Research Governance

Latest revision as of 16:09, 28 November 2023

⧼EGS Research Governance Desc⧽

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A

Austria +

The Austrian government officially created several national bodies for research self-regulation: Austrian Bioethics Commission, Advisory Board on Biotechnology and Genetic Engineering, and National Committee for the Protection of Animals used for Scientific Purposes. These are government advisory bodies regarding research ethics '"`UNIQ--ref-000001AE-QINU`"'. Forum for the Austrian Ethics Committees is a body that represents all 27 ethics committees in Austria. It consists of the Board and General Assembly, which have regular meetings once and twice a year '"`UNIQ--ref-000001AF-QINU`"'. Moreover, the Forum organises annual training for the members of ethics committees '"`UNIQ--ref-000001B0-QINU`"'. Some of ethics committees serve both as hospital, university and state committees. The work of committees is supervised by the Federal Office for Safety in Health Care '"`UNIQ--ref-000001B1-QINU`"'. Ethics committees at universities are compulsory only for the Medical Universities, which is stipulated by the University Act and additionally regulated by Hospital and Resort Act. Today, the majority of Austrian universities have non-statutory ethics committees. Some universities have a [https://www.uibk.ac.at/rektorenteam/forschung/ethikbeirat.html.en Board for Ethical Issues] (University of Innsbruck) or a [https://www.tugraz.at/en/tu-graz/organisational-structure/representative-bodies-for-members-of-tu-graz/commission-for-scientific-integrity-and-ethics/ Commission for Scientific Integrity and Ethics] (Graz University of Technology) or an [https://boku.ac.at/en/ethikplattform Ethics platform] and [https://boku.ac.at/en/besondere-organe-und-einrichtungen/ethics-committee Ethics committee] (Vienna University of Natural Resources and Life Sciences). Usually, opinions brought by university ethics committees, advisory boards and commissions are non-binding and serve as guidelines for researchers '"`UNIQ--ref-000001B2-QINU`"'. Austrian Agency for Research Integrity is responsible for raising awareness for the Standards of Good Scientific Practice. Since the Agency has no legal competence, its opinions are not binding and it is up to each institution whether to apply them. For the implementation of research integrity and good scientific practice, universities usually have individual guidelines which differ due to their academic autonomy. In 2015, there was a joint process to agree on common guidelines; all (at that time) 37 member organisations agreed '"`UNIQ--ref-000001B3-QINU`"'. Following the suggestion of Forum of the Austrian Ethics Committees, an annual training course for members of ethics committees is organised by the Centre of Ethics and Medicine of the Lower Austria State Academy. Moreover, the General Assembly of the Forum meets once a year during an annual Forum meeting '"`UNIQ--ref-000001B4-QINU`"'. In 2016, the Agency and Austrian Students Ombudsman founded a network for exchange of experiences in the area of conflict management, quality assurance and maintaining good scientific practice '"`UNIQ--ref-000001B5-QINU`"'. Austrian Agency for Research Integrity is also responsible for investigating cases of misconduct. Inquiry can be initiated by the members of the Agency and individuals, whereupon the Agency will decide its competence to bring statements in each case. However, those statements do not have any legal influence and it is up to each institution to bring decision about further actions in the cases of allegations of research misconduct '"`UNIQ--ref-000001B6-QINU`"'. Besides the Agency, cases of misconduct at Universities are handled by research integrity committees or similar bodies. Some cases of proven misconduct were published in media. The investigation of alleged cases of misconduct is confidential i.e. the identity of whistleblowers and accused are not revealed '"`UNIQ--ref-000001B7-QINU`"'. Austria does not have a specific law for the regulation of research and possible violations of research integrity. {| class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" align="left" | width="307" valign="top"|'''Bodies for RE+RI''' | width="445" valign="top"|'''Scope''' |- | width="307" valign="top"|[https://www.bundeskanzleramt.gv.at/en/topics/bioethics-commission?lang=en Austrian Bioethics Commission] | width="445" valign="top"|Advises the Federal Chancellor from an ethical point of view on all social, natural scientific and legal issues arising from the scientific developments in human medicine and human biology. |- | width="307" valign="top"|[https://satoriproject.eu/media/4.a-Country-report-Austria.pdf The Advisory Board on Biotechnology and Genetic Engineering] | width="445" valign="top"|Advises the authorities on basic questions of genetic engineering in relation to GMOs in contained use, the deliberate release and placing on the market of GMOs, and genetic analysis and genetic therapy in human beings. |- | width="307" valign="top"|[https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=20008142 National Committee for the Protection of Animals used for scientific purposes] | width="445" valign="top"|Advises government on research ethics. |- | width="307" valign="top"|[https://oeawi.at/vereinsorgane/?lang=en Austrian Agency for Research Integrity – The Commission for Research Integrity] | width="445" valign="top"|Investigates cases of research misconduct in Austria, evaluates the severity of each violation and recommends follow-up measures. |- | width="307" valign="top"|[http://www.ethikkommissionen.at/ Research Ethics Committees (federal and local)] | width="445" valign="top"|Provide opinion on research ethics. Some of them serve both as hospital, university, and state committees. |} '"`UNIQ--references-000001B8-QINU`"'

B

Bulgaria +

The Ministry of Education and Science is an overseeing body for education and research in Bulgaria while the Parliament is the decision making a body for the higher education institutions. There is the Academic Ethics Committee under the Ministry of Education and Science '"`UNIQ--ref-0000005E-QINU`"'. Bulgaria has Ethics Committee for Multi-Centre Trials '"`UNIQ--ref-0000005F-QINU`"' and around 150 local ethics committees, registered by the Bulgarian Drug Agency '"`UNIQ--ref-00000060-QINU`"'. These committees are established across different institutions (universities, hospitals etc.). Each committee has from 7 to 12 members from different fields of medicine and at least two non-medical members. Moreover, at least one member has to be financially independent of the institution. The work of local ethics committees and the Ethics Committee for Multi-Centre trials is supervised by the Central Ethics Committee which is responsible to the Council of Ministers. The Central Ethics Committee serves as an appeal body for cases that have been rejected by local ethics committees and Ethics Committee for Multi-Centre Trials, providing guidance to those committees '"`UNIQ--ref-00000061-QINU`"''"`UNIQ--ref-00000062-QINU`"'. Institutions have their codes or standard operating procedures that serve as a guide for ethics committees. For example, major universities have standard operating procedures for their ethics committees '"`UNIQ--ref-00000063-QINU`"'. There are no research integrity officers in Bulgarian research institutions. With regard to investigation of alleged misconduct, this role is usually taken by ethics committees situated at universities, hospitals and research institutions. Academic Ethics Committee, established by Ministry of Education and Science, is responsible for handling cases of misconduct in academia '"`UNIQ--ref-00000064-QINU`"''"`UNIQ--ref-00000065-QINU`"'. Bulgaria has no legislation regarding whistleblower protection or legal definition of whistleblowing. The Administrative Procedure Code (applied only in the public sector) allows reporting corruption, mismanagement and other illegal or inappropriate acts that affect state or public interests. Moreover, the Law on Conflict of Interests states that anyone can report an alleged conflict of interest if he or she has information about violations in public office '"`UNIQ--ref-00000066-QINU`"'. {| class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" align="left" | width="307" valign="top"|'''Bodies for RE+RI''' | width="445" valign="top"|'''Scope''' |- | width="307" valign="top"|[http://www.eurecnet.org/information/bulgaria.html Ethics Committee for Multi-Centre Trials] | width="445" valign="top"|Deals with application assessment for the research that will be conducted in more than one institution in Bulgaria. |- | width="307" valign="top"|[https://www.mh.government.bg/en/ministry/commissions/central-ethics-committee/ Central Ethics Committee] | width="445" valign="top"|Gives opinions on deontological and ethical issues in clinical trials when approached by the ethics committees, Bulgarian Drug Agency or by the contracting authority. |- | width="307" valign="top"|[https://cdn2.euraxess.org/sites/default/files/news/act_on_development_acadstaff_022019.pdf Academic Ethics Committee] | width="445" valign="top"|Deals with cases of misconduct in academia regarding award system, conflict of interest among science teams and detecting cases of plagiarism. |} '"`UNIQ--references-00000067-QINU`"'

C

Croatia +

Law on Research and Higher Education addresses RI '"`UNIQ--ref-0000021B-QINU`"'. It was one of the first to address RI in Europe '"`UNIQ--ref-0000021C-QINU`"'. National Committee for Ethics in Research and Higher Education is the highest advisory national body appointed by the Parliament of the Republic of Croatia '"`UNIQ--ref-0000021D-QINU`"'. Its goal is to promote ethical principles and values in research and high education, in business and society, as well as the application of the modern technologies and protection of the environment. The Committee for Ethics in Research and Higher Education has oversight over the procedures and receives appeals to the decision of institutions. However, they cannot actually enforce their opinion to the institutions. They can initiate the procedure for revoking a doctoral degree, but this procedure has to be performed by the institutions. The decisions of the Committee have been published in the past, but the current law and the bylaws of the Committee are not clear on this issue. There are no recent publicly available decisions of the Committee. Institutions have ethics committees that deal with research misconduct allegations. They are not public, except when there is a media release. {| class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" align="left" | width="376" valign="top"|'''Bodies for RE+RI''' | width="376" valign="top"|'''Scope''' |- | width="376" valign="top"|[https://www.azvo.hr/en/ethics-committee-in-science-and-higher-education National Committee for Ethics in Research and Higher Education] | width="376" valign="top"|Promotes ethical principles and values in research and higher education. |} '"`UNIQ--references-0000021E-QINU`"' +

