neuromodulatie en psychiatrie ethische implicaties bij onderzoek en behandeling n.
Download
Skip this Video
Loading SlideShow in 5 Seconds..
Neuromodulatie en psychiatrie : ethische implicaties bij onderzoek en behandeling PowerPoint Presentation
Download Presentation
Neuromodulatie en psychiatrie : ethische implicaties bij onderzoek en behandeling

Loading in 2 Seconds...

play fullscreen
1 / 43

Neuromodulatie en psychiatrie : ethische implicaties bij onderzoek en behandeling - PowerPoint PPT Presentation


  • 116 Views
  • Uploaded on

Neuromodulatie en psychiatrie : ethische implicaties bij onderzoek en behandeling. Bart Nuttin, Loes Gabriëls. K.U. Leuven : Gabriëls, van Kuyck, Welkenhuysen, Luyten, Ahmed, Prodanov, Van Laere, Dupont, Sunaert, Demeulemeester, Gybels, Tousseyn, Dewil, Vandenbroeck, Brak, Das, Arckens, Nuttin.

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Neuromodulatie en psychiatrie : ethische implicaties bij onderzoek en behandeling' - erol


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
neuromodulatie en psychiatrie ethische implicaties bij onderzoek en behandeling

Neuromodulatie en psychiatrie : ethische implicaties bij onderzoek en behandeling

Bart Nuttin, Loes Gabriëls

slide2

K.U. Leuven : Gabriëls, van Kuyck, Welkenhuysen, Luyten, Ahmed, Prodanov, Van Laere, Dupont, Sunaert, Demeulemeester, Gybels, Tousseyn, Dewil, Vandenbroeck, Brak, Das, Arckens, Nuttin.

Universiteit Antwerpen : Cosyns, Neefs, Vankerckhoven, Cluydts, …

Karolinska : Meyerson, Linderoth, Andréewitch, Mindus, Rück, …

Brown University : Friehs, Rasmussen, Greenberg, …

Cleveland Clinic : Rezai, Malone, …

Köln : Sturm, Klosterkötter, …

University of Michigan : Curtis, Abelson, …

Orlando : Goodman, Okun, Foot, …

Amsterdam – Utrecht : Bosch, Schuurman, …

Grenoble : Benabid, …

Medtronic Inc. : Mullett, Gielen, Rise, Stypulkowski, Langevin, …

slide3

Richtlijnen elektrische hersenstimulatie voor psychiatrische stoornissen

Relatie onderzoeker - industrie

Boek

Speciale situatie in Frankrijk

slide4

Richtlijnen elektrische hersenstimulatie voor psychiatrische stoornissen

Relatie onderzoeker - industrie

Boek

Speciale situatie in Frankrijk

dbs in psychiatric disorders
DBS in psychiatric disorders

Neurosurgical Clinics of North America, 14: XV-XVI, 2003

study requirements
Study requirements

1. An ethics committee should approve the investigational protocol

study requirements1
Study requirements

2. A patient assessment committee should evaluate each patient

acceptability of capsulotomy and dbs for ocd
Acceptability of capsulotomy and DBS for OCD
  • 84 psychiatrists questioned
  • 73 (87%) completed anonymous questionnaire
slide10
Requirements for the decision for capsulotomy or DBS

neurosurgeon +pt 0%

+ neurosurgeon+pt 3%

committee++neurosurgeon+pt 97%

slide11
Treatment of psychiatric patients with DBS remains investigational and is NOT considered standard therapy.
slide12
Treatment of psychiatric patients with DBS remains investigational and is NOT considered standard therapy.

FDA 2009 : Humanitariandeviceexemption (HDE) for DBS in OCD

slide13

In Europe : CE-mark

  • Treatment of psychiatric patients with DBS remains investigational and is NOT considered standard therapy.

