sponsors-–we have encountered editorial or institutional resistance simply because of pre-existing relationships with industry. Indeed, some journals and organizations view these relationships as categorically disqualifying, despite the critical content of the argument, while others accept mere disclosure.</p><p>Because we believe that this work cannot go forward without interactions with industry, and because we think that the capricious management of these conflicts is problematic, we propose guidance on how investigators, their academic institutions and industry can negotiate and manage putative conflicts of interests. We believe that this effort to articulate a collective set of expectations will inform behaviors and lead to communal norms for the disclosure and management of conflicts, all to the benefit of science and society. We believe that investigators who bring their conflicts forward should not be viewed prejudically for these relationships but rather judged on the ethical justification of why corporate relationships might be necessary to pursue specific translational hypotheses [<cite linkend="jne382782bib11">11</cite>].</p><p>Some might ask why we need such a document when organizations like the European Medicines Agency, the Association of American Medical Colleges, the US Institute of Medicine and the European Group on Ethics and Science and New Technologies to the European Commission (EGE)-–whose deliberations we draw upon here-–have all been promulgating recommendations [<cite linkend="jne382782bib12" range="jne382782bib12,jne382782bib13,jne382782bib14,jne382782bib15">12–15</cite>]. While it can be argued that rules for the handling of conflicts of interest should be the same for all medical disciplines, we would assert that there are aspects of DBS for neuropsychiatric disorders that warrant, indeed necessitate, special guidance for the field.</p><p>Previously, some of us and other commentators drafted early ethics guidelines for DBS in psychiatric disorders and we believe that progress in the field necessitates further elaboration, refinement and additions [<cite linkend="jne382782bib16" range="jne382782bib16,jne382782bib17,jne382782bib18,jne382782bib19">16–19</cite>]. We believe that there is a need for an updated statement related to DBS because of the complexity of device development and the invasive nature of implantation [<cite linkend="jne382782bib20">20</cite>].</p><p>Perhaps more critically, unlike the chemicals that constitute the building blocks for drug development, deep brain stimulators and other neuroprosthetic devices-–while therapeutic-–are also the tools of inquiry used by investigators to secure new knowledge about mechanisms of disease [<cite linkend="jne382782bib11">11</cite>]. These devices are probative and essential to scientific inquiry but are only available from industrial sources. This makes neuromodulation's reliance upon industry rather unique and-–in our view-–calls for this discrete effort [<cite linkend="jne382782bib07">7</cite>].</p><p>Finally, in contrast to the pharmaceutical industry and drug development, the neuromodulation community and the device industry is constituted by a smaller number of manufacturers and a smaller number of investigators. These dynamics can exert monopolistic pressures on relationships between investigators and industrial sponsors [<cite linkend="jne382782bib07">7</cite>, <cite linkend="jne382782bib21">21</cite>].</p><p>We undertake this offering knowing full well that the consensus we have reached as a group may not be fully reflective of the broader community of investigators and scholars engaged in neuromodulation research. This represents the opinions of our group and we acknowledge that there may be alternative perspectives. Nonetheless, we hope that this effort will be a touchstone for us to collectively move toward shared standards, norms and uniformity. We look forward to the comments of others and their constructive critique as we seek to achieve a consensus on these pressing concerns.</p></sec-level1><sec-level1 id="jne382782s2" label="2"><heading>Ethical principles</heading><p indent="no">Beneficence and distributive justice are the two over-arching ethical principles that motivate these guidelines for the management of conflicts of interest and investigative work in neuromodulation [<cite linkend="jne382782bib22">22</cite>]. Beneficence, or the pursuit of the ‘good’, takes the form of innovation and scientific discovery that seeks to maximize benefits and minimize harms, that is, the avoidance of its corollary non-maleficience. Justice is achieved through the appropriate delivery of these benefits to a historically marginalized population that has suffered and remains in need. Collectively, these principles constrain the systemic conditions under which investigators should receive private sector funding and compel the avoidance of corrosive practices. Investigators should not be driven by self-interest when pursuing corporate support but rather motivated by a desire to pursue important scientific work to enhance access to novel interventions [<cite linkend="jne382782bib07">7</cite>, <cite linkend="jne382782bib17">17</cite>].