sou · H5B3104 · 2017-12-15 00:00:00 — Another requirement is that the person to whom responsibility has been delegated must have the necessary powers to deal with the task. If no clear delegation has taken place, responsibility remains at the level immediately above. The second provision states that the research principal is respons- ible for applying for ethical review of research that is carried out under the principal’s aegis. This provision also regulates the division of responsibilities when two or more research principals participate in a single research project. In such cases, the research principals must jointly appoint a research principal to bear primary respons- ibility for the project. The research principal appointed is responsible for submitting a joint application for ethical review of the research project in its entirety, and for informing the other research principals of the Board’s decision. Board’s supervision Board supervises compliance with the Act and regulations issued pursuant to the Act. However, this does not apply to the extent that this supervision falls within another public agency’s area of responsibility (Section 34 of the Act). In the legislative history of the Act, it is stated that the research in need of supervision under the Act is the research not covered by the supervisory responsibility already borne by (currently) the Swedish Health and Social Care Inspectorate (), the and the Protection Authority. The research remaining to be supervised includes and psychological basic research conducted under the aegis of a principal other than a care provider, for example in connection with the departments of medicine at the HEIs (Govt. 2002/03:50, pp. 163 and 206). Accordingly, there is a smaller area remaining to be supervised. The Inquiry’s terms of reference state that the limitation on the Board’s supervisory responsibilities described in the legislative history of the Act have meant that supervision of research conducted within the framework of, for example, health and services is assumed to be performed by agencies other than the Board. has developed a practice whereby certain supervisory matters are transferred to other agencies. Furthermore, the Inquiry on supervision of personal data privacy (SOU 2016:65) notes that the dividing line, in terms of responsibility for supervision, between the Data Protection Authority and the Board has, to some extent, been perceived as unclear. In some cases, the Inquiry finds, this has meant that neither of these agencies have considered themselves able to carry out super- vision (report of the Inquiry cited above, pp. 194 and 195). The Inquiry was assigned to submit proposals that clarify the Board’s supervisory responsibility. The survey carried out by this Inquiry, too, shows that the Board and the Data Protection Authority do not agree on where to draw the line between the two agencies’ supervisory responsibilities regarding research involving processing of personal data. It has not emerged that there are demarcation problems regarding the Board’s supervisory responsibility in relation to that of or the . This Inquiry’s assessment is that the Board should supervise compliance with the Act and regulations issued pursuant to this Act, regardless of the activities to be reviewed. The approach considered most effective is to concen- trate in a single agency responsibility for all issues relating to inter- pretation and application of the Act. This also means a clear division of responsibilities so that all supervision of com- pliance with the Act, and with regulations issued under the Act, is exercised by the Board. The fundamental questions for the Board should be whether activities in question constitute “research” under the Act and, if so, whether the research is of the kind covered by the law’s ethical review requirements. If the answer to these questions is in the affirmative, the activities fall within the Board’s supervisory remit. The fact that these activities are also subject to another supervisory agency’s responsibility does not prevent the Board from reviewing an activity on the basis of the Act’s provisions. The Inquiry proposes that an explicit statement on the scope of the Board’s supervisory responsibility be inserted in Section 34 of the Act. This provision states that the Board supervises compliance with the rule that the research specified in Sections 3–5 of the Act may not be conducted without approval pursuant to Sections 6 and 6a. It also supervises compliance with the Act; regulations issued pursuant to this Act; and conditions announced in connection with approval following ethical review. In addition, the Inquiry also recommends repealing the provision whereby the Board does not exercise supervision in so far as this super- vision falls within another agency’s area of responsibility. Under the Board’s supervision, issues may arise that fall within another agency’s area of responsibility. Board may then need to consult, or refer the issues on a consultation basis to, another agency. The Inquiry takes the view that coope- ration between the agencies, through consultation and referral, is already an option pursuant to the provisions of the Swedish Administrative Procedure Act and that there is no need for further regulation in this regard. Overview of penal provisions in the Act A person who deliberately violates the provisions of Section 6 of the Act whereby research may be conducted only if it has been approved in an ethical review, or who violates a condition issued pursuant to an approval, is to be sentenced to a fine or imprisonment for no more than six months. is not imposed in petty cases, or if the offence is punishable under a provision in another statute (Section 38). The Inquiry’s terms of reference state that research carried out without approval may include research methods that entail risk of injury to a research subject or of encroachment on someone’s