Operating Procedures of the National Committee on Medical Research Ethics
https://tukija.fi/documents/1481661/1546647/TUKIJA_toimintaohje_ENG_11102016.pdf/760e4687-85a2-4f05-956c-2667e863a3ef/TUKIJA_toimintaohje_ENG_11102016.pdf
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Health / Drug Usage
Searching for indicator drug:
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6(11)p.(None): p.(None): October 2016p.(None): p.(None): p.(None): • The title of the proposed trial and details of the sponsor and the researcher in charge of the trial as well asp.(None): any other trial sites and the investigators in charge of these facilitiesp.(None): • The objectives, purpose, and rationale of the trial (the aim of the trial, primary and secondary endpoints)p.(None): • Trial design and methodsp.(None): • Basic information on the pharmacology of the medicinal product, such as its ATC group, mechanism of action, trialp.(None): phase, etc.p.(None): • The efficacy and safety of the investigational product based on prior information (brief description of thep.(None): results of animal tests and prior phases as well as adverse reactions) and information on the number of patients andp.(None): the time that the current dosage of the drug has been investigatedp.(None): • Sample size, main inclusion and exclusion criteriap.(None): • Any special groups involvedp.(None): • Information on whether vulnerable subjects are to be includedp.(None): • Treatments (especially invasive) to be carried out on subjects and foreseeable risks, benefits and disadvantagesp.(None): • Alternative treatmentsp.(None): • Justifications for the use of a placebop.(None): • Information on how personal data are to be treated during the trial and on information security measuresp.(None): (sources, data entry and storage, transfer and destruction)p.(None): • Information on any special features of the proposed trial, such as unusual trial design, first trial on huma
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• Conditions and requests for amendments (where necessary)p.(None): • Signatures (chairman and secretary of the meeting)p.(None): p.(None): Originals of TUKIJA’s opinions are sent to the applicant and copies to the researcher in charge. Opinions arep.(None): accompanied by minutes of the meeting during which the case in question was reviewed, which indicate the fee payablep.(None): for the opinion. TUKIJA’s fees are based on a Decree of the Finnish Ministry of Social Affairs and Health.p.(None): p.(None): Opinions are issued as soon as possible and in any case no later than two weeks from the meeting during which the casep.(None): in question was reviewed. Copies of the opinions are also forwarded to the Clinical Drug Trials Unit of the Finnishp.(None): National Agency for Medicines (Fimea).p.(None): p.(None): 3.5 Amendments to trial protocolsp.(None): p.(None): TUKIJA only reviews substantial amendments that are likely to have a bearing on the ethical aspects of trial proposals.p.(None): Substantial amendments include changes relating to the following, for example:p.(None): • The physical or mental integrity of subjectsp.(None): • The scientific value and significance of trialsp.(None): • The implementation of trial protocolsp.(None): • The quality or safety of investigational productsp.(None): p.(None): More detailed instructions on substantial amendments can be found in guidelines published by the European Commission.p.(None): p.(None): Applications for amendments must be accompanied by the form issued by the Finnish Ministry of Social Affairs andp.(None): ethics committee (Finnish Medical Research Act,p.(None): Section 10 (g). The lists must be accompanied by reports on the safety of subjects and the investigator’s opinion onp.(None): the impacts of the reported cases.p.(None): p.(None): If an annual list of adverse effects gives rise to suspicions that the safety of subjects has been compromised, TUKIJAp.(None): can refer the matter to the Finnish National Agency for Medicines.p.(None): p.(None): 3.7 Notifications of terminationp.(None): p.(None): Sponsors and investigators must inform the relevant ethics committee of the completion of clinical drug trials withinp.(None): 90 days. If a trial is discontinued prematurely, notification must be submitted within 15 days. The notification mustp.(None): specify the reasons for discontinuing the trial prematurely.p.(None): Notifications of termination must be made using the form specified by the Ministry of Social Affairs and Health.p.(None): p.(None): Summaries of the findings of clinical trials on medicinal product(s)must be submitted to the relevant ethics committeep.(None): within one year of completing trials.p.(None): p.(None): 4. APPLYING FOR ETHICS REVIEWS ON THE CONDITIONS FOR ESTABLISHING A BIOBANKp.(None): p.(None): 4.1 Establishing a biobankp.(None): p.(None): A favourable op
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Health / Health
Searching for indicator health:
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MD,p.(None): epidemiologyp.(None): Professor Kjell Nikus
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e): • Monitoring, steering and coordinating the processing of issues related to research ethics;p.(None): • Issuing national opinions on clinical trials on medicinal products, unless the duties are delegated to regionalp.(None): ethics committees;p.(None): • Issuing opinions on previously rejected trial proposals to regional ethics committees where these are resubmittedp.(None): unchanged;p.(None): • Issuing opinions on the conditions for establishing a biobank;p.(None): • Supporting and coordinating the activities of regional ethics committees regarding the procedures for requestingp.(None): opinions and matters of ethical principle including provision of related training;p.(None): • Participating in international cooperation on research ethics between authorities;p.(None): • Gathering and conveying information on research ethics issues and provide information on the international debatep.(None): on research ethics in the form of publications, training sessions and other such activities; andp.(None): p.(None): National Committee on Medical Research Ethics TUKIJAp.(None): Mannerheimintie 103b, 00280 Helsinki Telephone: +358 295p.(None): 209 111p.(None): PO Box 210, 00281 Helsinki E-mail:p.(None): tukija@valvira.fip.(None): p.(None): OPERATING PROCEDURES 3(11)p.(None): p.(None): October 2016p.(None): p.(None): p.(None): • Promoting the public debate on medical biomedical research.p.(None): p.(None): In other words, TUKIJA is responsible for carrying out ethics reviews on clinical trials on medicinal product, but itp.(None): can delegate the duties to regional ethics committees, which will then issue any necessary national opinions.p.(None): Applications for other medical research projects and clinical trials are reviewed by the regional ethics committee ofp.(None): the region in which the researcher in charge of the proposed trial is based or in which the trial is to be primarilyp.(None): carried out.p.(None): p.(None): Clinical trials on medicinal products are interventional studies carried out on human subjects for the purpose ofp.(None): finding out the effects of drugs in humans and compiling information on the absorption, distribution, metabolism, andp.(None): excretion of drugs in the human body. (Finnish Medical Research Act, Section 2 (6))p.(None): p.(None): Non-interventional trials are studies where the medicinal product(s) is (are) prescribed in the usual manner inp.(None): accordance with the terms of the marketing authorisation. The assignment of the patient to a particular therapeuticp.(None): strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of thep.(None): medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic orp.(None): monitoring procedures are applied to the patients, and epidemiological methods are used for the analysis of collectedp.(None): data. (Directive 2001/20/EC, Article 2 (c))p.(None): p.(None): Opinions issued by TUKIJA cannot be appealed. However, TUKIJA can request amendments to be introduced to applicationsp.(None): and they reconsider cases. Any proposal that has been previously been given a negative opinion by a regional ethicsp.(None): committee can be resubmitted unchanged, in whic