D

Denmark +

The Danish Ministry of Higher Education and Science supports the responsible research which should be aligned with the norms, values and expectations of society and create value for society in an ethical and responsible way. For this purpose, the Ministry organised conferences regarding responsible research and innovation. Moreover, research institutions in Denmark participate in the H2020 projects regarding research ethics and research integrity as a leader or partner . The Danish National Committee on Biomedical Research Ethics coordinates the work in 11 regional committees and provides guidelines and opinions among researchers '"`UNIQ--ref-00000088-QINU`"'. All research projects conducted in Denmark, involving human beings, human tissue, cells etc. must have a permission from the regional committee. Applications relating to a clinical trial must be submitted to the [https://www.ecdc.europa.eu/en/danish-health-and-medicines-authority Danish Health and Medicines Authority] and a Regional Committee on Health Research Ethics '"`UNIQ--ref-00000089-QINU`"'. Clinical trials concerning complex areas (e.g. for Advanced Therapy Medicinal Products) must be submitted to the National Committee on Health Research Ethics '"`UNIQ--ref-0000008A-QINU`"'. For the clinical trials of medicinal products, the sponsor must inform the [https://laegemiddelstyrelsen.dk/en/ Danish Medicines Agency] in the period of 90 days after completion of a trial, that the trial has been completed, and if it is a multinational trial the Agency must be informed after the trial is completed in Denmark. No later than one year after the trial has ended, the trial results must be entered in [https://eudract.ema.europa.eu/ EudraCT] '"`UNIQ--ref-0000008B-QINU`"'. Subsequently, data will be published on [http://www.clinicaltrialsregister.eu/ www.clinicaltrialsregister.eu]. In 2017, the Danish Research Misconduct Act came into force, establishing The Danish Committee on Research Misconduct - DCRM (previously Danish Committees on Scientific Dishonesty). The law stipulates the responsibility of DCRM to handle the cases of research misconduct. There is no right to appeal on decisions of DCRM to any other administrative authority. Those decisions are legally binding and sent directly to the parties involved in the case '"`UNIQ--ref-0000008C-QINU`"''"`UNIQ--ref-0000008D-QINU`"'. DCRM decisions are published in [https://ufm.dk/forskning-og-innovation/rad-og-udvalg/Naevnet-for-Videnskabelig-Uredelighedelighed/afgorelser/afgorelser Danish] and [https://ufm.dk/en/research-and-innovation/councils-and-commissions/The-Danish-Committee-on-Research-Misconduct/decisions/decisions English] in anonymised form, as well as annual report consisting investigated cases '"`UNIQ--ref-0000008E-QINU`"'. Work of the DCRM and compliance of institutions with the Act is supervised by the Ministry of Higher Education and Science '"`UNIQ--ref-0000008F-QINU`"'. While DCRM handles cases of research misconduct, each research institution is obliged to process cases of questionable research practices. If there is a possible case of research misconduct (falsification, fabrication and plagiarism), every institution has to make an initial assessment which will determine whether research misconduct is involved. If there has been misconduct in research, the case must be forwarded to DCRM which then opens an investigation. At the request of the Committee, the research institution at which the research was conducted assists the Committee regarding specific circumstances of the case '"`UNIQ--ref-00000090-QINU`"'. Research Misconduct Act stipulates the obligation of each institution to prepare a report about cases of the questionable research practices '"`UNIQ--ref-00000091-QINU`"'. The Danish Research Misconduct Act states that in processing cases of questionable research practices, research institutions can collaborate with other research institutions or external experts '"`UNIQ--ref-00000092-QINU`"'. The institutions send an annual report of handled cases of questionable research practices upon which the DCRM writes the annual report about research misconduct and status of questionable research practices '"`UNIQ--ref-00000093-QINU`"'. The Act states that anyone can raise a case concerning research misconduct by submitting a notification to the research institution at which the research was conducted. In the same time, it does not contain provisions regarding the protection of whistleblowers '"`UNIQ--ref-00000094-QINU`"'. The Danish Code of Conduct states that persons bringing forward suspicions in good faith should be protected from reprisals '"`UNIQ--ref-00000095-QINU`"'. Universities usually have special advisers, practice committees, ethics committees or research integrity officers, with the purpose of handling internal cases. Special advisers are appointed at the following universities: Aarhus University, Copenhagen Business School and University of Copenhagen '"`UNIQ--ref-00000096-QINU`"'. At the Aarhus University, special advisers on research integrity provide staff and students with advice regarding responsible research conduct and principles of research ethics '"`UNIQ--ref-00000097-QINU`"'. Practice committees are established at the following universities: Aarhus University, Aalborg University, Copenhagen Business School, IT University of Copenhagen, University of Copenhagen, Roskilde University, University of Southern Denmark '"`UNIQ--ref-00000098-QINU`"'. {| class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" align="left" | width="307" valign="top"|'''Bodies for RE+RI''' | width="445" valign="top"|'''Scope''' |- | width="307" valign="top"|[https://ufm.dk/en/research-and-innovation/councils-and-commissions/The-Danish-Committee-on-Research-Misconduct The Danish Committee on Research Misconduct] | width="445" valign="top"|Copes with cases of research misconduct. |- | width="307" valign="top"|[https://en.nvk.dk/ The National Committee on Health Research Ethics] | width="445" valign="top"|Ensures that health research projects are conducted responsibly and that the rights, safety and wellbeing of participants are protected. |- | width="307" valign="top"|[https://www.etiskraad.dk/english The Danish Council on Ethics] | width="445" valign="top"|Advises Danish Parliament in the aspect of biotechnology and works with ethical issues related to the health care sector. |- | width="307" valign="top"|[http://www.eurofawc.com/home/42 The Animal Ethics Council] | width="445" valign="top"|Provides advice and opinions to the Ministry of Environment and Food, regarding research involving animals. It also provides information to and engages in public debates about animal welfare and ethics. |- | width="307" valign="top"|[https://www.foedevarestyrelsen.dk/english/Animal/AnimalWelfare/The-Animal-Experiments-Inspectorate/Pages/default.aspx The Animal Experimentation Council] | width="445" valign="top"|Evaluates applications for animal experiments. The council members participate in inspections of faculties and experiments that use laboratory animals. |- | width="307" valign="top"|[https://www.lowinputbreeds.org/partners/ucph-cebra.html Danish Centre for Bioethics and Risk Assessment] | width="445" valign="top"|Provides advice regarding ethics in biological research. |} '"`UNIQ--references-00000099-QINU`"'

E

Estonia +

The Estonian Research Council promotes research integrity in Estonia '"`UNIQ--ref-000000A5-QINU`"', but there is no institution at the national level tasked with the implementation of research integrity among different institutions. [https://www.ut.ee/en/research-ethics-committee-university-tartu Research Ethics Committee of the University of Tartu] and [https://www.tai.ee/en/about-us/tallinn-medical-research-ethics-commitee Research Ethics Committee of the National Institute for Health Development] are two main ethics committees on research involving human subject. [https://www.sm.ee/et/eesti-bioeetika-ja-inimuuringute-noukogu The Estonian Committee on Bioethics and Human Research], established at the Ministry of Social Affairs, is responsible for ethics approvals concerning the research of [https://genomics.ut.ee/en/about-us/estonian-genome-centre Estonian Genome Center]. Together with the [https://www.agri.ee/et/eesmargid-tegevused/loomade-tervis-heaolu-ja-aretus/loomade-heaolu#loomkatsed Project Authorisation Committee for Animal Experiments], these committees provide oversight on research with humans or animals, but also in research involving human genes '"`UNIQ--ref-000000A6-QINU`"'. Estonian Research Ethics Committees write annual reports to the State Agency of Medicines and to the governmental bodies of their institution '"`UNIQ--ref-000000A7-QINU`"'. There are also two clinical ethics committees, the Ethics Committee of the Tallinn’s Children Hospital and Ethics Committee of the Tartu University Hospital '"`UNIQ--ref-000000A8-QINU`"'. Registration of clinical trials including medicinal products is mandatory and regulated by the Medicinal Products Act '"`UNIQ--ref-000000A9-QINU`"'. Ethics committees are also responsible for investigation of alleged research misconduct. For example, the Statute of the Research Ethics Committee of the University of Tartu states that in the case of the violation of research ethical principles, a member of the Committee has the right to delay the processing of the application or its approval until the circumstances are clarified '"`UNIQ--ref-000000AA-QINU`"'. The Estonian Code of Conduct for Research Integrity states that the research institution ensures the confidentiality of dealing with possible breaches and protects the dignity and inviolability of private life of all the parties involved '"`UNIQ--ref-000000AB-QINU`"'. Nevertheless, Estonia’s whistle-blower protection framework is one of the weakest in Europe. Public officials are required to report corruption and 2013 Amendment to Anti-Corruption Act protects public officials from retaliation. The country does not provide protection for public employees who report misconduct other than corruption or for private sector whistle-blowers. There is no anti-corruption institution in Estonia not agency that copes with whistle-blower issues. Corruption reports can be submitted to the Central Criminal Police through a hotline '"`UNIQ--ref-000000AC-QINU`"'. {| class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" align="left" | width="330" valign="top"|'''Bodies for RE+RI''' | width="421" valign="top"|'''Scope''' |- | width="330" valign="top"|[https://www.etag.ee/en/estonian-research-council/ Estonian Research Council] | width="421" valign="top"|Concentrates the funding of R&D and guarantees the better functioning of financing systems. |- | width="330" valign="top"|[https://www.agri.ee/et/eesmargid-tegevused/loomade-tervis-heaolu-ja-aretus/loomade-heaolu#loomkatsed Project Authorisation Committee for Animal Experiments] | width="421" valign="top"|Provides oversight on research involving animals. |- | width="330" valign="top"|[https://www.ut.ee/en/research-ethics-committee-university-tartu Research Ethics Committee of the University of Tartu] | width="421" valign="top"|Assesses the ethical aspects of human research in the field of medicine and natural sciences and other human research. |- |[https://tai.ee/en/about-us/tallinn-medical-research-ethics-commitee Research Ethics Committee of the National Institute for Health Development] |Provides its expert opinion for all surveys involving humans. |- | width="330" valign="top"|[https://www.sm.ee/et/eesti-bioeetika-ja-inimuuringute-noukogu Estonian Committee on Bioethics and Human Research] | width="421" valign="top"|Coordinates the activities of the committees and advises policy makers and governmental institutions in bioethics-related questions. It also participates in the preparation of relevant laws and governmental acts and educates the public about the issues in bioethics. Gives ethics approvals concerning the research of Estonian Genome Center. |} '"`UNIQ--references-000000AD-QINU`"'