</p><p>At a more dyadic level of relationships between doctor and patient or investigator and subject, the aforementioned systemic factors create the context for individualized informed consent for patient care or participation in clinical research. Here, the autonomy or self-determination of the patient or subject or their legally authorized representative must be defended against external forces that might inhibit the appropriate exercise of informed choice.</p><sec-level2 id="jne382782s2-1" label="2.1"><heading>Sources of conflict</heading><p indent="no">There are multiple sources of conflict of interest, including sources of funding, intellectual property exchange, and reimbursement specific to the conduct of DBS research and practice. For each of these areas, we will delineate the potential conflict and our assessment.</p></sec-level2><sec-level2 id="jne382782s2-2" label="2.2"><heading>Recommendations</heading><sec-level3 id="jne382782s2-2-1" label="2.2.1"><heading>Funding</heading><p indent="no">The cost of DBS research is high and its conduct may be dependent upon the provision of devices or funding by industry to investigators<fnref linkend="jne382782fn01"></fnref>. This can create reliance upon industry for access to needed devices and result in ensuing conflicts of interest. To mitigate these putative conflicts:
<ordered-list id="jne382782ol1" type="alpha"><list-item id="jne382782ol1.1" marker="a"><p indent="no">Investigators should, as a minimum, ‘disclose and justify’ why receipt of corporate funding is needed to sustain the work, promote access to scientific discovery and pursue the work safely and effectively [<cite linkend="jne382782bib17">17</cite>]. This disclosure and justification should be done explicitly in the public square.</p></list-item><list-item id="jne382782ol1.2" marker="b"><p indent="no">Investigators should seek to balance funding from corporate sources and other funders in order to dilute perceived and real conflicts [<cite linkend="jne382782bib23">23</cite>].</p></list-item><list-item id="jne382782ol1.3" marker="c"><p indent="no">Investigator conflicts of interests should be disclosed not only to subjects participating in research and institutions charged with regulatory oversight but also to their co-investigators who may not have similar financial involvements. Such conflicts should be disclosed to one's colleagues prospectively and early in the course of collaborative work.</p></list-item></ordered-list></p></sec-level3><sec-level3 id="jne382782s2-2-2" label="2.2.2"><heading>Rights of reference</heading><p indent="no">The provision of devices for the conduct of research requires industry to provide a right of reference (ROR) [<cite linkend="jne382782bib24">24</cite>, <cite linkend="jne382782bib25">25</cite>]-–permission to use pre-existing data about a device-–for investigators to utilize an established device for a new indication or a novel target. For example, in the United States, this ROR-–which includes device details and safety profile-–is necessary to obtain subsequent regulatory approval (Food and Drug Administration investigational device exemption (IDE)) for any study of that device for a new indication or target. Manufacturers are under no obligation to share their RORs with investigators.</p><p>Given the potential of an ROR denial to preclude scientific discovery, device manufacturers should seek to maintain the scientific commons by liberally viewing requests for an ROR by qualified investigators. This perspective is consistent with the ‘scientific commons’ and the humanitarian goals of science to provide open access to innovative therapies and the tools of discovery [<cite linkend="jne382782bib07">7</cite>, <cite linkend="jne382782bib17">17</cite>]. For these reasons, industry should not seek a competitive market advantage at critical stages of discovery.