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e): p.(None): 3. APPLYING FOR ETHICS REVIEWS ON CLINICAL TRIALS ON MEDICINAL PRODUCT(S)p.(None): p.(None): 3.1 Rulings on jurisdiction for clinical trials on medicinal product(s)p.(None): p.(None): p.(None): p.(None): National Committee on Medical Research Ethics TUKIJAp.(None): Mannerheimintie 103b, 00280 Helsinki Telephone: +358 295p.(None): 209 111p.(None): PO Box 210, 00281 Helsinki E-mail:p.(None): tukija@valvira.fip.(None): p.(None): OPERATING PROCEDURES 4(11)p
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rising two members of TUKIJA, a secretary, and the requiredp.(None): number of deputies. The members of the working group notify the secretary of their decisions by the deadline set by thep.(None): secretary. As a rule, the secretary records the working group’s rulings on the application forms and notifies thep.(None): applicants of the decisions via e-mail on the Friday of the same week. Written rulings are posted to applicants at thep.(None): earliest convenience.p.(None): Schedules may vary during holiday seasons.p.(None): p.(None): If the working group is unable to reach unanimous agreement on the secretary’s proposal, the jurisdiction for thep.(None): Ethics TUKIJAp.(None): Mannerheimintie 103b, 00280 Helsinki Telephone: +358 295p.(None): 209 111p.(None): PO Box 210, 00281 Helsinki E-mail:p.(None): tukija@valvira.fip.(None): p.(None): OPERATING PROCEDURES 5(11)p.(None): p.(None): October 2016p.(None): p.(None): p.(None): 5. Information for potential research subjectsp.(None): 6. Informed consent formp.(None): 7. Information on the procedures to be used to seek consentp.(None): 8. Scientific rationale in cases where potential research subjects are unable to give informed consent top.(None): participating in the proposed trialp.(None): 9. Information on the detailed procedures to be used for the recruitment of subjectsp.(None): 10. Other materials to be made available to potential subjects (CRFs, patient diaries, etc.)p.(None): 11. Description of the personal data file required under Section 10 of the Finnish Personal Data Act (No 523/1999)p.(None): 12. List of trial sites and investigators in Finlandp.(None): 13. Statement by the researcher in charge of the proposed trial regarding the quality of the trial facilities and thep.(None): available equipmentp.(None): 14. Statement on the aptitude of the researcher in charge of the proposed trial and the investigators based at otherp.(None): trial sites;p.(None): 15. The amounts for rewarding or compensating investigators and trial subjects and the relevant financial aspects ofp.(None): the sponsor and the site;p.(None): 16. Insurance cover available for potential subjects in cases where patient insurance and pharmaceutical injuriesp.(None): insurance do not cover the trialp.(None): p.(None): In case Swedish speaking patients are going to be recruited to the trial all the information given to them must bep.(None): written in Swedish. Swedish translations can be sent to TUKIJA for notification after TUKIJA has evaluated the originalp.(None): research proposal and its attachments. Swedish translations of patient information leaflets and informed consent formsp.(None): will not be evaluated in TUKIJAs meetings.p.(None): p.(None): TUKIJA keeps a register of the diary numbers of trial protocols, codes provided by sponsors, EudraCT numbers, detailsp.(None): of sponsors and contact persons, and the application dates. All documents associated with trials are time-stamped andp.(None): marked as confidential. Any amendments, additions and supplementary documents introduced to trial protocols arep.(None): recorded under the original diary number along with the dates on which they arrived and were processed. To avoidp.(None): confusion, applicants are asked to quote the diary number provided by TUKIJA in any subsequent correspondence orp.(None): enquiries.p.(None): p.(None): Sponsors must have a contact person in Finland to facilitate communication during the application procedure.p.(None): p.(None): Applicants are only issued confirmation of receipt once their applications are deemed admissible, i.e. once all of thep.(None): necessary information and documents have been supplied. The review process begins once applications have been deemedp.(None): admissible. More detailed information and instructions on the requirements relating to the admissibility ofp.(None): applications for ethics reviews can be found in the guidelines published by the European Commission.p.(None): p.(None): 3.3 Summaries of trial protocols (in Finnish or Swedish)p.(None): p.(None): The trial protocol must be summarised in Finnish or Swedish using plain language (understandable to laypersons) andp.(None): avoiding abbreviations or foreign expressions. The summary should be between 2 and 3 pages long and in any case no morep.(None): than 5 pages.p.(None): p.(None): The summary must cover the following:p.(None): p.(None): p.(None): National Committee on Medical Research Ethics TUKIJAp.(None): Mannerheimintie 103b, 00280 Helsinki Telephone: +358 295p.(None): 209 111p.(None): PO Box 210, 00281 Helsinki E-mail:p.(None): tukija@valvira.fip.(None): p.(None): OPERATING PROCEDURES 6(11)p.(None): p.(None): October 2016p.(None): p.(None): p.(None): • The title of the proposed trial and details of the sponsor and the researcher in charge of the trial as well asp.(None): any other trial sites and the investigators in charge of these facilitiesp.(None): • The objectives, purpose, and rationale of the trial (the aim of the trial, primary and secondary endpoints)p.(None): • Trial design and methodsp.(None): • Basic information on the pharmacology of the medicinal product, such as its ATC group, mechanism of action, trialp.(None): phase, etc.p.(None): • The efficacy and safety of the investigational product based on prior information (brief description of thep.(None): results of animal tests and prior phases as well as adverse reactions) and information on the number of patients andp.(None): the time that the current dosage of the drug has been investigatedp.(None): • Sample size, main inclusion and exclusion criteriap.(None): • Any special groups involvedp.(None): • Information on whether vulnerable subjects are to be includedp.(None): • Treatments (especially invasive) to be carried out on subjects and foreseeable risks, benefits and disadvantagesp.(None): • Alternative treatmentsp.