F

Finland +

Finland has several national bodies for research ethics and research integrity. Finnish National Board on Research Integrity (TENK) is appointed by the Ministry of Education and Culture on the proposal of the scientific community. TENK monitors research integrity by following and compiling statistics on violations of responsible conduct of research and acting as an appeal body on RCR investigations. It has issued national guidelines on research integrity and on ethical review in the human sciences. All Finnish research organisations are committed to these guidelines '"`UNIQ--ref-0000027E-QINU`"'. Besides research integrity TENK also coordinates the ethical reviewing of the human sciences. Ethical review of non-medical research involving human participants is based on a set of guidelines drawn up by the Finnish National Board on Research Integrity TENK - [https://tenk.fi/sites/default/files/2021-01/Ethical_review_in_human_sciences_2020.pdf The ethical principles of research with human participants and ethical review in the human sciences in Finland. Finnish National Board on Research Integrity TENK guidelines 2019]. TENK has created a network of Research Integrity Advisers. It has trained more than 144 advisers in 74 research organisations that provide advices to researchers and other staff in their organisations '"`UNIQ--ref-0000027F-QINU`"'. Finland has 9 regional research ethics committees established by the University hospital districts '"`UNIQ--ref-00000280-QINU`"'. There are independent and voluntary based research ethics committees for other fields, such as humanities or studies on national registers at universities and research centres '"`UNIQ--ref-00000281-QINU`"'. There are also many local ethics committees in hospitals, research institutes and universities '"`UNIQ--ref-00000282-QINU`"'. Finnish institutions have a high degree of cooperation when it comes to handling violations of research integrity and research ethics. Procedures for dealing with misconduct can be found in TENK guidelines which were signed by all universities, majority of universities of applied sciences and publicly funded research institutions. Guidelines suggest that each institution should deal with possible cases of misconduct '"`UNIQ--ref-00000283-QINU`"'. Research organisations who signed the agreement for adhering to TENK guidelines have taken the responsibility to follow the procedures named in guidelines when it comes to dealing with cases of alleged violations of the responsible conduct of research. The decision whether a violation of research integrity occurred is brought by the rector of the university, or if the university so decides, the chancellor, the rector of a university of applied sciences, or the director of the research organisation. The allegations of research misconduct and decision related to the allegations are reported to TENK for the purpose of monitoring the compliance with guidelines. If a party in the process is unsatisfied with the decision, the TENK statement regarding the case can be requested. As of 2023, the due time for provision of a TENK statement is one month. TENK does not publish its concrete decisions, but according to the Finnish law of general publicity, all official documents are available for stakeholders. Usually, rector investigates the alleged violations of research integrity upon the notification but in some cases, it can conduct the investigation of allegations that have come to his/her attention from other channels. Furthermore, TENK can also initiate the investigation if it has reasons to suspect misconduct occurred at the research organisation. If the allegations of research misconduct are unfounded, the rector’s decision to stop the investigation process can be publicly announced. Moreover, if the investigation confirms the research misconduct the findings contained in the final report must be published at least in the publication channel where the fraudulent research findings or results based on fraudulent means have already been published. If the investigation finds that the person alleged of misconduct has not violated the responsible conduct of research, an effort must be made to publish the findings of the investigation in an appropriate publication channel if the person alleged of misconduct wants, or if there are other compelling reasons. TENK statements are publicly available and in its annual report cases of research misconduct are presented in the anonymous form '"`UNIQ--ref-00000284-QINU`"'. According to TENK guidelines, the written allegation of research misconduct cannot be submitted anonymously. Moreover, in accordance with The Act on Openness of Government, the research organisation is when sending the documents to TENK, obliged to take into account the secrecy obligations that apply to the information included in the documents '"`UNIQ--ref-00000285-QINU`"'. Interventional clinical trials on medicinal products must be reported to the Finnish Medicine Agency (FIMEA). FIMEA does not need to be notified of investigations other than interventional trials '"`UNIQ--ref-00000286-QINU`"'. The sponsor or the person responsible for the trial must provide a report on the results of the trial to FIMEA, not later than one year after the trial ends. The report on the results must also be submitted to the EU Clinical Trials Register '"`UNIQ--ref-00000287-QINU`"'. {| class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" align="left" | width="236" valign="top"|'''Bodies for RE+RI''' | width="516" valign="top"|'''Scope''' |- | width="236" valign="top"|[https://www.tenk.fi/en Finnish National Board on Research Integrity (TENK)] | width="516" valign="top"|Promotes the responsible conduct of research, prevents research misconduct, promotes discussion and spreads information on research integrity in Finland. It has issued national guidelines on research integrity and on ethical review in the human sciences. It acts as an appeal body on RCR investigations, monitors RI by following and complying statistics on violations of RCR, coordinates the ethical reviewing of the human sciences and provides advice in problematic situations. |- | width="236" valign="top"|[https://etene.fi/en/frontpage National Advisory Board on Social Welfare and Health Care Ethics (ETENE)] | width="516" valign="top"|Discusses general principles in ethical issues in the field of social welfare and health care. |- | width="236" valign="top"|[https://tukija.fi/en/frontpage National Committee on Medical Research Ethics (TUKIJA)] | width="516" valign="top"|Serves as an expert on research ethics, advises regional ethics committees in the matters of ethical principle related to medical research and provides training. It is responsible for issuing opinions on the ethics of clinical drug trials that are to be run in Finland unless this task is delegated to a regional ethics committee. The Committee also evaluates the conditions for establishing a biobank. |- | width="236" valign="top"|[https://mmm.fi/en/laboratory-animals Council on the protection of animals used for scientific or educational purposes] | width="516" valign="top"|Monitors and promotes the implementation of the principle of replacement, reduction and refinement (“3R principle”). It issues proposals and statements to promote the principle and gives statements on other important measures and proposals concerning the use and welfare of animals used for scientific or educational purposes. |- | width="236" valign="top"|[http://www.btnk.fi/en/ National Advisory Board on Biotechnology] | width="516" valign="top"|Promotes cooperation between authorities, researchers and operators in biotechnology, monitors developments and research in gene technology as well as its health and environmental impacts. In addition, the Board monitors and promotes international cooperation in biotechnology and takes into account the ethical considerations of gene technology. |- | width="236" valign="top"|[https://geenitekniikanlautakunta.fi/en/frontpage Board for Gene Technology] | width="516" valign="top"|Acts as the authorising body regarding the use of genetically modified organisms in accordance with the Gene Technology Act (377/1995). |} '"`UNIQ--references-00000288-QINU`"'