privacy. Particularly vulnerable patients may be exposed to very high health risks by research being conducted without approval. It is therefore questionable whether the range of punishment for violations of the Act provides sufficient scope for balanced consideration of the gravity of the most reprehensible acts. The Inquiry’s remit has included reviewing the range of punishment for breaches of the Act. Under current regulations, there is criminal liability for a person who violates Section 6, or in other words the person performing the actual research (practical research work) without prior approval. As stated above, the Inquiry proposes that representatives of a research principal who disregards the responsibility stated in Section 23 may incur criminal liability pursuant to Section 38 of the Act. Criminal liability for the research principal does not exclude the possibility that the individual researcher who performs the research may also be punished. This may happen if, for example, the re- searcher contravenes the research principal’s instructions or other- wise, wilfully or through gross negligence, conducts research in violation of the Act. The Inquiry notes that breaches of the Act may take very different forms, and that their penal value may vary widely. The current penal latitude does not reflect existing differences, and does not cover the more serious cases. The Inquiry proposes that the maximum sentence for wilful offences be increased to two years’ imprisonment. The purpose of this is for the range of punishment to allow scope for a proportional penalty for serious contraventions of the Act as well. Circumstances that raise the penal value are, for example, that research has been conducted over a long period or repeatedly without ethical permission, or that a large number of human research subjects have been involved. It may also be a matter of research conducted without ethical permission and resulting in the research subjects’ exposure to major risks of detri- ment – physical, psychological or in terms of personal integrity. The Inquiry recommends introducing criminal liability for gross negligence as well. The range of punishment is then fines or im- prisonment for at most six months. Criminal liability may be imposed for reckless disregard of statutory law if, for example, a representative of the research principal entirely fails to gain control of what goes on at a workplace or gravely neglects the supervision of the organisation. In petty cases, as to date, no criminal responsibility is imposed. The Inquiry proposes that the penal provision in the Ethical Review Act should no longer be subsidiary in relation to penal provisions in other statutes. This means that criminal liability under the Act can be imposed when an action fully or partially meets the necessary condition for another offence as well. Activities in boundary area between clinical research and healthcare In the Swedish Health and Act (2017:30), “health and services” refers to measures to prevent, examine and treat diseases and injuries by means. Health and services must be provided in such a way as to meet the requirements for good care. Under the Swedish Patient (2010:659), health professionals must perform their work in accordance with science and proven experience. A patient must be given expert, con- siderate healthcare that meets these requirements. The Swedish Patient (2014:821), too, states that the patient must benefit from specialist, caring health and services of high quality that correspond to science and proven experience. Under the Inquiry’s terms of reference, the requirement that care measures must be based on science and proven experience does not exclude the application of some clinical development efforts in the care services. The terms of reference state that it is not always entirely clear how the existing regulations apply to activities in the boundary area between health and clinical research. The Inquiry was to clarify the rules that apply, and should apply, to the clinical development taking place in the boundary area between healthcare and clinical research. The Inquiry was also to propose how closer cooperation can be achieved between the agencies working in the areas of healthcare and clinical research and the agencies that exercise supervision over the sector. The Inquiry notes that the main rule, simply expressed, is that health and services are to be conducted in accordance with science and proven experience and that the only statutory exception to this principle is necessity (jus necessitatis), which is expressed in the Penal Code. However, it is unclear how far this is applicable in the healthcare sector. The principle that the work must be con- ducted on the basis of science and proven experience does not apply to clinical research. This research may be conducted only if it has been approved in an ethical review. It may thus be noted that there is no “grey area”, in a strictly legal sense, between healthcare and clinical research. In cases where a treatment, method or other measure that is unsupported by science or proven experience is implemented or undertaken in the health and services it can, if it meets the requisites laid down in the Act, be defined as research according to the act. Such activities require ethical approval to be allowed to proceed. Nonetheless, this does not rule out the possi- bility that it may also involve health or services. As soon as a measure is taken that lacks support in science and proven experience, it must be deemed to be research, and the pro- visions of the Act become applicable. This approach is the best guarantee for individuals’ health and privacy. Research may be approved under the Act only if the risks it may entail for the health, safety and personal privacy of human research subjects are outweighed by its scientific value. People’s welfare must be given precedence over the needs of society and science. The