(None): • Justifications for the use of a placebop.(None): • Information on how personal data are to be treated during the trial and on information security measuresp.(None): (sources, data entry and storage, transfer and destruction)p.(None): • Information on any special features of the proposed trial, such as unusual trial design, first trial on humansp.(None): (phase I), etc.p.(None): p.(None): 3.4 Reviews of trial protocols by TUKIJAp.(None): p.(None): Meeting agendas, documents relating to the trial proposals that are to be reviewed, and other necessary documentationp.(None): are sent to all members of TUKIJA (or their personal deputies where members are unable to attend) at least one weekp.(None): prior to each meeting. One member (the person responsible for presenting each trial protocol) is given all originalp.(None): copies.p.(None): p.(None): The minutes of meetings generally specify the diary numbers of any trial proposals reviewed, the names of the personsp.(None): responsible for presenting the protocols, any necessary trial codes, and information on whether the proposals discussedp.(None): were approved, whether additional information had to be requested, or whether the proposals were rejected, as well asp.(None): the fees collected for the reviews. TUKIJA can approve proposals subject to certain conditions that must be satisfiedp.(None): before the trial can commence. Unsuccessful applicants are given detailed explanations of why their applications werep.(None): rejected.p.(None): p.(None): Applicants can expect opinions from TUKIJA within 60 days of submitting admissible applications. Applications relatingp.(None): to trials that concern medicinal product(s) aimed at gene therapy or somatic cell treatment or drugs that includep.(None): genetically modified organisms can take up to 90 days to process.p.(None): TUKIJA can extend the deadline by a further 90 days if extensive additional investigations are deemed necessary. Nop.(None): deadline has been set for opinions relating to xenogeneic cell therapy.p.(None): p.(None): TUKIJA can only make one request for additional information to investigators or sponsors. The time required forp.(None): obtaining any necessary additional information does not count towards the deadline.p.(None): p.(None): p.(None): p.(None): National Committee on Medical Research Ethics TUKIJAp.(None): Mannerheimintie 103b, 00280 Helsinki Telephone: +358 295p.(None): 209 111p.(None): PO Box 210, 00281 Helsinki E-mail:p.(None): tukija@valvira.fip.(None): p.(None): OPERATING PROCEDURES 7(11)p.(None): p.(None): October 2016p.(None): p.(None): p.(None): If additional information is required, TUKIJA defers the application in question and issues a written request to thep.(None): applicant. The case is then resumed at a later date. Requests for additional information specify the date by which thep.(None): requested information must be submitted to TUKIJA’s secretary in order for TUKIJA to be able to resume the case in itsp.(None): next meeting. Requests for additional information are addressed to the researcher in charge of the trial in questionp.(None): and to the sponsor and sent off as soon as possible and in any case no later than one week from the meeting duringp.(None): which TUKIJA began to review the case. E-mail and fax can be used to speed up communication.p.(None): p.(None): TUKIJA can also consult external experts on trial protocols. In such cases, TUKIJA notifies the sponsor and thep.(None): researcher in charge of the trial in question about its plan to consult an external expert in advance. Afterwards,p.(None): TUKIJA asks the sponsor and the investigator to inspect the expert’s opinion and to give comments.p.(None): p.(None): Opinions issued by TUKIJA include the following information:p.(None): • Datep.(None): • Diary number, title and code of the trialp.(None): • Documents reviewed
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plicants are brief summariesp.(None): of the contents of the updates/changes in Finnish or Swedish, accompanied by the investigator’s opinion on the effectsp.(None): of the proposed amendments. If the updates introduced top.(None): investigators’ brochures call for amendments in other documents such as the information presented to potential researchp.(None): subjects, applicants must notify TUKIJA of the same in connection with providing summaries and the investigator’sp.(None): opinion on the effects of the proposed amendments.p.(None): p.(None): Applicants can expect opinions on proposed amendments within 35 days of submitting admissible applications. The timep.(None): required for obtaining any necessary additional information does not count towards the deadline.p.(None): p.(None): As a rule and without infringement of the secrecy regulations the opinions of the amendments to trial protocols arep.(None): recorded to the minutes of the meeting.p.(None): p.(None): 3.6 Annual list of serious adverse effectsp.(None): p.(None): Sponsors are responsible for compiling lists of suspected cases of serious adverse effects identified in connectionp.(None): with trials each year for the relevant ethics committee (Finnish Medical Research Act,p.(None): Section 10 (g). The lists must be accompanied by reports on the safety of subjects and the investigator’s opinion onp.(None): the impacts of th
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): Mannerheimintie 103b, 00280 Helsinki Telephone: +358 295p.(None): 209 111p.(None): PO Box 210, 00281 Helsinki E-mail:p.(None): tukija@valvira.fip.(None): p.(None): OPERATING PROCEDURES 9(11)p.(None): p.(None): October 2016p.(None): p.(None): p.(None): protection of privacy and self-determination laid down in this act and elsewhere in law and present a justifiable viewp.(None): on the ethicality of the activities.p.(None): p.(None): Applications submitted to TUKIJA must be accompanied by the following documents:p.(None): 1. Application form published by TUKIJAp.(None): 2. Name or other identifier of the biobank;p.(None): 3. Owner of the biobank, business name of the owner and main financiers of the biobank;p.(None): 4. Location and method of storing the samples and information associated with them and an account of arranging thep.(None): management of information in the registers;p.(None): 5. Description of the biobank's area(s) of research and an account of the principles and terms to be applied in thep.(None): collection, granting of access to for the purposes of biobank research and other processing of samples and informationp.(None): associated with them and restrictions concerning the use of samples;p.(None): 6. The consent form used and a model for a written report to be submitted when requesting consent or information onp.(None): the content of the report and a description of submitting the report;p.(None): 7. An account of whether samples and related information other than those based on consent will be stored in thep.(None): biobank;p.(None): 8. An account of whether samples and related information other than those owned by the biobank will be stored in thep.(None): biobank and, if necessary, information on the owner of the samples;p.(None): 9. An action plan that outlines the planned scale of the biobanking activities, the organisation of the activitiesp.(None): and the division of responsibilities;p.(None): 10. Statement on th