France +

[https://www.hceres.fr/sites/default/files/media/downloads/2015_French_RI_Charter_0.pdf National charter for research integrity] was introduced in 2015. It is aligned with [https://euraxess.ec.europa.eu/jobs/charter/european-charter European Charter for Researchers], [https://wcrif.org/guidance/singapore-statement Singapore Statement on Research Integrity] and [https://allea.org/code-of-conduct/ European Code of Conduct for Research Integrity]. The Charter addresses compliance with legislative and regulatory requirements, reliability of research work, communication, responsibility in collective work, impartiality and independence in assessment and expertise, collaborative work and plurality of activities, and training. By the end of April 2019, more than 45 research institutions signed the Charter agreeing to abide by seven principles in the field of professional ethics '"`UNIQ--ref-00000010-QINU`"'. In 2017, the French [https://www.hceres.fr/en/french-office-research-integrity Office for Research Integrity (OFIS)] was established as a department of [https://www.hceres.fr/en/missions High Council for Evaluation of Research and Higher Education]. Its purpose is threefold: - Monitoring, particularly in the context of the new forms that research is taking (participatory science, big data, data reuse, open science); - Observation of compliance with the code of ethics for research professions by the institutions that have adopted it since 2015; - Coordination of national scientific communities on issues of scientific integrity, particularly through the network of advisers in the establishments that have signed the charter. The OFIS benefits from the conditions to guarantee its independence to support, coordinate and facilitate the action of higher education and research establishments which have signed the charter '"`UNIQ--ref-00000011-QINU`"'. OFIS is the national advisory body on research integrity in France '"`UNIQ--ref-00000012-QINU`"'. The French Advisory Board for Research Integrity guides and oversees the work of the OFIS '"`UNIQ--ref-00000013-QINU`"'. The [https://www.ccne-ethique.fr/en/pages/presenting-national-consultative-ethics-committee-health-and-life-sciences National Consultative Ethics Committee for Health and Life Sciences] (CCNE) has an advisory role in dealing with ethical concerns in the community '"`UNIQ--ref-00000014-QINU`"'. Further, the National Committee for Ethics in Animal Research brought up a [https://cache.media.enseignementsup-recherche.gouv.fr/file/Encadrement_des_pratiques_de_recherche/58/1/Charte_nationale_portant_sur_l_ethique_de_l_experimentation_animale-version_anglaise_243581.pdf National charter on the ethics of animal experimentation]. There are 39 Ethics Committees in France. These Committees of Protection of Persons (CPP) are divided up into 7 regions all over the country '"`UNIQ--ref-00000015-QINU`"'. Research institutions, such as universities, the [http://www.cnrs.fr/fr/le-cnrs National Center for Scientific Research (CNRS)], [https://www.inserm.fr/en National Institute for Health and Medical Research (INSERM)] and the [https://www.cirad.fr/en French Agricultural Research Centre for International Development (CIRAD)], are obliged to prevent and handle misconduct cases. Generally, these institutions have investigatory and decision-making authority '"`UNIQ--ref-00000016-QINU`"'. The French legal system provides protection for whistle-blowers. “Sapin II” law from 2016 requires that companies establish internal whistleblowing hotlines which would allow employees to report violations of the corporate code of conduct. Disclosure of confidential information about whistle-blowers or alleged violators may be punishable by two years of incarceration or a fine of €300,000 '"`UNIQ--ref-00000017-QINU`"'. This can be applied in private companies with at least 50 employees '"`UNIQ--ref-00000018-QINU`"'. {| class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" align="left" | width="257" valign="top"|'''Bodies for RE+RI''' | width="494" valign="top"|'''Scope''' |- | width="257" valign="top"|[https://www.hceres.fr/fr/ofis The French Office for Scientific Integrity (OFIS)] | width="494" valign="top"|Provides support to higher education and research institutions, observes implementation of the National charter, contributes to the promotion of research integrity at the national and international level. |- | width="257" valign="top"|[http://www.eurecnet.org/information/france.html Ethics Committees (Committees for the Protection of Persons)] | width="494" valign="top"|Have responsibility for decisions concerning interventional studies, standard of care studies, medical and other health products and further research areas. |- | width="257" valign="top"|[https://www.ccne-ethique.fr/en/pages/presenting-national-consultative-ethics-committee-health-and-life-sciences The National Consultative Ethics Committee for Health and Life Sciences (CCNE)] | width="494" valign="top"|Has an advisory role in dealing with ethical concerns in the community. All issues of medically assisted procreation and experiments on humans have to be addressed by the CCNE. |- | width="257" valign="top"|[http://www.cnrs.fr/en/cnrs The National Centre for Scientific Research (CNRS)] | width="494" valign="top"|Conducts research, transfers research results, trains through research and contributes to scientific policy. |- | width="257" valign="top"|[https://www.recherche-animale.org/sites/default/files/scientific_research_and_animal_experimentation_-_state_of_affairs.pdf The National Commission on Animal Experimentation (CNEA)] | width="494" valign="top"|Promotes good practices in breeding, care and handling of laboratory animals. |- | width="257" valign="top"|[https://www.assemblee-nationale.fr/11/documents/index-oecst-gb.asp Parliamentary Office for evaluation] [https://www.assemblee-nationale.fr/11/documents/index-oecst-gb.asp of scientific and technological options (OPECST)] | width="494" valign="top"|Informs Parliament of scientific and technological options in order to make its decisions clear. It collects information, launches study programmes and carries out assessments. |- | width="257" valign="top"|[http://www.hautconseildesbiotechnologies.fr/en/article/what-hcb-does The High Council on Biotechnology - Scientific Committee and Economic, Ethical and Social Committee] | width="494" valign="top"|Advises the French government on issues relating to GMOs and other types of biotechnology. |- | width="257" valign="top"|[https://www.assemblee-nationale.fr/commissions/plaquette_opecst_anglais.pdf The Parliamentary Office for Scientific and Technological Assessment] | width="494" valign="top"|Collects information, launches study programmes and carries out assessments in order to inform Parliament of the consequences of the choice of scientific and technological options. |- | width="257" valign="top"|[https://www.enseignementsup-recherche.gouv.fr/cid138740/le-college-de-deontologie-de-l-enseignement-superieur-de-la-recherche-et-de-l-innovation.html Council of Deontology - French Ministry of Education, Higher Education and Research] | width="494" valign="top"|Takes part in a network of national bodies competent in matters of deontology, ethics and integrity. |} '"`UNIQ--references-00000019-QINU`"'

G

Greece +

There are two national bodies for research ethics and research integrity in Greece – the National Bioethics & Technoethics Committee (which replaced National Bioethics Commission), having consultative role, and the National Ethics Committee for Clinical Trials of the Ministry of Health at the National Organization for Medicines, the only relevant organisation with legal mandate in Greece '"`UNIQ--ref-000001CC-QINU`"'. Apart from those, the National Committee for the Protection of Animals used for Scientific Purposes (NCPASC) was established in 2013 as an entity of the Ministry of Rural Development and Food and advisory body regarding matters related to research with animals '"`UNIQ--ref-000001CD-QINU`"'. Besides the national organisations, there are local institutional research ethics committees in all Universities and Research Centres with the task of dealing with issues of research integrity as well '"`UNIQ--ref-000001CE-QINU`"'. All Greek Universities must have a Deontology Committee (DC). DCs are manned by the Deans and the vice-Rector responsible for Academic Affairs, Student Care and Lifelong Education. Their responsibilities include drafting a Code of Conduct (CoC) for academic, administrative and research issues, safeguarding the application of the CoC and pinpoint research misconduct, preparing an annual report concerning the application of the CoC and suggest any needed additions and examining allegation of research misconduct coming from the institute's community. If such an allegation has a basis a report is sent to the Rector to proceed with a formal investigation '"`UNIQ--ref-000001CF-QINU`"'. From March 2018, a Research Ethics and Deontology Committee (REDC) is active in each RPO. Their main task is to apply ethical assessment in research proposals '"`UNIQ--ref-000001D0-QINU`"'. All Greek Research Performing Organisations must also have Research Ethics and Deontology Committee (REDC) '"`UNIQ--ref-000001D1-QINU`"'. [http://139.91.151.169/index_main.php?c=46&l=e FORTH Ethics Committee (FEC)], created in 2005, is an advisory body for the research personnel of FORTH. FEC provides ethical review of research proposals submitted by the researchers. There are also two networks regarding research integrity, which work on the promotion and training to help scientists comply with the highest standards of research ethics and research integrity '"`UNIQ--ref-000001D2-QINU`"'. [http://earthnet.ntua.gr/description/?lang=en Ethical Aspects in Research and Technology for Human (EARTHnet)] is a leading network regarding RE+RI. The network works on raising awareness among Greek academic community on research ethics and research integrity issues, promotes the institutionalisation of a national code of conduct for research and the establishment of a national research ethics and research integrity committee. [http://www.rcr.gr/index.php/en/ The Network of Responsible Conduct of Research in Greece (RCR-Greece)] was founded by researchers, professors, scientists and professionals to promote research integrity and for the purpose of education and training for scientists in the field of research integrity. Greece does not have a national code of conduct for research integrity but most universities have developed their codes, together with the code of research ethics. One of the priorities of the EARTHnet is to promote the establishment of the national research ethics and research integrity committee and drafting the National Code of Conduct for Research '"`UNIQ--ref-000001D3-QINU`"'. Ad-hoc committees or Research Performing Organisations, for example universities and research institutions, cope with cases of research misconduct. The procedures are described by the internal Code of Conduct of each institution '"`UNIQ--ref-000001D4-QINU`"'. The publication of cases of misconduct depends on each institution. For example, the Technological Educational Institute of Crete in its Code of Ethics states that sharing information with the community will be discussed in each case and then decided whether to publish information or not '"`UNIQ--ref-000001D5-QINU`"'. Greece does not have a law or a provision on whistleblower protection, so it is obliged to comply with the 2019 EU Directive to implement an ad-hoc legislation by the end of 2021 '"`UNIQ--ref-000001D6-QINU`"'. {| class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" align="left" | width="307" valign="top"|'''Bodies for RE+RI''' | width="445" valign="top"|'''Scope''' |- | width="307" valign="top"|[http://www.bioethics.gr/index.php/en National Bioethics Commission] [https://www.thenationalherald.com/greece_sciences/arthro/greece_establishes_a_national_bioethics_and_technoethics_committee-2214392/ (National Bioethics and Technoethics Committee)] | width="445" valign="top"|Investigates the ethical, social and legal aspects arising from research advances in biology, biotechnology, medicine genetics as well as those related to the development and social integration of new and emerging technologies. It also provides recommendations to the Prime Minister and the Parliament, collaborates with international organizations and related bodies, represents Greece to international fora, and informs the public on issues regarding biotechnological advances and the impact of their applications. It publishes the e-journal “[http://www.bioethics.gr/index.php/journal-bio-ethica BIOETHICA]” and it organises educational activities for [http://www.bioethics.gr/index.php/enimerosi schools]. |- | width="307" valign="top"|[https://www.eof.gr/web/guest National Organization for Medicines] | width="445" valign="top"|Aims to promote and regulate good clinical practice in the conduct of clinical trials. Moreover, it issues approval for clinical trials. |- | width="307" valign="top"|[http://anilab.decentral.minagric.gr/index.php/en/ National Committee for the Protection of Animals used for Scientific Purposes (NCPASC)] | width="445" valign="top"|Provides advices to the competent authorities, to the animal welfare bodies as well as to the Protocol Evaluation Committees on matters relating to the acquisition, breeding, accommodation, care and use of animals in procedures, for issues of the continuing education and training of persons who are involved in the implementation of the P.D. 56/2013 and also ensures the exchange and communication of best practices. It exchanges information on the functioning of the animal welfare bodies and the evaluation of projects by the competent central authority, as well as on best practices within the European Union. |} '"`UNIQ--references-000001D7-QINU`"'