application of an unproven method in the healthcare sector must take place within the framework of a research project that has to undergo ethical review before it can start. The Inquiry notes that in health and services, situations may arise where there is no established method but measures must nonetheless be taken immediately or relatively promptly. There is not always scope for formulating a research project and applying for ethical review. For such situations, there should be scope for the ethical review to take place retrospectively instead. This makes it feasible to take emergency or urgent measures without neglecting the requirement of ethical review. If the situation is so acute that a measure must be taken immediately, the starting point should be that the application for ethical review must be drawn up and submitted as soon as possible after the measure has been taken. In situations where there is enough time to submit an application, but not to wait for a decision from the ethical review board, the urgent action should be taken before a decision on the ethical issue has been made. The Inquiry recommends inserting in the Act a provision stating that a research measure referred to in the Act may, if it is associated with healthcare and if it would seriously threaten the patient’s life or health to await the ethical review, be implemented although it has not been ethically reviewed. In such cases, the ethical review must be done retrospectively. If the ethical review has not been applied for, it should be done promptly after the measure has been taken. Sections 13–22 of the Act contain specific pro- visions regarding information given to, and consent obtained from, the human research subject. The provisions should also apply to re- search that undergoes retrospective ethical review, unless it is impeded by the emergency nature of the measure or for some other reason. The option of a retrospective review does not apply in clinical drug trials. It should not, in the Inquiry’s judgement, be possible for conduct of research connected with healthcare provided to ward off a danger that acutely and severely threatens a person’s life or health to result in criminal responsibility under the Act. An incorrect assessment of how urgent a situation is should also, in the great majority of cases, fall outside the punishable category of offences. Ethical review of new methods in healthcare Under Chapter 5, Section 3 of the Health and Act, before a new diagnostic or treatment method that may have a bearing on human dignity and privacy begins to be applied in healthcare, the care provider must ensure that the method has been assessed from individual and socioethical aspects. The purpose is to ensure that the ethical aspects of new diagnostic and treatment methods are assessed before these methods are put into practice in health and services. The Inquiry was assigned to propose how Chapter 5, Section 3 of the Health and Act, which has not had the intended impact in practice, can be clarified. The Inquiry recommends expanding and clarifying the provision in Chapter 5, Section 3 of the Act. The provision should be amended in such a way that the word “new” is removed. Instead, it is stated that the assessment should be made before a diagnostic or treatment method that may have a bearing on human dignity and privacy begins to be applied in a care provider’s activities. Here, the purpose is to clarify that the crux is whether the diagnostic or treatment method has been used previously in the current care provider’s activities or not, and an assessment should be made even if the method is, in general, not new. According to the Inquiry’s proposal, the assessment should be carried out by a specific body. This means that the assessment must be done in consultation among individuals who have the necessary expertise to ensure that the assessment meets the legal requirements. Moreover, the body must have its own place in the care provider’s organisation and may not be put together ad hoc when needed. The Act should specify what is meant by the statement that a dia- gnostic or treatment method may have a bearing on human dignity and privacy. An assessment is called for regarding methods that touch on existential issues. Examples are reproduction technology and foetal diagnostics; methods derived from biotechnology, such as genetic investigations and analyses, gene therapy and stem-cell research; and methods that may affect brain function. The provision is not exhaustive: an assessment may also relate to other methods concerning similar ethical issues, including those that may come to the fore in the future as new research findings emerge. The Inquiry proposes a provision that specifies what is meant by an“assessment” under Section 3. This assessment includes identifying those the method concerns, directly or indirectly; defining precisely what consequences various alternative methods have; describing the interests of those affected in the short and long term; highlighting conflicts of interest and attempting to resolve them according to stated ethical principles; and analysing the rights and obligations, in various situations, of the stakeholders involved. The assessment and the reasons for it should be documented, which means there must be some form of documentation showing that an assessment was carried out, and how this was done. The intention is not to extend the assessment requirement beyond what already applies, but to clarify which minimum requirements are imposed on the quality and scope of the ethical assessment. In cases where the care provider judges that the method should undergo an in-depth analysis or be assessed at national level, the Inquiry recommends allowing the care provider to defer the question to a public agency with overarching national responsibility. The Government should decide which agency is to bear this responsi- bility. Entry into force and