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p.(None): Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws,p.(None): regulations and administrative provisions of the Member States relating to the implementation of good clinical p
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Social / Access to Social Goods
Searching for indicator access:
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color: LightGray">protection of privacy and self-determination laid down in this act and elsewhere in law and present a justifiable viewp.(None): on the ethicality of the activities.p.(None): p.(None): Applications submitted to TUKIJA must be accompanied by the following documents:p.(None): 1. Application form published by TUKIJAp.(None): 2. Name or other identifier of the biobank;p.(None): 3. Owner of the biobank, business name of the owner and main financiers of the biobank;p.(None): 4. Location and method of storing the samples and information associated with them and an account of arranging thep.(None): management of information in the registers;p.(None): 5. Description of the biobank's area(s) of research and an account of the principles and terms to be applied in thep.(None): collection, granting of access to for the purposes of biobank research and other processing of samples and informationp.(None): associated with them and restrictions concerning the use of samples;p.(None): 6. The consent form used and a model for a written report to be submitted when requesting consent or information onp.(None): the content of the report and a description of submitting the report;p.(None): 7. An account of whether samples and related information other than those based on consent will be stored in thep.(None): biobank;p.(None): 8. An account of whether samples and related information other than those owned by the biobank will be stored in thep.(None): biobank and, if necessary, information on the owner of the samples;p.(None): 9. An action plan that outlines the planned scale of the biobanking
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Social / Child
Searching for indicator vulnerable:
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nd rationale of the trial (the aim of the trial, primary and secondary endpoints)p.(None): • Trial design and methodsp.(None): • Basic information on the pharmacology of the medicinal product, such as its ATC group, mechanism of action, trialp.(None): phase, etc.p.(None): • The efficacy and safety of the investigational product based on prior information (brief description of thep.(None): results of animal tests and prior phases as well as adverse reactions) and information on the number of patients andp.(None): the time that the current dosage of the drug has been investigatedp.(None): • Sample size, main inclusion and exclusion criteriap.(None): • Any special groups involvedp.(None): • Information on whether vulnerable subjects are to be includedp.(None): • Treatments (especially invasive) to be carried out on subjects and foreseeable risks, benefits and disadvantagesp.(None): • Alternative treatmentsp.(None): • Justifications for the use of a placebop.(None): • Information on how personal data are to be treated during the trial and on information security measuresp.(None): (sources, data entry and storage, transfer and destruction)p.(None): • Information on any special features of the proposed trial, such as unusual trial design, first trial on humansp.(None): (phase I), etc.p.(None): p.(None): 3.4 Reviews of trial protocols by TUKIJAp.(None): p.(None): Meeting agendas, documents relating to the trial proposals that are to be reviewed, and other necessary documentationp.(None): are sent to all members of TUKIJA (or their personal deputies where members are unable to attend) at l
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Social / Educational
Searching for indicator educational:
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or: LightGreen">Health on Clinical Trials on Medicinal Product (841/2010) Decree of thep.(None): Ministry of Social Affairs and Health on the Compensation for Research Participation (82/2011)p.(None): Biobank Act (688/2012)p.(None): Government Decree on Consent for Biobank (643/2013)p.(None): Decree of Ministry of Social Affairs and Health on Notification of Biobank (649/2013)p.(None): Act of the Medical Use of Human Organs and Tissues (101/2001, amended 547/2007, 778/2009, 653/2010, 336/2011, 689/2012,p.(None): 277/2013)p.(None): p.(None): 1.1 Members of TUKIJA (up to 30 September 2018), including educational background and expertise relevant to TUKIJA'sp.(None): operationsp.(None): p.(None): Chairmanp.(None): Docent Tapani Keränen MD, clinical pharmacology and neurologyp.(None): p.(None): Deputy Chairmanp.(None): Medical Specialist Miia Turpeinen MD, docent, clinical pharmacology and pharmacotherapyp.(None): p.(None): Membersp.(None): Professor Janne Backman MD, clinical pharmacology Medical Specialist Sirkkup.(None): Jyrkkiö MD, docent, oncologist Professor Markku Koskenvuo MD,p.(None): epidemiologyp.(None): Professor Kjell Nikus MD, cardiology Advisory Medical Officer Kristianp.(None): Läksy MD, psychiatryp.(None): Medical Specialist Kristiina Aalto MD, docent, paedi
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Social / Linguistic Proficiency
Searching for indicator language:
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A in any subsequent correspondence orp.(None): enquiries.p.(None): p.(None): Sponsors must have a contact person in Finland to facilitate communication during the application procedure.p.(None): p.(None): Applicants are only issued confirmation of receipt once their applications are deemed admissible, i.e. once all of thep.(None): necessary information and documents have been supplied. The review process begins once applications have been deemedp.(None): admissible. More detailed information and instructions on the requirements relating to the admissibility ofp.(None): applications for ethics reviews can be found in the guidelines published by the European Commission.p.(None): p.(None): 3.3 Summaries of trial protocols (in Finnish or Swedish)p.(None): p.(None): The trial protocol must be summarised in Finnish or Swedish using plain language (understandable to laypersons) andp.(None): avoiding abbreviations or foreign expressions. The summary should be between 2 and 3 pages long and in any case no morep.(None): than 5 pages.p.(None): p.(None): The summary must cover the following:p.(None): p.(None): p.(None): National Committee on Medical Research Ethics TUKIJAp.(None): Mannerheimintie 103b, 00280 Helsinki Telephone: +358 295p.(None): 209 111p.(None): PO Box 210, 00281 Helsinki E-mail:p.(None): tukija@valvira.fip.(None): p.(None): OPERATING PROCEDURES 6(11)p.(None): p.(None): October 2016p.(None): p.(None): p.(None): • The title of the proposed trial and details of the sponsor and the researcher in charge of the trial as well asp.(None): any other trial sites
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Social / Philosophical Differences/Difference of Opinion
Searching for indicator opinion:
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ne): Non-interventional trials are studies where the medicinal product(s) is (are) prescribed in the usual manner inp.(None): accordance with the terms of the marketing authorisation. The assignment of the patient to a particular therapeuticp.(None): strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of thep.(None): medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic orp.(None): monitoring procedures are applied to the patients, and epidemiological methods are used for the analysis of collectedp.(None): data. (Directive 2001/20/EC, Article 2 (c))p.(None): p.(None): Opinions issued by TUKIJA cannot be appealed. However, TUKIJA can request amendments to be introduced to applicationsp.(None): and they reconsider cases. Any proposal that has been previously been given a negative opinion by a regional ethicsp.(None): committee can be resubmitted unchanged, in which case the regional ethics committee in question is obligated to referp.(None): the case to TUKIJA. Previously rejected proposals can also be resubmitted to the ethics committee that initiallyp.(None): reviewed the case after any amendments requested by said ethics committee have been introduced.p.(None): p.(None): TUKIJA is also responsible for carrying out ethics reviews on the conditions for establishing a new biobank. Thisp.(None): evaluation is to be done before the biobank makes a notification to the National Supervisory Authority for Welfare a
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resumed at a later date. Requests for additional information specify the date by which thep.(None): requested information must be submitted to TUKIJA’s secretary in order for TUKIJA to be able to resume the case in itsp.(None): next meeting. Requests for additional information are addressed to the researcher in charge of the trial in questionp.(None): and to the sponsor and sent off as soon as possible and in any case no later than one week from the meeting duringp.(None): which TUKIJA began to review the case. E-mail and fax can be used to speed up communication.p.(None): p.(None): TUKIJA can also consult external experts on trial protocols. In such cases, TUKIJA notifies the sponsor and thep.(None): researcher in charge of the trial in question about its plan to consult an external expert in advance. Afterwards,p.(None): TUKIJA asks the sponsor and the investigator to inspect the expert’s opinion and to give comments.p.(None): p.(None): Opinions issued by TUKIJA include the following information:p.(None): • Datep.(None): • Diary number, title and code of the trialp.(None): • Documents reviewed (including versions and dates)p.(None): • Trial sites and locationsp.(None): • Details of the researcher in charge of the trial and the investigators based at other trial sitesp.(None): • TUKIJA’s opinion on the trialp.(None): • Conditions and requests for amendments (where necessary)p.(None): • Signatures (chairman and secretary of the meeting)p.(None): p.(None): Originals of TUKIJA’s opinions are sent to the applicant and copies to the researcher in charge. Opinions arep.(None): accompanied by minutes of the meeting during which the case in question was reviewed, which indicate the fee payablep.(None): for the opinion. TUKIJA’s fees are based on a Decree of the Finnish Ministry of Social Affairs and Health.p.(None): p.(None): Opinions are issued as soon as possible and in any case no later than two weeks from the meeting during which the casep.(None): in question was reviewed. Copies of the opinions are also forwarded to the
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IJA include the following information:p.(None): • Datep.(None): • Diary number, title and code of the trialp.(None): • Documents reviewed (including versions and dates)p.(None): • Trial sites and locationsp.(None): • Details of the researcher in charge of the trial and the investigators based at other trial sitesp.(None): • TUKIJA’s opinion on the trialp.(None): • Conditions and requests for amendments (where necessary)p.(None): • Signatures (chairman and secretary of the meeting)p.(None): p.(None): Originals of TUKIJA’s opinions are sent to the applicant and copies to the researcher in charge. Opinions arep.(None): accompanied by minutes of the meeting during which the case in question was reviewed, which indicate the fee payablep.(None): for the opinion. TUKIJA’s fees are based on a Decree of the Finnish Ministry of Social Affairs and Health.p.(None): p.(None): Opinions are issued as soon as possible and in any case no later than two weeks from the meeting during which the casep.(None): in question was reviewed. Copies of the opinions are also forwarded to the Clinical Drug Trials Unit of the Finnishp.(None): National Agency for Medicines (Fimea).p.(None): p.(None): 3.5 Amendments to trial protocolsp.(None): p.(None): TUKIJA only reviews substantial amendments that are likely to have a bearing on the ethical aspects of trial proposals.p.(None): Substantial amendments include changes relating to the following, for example:p.(None): • The physical or mental integrity of subjectsp.(None): • The scientific value and significance
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.(None): Applications for amendments must be accompanied by the form issued by the Finnish Ministry of Social Affairs andp.(None): Health, a summary of the main contents of the updates/changes and thep.(None): p.(None): p.(None): National Committee on Medical Research Ethics TUKIJAp.(None): Mannerheimintie 103b, 00280 Helsinki Telephone: +358 295p.(None): 209 111p.(None): PO Box 210, 00281 Helsinki E-mail:p.(None): tukija@valvira.fip.(None): p.(None): OPERATING PROCEDURES 8(11)p.(None): p.(None): October 2016p.(None): p.(None): p.(None): investigator’s opinion on the impact that the proposed amendments are likely to have on the ethics of trials.p.(None): p.(None): As regards amendments introduced to investigators’ brochures, all that is required from applicants are brief summariesp.(None): of the contents of the updates/changes in Finnish or Swedish, accompanied by the investigator’s opinion on the effectsp.(None): of the proposed amendments. If the updates introduced top.(None): investigators’ brochures call for amendments in other documents such as the information presented to potential researchp.(None): subjects, applicants must notify TUKIJA of the same in connection with providing summaries and the investigator’sp.(None): opinion on the effects of the proposed amendments.p.(None): p.(None): Applicants can expect opinions on proposed amendments within 35 days of submitting admissible applications. The timep.(None): required for obtaining any necessary additional information does not count towards the deadline.p.(None): p.(None): As a rule and without infringement of the secrecy regulations the opinions of the amendments to trial protocols arep.(None): recorded to the minutes of the meeting.p.(None): p.(None): 3.6 Annual list o