I

Ireland +

Ireland has two national bodies for research ethics and research integrity – the National Forum on Research Integrity '"`UNIQ--ref-0000003E-QINU`"' and the National Office for Research Ethics Committees '"`UNIQ--ref-0000003F-QINU`"'. The National Forum on Research Integrity, established in June 2015, is coordinated by the Irish Universities Association (IUA) and the Technological Higher Education Association (THEA). One of its goals is to support the implementation of research integrity policies. To that end, it has released a National [https://www.iua.ie/wp-content/uploads/2019/08/IUA_Research_Integrity_in_Ireland_Report_2019.pdf Policy Statement on Ensuring Research Integrity in Ireland], revised in 2019 to align with the European Code of Conduct for Research Integrity '"`UNIQ--ref-00000040-QINU`"'. It has also developed guidelines for HEIs on improving their research integrity processes and will publish a Framework for ensuring Research Integrity in Collaborative Agreements in 2021. The National Research Integrity Forum has a broad membership, including representation from all publicly funded higher education institutions, government research institutions, research funders and the state agencies responsible for quality and regulation of the higher education system '"`UNIQ--ref-00000041-QINU`"'. While the Health Research Board (HRB), one of the members of the National Forum, was the first to develop policies and guidelines for the promotion of research integrity, all funding agency members now have these in place. In addition, the Higher Education Authority, who provide core funding and governance oversight for the higher education sector in Ireland issued its own principles of good research practice for the HE Sector in 2020 '"`UNIQ--ref-00000042-QINU`"'. There are numerous research ethics committees in higher education institutions and hospitals/healthcare settings of which 12, based in hospitals, were recognised by the Department of Health for the purpose of providing ethics approval for regulated clinical trials '"`UNIQ--ref-00000043-QINU`"'. However, with the advent of the National Research Ethics Committees, approval for multicentre regulated clinical trials, and trials involving medical devices will in future be provided centrally through the relevant National Research Ethics Committee '"`UNIQ--ref-00000044-QINU`"'. The National Office for Research Ethics Committees is an important new addition to the research environment in Ireland. While they dealt exclusively with Covid-19 projects in 2020, in 2021 and beyond they will establish National Research Ethics Committees (NRECs) in prescribed areas of multi-site health research and absorb the currently recognised committees. In addition, there are many research ethics committees in universities and other research institutions that provide approval for non-regulated healthcare interventions and experimentation involving human subjects and tissue, and animals. It is hoped that, in the case of multicentre research studies requiring this type of ethics approval, the development of future committees by the NREC will harmonise and centralise this activity to some extent. When it comes to handling allegations of research misconduct, the National Forum has established guidelines for their members to make uniform their policies and practices. [https://www.iua.ie/wp-content/uploads/2019/08/Guidelines-for-RI-investigations-FINAL-17-08-16-1.pdf The Guidelines for the Investigation of Misconduct in Research] do not oblige adoption of a single standardised procedure but provide principles and guidelines. According to these guidelines, allegations of misconduct should be sent to the Research Integrity Officer (RIO) anonymously and backed up by any available evidence. Then, the research institution where the researcher is employed or is a registered research student performs the investigation. The National Forum also collects and publishes data on misconduct investigations in member organisations on an annual basis '"`UNIQ--ref-00000045-QINU`"'. The Protected Disclosures Act 2014 aims to protect people who raise concerns about possible wrongdoing in the workplace (including, but not limited to, research misconduct). The Act, which came into effect on 15 July 2014, is often called the whistleblower legislation. It provides for redress for employees who are dismissed or otherwise penalised for having reported possible wrongdoing in the workplace '"`UNIQ--ref-00000046-QINU`"'. {| class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" align="left" | width="271" valign="top"|'''Bodies for RE+RI''' | width="480" valign="top"|'''Scope''' |- | width="271" valign="top"|[http://www.iua.ie/wp-content/uploads/2014/06/National-Policy-Statement-on-Ensuring-Research-Integrity-in-Ireland-2014.pdf The National Forum on Research Integrity] | width="480" valign="top"|Aims to support the implementation of research integrity policies, including training, and to ensure alignment with international and best practices for research integrity. |- | width="271" valign="top"| [https://www.nrecoffice.ie/ The National Office for Research Ethics Committees] | width="480" valign="top"|Working alongside local research ethics committees and supported by the National Office team, the NRECs will work in a mixed-model system to support research ethics across the spectrum of health research in Ireland. |} '"`UNIQ--references-00000047-QINU`"'

L

Lithuania +

Lithuania has several national bodies for research integrity: The Lithuanian Committee for Medical Ethics, established under the Ministry of Health in 1995 and later renamed to the Lithuanian Bioethics Committee '"`UNIQ--ref-00000049-QINU`"', the Office of the Ombudsperson for Academic Ethics and Procedures '"`UNIQ--ref-0000004A-QINU`"', the Pharmaceutical Marketing Ethics Commission and Research Council of Lithuania '"`UNIQ--ref-0000004B-QINU`"'. Regional research ethics committees are based at the universities with the tertiary medical education level. For the ethical supervision of biomedical research in the Kaunas region, the Kaunas Regional Biomedical Research Ethics Committee was established at the Kaunas Medical University in 2001. The Vilnius Regional Biomedical Research Ethics Committee was established at Vilnius University in 2008. Since 1997, hospital ethics committees have been established in most healthcare institutions '"`UNIQ--ref-0000004C-QINU`"'. The State Medicines Control Agency (SMCA) is Lithuanian governmental body responsible for approval of clinical trials regarding medicinal products '"`UNIQ--ref-0000004D-QINU`"'. Lithuania does not have a national code of research conduct, but it has several codes of ethics related to professional ethics in the medical field '"`UNIQ--ref-0000004E-QINU`"'. Higher education institutions have their codes of academic ethics that encompass research ethics too. This approach allowed to ensure the autonomy of higher education institutions in developing and specifying their code of academic ethics. Furthermore, higher education institutions are encouraged to implement Guidelines for Ethical Review '"`UNIQ--ref-0000004F-QINU`"', developed and approved by the Ombudsperson for Academic Ethics and Procedures. Codes of ethics of all higher education institutions are publicly available on their websites. Also, the Lithuanian University Rectors’ Conference took the lead to develop Guidelines for Publication Ethics which were publicized in 2019 '"`UNIQ--ref-00000050-QINU`"'. Office of the Ombudsperson for Academic Ethics and Procedures is responsible for handling allegations related to academic ethics and procedures in academia. The Office encourages higher education institutions to adhere to academic ethics and procedures, monitors their compliance with recommendations for approval, implementation, and monitoring codes of academic ethics, and cooperates in solving problems related to violations of academic ethics and procedures. The investigation is conducted upon received complaints or at the own motion. All [https://etikostarnyba.lt/en/decisions/ decisions] of the Ombudsperson are anonymised and publicly available online for a year within one month if they are not appealed to court '"`UNIQ--ref-00000051-QINU`"'. The new Law on Protection of Whistle-blowers entered into force in 2019. The Law applies to both public and private sectors. Its aim is to create conditions for individuals, including employees, to confidentially provide information about a suspected infringement and to avoid negative consequences related to whistleblowing. Individuals can disclose information about a criminal or administrative violation, inappropriate conduct by a colleague and other infringements that might affect the public interest. According to this Law, a whistle-blower does not have to be sure that the information is correct or to have evidence. The whistle-blower will still be legally protected '"`UNIQ--ref-00000052-QINU`"'. {| class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" align="left" | width="295" valign="top"|'''Bodies for RE+RI''' | width="456" valign="top"|'''Scope''' |- | width="295" valign="top"|[http://bioetika.sam.lt/index.php?1608991497 The Lithuanian Bioethics Committee (LBC)] | width="456" valign="top"|Provides advice to the governmental bodies, informs the general public about bioethical issues, and coordinates activities of the regional ethics committees. It issues approvals to conduct biomedical research and opinions for clinical trials on medicinal products, prepares legal documents related to the ethical review of research, submits amendments to them and consults on ethical and legal aspects of biomedical research. |- |[https://etikostarnyba.lt/en/main Office of the Ombudsperson for Academic Ethics and Procedures of the Republic of Lithuania] |Responsible for the handling of complaints and initiation of investigations on higher education institutions’ violations related to academic ethics and procedures. The Office is also responsible for undertaking preventive actions (e.g., training, consultancy). |- | width="295" valign="top"|[https://www.vaistukodeksas.lt/en/pharmaceutical-marketing-ethics-commission/ The Pharmaceutical Marketing Ethics Commission] | width="456" valign="top"|Supervises companies’ compliance with the Code of Ethics for governing pharmaceutical marketing and relations with health care professionals as well as relations between the pharmaceutical industry and patient organisations. |- | width="295" valign="top"|[https://www.lmt.lt/en The Ethics Commission of the Scientific Council (Research Council of Lithuania)] | width="456" valign="top"|Oversees research and knowledge exchange functions in relation to universities and institutes which includes providing block grant funding to the national research and education institutions, for research and development, developing and implementing national funding streams, supporting, and encouraging academic participation in EU Framework Programmes, overseeing the sustainability of the Higher Education research base in Lithuania, and promoting international collaborations. |} '"`UNIQ--references-00000053-QINU`"'