FDA 2009 : Humanitariandeviceexemption (HDE) for DBS in OCD

study requirements2
Study requirements

3. Candidates for DBS surgery should meet defined criteria for severity, chronicity, disability and treatment refractoriness

study requirements3
Study requirements

4. Able to provide their informed consent.

study requirements4
Study requirements

5. The study should be conducted at or supervised by a clinical research center.

study requirements5
Study requirements

6. The investigative team :

A. A functional neurosurgical team with established experience in DBS

B. A team of psychiatrists with extensive experience in the psychiatric condition under investigation

study requirements6
Study requirements

7. The procedure should never be performed for political, law enforcement, or social purposes.

study requirements7
Study requirements
  • Investigations in this area should proceed cautiously to maintain the trust necessary for scientific progress.
slide20

Richtlijnen elektrische hersenstimulatie voor psychiatrische stoornissen

Relatie onderzoeker - industrie

Boek

Speciale situatie in Frankrijk

slide21

An EthicalManifestoforResearchers, Engineers and Cliniciansengaged in the Development of TherapeuticDeepBrainStimulation

J. Fins, T. Schlaepfer, B. Nuttin, C. Kubu, T. Galert, V. Sturm, R. Merkel, H. Mayberg

November 16, 2010

disclosure
Disclosure
  • Medtronic is providing grants for research, education and traveling
  • Patent : DBS in OCD
  • Grants : OT, FWO, IWT, SBO
slide24

Investigators should not be driven by self-interest when pursuing corporate support

but

They should be motivated by a desire to pursue important scientific work to enhance access to novel therapies

slide25

Investigators should, “disclose and justify” why receipt of corporate funding is needed to sustain the work

slide26

Investigators should seek to balance funding from corporate sources and other funders in order to dilute perceived and real conflicts.

slide27

Conflicted investigators should be able to pursue their scientific work in order to elucidate mechanism of action and ensure the safety of early phase studies.

But they should assume a step-back role as soon as feasible in order to minimize the possibility generating data which might be open to critique

slide29

Investigators should not publish data in journals whose editorial content is controlled by their sponsor.

relationship medical researchers industry
Relationship medical researchers – industry
  • Some journals view it as disqualifying, despite the critical content of the argument
  • Others accept mere disclosure
  • Such conflict of interest, if properly disclosed and managed, should be viewed with editorial neutrality (European Academy)
slide32

Richtlijnen elektrische hersenstimulatie voor psychiatrische stoornissen

Relatie onderzoeker - industrie

Boek

Speciale situatie in Frankrijk

slide34
Europäische Akademie zur Erforschung von Folgen wissenschaftlich-technischer Entwicklungen Bad Neuenahr-Ahrweiler GmbH

Merckel R, Boer G, Galert T, Fegert J, Hartman D, Nuttin B, Rosahl S

Intervening in the Brain

Changing Psyche and Society (Springer Verlag)

Recommendations

enhancement
Enhancement

If availability of purchasable mental enhancements increases

It may lead to unequal social distribution of wealth, and hence of social opportunities

Governments should counteract

dbs for psychiatric disorders in prisoners
DBS for psychiatric disorders in prisoners
  • Not in the research phase (one should not use vulnerable people for research)
  • DBS for freedom versus DBS for treatment

Try to untie both

slide39

Richtlijnen elektrische hersenstimulatie voor psychiatrische stoornissen

Relatie onderzoeker - industrie

Boek

Speciale situatie in Frankrijk

slide40
Comité consultatif National d’Ethique pour les sciences de la vie et de la santé, Avis N°71 24 La neurochirurgie fonctionelle d’affections psychiatriques sévères, 2002.
  • France wires up to treat obsessive disorder, Sally Goodman, Nature 417, 677, June 2002.
  • French psychiatrists
slide42

Richtlijnen elektrische hersenstimulatie voor psychiatrische stoornissen

Relatie onderzoeker - industrie

Boek

Speciale situatie in Frankrijk

slide43
Dank voor de uitnodiging

Dank voor Uw aandacht