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background-color: Yellow">opinion on the impact that the proposed amendments are likely to have on the ethics of trials.p.(None): p.(None): As regards amendments introduced to investigators’ brochures, all that is required from applicants are brief summariesp.(None): of the contents of the updates/changes in Finnish or Swedish, accompanied by the investigator’s opinion on the effectsp.(None): of the proposed amendments. If the updates introduced top.(None): investigators’ brochures call for amendments in other documents such as the information presented to potential researchp.(None): subjects, applicants must notify TUKIJA of the same in connection with providing summaries and the investigator’sp.(None): opinion on the effects of the proposed amendments.p.(None): p.(None): Applicants can expect opinions on proposed amendments within 35 days of submitting admissible applications. The timep.(None): required for obtaining any necessary additional information does not count towards the deadline.p.(None): p.(None): As a rule and without infringement of the secrecy regulations the opinions of the amendments to trial protocols arep.(None): recorded to the minutes of the meeting.p.(None): p.(None): 3.6 Annual list of serious adverse effectsp.(None): p.(None): Sponsors are responsible for compiling lists of suspected cases of serious adverse effects identified in connectionp.(None): with trials each year for the relevant ethics committee (Finnish Medical Research Act,p.(None): Section 10 (g). The lists must be accompanied by reports on the safety of subjects and the investigator’s opinion onp.(None): the impacts of the reported cases.p.(None): p.(None): If an annual list of adverse effects gives rise to suspicions that the safety of subjects has been compromised, TUKIJAp.(None): can refer the matter to the Finnish National Agency for Medicines.p.(None): p.(None): 3.7 Notifications of terminationp.(None): p.(None): Sponsors and investigators must inform the relevant ethics committee of the completion of clinical drug trials withinp.(None): 90 days. If a trial is discontinued prematurely, notification must be submitted within 15 days. The notification mustp.(None): specify the reasons for discontinuing the trial prematurely.p.(None): Notifications of termination must be made using the form specified by the Ministry of Social Affairs and Social Affairs and Health.p.(None): p.(None): Summaries of the findings of clinical trials on medicinal product(s)must be submitted to the relevant ethics committeep.(None): within one year of completing trials.p.(None): p.(None): 4. APPLYING FOR ETHICS REVIEWS ON THE CONDITIONS FOR ESTABLISHING A BIOBANKp.(None): p.(None): 4.1 Establishing a biobankp.(None): p.(None): A favourable opinion by the TUKIJA is a precondition of the establishment of the biobank. TUKIJA must issue itsp.(None): statement within 60 days of receiving the valid request for statement. For its statement, TUKIJA must determine whetherp.(None): the activities of the biobank meet the conditions concerning thep.(None): p.(None): National Committee on Medical Research Ethics TUKIJAp.(None): Mannerheimintie 103b, 00280 Helsinki Telephone: +358 295p.(None): 209 111p.(None): PO Box 210, 00281 Helsinki E-mail:p.(None): tukija@valvira.fip.(None): p.(None): OPERATING PROCEDURES 9(11)p.(None): p.(None): October 2016p.(None): p.(None): p.(None): protection of privacy and Social Affairs and Health on the Fees Chargedp.(None): for Opinions of the National Advisory Board on Health Care Ethics and Regional Ethics Committees. The decree governsp.(None): all cases that require an ethics review and an opinion to be issued by TUKIJA.p.(None): p.(None): If applicant/sponsor and investigator want TUKIJA to issue opinions on matters that TUKIJA would otherwise file asp.(None): notifications, the subsequent fees can be based on the fees payable for amending trial protocols. No fees are chargedp.(None): for filing notifications.p.(None): p.(None): p.(None): National Committee on Medical Research Ethics TUKIJAp.(None): Mannerheimintie 103b, 00280 Helsinki Telephone: +358 295p.(None): 209 111p.(None): PO Box 210, 00281 Helsinki E-mail:p.(None): tukija@valvira.fip.(None): p.(None): OPERATING PROCEDURES 10(11)p.(None): p.(None): October 2016p.(None): p.(None): p.(None): Applicants/sponsors are requested to notify the invoicing address and Busin
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Social / Police Officer
Searching for indicator officer:
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one): 1.1 Members of TUKIJA (up to 30 September 2018), including educational background and expertise relevant to TUKIJA'sp.(None): operationsp.(None): p.(None): Chairmanp.(None): Docent Tapani Keränen MD, clinical pharmacology and neurologyp.(None): p.(None): Deputy Chairmanp.(None): Medical Specialist Miia Turpeinen MD, docent, clinical pharmacology and pharmacotherapyp.(None): p.(None): Membersp.(None): Professor Janne Backman MD, clinical pharmacology Medical Specialist Sirkkup.(None): Jyrkkiö MD, docent, oncologist Professor Markku Koskenvuo MD,p.(None): epidemiologyp.(None): Professor Kjell Nikus MD, cardiology Advisory Medical Officer Kristianp.(None): Läksy MD, psychiatryp.(None): Medical Specialist Kristiina Aalto MD, docent, paediatrics Professor Timo Paavonenp.(None): MD, pathologyp.(None): Senior legal adviser Sirpa Soini LLM, medical and bio lawp.(None): University Lecturer Liisa Nieminen LLD, M.Pol.Sc, docent, medical and bio lawp.(None): Research Scientist Helena Siipi PhD (Politics), docent, MA (Educ.), ethics, lay memberp.(None): Administrative Secretaryp.(None): Sirpa-Maija Vuorinen M.Sc. (Econ. & Bus. Adm.), lay memberp.(None): Professor Sanna Salanterä PhD (Health Sciences), clinical nursing science Professorp.(None): Heikki Tikkanen MD, spor
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Social / Religion
Searching for indicator special:
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nistry of Social Affairs and Health has produced a form to be used in connection with rulings onp.(None): jurisdiction. The same form is used both by the applicants and by TUKIJA. Applicants are also requested to submit theirp.(None): applications to TUKIJA’s secretary in electronic format (as word or rft files) by e-mail to tukija(at)valvira.fi.p.(None): p.(None): Applications must be submitted to TUKIJA by the end of office hours on the Monday of the weekp.(None): during which rulings are required at the latest. TUKIJA’s secretary reviews the applications and issues proposals onp.(None): their admissibility via e-mail. Deadlines for submitting applications for rulings on jurisdiction are posted onp.(None): TUKIJA’s website at www.tukija.fi. Jurisdiction issues are referred to a special working group which convenes, as ap.(None): rule, once a fortnight.p.(None): p.(None): The ruling on jurisdiction is used by the working group comprising two members of TUKIJA, a secretary, and the requiredp.(None): number of deputies. The members of the working group notify the secretary of their decisions by the deadline set by thep.(None): secretary. As a rule, the secretary records the working group’s rulings on the application forms and notifies thep.(None): applicants of the decisions via e-mail on the Friday of the same week. Written rulings are posted to applicants at thep.(None): earliest convenience.p.(None): Schedules may vary during holiday seasons.p.(None): p.(None): If the working group is unable to reach unanimous agreement on the secretary’s proposal, the jurisdiction for thep.(None): ethics review remains with TUKIJA. The secretary draws up weekly minutes of the working group’s de
