{"id":1298,"date":"2018-05-07T07:43:58","date_gmt":"2018-05-07T05:43:58","guid":{"rendered":"https:\/\/blog.ki.se\/rektor\/?p=1298"},"modified":"2018-05-15T13:01:13","modified_gmt":"2018-05-15T11:01:13","slug":"tillsatt-ny-utredning-om-anvandning-av-obeprovade-metoder-inom-halso-och-sjukvarden","status":"publish","type":"post","link":"https:\/\/blog.ki.se\/rektor\/2018\/05\/07\/tillsatt-ny-utredning-om-anvandning-av-obeprovade-metoder-inom-halso-och-sjukvarden\/","title":{"rendered":"Tills\u00e4tt ny utredning om anv\u00e4ndning av obepr\u00f6vade metoder inom h\u00e4lso- och sjukv\u00e5rden"},"content":{"rendered":"

In English below<\/strong><\/p>\n

Utredningen \u201dEtikpr\u00f6vning \u2013 en \u00f6versyn av reglerna om forskning och h\u00e4lso- och sjukv\u00e5rd<\/a>\u201d presenterade sitt slutbet\u00e4nkande i slutet av f\u00f6rra \u00e5ret. Nu under v\u00e5ren har remissinstanserna yttrat sig om f\u00f6rslagen. S\u00e5 \u00e4ven vi p\u00e5 Karolinska Institutet.<\/p>\n

Det h\u00e4r \u00e4r en viktig utredning om ett viktigt \u00e4mne. Etiken och regelverket i gr\u00e4nslandet mellan forskning och v\u00e5rd beh\u00f6ver ses \u00f6ver, det visar inte minst de fr\u00e5gest\u00e4llningar som kom upp i samband med Macchiarini-fallet.<\/p>\n

Behov av f\u00f6rtydliganden<\/h4>\n

L\u00e5t mig f\u00f6rst konstatera att vi tycker att de flesta f\u00f6rslag som utredaren presenterar \u00e4r bra och i flera fall helt n\u00f6dv\u00e4ndiga. Det \u00e4r exempelvis utm\u00e4rkt att det f\u00f6resl\u00e5s en rad f\u00f6rtydliganden kring definitioner, mandat och ansvarsf\u00f6rdelningar n\u00e4r det g\u00e4ller etikpr\u00f6vningar generellt. Likas\u00e5 \u00e4r f\u00f6rslagen om \u00f6kad tillsyn och sk\u00e4rpta straff f\u00f6r brott mot etikpr\u00f6vningslagen n\u00e5got som rimligen b\u00f6r leda till en st\u00f6rre efterlevnad av och medvetenhet om det forskningsetiska regelverket.<\/p>\n

Slutbet\u00e4nkandet inneh\u00e5ller dock ocks\u00e5 n\u00e5gra f\u00f6rslag som \u00e4r problematiska. Det handlar framf\u00f6rallt om hur anv\u00e4ndande av tidigare opr\u00f6vade metoder ska regleras, huruvida etikpr\u00f6vningar ska kunna ske i efterhand och var gr\u00e4nsen ska s\u00e4ttas mellan forskning och h\u00e4lso- och sjukv\u00e5rd.<\/p>\n

Etikpr\u00f6vning i efterhand<\/h4>\n

Enligt utredningen ska anv\u00e4ndning av obepr\u00f6vade metoder alltid ske inom ramen f\u00f6r ett forskningsprojekt d\u00e4r allts\u00e5 en obligatorisk etikpr\u00f6vning m\u00e5ste g\u00f6ras. I vissa fall, f\u00f6resl\u00e5r utredningen, ska en s\u00e5dan etikpr\u00f6vning kunna ske i efterhand. Det r\u00f6r sig i praktiken om fall d\u00e4r en sv\u00e5rt sjuk patient i en akut situation f\u00e5r en tidigare opr\u00f6vad behandling f\u00f6r att om m\u00f6jligt bota eller lindra sjukdomen.<\/p>\n