</p></sec-level3><sec-level3 id="jne382782s2-2-3" label="2.2.3"><heading>Intellectual property rights</heading><p indent="no">Intellectual property rights in DBS will generally be related to the conceptualization of a new application (new disease, target or method) and/or the development of a novel device. Under the US Bayh–Dole Act of 1980, investigators and their institutions receiving federal funding retain the intellectual property rights of their discoveries in order to negotiate applications with industry and accelerate the pace of innovation from bench to bedside [<cite linkend="jne382782bib26">26</cite>]. This model of dissemination is being considered for the European context, as some commentators note that the EU suffers from weak intellectual property laws and poor performance with respect to bringing good ideas forward to market [<cite linkend="jne382782bib27">27</cite>]. Beyond the need for harmonization with the EU, there are often inadequate incentives for academics to engage in innovation versus publication of conventional research and little infra-structural support for academics who try to patent their ideas. (See reference [<cite linkend="jne382782bib27">27</cite>] for a comprehensive analysis of the European patent law, the Bayh–Dole Act and a country-by-country review of variance in IP practices.)</p><p>Despite its putative value within the United States and in the European context, the Bayh–Dole Act can also create challenges. When ideas gain potential market value and become commoditized, conflicts of interest can arise. They can occur between investigators and their home institutions as well as amongst institutional officials with differing priorities (e.g. between the Technology Transfer Office and the Conflicts Office). To manage these conflicts:
<ordered-list id="jne382782ol2" type="alpha"><list-item id="jne382782ol2.1" marker="a"><p indent="no">The exchange of intellectual property rights by an investigator to a corporate sponsor should be done transparently and include all institutional officials who regulate conflicts of interest, e.g. Conflict of Interest Panels, Institutional Review Boards, Technology Transfer Offices and Ethics Committees. This joint disclosure should ideally result in an institutional conflict of interest management plan.</p></list-item><list-item id="jne382782ol2.2" marker="b"><p indent="no">Payments, royalties, fees and stock options should be determined based on prospectively determined and established institutional policy.</p></list-item><list-item id="jne382782ol2.3" marker="c"><p indent="no">Corporate payments, royalties and fees should be designed to maximize the viability and sustainability of the scientific work [<cite linkend="jne382782bib07">7</cite>, <cite linkend="jne382782bib17">17</cite>]. Institutions should aid their investigators in these negotiations to secure these objectives and avoid short-term settlements, which generate ‘cash flow’ but fail to catalyze longitudinal research programs.</p></list-item><list-item id="jne382782ol2.4" marker="d"><p indent="no">Investigators pursuing the work who have putative conflicts of interest (including, but not limited to, intellectual property rights related to earlier discoveries) should be able to pursue their scientific work in order to elucidate mechanism of action and ensure the safety of early phase studies. Their involvement in such studies helps to ensure the safety of subjects and maximizes the likelihood of success at an early critical juncture in the maturation of the work [<cite linkend="jne382782bib07">7</cite>]. Conflicted investigators should assume a step-back role-–ceding the actual conduct of industry sponsored clinical studies to other un-conflicted qualified investigators-–as soon as feasible in order to minimize the possibility generating data that might be open to critique because of a potential conflict of interest [<cite linkend="jne382782bib21">21</cite>].</p></list-item><list-item id="jne382782ol2.5" marker="e"><p indent="no">Conflicted investigators should feel free to pursue longitudinal research related to their discovery outside of industry sponsored pivotal trials. Contractual arrangements between investigators, the academy and industry should not preempt the investigator's academic freedom to pursue their scientific work.</p></list-item><list-item id="jne382782ol2.6" marker="f"><p indent="no">Access to specialized DBS care that results from one's research should be an ethical principle embraced by all along the research continuum. Investigators, institutions and industry might consider what to do with some percentage of royalties garnered through the ownership of intellectual property earned, in part, through the participation of human subjects afflicted with a disease or malady under study. Collectively, they should seek to use their influence with industry to advocate for the underserved and work to ensure that the exclusivity granted by patents does not make products so prohibitively expensive that access is compromised. This might be achieved by directing a percentage of proceeds to a not-for-profit use underwriting surgeries on patients who would otherwise be unable to be treated, or for support of translational research [<cite linkend="jne382782bib07">7</cite>, <cite linkend="jne382782bib17">17</cite>].