transitional regulations The date proposed for the entry into force of these amendments is 1 January 2019. The changes in the Act should, how- ever, not apply to research starting before the entry into force of the act. Avtalet om läkarutbildning och forskning i hälso- Europeiska konventionen om skydd för de mänskliga rättigheterna och de grundläggande för miljö, areella näringar och för hälsa, arbetsliv och välfärd Inspektionen för vård och omsorg om ändring i lagen (2003:460) om etikprövning av forskning som avser människor Härigenom föreskrivs i fråga om lagen (2003:460) om etikpröv- ning av forskning som avser människor dels att 2, 6, 23, 34 och 38 §§ ska ha följande lydelse, dels att rubriken före 23 § ska ha följande lydelse, dels att det ska införas tre nya paragrafer, 6 a, 23 a och 23 b §§, och närmast före 23 b § en ny rubrik av följande lydelse. I denna lag avses med forskning: vetenskapligt expe- rimentellt eller teoretiskt arbete för att inhämta ny kunskap och utvecklingsarbete på vetenskap- lig grund, dock inte sådant arbete som utförs inom ramen för hög- skoleutbildning på grundnivå eller på avancerad nivå, forskningshuvudman: en statlig myndighet eller en fysisk eller juridisk person i vars verk- samhet forskningen utförs, forskning: vetenskapligt expe- rimentellt eller vetenskapligt teo- retiskt arbete och vetenskapliga studier genom observation, om arbetet eller studierna sker för att hämta in ny kunskap, samt ut- vecklingsarbete på vetenskaplig grund, forskningshuvudman: en eller flera statliga myndigheter eller fysiska eller juridiska perso- ner i vars verksamhet forsk- ningen utförs, 1 Senaste lydelse 2008:192. forskningsperson: en levande människa som forskningen avser, och behandling av personuppgifter: sådan behandling som anges i 3 § personuppgiftslagen (1998:204). Forskning som avses i 3–5 §§ Forskning som avses i 3–5 §§ får utföras bara om den har god- får, utom i fall som anges i 6 a §, känts vid en etikprövning. utföras bara om den har god- känts vid en etikprövning. avse ett visst projekt eller en del av ett projekt eller en på något avse ett visst projekt eller en del liknande sätt bestämd forsk- av ett projekt eller en på något liknande sätt bestämd forsk- behandling av sådana person- uppgifter som avses i 3 § bara behandling av sådana person- om behandlingen har godkänts uppgifter som avses i 3 § bara om behandlingen har godkänts Ett godkännande upphör att gälla, om inte forskningen har börjat utföras senast efter det att beslutet om godkännande vann laga kraft. Ett godkännande enligt denna lag medför inte att forskningen får utföras, om den strider mot någon annan författning. En forskningsåtgärd som avses i 3–5 §§ får utföras trots att den inte har etikprövats, om den har samband med hälso- och sjukvård och om det skulle allvarligt hota patientens liv eller hälsa att avvakta en etikprövning. I såda- na fall ska etikprövning ske i efterhand. Om etikprövning inte redan har sökts, ska det ske skyndsamt efter det att forsk- ningsåtgärden har vidtagits. Forskningshuvudmannen an- svarar för att forskning som anges i 3–5 §§ i forskningshuvud- mannens verksamhet inte utförs i strid med bestämmelserna om godkännande enligt 6 § och för att villkor som har meddelats i samband med godkännande vid etikprövning följs.23 a §Forskningshuvudmannen an- svarar för att det görs en ansökan om etikprövning enligt 6 eller 6 a § av forskning som utförs i huvudmannens verksamhet.När flera forskningshuvud- män medverkar i ett och samma forskningsprojekt ska de gemen- samt utse en huvudansvarig forskningshuvudman för projek- tet. Den huvudansvarige forsk- ningshuvudmannen ansvarar för att det görs en samlad ansökan49 Bestämmelserna i 13–22 §§ ska gälla även vid forsknings- åtgärder som etikprövas i efter- hand enligt första stycket, om det inte på grund av åtgärdens akuta karaktär eller av något annat skäl finns hinder mot det. Vad som sägs i första och andra styckena gäller inte klinisk Ansökan om etikprövning av forskning skall göras av forsk- ningshuvudmannen. om etikprövning av forsknings- projektet i dess helhet och för att informera övriga forsknings- huvudmän om etikprövnings- nämndens beslut. Bedömning av forskning inom ramen för högskoleutbildning på grundnivå eller på avancerad nivå 3–5 §§ ska bedrivas enbart av student inom ramen för högskole- utbildning på grundnivå eller på avancerad nivå och arbetet eller studien ska utföras vid ett uni- versitet eller en högskola som av- ses i 1 kap. (1992:1434), studien bedömas ur ett forsk- särskilt organ hos lärosätet innan tillsyn över att forskning som denna lag och föreskrifter som anges i 3–5 §§ inte bedrivs utan har meddelats med stöd av lagen. godkännande enligt 6 eller 6 a § Detta gäller dock inte i den mån samt att denna lag, föreskrifter tillsynen faller inom någon annan som har meddelats med stöd av lagen och villkor som har med- delats i samband med godkännan- de vid etikprövning följs. Den centrala nämnden får bestämma att ett tillsynsbeslut skall gälla . Den centrala nämnden får bestämma att ett tillsynsbeslut ska gälla . Den som uppsåtligen bryter Den som uppsåtligen bryter mot 6 § första stycket eller mot mot 6 § första stycket eller mot ett villkor som har meddelats ett villkor som har meddelats med stöd av 6 § första stycket med stöd av 6 § första stycket skall dömas till böter eller eller mot 23 § ska dömas till böter eller fängelse i högst två ringa fall döms inte till ansvar. Om gärningen begås av grov Till ansvar enligt första stycket oaktsamhet döms till böter eller döms inte om gärningen är belagd med straff enligt bestämmelse i I ringa fall döms inte till någon annan författning. ansvar enligt första stycket. Den som har överträtt ett vitesföreläggande enligt 35 § får inte dömas till ansvar för en gärning som omfattas av föreläggandet. Denna lag träder i kraft . Lagen ska dock inte tillämpas på forskning som börjat utföras före ikraftträdandet. om ändring i högskolelagen (1992:1434)