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cher in charge of the trial as well asp.(None): any other trial sites and the investigators in charge of these facilitiesp.(None): • The objectives, purpose, and rationale of the trial (the aim of the trial, primary and secondary endpoints)p.(None): • Trial design and methodsp.(None): • Basic information on the pharmacology of the medicinal product, such as its ATC group, mechanism of action, trialp.(None): phase, etc.p.(None): • The efficacy and safety of the investigational product based on prior information (brief description of thep.(None): results of animal tests and prior phases as well as adverse reactions) and information on the number of patients andp.(None): the time that the current dosage of the drug has been investigatedp.(None): • Sample size, main inclusion and exclusion criteriap.(None): • Any special groups involvedp.(None): • Information on whether vulnerable subjects are to be includedp.(None): • Treatments (especially invasive) to be carried out on subjects and foreseeable risks, benefits and disadvantagesp.(None): • Alternative treatmentsp.(None): • Justifications for the use of a placebop.(None): • Information on how personal data are to be treated during the trial and on information security measuresp.(None): (sources, data entry and storage, transfer and destruction)p.(None): • Information on any special features of the proposed trial, such as unusual trial design, first trial on humansp.(None): (phase I), etc.p.(None): p.(None): 3.4 Reviews of trial protocols by TUKIJAp.(None): p.(None): Meeting agendas, documents relating to the trial proposals that are to be reviewed, and other necessary documentationp.(None): are sent to all members of TUKIJA (or their personal deputies where members are unable to attend) at least one weekp.(None): prior to each meeting. One member (the person responsible for presenting each trial protocol) is given all originalp.(None): copies.p.(None): p.(None): The minutes of meetings generally specify the diary numbers of any trial proposals reviewed, the names of the personsp.(None): responsible for presenting the protocols, any necessary trial codes, and information on whether the proposals discussedp.(None): were approved, whether additional information had to be requested, or whether the proposals were rejected, as well as
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Social / Social
Searching for indicator social:
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docent, oncologist Professor Markku Koskenvuo MD,p.(None): epidemiologyp.(None): Professor Kjell Nikus MD, cardiology Advisory Medical Officer Kristianp.(None): Läksy MD, psychiatryp.(None): Medical Specialist Kristiina Aalto MD, docent, paediatrics Professor Timo Paavonenp.(None): MD, pathologyp.(None): Senior legal adviser Sirpa Soini LLM, medical and bio lawp.(None): University Lecturer Liisa Nieminen LLD, M.Pol.Sc, docent, medical and bio lawp.(None): Research Scientist Helena Siipi PhD (Politics), docent, MA (Educ.), ethics, lay memberp.(None): Administrative Secretaryp.(None): Sirpa-Maija Vuorinen M.Sc. (Econ. & Bus. Adm.), lay memberp.(None): Professor Sanna Salanterä PhD (Health Sciences), clinical nursing science Professorp.(None): Heikki Tikkanen MD, sports and exercise medicine, clinical physiologyp.(None): p.(None): p.(None): National Committee on Medical Research Ethics TUKIJAp.(None): Mannerheimintie 103b, 00280 Helsinki Telephone: +358 295p.(None): 209 111p.(Non
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REGIONAL ETHICS COMMITTEESp.(None): p.(None): 2.1 Responsibilities of TUKIJAp.(None): p.(None): TUKIJA’s responsibilities includep.(None): p.(None): • Serving as an expert on research ethics;p.(None): • Monitoring, steering and coordinating the processing of issues related to research ethics;p.(None): • Issuing national opinions on clinical trials on medicinal products, unless the duties are delegated to regionalp.(None): ethics committees;p.(None): • Issuing opinions on previously rejected trial proposals to regional ethics committees where these are resubmittedp.(None): unchanged;p.(None): • Issuing opinions on the conditions for establishing a biobank;p.(None): • Supporting and coordinating the activities of regional ethics committees regarding the procedures for requestingp.(None): opinions and matters of ethical principle including provision of related training;p.(None): • Participating in international cooperation on research ethics between authorities;p.(None): • Gathering and conveying information on research ethics issues and provide information on the international debatep.(None): on research ethics in the form of publications, training sessions and other such activities; andp.(None): p.(None): National Committee on Medical Research Ethics TUKIJAp.(None): Mannerheimintie 103b, 00280 Helsinki Telephone: +358 295p.(None): 209 111p.(None): PO Box 210, 00281 Helsinki E-mail:p.(None): tukija@valvira.fip.(None): p.(None): OPERATING PROCEDURES 3(11)p.(None): p.(None): October 2016p.(None): p.(None): p.(None): • Promoting the public debate on medical biomedical research.p.(None): p.(None): In other words, TUKIJA is responsible for carrying out ethics reviews on clinical trials on medicinal product, but itp.(None): can delegate the duties to regional ethics committees, which will then issue any necessary national opinions.p.(None): Applications for other medical research projects and clinical trials are reviewed by the regional ethics committee ofp.(None): the region in which the researcher in charge of the proposed trial is based or in which the trial is to be primarilyp.(None): carried out.p.(None): p.(None): Clinical trials on medicinal products are interventional studies carried out on human subjects for the purpose ofp.(None): finding out the effects of drugs in humans and compiling information on the absorption, distribution, metabolism, andp.(None): excretion of drugs in the human body. (Finnish Medical Research Act, Section 2 (6))p.(None): p.(None): Non-interventional trials are studies where the medicinal product(s) is (are) prescribed in the usual manner inp.(None): accordance with the terms of the marketing authorisation. The assignment of the patient to a particular therapeuticp.(None): strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of thep.(None): medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic orp.(None): monitoring procedures are applied to the patients, and epidemiological methods are used for the analysis of collectedp.(None): data. (Directive 2001/20/EC, Article 2 (c))p.(None): p.(None): Opinions issued by TUKIJA cannot be appealed. However, TUKIJA can request amendments to be introduced to applicationsp.(None): and they reconsider cases. Any proposal that has been previously been given a negative opinion by a regional ethicsp.(None): committee can be resubmitted unchanged, in which case the regional ethics committee in question is obligated to referp.(None): the case to TUKIJA. Previously rejected proposals can also be resubmitted to the ethics committee that initiallyp.(None): reviewed the case after any amendments requested by said ethics committee have been introduced.p.(None): p.(None): TUKIJA is also responsible for carrying out ethics reviews on the conditions for establishing a new biobank. Thisp.(None): evaluation is to be done before the biobank makes a notification to the National Supervisory Authority for Welfare andp.(None): Health for the purposes of the national biobank register.p.(None): p.(None): 2.2 Responsibilities of regional ethics committeesp.(None): p.(None): The responsibilities of regional ethics committees includep.(None): • Issuing opinions on proposals referred to them by TUKIJA;p.(None): • Issuing opinions on other medical studies that fall within their jurisdiction;p.(None): • Issuing opinions on the transfer of the old biological samples to a biobank;p.(None): • Issuing opinions on the change of purpose for which biological samples will be used if the consent for such usep.(None): cannot be received by the donor himself/herself.p.(None): • Monitoring and steering the processing of research ethics issues in its region;p.(None): p.(None): 3. APPLYING FOR ETHICS REVIEWS ON CLINICAL TRIALS ON MEDICINAL PRODUCT(S)p.(None): p.(None): 3.1 Rulings on jurisdiction for clinical trials on medicinal product(s)p.(None): p.(None): p.(None): p.(None): National Committee on Medical Research Ethics TUKIJAp.(None): Mannerheimintie 103b, 00280 Helsinki Telephone: +358 295p.(None): 209 111p.(None): PO Box 210, 00281 Helsinki E-mail:p.(None): tukija@valvi