Luxembourg +

Luxembourg has four national bodies for research ethics and research integrity: The National Research Ethics Committee (CNER) '"`UNIQ--ref-0000030C-QINU`"', National Data Protection Commission (CNPD) '"`UNIQ--ref-0000030D-QINU`"', National Consultative Ethics Committee for Life Sciences and Health (CNE) '"`UNIQ--ref-0000030E-QINU`"' and National Commission for Research Integrity - The Luxembourg Agency for Research Integrity (LARI) '"`UNIQ--ref-0000030F-QINU`"'. Luxembourg does not have a national code of research conduct, but all research institutions have developed guidelines and policies for good research practice, research integrity, and ethics in research. In most cases, Luxembourg follows the guidelines of the [https://allea.org/code-of-conduct/ European Code of Conduct for Research Integrity] and of the League of European Research Universities “Towards a Research Integrity Culture at Universities: from recommendation to implementation” '"`UNIQ--ref-00000310-QINU`"'. The University of Luxembourg has established several committees for handling questions in the field of research ethics. - The Ethics Advisory Committee provides advice on ethical issues involved in the activities of the university’ community, addresses complaints, and conducts investigations regarding alleged discrimination at the university. The investigation and advice are provided upon request of the University Council or the Rectorate '"`UNIQ--ref-00000311-QINU`"'. - The ombudsman's office offers conflict management coaching, shuttle diplomacy, mediation, restorative circles and conferences to mitigate workplace conflicts '"`UNIQ--ref-00000312-QINU`"'. - The Ethics Review Panel is responsible for providing ethics reviews of research proposals and publications regarding human participants, human biological material, animals, or potentially harmful changes to the environment '"`UNIQ--ref-00000313-QINU`"'. - The Animal Experimentation Ethics Committee (AEEC) is responsible for ensuring, on behalf of the University of Luxembourg, that care and use of animals for research and teaching are conducted in compliance with the law regulating the protection of animals used for scientific purposes '"`UNIQ--ref-00000314-QINU`"'. - The Biosafety Committee is responsible for ensuring compliance with the biosafety policies and measures at the University of Luxembourg '"`UNIQ--ref-00000315-QINU`"'. - The doctoral education agreement (DEA) defines the role and duties of the supervisee and the supervisor and describes the tasks foreseen in the doctoral thesis work plan. It also provides information and contacts related to data protection, intellectual property, ethics and research integrity. Should a conflict persist, an escalation path is proposed '"`UNIQ--ref-00000316-QINU`"'. - The University hosts a Dispute Committee is an independent administrative body, yet internal to the institution, whose mission is to decide, in law, according to an adversarial (quasi-judicial) procedure, certain categories of disputes between, on the one hand, the “users” of the University (ie current students, former students and / or potential students of the University of Luxembourg) and, on the other hand, the decision-making bodies of the University of Luxembourg '"`UNIQ--ref-00000317-QINU`"'. The Luxembourg Agency for Research Integrity (LARI) is responsible for handling alleged cases of research misconduct. The cases are investigated by the Commission for the Research Integrity (CRI) which is a part of LARI '"`UNIQ--ref-00000318-QINU`"'. The Commission may be called upon by any person or organisation with a legal capacity which has knowledge of suspected scientific misconduct occurring in LARI member organisations. Moreover, the Commission may also investigate cases of suspected scientific misconduct on their own initiative. If the case of alleged misconduct has happened more than 10 years ago, the Commission can refuse to handle the cases. After reviewing the case, the commission will take the decision to conduct an investigation, not to initiate an investigation, or suspend the case '"`UNIQ--ref-00000319-QINU`"'. If the Commission decides to initiate the investigation, its decision will be sent to the person or organisation that has reported the case, the person(s) to whom the allegations refer to, the head of the affected research institution, and the National Research Fund (FNR) if the case occurs in relation with the FNR funded project or researcher. In exceptional cases, the Commission can decide not to communicate the decision to abovementioned parties due to the higher priority of protecting the accused person. Upon completion of the investigation, the Commission member leading the investigation shall compose a summary opinion which contains an assessment of the results of the investigation. This will be presented to other members for approval. The opinion is further sent to the person or institution which called upon Commission if it is directly affected by allegations, and to the person to whom the allegation referred. The opinion is also sent to the LARI Board for information purposes '"`UNIQ--ref-0000031A-QINU`"'. Luxembourg law does not have a formal definition of the term “whistleblowing”. There are specific provisions in the Labour Code designed to protect public and private sector employees who report alleged corruption or abuse of influence in their workplace. The employees are protected if the reports are made in good faith. These provisions protect employees from employment agreement reprisals and terminations due to whistleblowing '"`UNIQ--ref-0000031B-QINU`"'. {| class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" align="left" | width="297" valign="top"|'''Bodies for RE+RI''' | width="455" valign="top"|'''Scope''' |- | width="297" valign="top"|[https://lari.lu/about/about-lari/ The Luxembourg Agency for Research Integrity (LARI)] | width="455" valign="top"|Provides free research ethics consultations for researchers. It is also responsible for addressing cases of alleged research misconduct. |- | width="297" valign="top"|[https://www.cner.lu/en-gb/About-us National Research Ethics Committee (CNER)] | width="455" valign="top"|It is responsible for the protection of participants in clinical trials involving experimental drugs, therapies and medical devices. Besides clinical trials, CNER protects people included in different research studies, e.g. academic research. |- | width="297" valign="top"|[https://cne.public.lu/fr/commission.html The National Consultative Commission of Ethics for Life Sciences and Health (CNE)] | width="455" valign="top"|It is responsible for addressing ethical concerns in the fields of biology, medicine, and health. The Committee can address concerns on its own initiative or at the request of Government and respective European Directives. |- | width="297" valign="top"|[https://cnpd.public.lu/en/commission-nationale/missions.html National Data Protection Commission (CNPD)] | width="455" valign="top"|CNPD verifies the legality of the processing of personal data and ensures that the personal freedom and rights regarding data protection are respected. Research projects involving humans also have to be notified to or authorized by the CNPD. |} '"`UNIQ--references-0000031C-QINU`"'

M

Moldova +

Moldova does not have an official structure for research integrity. The National Authority for Integrity is dealing only with public servants and head of institutes '"`UNIQ--ref-0000012D-QINU`"'. It ensures the integrity in the exercise of a public office or public dignity and the prevention of corruption through the control of the property and personal interests and the observance of the legal regime of conflicts of interests, incompatibilities and restrictions '"`UNIQ--ref-0000012E-QINU`"'. There are no trainings in research integrity intended for research integrity officers '"`UNIQ--ref-0000012F-QINU`"'. The State Agency for Intellectual Property, a public institution under the authority of the Government, performs seminars in the field of intellectual property protection on industrial property rights, copyrights and neighbouring rights. The aim of these seminars is to strengthen knowledge in the field of copyright protection and related rights. The target groups are mainly teachers and students. The seminars are not compulsory and the outcomes are not assessed '"`UNIQ--ref-00000130-QINU`"'. The National Agency for Research and Development (NARD) was established in 2018. It is a central administrative authority under the Government of the Republic of Moldova. NARD is responsible for the implementation of the research, innovation and development of national policy, the EU Framework Programme for Research and Innovation Horizon 2020 and other European Programmes, and the coordination of Moldovan Office for Science and Technology in Brussels (MOST). Its overall objective is to ensure excellence and performance in achieving national priorities in the areas of research, innovation and development '"`UNIQ--ref-00000131-QINU`"'. The Academy of Sciences of Moldova (ASM) is the highest scientific forum of the country. It coordinates scientific and innovation activity, serves as a scientific consultant of the public authorities of the Republic of Moldova, and it has an autonomous statute and acts on the basis of self-administration principles '"`UNIQ--ref-00000132-QINU`"'. Universities have courses on Professional ethics and culture at the graduate level and masters’ degree level which are designed by the faculties themselves '"`UNIQ--ref-00000133-QINU`"'. By the decision of the minister of Education no. 1045/2015 the courses on professional ethics and culture are compulsory and the outcomes are assessed. At the end of the course students have examinations '"`UNIQ--ref-00000134-QINU`"'. Usually in Universities, especially in the State University of Medicine and Pharmaceuticals, there are Commissions/Committees of ethics which are approved by the Senates. Academy of Sciences also has ethics committees. No education is provided for the members of the commissions/committees '"`UNIQ--ref-00000135-QINU`"'. The degree of cooperation between universities and research institutions is very weak, given the heavy teaching workload for university professors (up to 1000 hours/year) and lack of research grants incentivizing cooperation and/or mobility between the two sides '"`UNIQ--ref-00000136-QINU`"'. Clinical trials require the approval of the Agency for Medicines and Medical Devices '"`UNIQ--ref-00000137-QINU`"'. Moldova does not have a national document regarding research integrity '"`UNIQ--ref-00000138-QINU`"'. At some extent, the Code of Professional Ethics and Deontology for Scientific and Didactico-Scientific Staff adopted by the National Agency for Quality Assurances in Education and Research is interpreted as national guide in the field '"`UNIQ--ref-00000139-QINU`"'. Institutional ethics committees deal with cases of misconduct. These cases are usually solved institutionally and are not publicly available. There were only a few cases, referring to public people, which were made publicly available (plagiarized PhD thesis). In practice, there were approved ad hoc commissions designated by the different institution to investigate cases. Usually, the commission proved even the misconduct; the court had another opinion '"`UNIQ--ref-0000013A-QINU`"'. Moldova does not have a whistleblower law and there is no specific legal protection for whistleblowers in the private sector. The only development in recent years has been the 2013 Framework Regulation on Whistleblowers, which has created a system to provide civil servants with opportunities to report wrongdoing within public authorities and protect them from retaliation. This Framework has required all government agencies to enact whistleblower procedures. The government’s National Anticorruption Centre (NAC) is overseeing its implementation '"`UNIQ--ref-0000013B-QINU`"'. '"`UNIQ--references-0000013C-QINU`"'