</p></list-item></ordered-list></p></sec-level3><sec-level3 id="jne382782s2-2-4" label="2.2.4"><heading>Consent</heading><p indent="no">The relationship between respect for people and the origins of informed consent date to landmark judicial rulings in the 20th century addressed the right to self-dominion and considered necessary elements of disclosure [<cite linkend="jne382782bib28" range="jne382782bib28,jne382782bib29,jne382782bib30,jne382782bib31,jne382782bib32,jne382782bib33">28–33</cite>], the Nuremberg Code [<cite linkend="jne382782bib34">34</cite>] promulgated in the late 1940s and the Belmont Report [<cite linkend="jne382782bib35">35</cite>] in the 1970s addressed the centrality of informed consent as well as the research context, but did little to address how external economic forces might impinge upon the patient's self-determination and autonomous choice.</p><p>More recently, and from a European source, has come the Opinion of the European Group on Ethics and Science and New Technologies to the European Commission (EGE) entitled ‘Ethical Aspects of ICT (Information and Communication Technologies) Implants in the Human Body’ [<cite linkend="jne382782bib36">36</cite>]. This comprehensive document set within a context of shared European values, like human dignity, speaks of the limits of the ‘freedom of individual free choice’ when such consent violates fundamental and inviolable principles like human dignity. According to the EGE's speculative analysis, such affronts might occur when computer–DBS interfaces somehow compromised personal privacy or tethered an individual in such a way as to compromise free movement or autonomy.</p><p>Notwithstanding these limits placed on consent, we would still assert that the economics of DBS research and practice necessitate that additional disclosures occur. While these disclosures are necessary, as per the analysis of the European Group, they would be insufficient if consent were being requested for practices that were somehow contrary to deeply held values. With this in mind, we would amend current consent practices as follows:
<ordered-list id="jne382782ol3" type="alpha"><list-item id="jne382782ol3.1" marker="a"><p indent="no">Patients and/or their legally authorized representatives should be made fully aware of putative conflicts of interest in all informed consent discussions.</p></list-item><list-item id="jne382782ol3.2" marker="b"><p indent="no">Investigators should err on the side of over-disclosure to ensure transparency in this process. In all cases, as a minimum, information about corporate relationships and/or IP rights (as determined by investigators in consultation with institutional officials) should be shared with prospective participants and/or their surrogates.</p></list-item><list-item id="jne382782ol3.3" marker="c"><p indent="no">Elements of disclosure include any receipt or promised receipt of payments, royalties, fees and stock options made to the investigator and his or her team or institution. It might also include the name(s) of the manufacturer(s) of any device or component of device (electrode, pacemaker) that is being implanted and information about any role that these additional companies might have in funding the research.</p></list-item><list-item id="jne382782ol3.4" marker="d"><p indent="no">Investigators should seek to avoid the ‘therapeutic misconception’ by inappropriately labeling an investigational device as a ‘therapy’ or as ‘therapeutic’ while it remains investigational [<cite linkend="jne382782bib37">37</cite>, <cite linkend="jne382782bib38">38</cite>].</p></list-item></ordered-list></p></sec-level3><sec-level3 id="jne382782s2-2-5" label="2.2.5"><heading>Corporate compliance, and academic and corporate role sequestration</heading><p indent="no">The range of individuals and entities involved in DBS research necessitate that there are consistent and systemic efforts to regulate this research and corporate compliance related to applicable laws and ethical norms. This also requires that institutional entities appreciate their discrete responsibilities. To these ends:
<ordered-list id="jne382782ol4" type="alpha"><list-item id="jne382782ol4.1" marker="a"><p indent="no">Investigators, institutions and any corporate sponsor should adhere to all regulatory requirements to evaluate new devices or established devices for new applications using an appropriate device approval pathway [<cite linkend="jne382782bib39">39</cite>].</p></list-item><list-item id="jne382782ol4.2" marker="b"><p indent="no">Investigators receiving funding from corporate sources should work closely with their institutional officials to ensure compliance with their local conflict-of-interest panels to whom full disclosure of the nature and scope of these relationships should be made. This includes payments, stipends, royalties and stock options [<cite linkend="jne382782bib21">21</cite>].</p></list-item><list-item id="jne382782ol4.3" marker="c"><p indent="no">Notwithstanding any adverse impact on the market standing of a corporate sponsor, all adverse events should be reported to the proper local and governmental regulatory bodies [<cite linkend="jne382782bib40">40</cite>]. Central to the discernment of toxicity and adverse events is the constitution of a Data Safety Monitoring Board (DSMB) that has the requisite expertise to evaluate questions of efficacy and toxicity for this area of specialized research. In this way, the ethical principles of both beneficence (efficacy) and non-malefiecence (toxicity) can best be balanced and proportionate.</p></list-item><list-item id="jne382782ol4.4" marker="d"><p indent="no">Investigators who conduct sponsored research should not have, or assume, corporate fiduciary roles, as board members entrusted with potential oversight responsibility of their own research and conduct. Membership on scientific advisory boards is appropriate so long as there is role sequestration with respect to corporate governance [<cite linkend="jne382782bib21">21</cite>].</p></list-item><list-item id="jne382782ol4.5" marker="e"><p indent="no">Academics who conduct such research should not also be employees of the companies sponsoring their work. All consultancies should be vetted by their local institutional conflicts boards [<cite linkend="jne382782bib21">21</cite>, <cite linkend="jne382782bib41">41</cite>].</p></list-item><list-item id="jne382782ol4.6" marker="f"><p indent="no">In order to maintain clarity about roles and ensure proper oversight, we recommend that any consultancy payments to investigators from corporate entities remain less than or equal to half of the investigator's yearly academic salary and in all cases represent fair market value of the services provided [<cite linkend="jne382782bib42">42</cite>].</p></list-item><list-item id="jne382782ol4.7" marker="g"><p indent="no">Corporate sponsors and investigators should seek to avoid therapeutic misconception by avoiding the adoption of promotional language that inappropriately labels an investigational device as a ‘therapy’ or as ‘therapeutic’ [<cite linkend="jne382782bib37">37</cite>, <cite linkend="jne382782bib39">39</cite>].</p></list-item></ordered-list></p></sec-level3><sec-level3 id="jne382782s2-2-6" label="2.2.6"><heading>Presentations and publishing</heading><p indent="no">The range of potential conflicts, diversity of funders and peculiarities related to device development and DBS necessitates that these relationships are properly disclosed and communicated to the broader scientific community through scholarly publications and presentations.
<ordered-list id="jne382782ol5" type="alpha"><list-item id="jne382782ol5.1" marker="a"><p indent="no">Investigators should not present findings or publish data at programs or publish in journals whose editorial content is controlled by their sponsor. They should not engage in selective reporting of results [<cite linkend="jne382782bib43">43</cite>] and we agree that there should be mandatory disclosure of DBS trial results [<cite linkend="jne382782bib44">44</cite>].</p></list-item><list-item id="jne382782ol5.2" marker="b"><p indent="no">Investigators should always assume responsibility for their written work and abjure corporately sponsored ghost-written publications.</p></list-item><list-item id="jne382782ol5.3" marker="c"><p indent="no">As a question of academic freedom and the conduct of science, investigators should be neither delayed in nor precluded from publishing negative results because of a potential adverse market impact upon on a corporate sponsor.</p></list-item><list-item id="jne382782ol5.4" marker="d"><p indent="no">When a DBS trial registry is available, investigators should register their results [<cite linkend="jne382782bib45">45</cite>].</p></list-item><list-item id="jne382782ol5.5" marker="e"><p indent="no">Investigators should seek to disclose and justify their interactions with industry in their published works, and peer reviewers and editors should seek such disclosure and explication as an element of publication submission [<cite linkend="jne382782bib17">17</cite>].