KI delar inte utredningens bed\u00f6mning. Vi menar att det vore direkt ol\u00e4mpligt att inf\u00f6ra ett system d\u00e4r etikpr\u00f6vningen till\u00e5ts ske i efterhand och d\u00e4r sjukv\u00e5rd definieras som forskning.<\/p>\n

Etikpr\u00f6vning innan studien<\/h4>\n

Forskning som g\u00f6rs inom h\u00e4lso- och sjukv\u00e5rdens ram ska alltid \u2013 alltid \u2013 etikpr\u00f6vas innan studien p\u00e5b\u00f6rjas. F\u00f6r oss \u00e4r detta fundamentalt. Att ge en m\u00f6jlighet till etikpr\u00f6vning i efterhand kommer att f\u00f6rsvaga etikpr\u00f6vningens st\u00e4llning, vilket \u00e4r tv\u00e4rtemot utredarens \u00f6vriga f\u00f6rslag. Och det blir fel att anv\u00e4ndning av obepr\u00f6vade metoder p\u00e5 allvarligt sjuka patienter ska kallas forskning. I en debattartikel <\/a>skriver representanter f\u00f6r Vetenskapsakademien och Statens medicinsk-etiska r\u00e5d att syftet med anv\u00e4ndning av obepr\u00f6vade metoder \u00e4r att r\u00e4dda en patient, inte att f\u00e5 fram ny kunskap. Vi h\u00e5ller med.<\/p>\n

Naturligtvis f\u00e5r lagar och regler inte hindra att en sv\u00e5rt sjuk patient kan behandlas med en tidigare opr\u00f6vad metod. Men en s\u00e5dan behandling ska inte definieras som forskning. Den b\u00f6r kallas f\u00f6r vad den \u00e4r: h\u00e4lso- och sjukv\u00e5rd. Och d\u00e4rmed ska inte en s\u00e5dan insats regleras enligt etikpr\u00f6vningslagens best\u00e4mmelser. En m\u00f6jlighet \u00e4r att etablera en jourverksamhet f\u00f6r pr\u00f6vning av akuta \u00e5tg\u00e4rder d\u00e4r Inspektionen f\u00f6r v\u00e5rd och omsorg som tillsynsmyndighet har ett ansvar.<\/p>\n

Tills\u00e4tt en ny utredning<\/h4>\n

Konsekvensen av detta \u00e4r att h\u00e4lso- och sjukv\u00e5rdslagstiftningen b\u00f6r ses \u00f6ver och att det h\u00e4r b\u00f6r inf\u00f6ras regler kring anv\u00e4ndandet av obepr\u00f6vade metoder. D\u00e4rf\u00f6r f\u00f6resl\u00e5r KI att det tills\u00e4tts en ny utredning med just detta syfte. Beslut om en s\u00e5dan ny utredning b\u00f6r tas s\u00e5 snart som m\u00f6jligt \u2013 det h\u00e4r \u00e4r fr\u00e5gor som \u00e4r mycket angel\u00e4gna.<\/p>\n

 <\/p>\n

Launch a new investigation into use of untested methods in the health care<\/h1>\n

The conclusions of the investigation \u201cEthical review \u2013 a summary of the rules applicable to research and healthcare\u201d (“Etikpr\u00f6vning – en \u00f6versyn av reglerna om forskning och h\u00e4lso- och sjukv\u00e5rd<\/a>“)were presented at the end of last year. Now, in the spring, the referral bodies \u2013 including us at Karolinska Institutet \u2013 have issued a statement on its recommendations.<\/p>\n

This is an important investigation into an important subject. Ethics and the regulations in the region where research and care meet require revision, as is particularly apparent from the issues that arose in connection with the Macchiarini case.<\/p>\n

Need for clarification<\/h4>\n

Allow me first to confirm that we think that most recommendations presented by the investigator are good, and in many cases absolutely necessary. It is excellent, for example, that the recommendations include a series of clarifications concerning definitions, mandates and the allocation of responsibilities with respect to ethical review in general. Similarly, the proposals concerning increased inspection and more severe punishment for violations of the Ethical Review Act should reasonably lead to improved compliance with and awareness of the research ethical regulations.<\/p>\n