N

Netherlands +

The Netherlands Research Integrity Network (NRIN) is responsible for promoting research integrity. It is intended for raising awareness, providing relevant information and discussing issues related to research integrity and responsible conduct of research.'"`UNIQ--ref-0000003B-QINU`"' It also aims to facilitate collaboration, exchange and mutual learning by offering training and education for different audiences, developing and exchanging teaching materials and best practices, enabling of consultation and intervision, and providing advice to decision makers.'"`UNIQ--ref-0000003C-QINU`"' As for allegations of research misconduct, research institutions have Boards responsible for investigations. Institutions are affiliated with the Netherlands Board on Research Integrity (LOWI), an independent body, established by the Royal Netherlands Academy of Arts and Sciences (KNAW), the Netherlands Organisation for Scientific Research (NWO), and the Association of Universities in the Netherlands (VSNU). The LOWI advises the Boards of its affiliated institutions, such as universities and research institutes, regarding possible violations of principles of research integrity. The LOWI’s task is to advise the Board on complaints concerning a (provisional) decision regarding the alleged violation of the principles of research integrity by one or more Defendants. The LOWI meetings are not open to the public but their opinions/conclusions are published on the LOWI website, in anonymised form.'"`UNIQ--ref-0000003D-QINU`"' The Netherlands has Central Committee on Research Involving Human Subjects (CCMO) and 18 accredited Medical Research Committees (MRECs) that are responsible for reviewing medical scientific research with human subjects.'"`UNIQ--ref-0000003E-QINU`"' Whistleblowers are legally protected in The Netherlands. General protection of whistle-blowers is defined in the Dutch House for whistleblowers Act. Also, scientific integrity counsellors have been appointed at universities and KNAW and NWO institutes to provide assistance to whistleblowers and those accused of scientific misconduct.'"`UNIQ--ref-0000003F-QINU`"''"`UNIQ--ref-00000040-QINU`"' {| class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" align="left" | width="226" valign="top"|'''National bodies for RE+RI''' | width="236" valign="top"|'''Scope''' |- | width="226" valign="top"|[https://lowi.nl/ Netherlands Board on Research Integrity (LOWI)] | width="236" valign="top"|The LOWI advises the Boards of its affiliated institutions regarding alleged violations of principles of research integrity. |- | width="226" valign="top"|[https://www.ceg.nl/about-ceg The Netherlands Centre for Ethics and Health] | width="236" valign="top"|The CEG identifies and informs about developments in the field of health which deserve a place on the government’s ethical policy agenda. |- | width="226" valign="top"|[https://english.ccmo.nl/ The Central Committee on Research Involving Human Subjects] | width="236" valign="top"|The CCMO protects subjects taking part in medical research by reviewing the research on the basis of the statutory provisions laid down for them and taking into account the interests of medical progress. |- | width="226" valign="top"|[https://english.ncadierproevenbeleid.nl/ The Central Committee on Animal Experimentation] | width="236" valign="top"|The CCD is the only institution which can grant permits for animal experiments. |- | width="226" valign="top"|[https://www.loketgentherapie.nl/en/gene-therapy-office/overview-of-assessment-bodies/cogem The Netherlands Commission on Genetic Modification] | width="236" valign="top"|The task of the Netherlands Commission on Genetic Modification (COGEM Netherlands Commission on Genetic Modification ) is to advise the Minister of Infrastructure and Water either at the minister’s request or on its own initiative, with regard to the risks of GMOs for people and the environment. |- | width="226" valign="top"|[https://english.ncadierproevenbeleid.nl/ The Netherlands Advice Committee on Animal Experimentation] | width="236" valign="top"|The NCad achieves visible improvements that are specifically related to the Replacement, Reduction and Refinement (3Rs) of animal procedures and to the associated ethical review in scientific research (including applied scientific research) and teaching. Its goal, in doing so, is to minimize laboratory animal use at both national and international level. |} '"`UNIQ--references-00000041-QINU`"'

Norway +

The current Norwegian research ethics system is regulated by the Research Ethics Act of 2017, which secures the independence of the ethical committees, promotes the individual researcher’s responsibility to familiarise with and follow ethical standards, and emphasises that research institutions must ensure that all research conducted in their institution is in accordance with ethical standards '"`UNIQ--ref-0000015B-QINU`"'. The three National Research Ethics Committees – The National Committee for Medical and Health Research Ethics (NEM), The National Committee for Research Ethics in the Social Sciences and the Humanities (NESH), and The National Commission for Research Ethics in Science and Technology (NENT) – were established in 1990 to coordinate and support work on research ethics on a national level. The National Commission for the Investigation of Research Misconduct (GRU) was established in 2007 as a separate commission for the investigation of research misconduct, in accordance with the first Research Ethics Act of 2006. Since 2008, there is also The National Committee for Research Ethics on Human Remains (SKJ). In 2013 these bodies were united as the National Research Ethics Committees in Norway (FEK) established as a separate unit under the Ministry of Education and Research (KD) '"`UNIQ--ref-0000015C-QINU`"''"`UNIQ--ref-0000015D-QINU`"'. At the national level, NEM, NESH, and NENT have a proactive approach, aimed at teaching or at approving or advising research projects. GRU is in charge of investigating serious cases of research misconduct, providing guidance to individual researchers and institutions, as well as overseeing their work. Moreover, GRU can investigate cases of research misconduct that happened abroad if they involve researchers employed by a Norwegian institution. '"`UNIQ--ref-0000015E-QINU`"'. The members of all the national committees are appointed by KD based on input from The Research Council of Norway. GRU is chaired by the person with judicial experience and members are appointed from different scientific fields. Moreover, at least one member should be from abroad '"`UNIQ--ref-0000015F-QINU`"'. All medical and health research projects involving human subjects require the approval of Regional Committees for Medical and Health Research Ethics (REK). The Norwegian Board of Health Supervision has supervisory responsibility for medical and health research. It can intervene if research projects or research biobanks are operated in a harmful manner. It can supervise research regardless of where the research is conducted. Norwegian Medicines Agency has a supervisory role for clinical trials of medicines. All animal experiments are subject to notification and approval before they can start. '"`UNIQ--ref-00000160-QINU`"'. There are 7 REKs in Norway situated in 5 different regions. Universities, i.e. medical faculties have ethics committees for medical and health research ethics which are guided by NEM. Moreover, NEM is an appeal body for these ethics committees '"`UNIQ--ref-00000161-QINU`"'. Health Trusts have established procedures for handling issues regarding research ethics and some have established ombudsman '"`UNIQ--ref-00000162-QINU`"'. Most Norwegian universities emphasize the responsibility of each researcher to adhere to ethical standards and the institutional responsibility to promote ethical standards. Moreover, universities usually have guidelines for research ethics and some universities have action plans for promoting good research practice and preventing research misconduct. Universities should have an ethics committee and/or committee for the investigations of misconduct '"`UNIQ--ref-00000163-QINU`"'. The Norwegian Association for Higher Education Institutions (UHR) has also developed guidelines for processing issues of research ethics and promotes them among universities '"`UNIQ--ref-00000164-QINU`"'. The Association of Norwegian Research Institutes (FFA) established an ethics committee for 48 institutes to deal with cases of misconduct and provide advice and support regarding ethics and integrity in research '"`UNIQ--ref-00000165-QINU`"'. Norway has a number of guidelines and checklists regarding ethics and integrity in the different scientific fields, for example [https://www.forskningsetikk.no/en/guidelines/science-and-technology/guidelines-for-research-ethics-in-science-and-technology/ Guidelines for Research Ethics in Science and Technology] (NENT), [https://www.forskningsetikk.no/en/guidelines/social-sciences-humanities-law-and-theology/guidelines-for-research-ethics-in-the-social-sciences-humanities-law-and-theology/ Guidelines for Research Ethics in the Social Sciences and Humanities] (NESH) and various [https://www.forskningsetikk.no/en/guidelines/medical-and-health-research/ guidelines] (NEM). Based on the provisions of the Research Ethics Act on, each institution should prevent and handle cases of research misconduct. All research institutions must have an independent commission for investigation of possible cases of scientific misconduct. Moreover, institutions must inform GRU about handled cases and institutions are in charge of sanctions, whether they are proposed by the Commission or brought by the institution '"`UNIQ--ref-00000166-QINU`"'. Although investigations of alleged cases of research misconduct are done usually by institutions, some cases are handled by the GRU. The Commission can handle cases that are brought by individual researchers, institutions or it can decide to conduct an investigation by itself if it has knowledge about the non-adequate handle of the case at the local level. It also investigates more serious cases of research misconduct. Cases of research misconduct are usually published annually and anonymously by the Commission '"`UNIQ--ref-00000167-QINU`"'. According to the Act relating to the working environment, working hours and employment protection, an employee has a right to notify censurable conditions at the employer's undertaking. When supervisory authorities or other public authorities receive notification concerning censurable conditions, any person who performs work or services for the body receiving such notification shall be obliged to prevent other persons from gaining knowledge of employees' names or other information identifying employees '"`UNIQ--ref-00000168-QINU`"'. {| class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" align="left" | width="224" valign="top"|'''Bodies for RE+RI''' | width="527" valign="top"|'''Scope''' |- | width="224" valign="top"|[https://www.forskningsetikk.no/en/about-us/who-are-we-and-what-do-we-do/ The National Research Ethics Committees in Norway (FEK)] | width="527" valign="top"|Ensure that all research is conducted in accordance with recognized research ethical norms. The committees do preventive work, counselling, publish general and specific decisions and investigate individual cases concerning possible misconduct. |- | width="224" valign="top"|[https://www.forskningsetikk.no/en/about-us/our-committees-and-commission/nem/about-nem/ The National Committee for Medical and Health Research Ethics (NEM)] | width="527" valign="top"|Addresses complaints under the Health Research Act on decisions in Regional Committees for Medical and Health Research Ethics (REK). |- | width="224" valign="top"|[https://www.forskningsetikk.no/en/about-us/our-committees-and-commission/nent/about-nent/ The National Committee for Research Ethics in Science and Technology (NENT)] | width="527" valign="top"|The committee provides counsels and recommendations concerning ethical questions in concrete research projects in the area of science and technology, including agriculture and fisheries. In addition, it organises seminars and publishes reports and books on research ethics issues. |- | width="224" valign="top"|[https://www.forskningsetikk.no/en/about-us/our-committees-and-commission/nesh/about-nesh/ The National Committee for Research Ethics in the Social Sciences and the Humanities (NESH)] | width="527" valign="top"|Gives its opinion concerning ethical questions on specific research projects in the area of social sciences and humanities and evaluates these projects. In addition to giving advice in individual cases, external activities such as the organisation of seminars on research ethical issues are an important part of NESH’s work. |- | width="224" valign="top"|[https://www.forskningsetikk.no/en/about-us/our-committees-and-commission/granskingsutvalget/about-the-commission/ The National Commission for the Investigation of Research Misconduct (GRU)] | width="527" valign="top"|Guides the research institutions on how to handle cases on research misconduct. The research institutions shall also report to the commission on the handling of all misconduct cases. |- | width="224" valign="top"|[https://www.forskningsetikk.no/en/about-us/our-committees-and-commission/skjelettutvalget/ The National Committee for Research Ethics on Human Remains (SKJ)] | width="527" valign="top"|Evaluates the ethical aspects of research where the source material consists of human remains which are in public museums and collections, or which will be found in future archaeological and other surveys. |} '"`UNIQ--references-00000169-QINU`"'