</p></list-item><list-item id="jne382782ol5.6" marker="f"><p indent="no">Journals should carefully review ‘disclose and justify’ attestations and have a policy on disqualifying conflicts of interest and publication. Given the unavoidable involvement of industry, investigators and their institutions in DBS research, journals should not make categorical judgments about the suitability of a paper solely based on the presence of a disclosed conflict. Such conflicts, if properly disclosed and managed, can provide an important perspective that is otherwise unobtainable in the literature. As such, they should be viewed with editorial neutrality.</p></list-item></ordered-list></p></sec-level3></sec-level2></sec-level1><sec-level1 id="jne382782s2-2-7" label="2.2.7"><heading>Conclusion</heading><p indent="no">The unavoidable mix of industry and academia makes it essential that DBS practitioners, investigators and sponsors adhere to high ethical standards that will sustain this work for the long haul. We hope that this document provides ethical guidance for the management of conflicts of interest for all those engaged in the development of therapeutic deep brain stimulation for neuropsychiatric disorders and serves as a moral compass for this journey of discovery.</p></sec-level1><acknowledgment><heading>Acknowledgments</heading><p indent="no">‘Deep Brain Stimulation in Psychiatry. Guidance for Responsible Research and Application’ was funded by an unrestricted grant from the Volkswagen Stiftung, Hanover, to the Europäische Akademie Bad Neuenahr-Ahrweiler GmbH and the Department of Psychiatry of the University of Bonn.</p><p indent="no"><italic>Funding</italic>. The authors are part of a research group ‘Deep Brain Stimulation in Psychiatry. Guidance for Responsible Research and Application’ was funded by an unrestricted grant from the Volkswagen Stiftung, Hanover, to the Europäische Akademie Bad Neuenahr-Ahrweiler GmbH and the Department of Psychiatry of the University of Bonn. The aim of this project was to examine how recognized standards of research and practice in psychiatry need to be modified in order to account for the special requirements of DBS. This group consists of Thomas E Schlaepfer, MD (chair), Bonn; Joseph J Fins, MD, FACP, Weill Cornell Medical College, NY; Cynthia S Kubu, PhD, MA, Cleveland, OH; Helen S Mayberg, MD, FRCPC, Atlanta, GA; Reinhard Merkel, PhD, Hamburg; Bart Nuttin, MD, PhD, Leuven; Volker Sturm, MD, Cologne; Thorsten Galert, PhD, MA, Bad Neuenahr-Ahrweiler (project coordinator).</p><p indent="no"><italic>Competing interests</italic>. JJF and CSK are unfunded co-investigators in the DBS in MCS clinical trails funded by Intelect Inc. The authors have previously published on deep brain stimulation for psychiatric disorders. BN holds a patent on DBS for obsessive–compulsive disorder and has received limited funding from Medtronic, Inc. for research travel and education. HSM has been, and remains, involved in studies of DBS for depression funded by non-industry foundation sponsors. She holds consults and receives licensing fees for intellectual property related to DBS for depression from St Jude Medical, and holds a physician sponsored IDE for non-industry funded ongoing studies. VS and TS received limited funding from Medtronic Inc. for an investigator-initiated study of DBS for treatment resistant major depression. VS is a shareholder of a German limited society (so-called GmbH) developing novel stimulus sequences for DBS treatment-optimization in parallel with the design of DBS-related system software and hardware. He also holds a patent for DBS for dementia. VS has also received funding from Medtronic, Inc. for presentations. CSK receives limited funding from Medtronic for an industry sponsored trial for DBS for treatment resistant depression and is Co-PI on a NINDS grant examining the ethics of control in DBS for Parkinson's disease and a co-investigator in an NIMH funded study examining DBS for the treatment of OCD. She is co-author on a patent filed for the treatment of neuropsychological disorders.</p></acknowledgment></body><back><references><heading>References</heading><reference-list type="numeric"><journal-ref id="jne382782bib01"><authors><au><second-name>Deuschl</second-name><first-names>G</first-names></au><others><italic>et al</italic></others></authors><year>2006</year><art-title>A randomized trial of deep-brain stimulation for Parkinson's disease</art-title><jnl-title>N. Engl. 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Investigators in this interdisciplinary space will include an array of engineers (electrical, material, biomedical and others); physician–scientists from multiple specialty areas (neurology, neurosurgery, psychiatry and others); and other clinicians engaged in patient care and translational research.