Etikprövning fallrapport
Överklagandenämnden för etikprövning har återigen kommit fram till att en typisk fallbeskrivning inte ska etikprövas. Enligt Jörgen Svidén, kanslichef på ÖNEP, innebär det att praxis har skapats. The purpose of the Ethical Review Act is to protect individuals and the respect for human dignity in research. Risks and knowledge gains are two factors that must be balanced against each other in the reviews. The Swedish Act concerning the ethical review of research involving humans.
Research participants must be protected against the risk of detriment, whether physically, mentally or in terms of personal data privacy. The public must be given access to and influence over the ethical review of research. The legal certainty of research participants and researchers alike must be safeguarded. Entity responsible for research : a government agency or a natural or legal person in whose activities the research is conducted.
Processing of personal data : The processing specified in Article 4. The research may only be approved if it can be conducted with respect for human dignity, Section 7.
Guidelines for applying for ethical review - Faculty of Law
Human rights and fundamental liberties must always be considered in ethical reviewing, as must the scope for new knowledge through research. Human welfare should always be given precedence over the needs of society and science, Section 8. Research may be approved only if the risks it may pose to the health, safety and personal integrity of research participants are counterbalanced by its scientific value, Section 9. Research cannot be approved if the anticipated result is attainable by some other means that entail s lesser risks for the health, safety, and personal integrity of the research participants.
Processing of sensitive personal data and information relating to criminal acts may only be approved if this is necessary for the research to be carried out, Section The research may be approved only if it is to be conducted by, or under the supervision of, a researcher who possesses the requisite research expertise, Section Research including a physical intervention on a living person, making use of a method that aims to affect a human being physically or mentally, involving an obvious risk of detriment to the research participant in body or mind, or carried out on biological material from a living human being and traceable back to that person, may be carried out only if the research participants have consented to the research that concerns them personally.
This consent must be voluntary, explicit, and specific to particular research. The consent must be documented. If a research participant is in a situation of dependency with respect to the entity responsible or a researcher, or if the subject may be presumed to have difficulties in asserting his or her personal rights, issues relating to information and consent should receive particular attention during the ethical review.
Young people aged 15—17 give their own consent if they understand what the research means for themselves personally. Consent may be withdrawn at any time with immediate effect. However, the data collected before the withdrawal date may be used in the research. The research may not be implemented with respect to individual research participants who, in any way, express personal reluctance to take part, or if anyone whom consultation has taken place with is opposed to its implementation.
An approval expires if the research does not commence within two years after the decision has gained legal effect. Anyone who intentionally or through gross negligence conducts research without approval or violates the terms of an approval may be fined or given a custodial sentence. The entity responsible for the research needs to make sure that no research subject to the Ethical Review Act is carried out without an approval.
Entity responsible for research Forskningshuvudman The entity responsible for research is the natural or legal person in whose activities the research is carried out, such as a higher education institution,…. The Swedish Ethical Review Authority neither can nor may issue any advance ruling on the question of whether an ethical review is required. It falls on the entity responsible for the research to decide whether an initial application needs to be submitted.
Substantial amendments to an ongoing and previously approved study normally require…. Payment of the fee is made using an invoice OCR number that you receive when you submit your application. Payment is made to bank giro The fee for an amendment is SEK 2, Payment of the fee is made using a reference….
What the Act says. Research may only be approved if it can be conducted with respect for human dignity. Purpose Section 1 The purpose of the Act is to protect individuals and human dignity when research is conducted. Research participant : A living person who takes part in research as its subject. Scope Sections 3—5 The Act applies to research conducted in Sweden if the research involves physical intervention, on living and deceased persons alike is carried out with a method that aims to affect the research participant physically or mentally, or involves an obvious risk of harm to them in body or mind are performed on biological material from a living or deceased human being and can be traced back to that person involves processing of sensitive personal data or of personal data relating to criminal offences.
Basics of ethical reviewing Sections 7—11 The research may only be approved if it can be conducted with respect for human dignity, Section 7.
Praxis har skapats om att inte etikpröva typiska fallbeskrivningar
Information and consent Sections 13—19 Research including a physical intervention on a living person, making use of a method that aims to affect a human being physically or mentally, involving an obvious risk of detriment to the research participant in body or mind, or carried out on biological material from a living human being and traceable back to that person, may be carried out only if the research participants have consented to the research that concerns them personally.
Even if the latter condition is not fulfilled the research may be carried out, provided that: the purpose is to contribute to a result that may be of benefit to the research participant or anyone else who suffers from the same or similar illness or disorder, and the research entails an insignificant risk of injury and negligible discomfort for the research participant. Special conditions An approval from the Ethical Review Authority must be in place before the research can begin.
Responsibility for research The entity responsible for the research needs to make sure that no research subject to the Ethical Review Act is carried out without an approval.