S

Spain +

Spain has several bodies for RI – the Ethics Committee of the Spanish National Research Council (CSIC), the Spanish Research Ethics Committee (CEEI), the National Commission on Assisted Human Reproduction and the Commission for the Donation and Use of Human Cells and Tissues. From 2011 the Ethics Committee of the Spanish National Research Council (CSIC) has been a member of European Network of Research Integrity Office (ENRIO) and responsible for raising awareness of researchers about the importance of research integrity '"`UNIQ--ref-000000E5-QINU`"'. Its aim is also to prevent research misconduct and unacceptable research practices '"`UNIQ--ref-000000E6-QINU`"'. To that end, the Committee has created the [http://enacti2ng-itn.cbm.uam.es/images/Documentation/CBP_CSIC_en.pdf Code of Good Scientific Practices of CSIC], the [https://www.cnb.csic.es/documents/ConflictosInteresCSIC.pdf CSIC Manual of Conflicts of Interest] and the [http://icmab.es/images/gender/Declaracion-nacional-integridad-cientifica.pdf Spanish National Statement of Research Integrity]. CSIC is also responsible for dealing with ethical conflicts. Any individual or institution can bring a case to the attention of the Committee, whose field of competence is limited to CSIC and its employees '"`UNIQ--ref-000000E7-QINU`"''"`UNIQ--ref-000000E8-QINU`"'. There are also a number of Spanish national associations for ethics assessment of research, centred mainly in bioethics and biomedical research. They include the National Association of Research Ethics Committees, the Network of Ethics Committees in Universities and Public Research Centres in Spain and the Spanish Association of Bioethics '"`UNIQ--ref-000000E9-QINU`"'. All the autonomous communities have Research Ethics Committees and Research Ethics Committees for drugs that perform the ethical assessment of research projects performed in the region. These committees have a special accreditation regulated by the Royal Decree 1090/2015 '"`UNIQ--ref-000000EA-QINU`"'. The Research Ethics Committees and ad hoc commissions are in charge of settling scientific integrity problems. They are independent and their decisions can be binding, although there is a right of appeal. The official list of proven misconduct regulated by authorities is not publicly available at the moment '"`UNIQ--ref-000000EB-QINU`"'. Spanish policies and initiatives to support ethics practices in the private industry mostly concern corporate social responsibility. Any industry can create an independent Research Ethics Committee or ascribe to any existent Research Ethics Committee, but each Research Ethics Committee must be authorized by the regional autonomies through an accreditation process strictly controlled by the health authorities. Large companies may have their own good practices codes, especially in the pharmaceutical sector '"`UNIQ--ref-000000EC-QINU`"'. Aside from Research Ethics Committees, professional organizations can also sanction research misconducts. For example, deontological commissions related to the professional organizations act independently to sanction the professionals involved in research misconducting '"`UNIQ--ref-000000ED-QINU`"'. If misconduct affects human beings, Justice system starts a process of investigation '"`UNIQ--ref-000000EE-QINU`"'. The protection of whistle-blowers is not addressed in regulations related to RI. There is no specific law on whistle-blower protection for employees in Spain so citizens must personally come forward in order for their claim to be investigated. The only legislative regulation loosely related to whistleblowing is a provision allowing citizens to anonymously report conflicts of interest of high-ranking officials and members of Parliament and a whistle-blower e-mail hotline that allows anonymous reporting of anticompetitive behaviour '"`UNIQ--ref-000000EF-QINU`"'. {| class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" align="left" width="642" | width="302" valign="top"|'''Bodies for RE+RI''' | width="340" valign="top"|'''Scope''' |- | width="302" valign="top"|[https://www.csic.es/en/csic/scientific-integrity-and-ethics-csic/csic-ethics-committee Ethics Committee of the Spanish National Research Council] | width="340" valign="top"|Investigates, trains and promotes RI. It also issues reports and formulates recommendations about ethical and deontological principles related to research activity. |- | width="302" valign="top"|[https://eng.isciii.es/eng.isciii.es/Paginas/Inicio.html The Research Ethics Committee of the Carlos III Health Institute] | width="340" valign="top"|Contributes to improving the health of all citizens through the promotion of research and innovation in Health Sciences and Biomedicine and through the provision of groundbreaking scientific and technical services and educational programmes directed towards the National Health System. |- | width="302" valign="top"|[http://www.comitedebioetica.es/ The Spanish Bioethics Committee] | width="340" valign="top"|Issues reports, proposals and recommendations for public authorities at state and regional level on matters related to the ethical and social implications of Biomedicine and Health Sciences. It is also responsible for establishing the general principles for the production of codes of good practice in scientific research and for representing Spain in supranational and international forums and bodies involved in bioethics. |- | width="302" valign="top"|[https://www.global-regulation.com/translation/spain/1441251/royal-decree-42-2010-of-15-january%252c-which-regulates-the-national-commission-for-assisted-human-reproduction.html The National Commission on Assisted Human Reproduction] | width="340" valign="top"|Provides guidance on the use of assisted human reproduction techniques and collaborates with public administrations with regard to this matter. |- | width="302" valign="top"|[https://www.boe.es/diario_boe/txt.php?id=BOE-A-2010-18654 The Commission for the Donation and Use of Human Cells and Tissues] | width="340" valign="top"|Advises and guides research with biological samples of human embryonic nature and contributes to the updating and dissemination of scientific and technical knowledge in this matter. |} '"`UNIQ--references-000000F0-QINU`"'

Sweden +

In recent years Sweden’s institutional structure regarding research ethics and research integrity has been centralized. The National Board for Assessment of Research Misconduct is a new Swedish governmental agency formed January 1 2020. The Board took over the responsibilities of dealing with the cases of research misconduct from the Swedish HEI. Decisions by the Board are published regularly on their website in Swedish and can be appealed to the Administrative Court in Uppsala '"`UNIQ--ref-000000C3-QINU`"'. The responsibility of dealing with deviations from good research practice still lies with the HEI, but [https://suhf.se/in-english/ The Association of Swedish Higher Education Institutions (SUHF)] has published recommendation on how to deal with allegations of deviations from good research practice '"`UNIQ--ref-000000C4-QINU`"'. The Swedish Ethical Review Authority, previously known as the Ethics Review Board, is a public agency under the Ministry of Education. It has replaced the regional ethical review committees in their responsibilities of providing ethics review and advice regarding research with humans '"`UNIQ--ref-000000C5-QINU`"'. In case when the Swedish Ethical Review Authority evaluates unfavourably applications for ethics review of research on humans, biological material and sensitive personal data, research principals can appeal that decision at the Swedish Ethics Review Appeals Board (ÖNEP) '"`UNIQ--ref-000000C6-QINU`"', an independent statutory body under the Department of Education '"`UNIQ--ref-000000C7-QINU`"'. The ÖNEP is also responsible for the supervision of the observance of the Ethical Review Act and regulations supported by the law. Apart from that, it issues ethical guidelines and laws that regulate and place ethical demands on research '"`UNIQ--ref-000000C8-QINU`"'. The Swedish Research Council, Sweden’s largest governmental research funding body, publish “good research practice” that gives an overview of research ethics and includes recommendation on good research practice. Researcher applying for funding are asked to include a discussion of the ethical aspects of their proposed research project in their application '"`UNIQ--ref-000000C9-QINU`"'. Sweden does not have a national code for research integrity, which has resulted in different terminologies on research misconduct as well as different procedures for handling research misconduct cases within local research institutions in the past. The Swedish Research Council has its own ethical guidelines and internal Expert Group on Ethics '"`UNIQ--ref-000000CA-QINU`"' which has published the book [https://www.vr.se/download/18.5639980c162791bbfe697882/1555334908942/Good-Research-Practice_VR_2017.pdf Good Research Practice] intended primarily for researchers '"`UNIQ--ref-000000CB-QINU`"'. Research integrity is a mandatory part of the curriculum for PhD students '"`UNIQ--ref-000000CC-QINU`"'. Clinical trials involving medicines and medical devices must be approved by the Medical products Agency '"`UNIQ--ref-000000CD-QINU`"'. The Agency's task is to ensure that both the individual patient and healthcare professionals have access to safe and effective medicinal products and that these are used in a rational and cost-effective manner '"`UNIQ--ref-000000CE-QINU`"'. {| class="wikitable sortable mw-collapsible mw-collapsed" border="1" cellspacing="0" cellpadding="0" align="left" | width="224" valign="top"|'''Bodies for RE+RI''' | width="527" valign="top"|'''Scope''' |- | width="224" valign="top"|[https://www.oredlighetsprovning.se/in-english The National Board for Assessment of Research Misconduct] | width="527" valign="top"|Investigates research misconduct, cases that previously were handled by the Swedish universities. |- | width="224" valign="top"|[https://www.registerforskning.se/en/the-ethics-review-boards-become-the-swedish-ethical-review-authority/ The Swedish Ethical Review Authority] | width="527" valign="top"|Examines applications for ethics review of research involving humans and human biological material. |- | width="224" valign="top"|[https://www.onep.se/en/start/the-ethics-review-appeals-board/ Ethical Review Appeals Board] | width="527" valign="top"|Responsible for those applications evaluated as unfavourable by the Swedish Ethical Review Authority. It also has some responsibilities for the supervision of the observance of the Ethical Review Act and regulations supported by the law. Apart from that, it issues ethical guidelines and laws that regulate and place ethical demands on research. |- | width="224" valign="top"|[https://www.vr.se/english.html Swedish Research Council] | width="527" valign="top"|Publish “good research practice” that gives an overview of research ethics and includes recommendation on good research practice. Researcher applying for funding are asked to include a discussion of the ethical aspects of their proposed research project. |} '"`UNIQ--references-000000CF-QINU`"'

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