However, the conclusions also include some proposals that are problematic. This concerns primarily regulation of the use of previously untested methods, whether it should be possible to conduct ethical reviews retroactively, and where the dividing line should lie between research and healthcare.<\/p>\n

Retroactive ethical review<\/h4>\n

According to the investigation, the use of untested methods should always be in the context of a research project, and accordingly require compulsory ethical review. The investigation proposes that it should be possible in some cases for such ethical review to be performed in retrospect. In practice, these are cases in which a severely ill patient in an urgent situation is given previously untested treatment in order to cure or alleviate the illness, if possible.<\/p>\n

KI is taking part in assessment of the investigation. It is our opinion that it would be directly inappropriate to introduce a system in which retroactive ethical review is permitted and in which healthcare is defined as research.<\/p>\n

Ethical review before the study<\/h4>\n

Research conducted in the context of healthcare must always<\/em> be subject to ethical review before commencement of the study. This is a fundamental issue for us. Allowing retroactive ethical review will weaken the position of ethical review, which conversely is the investigator\u2019s other proposal. In addition, it would be wrong for the use of untested methods on seriously ill patients to be referred to as research. In a\u00a0debate article<\/a>, representatives of the Royal Swedish Academy of Sciences and the Swedish National Council on Medical Ethics writes that the purpose of using untested methods is to save a patient\u2019s life, and not to acquire new knowledge. We agree.<\/p>\n

Laws and regulations clearly should not exclude the possibility of a patient being treated using a previously untested method. However, such treatment must not be described as research, but rather it should be called what it is: healthcare. Such a measure should accordingly not be regulated in accordance with the provisions of the Ethical Review Act. One possibility is to establish an on-call activity for investigating emergency actions in which the Health and Social Care Inspectorate as a supervisory authority would have a responsibility.<\/p>\n

Launch a new investigation<\/h4>\n

The consequence of this is that healthcare legislation should be reviewed and that regulations should be introduced concerning the use of untested methods. KI therefore proposes that a new investigation should be launched for precisely this purpose. A new investigation of this kind should be decided on as soon as possible since these are very pressing issues.<\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

In English below Utredningen \u201dEtikpr\u00f6vning \u2013 en \u00f6versyn av reglerna om forskning och h\u00e4lso- och sjukv\u00e5rd\u201d presenterade sitt slutbet\u00e4nkande i slutet av f\u00f6rra \u00e5ret. Nu under v\u00e5ren har remissinstanserna yttrat […]<\/p>\n","protected":false},"author":100,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[128,160,33],"tags":[237,238,231],"class_list":["post-1298","post","type-post","status-publish","format-standard","hentry","category-ethics","category-halso-och-sjukvard","category-health-care","tag-etik","tag-etikprovning","tag-utredning"],"acf":[],"yoast_head":"\nTills\u00e4tt ny utredning om anv\u00e4ndning av obepr\u00f6vade metoder inom h\u00e4lso- och sjukv\u00e5rden - Ole Petter Ottersen, president Karolinska Institutet 2017-2023<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/blog.ki.se\/rektor\/2018\/05\/07\/tillsatt-ny-utredning-om-anvandning-av-obeprovade-metoder-inom-halso-och-sjukvarden\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Tills\u00e4tt ny utredning om anv\u00e4ndning av obepr\u00f6vade metoder inom h\u00e4lso- och sjukv\u00e5rden - Ole Petter Ottersen, president Karolinska Institutet 2017-2023\" \/>\n<meta property=\"og:description\" content=\"In English below Utredningen \u201dEtikpr\u00f6vning \u2013 en \u00f6versyn av reglerna om forskning och h\u00e4lso- och sjukv\u00e5rd\u201d presenterade sitt slutbet\u00e4nkande i slutet av f\u00f6rra \u00e5ret. 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