</p></footnote></footnotes></back></article></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="eng"><title>Ethical guidance for the management of conflicts of interest for researchers, engineers and clinicians engaged in the development of therapeutic deep brain stimulation</title></titleInfo><titleInfo type="abbreviated"><title>Perspective</title></titleInfo><titleInfo type="alternative" lang="eng"><title>Ethical guidance for the management of conflicts of interest for researchers, engineers and clinicians engaged in the development of therapeutic deep brain stimulation</title></titleInfo><name type="personal"><namePart type="given">Joseph J</namePart><namePart type="family">Fins</namePart><affiliation>Division of Medical Ethics, New York Presbyterian-Weill Cornell Medical Center, 435 East 70th Street, Suite 4-J, New York, NY 10021, USA</affiliation><affiliation>E-mail: jjfins@med.cornell.edu</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Thomas E</namePart><namePart type="family">Schlaepfer</namePart><affiliation>University of Bonn, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Bart</namePart><namePart type="family">Nuttin</namePart><affiliation>University Hospitals, Leuven, Belgium</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Cynthia S</namePart><namePart type="family">Kubu</namePart><affiliation>The Cleveland Clinic, Cleveland, OH, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Thorsten</namePart><namePart type="family">Galert</namePart><affiliation>Europische Akademie, Bad Neuenahr-Ahrweiler, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Volker</namePart><namePart type="family">Sturm</namePart><affiliation>University of Cologne, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Reinhard</namePart><namePart type="family">Merkel</namePart><affiliation>University of Hamburg School of Law, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Helen S</namePart><namePart type="family">Mayberg</namePart><affiliation>Emory University School of Medicine, Atlanta, GA, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="review-article" displayLabel="review">review</genre><genre type="research-article" displayLabel="review"></genre><originInfo><publisher>IOP Publishing</publisher><dateIssued encoding="w3cdtf">2011</dateIssued><copyrightDate encoding="w3cdtf">2011</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType><note type="production">Printed in the UK</note></physicalDescription><abstract>The clinical promise of deep brain stimulation (DBS) for neuropsychiatric conditions is coupled with the potential for ethical conflicts of interest because the work is so heavily reliant upon collaborations between academia, industry and the clinic. To foster transparency and public trust, we offer ethical guidance for the management of conflicts of interest in the conduct of DBS research and practice so that this nascent field can better balance competing goods and engineer new and better strategies for the amelioration of human suffering. We also hope that our ethical analysis will be of relevance to those working with other related neuroprosthetic devices, such brain-computer interfaces and neural arrays, which naturally share many of the same concerns.</abstract><relatedItem type="host"><titleInfo><title>Journal of Neural Engineering</title></titleInfo><titleInfo type="abbreviated"><title>J. Neural Eng.</title></titleInfo><genre type="journal">journal</genre><identifier type="ISSN">1741-2560</identifier><identifier type="PublisherID">jne</identifier><identifier type="CODEN">JNEIEZ</identifier><identifier type="URL">stacks.iop.org/JNE</identifier><part><date>2011</date><detail type="volume"><caption>vol.</caption><number>8</number></detail><detail type="issue"><caption>no.</caption><number>3</number></detail><extent unit="pages"><start>1</start><end>6</end><total>6</total></extent></part></relatedItem><identifier type="istex">D964DED97D4846E61F366CEB29BF4617B8A58DD4</identifier><identifier type="DOI">10.1088/1741-2560/8/3/033001</identifier><identifier type="PII">S1741-2560(11)82782-5</identifier><identifier type="articleID">382782</identifier><identifier type="articleNumber">033001</identifier><accessCondition type="use and reproduction" contentType="copyright">2011 IOP Publishing Ltd</accessCondition><recordInfo><recordContentSource>IOP</recordContentSource><recordOrigin>2011 IOP Publishing Ltd</recordOrigin></recordInfo></mods></metadata><enrichments><json:item><type>multicat</type><uri>https://api.istex.fr/document/D964DED97D4846E61F366CEB29BF4617B8A58DD4/enrichments/multicat</uri></json:item></enrichments><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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