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e): p.(None): The ruling on jurisdiction is used by the working group comprising two members of TUKIJA, a secretary, and the requiredp.(None): number of deputies. The members of the working group notify the secretary of their decisions by the deadline set by thep.(None): secretary. As a rule, the secretary records the working group’s rulings on the application forms and notifies thep.(None): applicants of the decisions via e-mail on the Friday of the same week. Written rulings are posted to applicants at thep.(None): earliest convenience.p.(None): Schedules may vary during holiday seasons.p.(None): p.(None): If the working group is unable to reach unanimous agreement on the secretary’s propo
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p.(None): National Committee on Medical Research Ethics TUKIJAp.(None): Mannerheimintie 103b, 00280 Helsinki Telephone: +358 295p.(None): 209 111p.(None): PO Box 210, 00281 Helsinki E-mail:p.(None): tukija@valvira.fip.(None): p.(None): OPERATING PROCEDURES 5(11)p.(None): p.(None): October 2016p.(None): p.(None): p.(None): 5. Information for potential research subjectsp.(None): 6. Informed consent formp.(None): 7. Information on the procedures to be used to seek consentp.(None): 8. Scientific rationale in cases where potential research subjects are unable to give informed consent top.(None): participating in the proposed trialp.(None): 9. Information on the detailed procedures to be used for the recruitment of subjectsp.(None): 10. Other materials to be made available to potential subjects (CRFs, patient diaries, etc.)p.(None): 11. Description of the personal data file required under Section 10 of the Finnish Personal Data Act (No 523/1999)p.(None): 12. List of trial sites and investigators in Finlandp.(None): 13. Statement by the researcher in charge of the proposed trial regarding the quality of the trial facilities and thep.(None): available equipmentp.(None): 14. Statement on the aptitude of the researcher in charge of the proposed trial and the investigators based at otherp.(None): trial sites;p.(None): 15. The amounts for rewarding or compensating investigators and trial subjects and the relevant financial aspects ofp.(None): the sponsor and the site;p.(None): 16. Insurance cover available for potential subjects in cases where patient insurance and pharmaceutical injuriesp.(None): insurance do not cover the trialp.(None): p.(None): In case Swedish speaking patients are going to be recruited to the trial all the information given to them must bep.(None): written in Swedish. Swedish translations can be sent to TUKIJA for notification after TUKIJA has evaluated the originalp.(None): research proposal and its attachments. Swedish translations of patient information leaflets and informed consent formsp.(None): will not be evaluated in TUKIJAs meetings.p.(None): p.(None): TUKIJA keeps a register of the diary numbers of trial protocols, codes provided by sponsors, EudraCT numbers, detailsp.(None): of sponsors and contact persons, and the application dates. All documents associated with trials are time-stamped andp.(None): marked as confidential. Any amendments, additions and supplementary documents introduced to trial protocols arep.(None): recorded under the original diary number along with the dates on which they arrived and were processed. To avoidp.(None): confusion, applicants are asked to quote the diary number provided by TUKIJA in any subsequent correspondence orp.(None): enquiries.p.(None): p.(None): Sponsors must have a contact person in Finland to facilitate communication during the application procedure.p.(None): p.(None): Applicants are only issued confirmation of receipt once their applications are deemed admissible, i.e. once all of thep.(None): necessary information and documents have been supplied. The review process begins once applications have been deemedp.(None): admissible. More detailed information and instructions on the requirements relating to the admissibility ofp.(None): applications for ethics reviews can be found in the guidelines published by the European Commission.p.(None): p.(None): 3.3 Summaries of trial protocols (in Finnish or Swedish)p.(None): p.(None): The trial protocol must be summarised in Finnish or Swedish using plain language (understandable to laypersons) andp.(None): avoiding abbreviations or foreign expressions. The summary should be between 2 and 3 pages long and in any case no morep.(None): than 5 pages.p.(None): p.(None): The summary must cover the following:p.(None): p.(None): p.(None): National Committee on Medical Research Ethics TUKIJAp.(None): Mannerheimintie 103b, 00280 Helsinki Telephone: +358 295p.(None): 209 111p.(None): PO Box 210, 00281 Helsinki E-mail:p.(None): tukija@valvira.fip.(None): p.(None): OPERATING PROCEDURES 6(11)p.(None): p.(None): October 2016p.(None): p.(None): p.(None): • The title of the proposed trial and details of the sponsor and the researcher in charge of the trial as well asp.(None): any other trial sites and the investigators in charge of these facilitiesp.(None): • The objectives, purpose, and rationale of the trial (the aim of the trial, primary and secondary endpoints)p.(None): • Trial design and methodsp.(None): • Basic information on the pharmacology of the medicinal product, such as its ATC group, mechanism of action, trialp.(None): phase, etc.p.(None): • The efficacy and safety of the investigational product based on prior information (brief description of thep.(None): results of animal tests and prior phases as well as adverse reactions) and information on the number of patients andp.(None): the time that the current dosage of the drug has been investigatedp.(None): • Sample size, main inclusion and exclusion criteriap.(None): • Any special groups involvedp.(None): • Information on whether vulnerable subjects are to be includedp.(None): • Treatments (especially invasive) to be carried out on subjects and foreseeable risks, benefits and disadvantagesp.(None): • Alternative treatmentsp.(None): • Justifications for the use of a placebop.(None): • Information on how personal data are to be treated during the trial and on information security measuresp.(None): (sources, data entry and storage, transfer and destruction)p.(None): • Information on any special features of the proposed trial, such as unusual trial design, first trial on humansp.(None): (phase I), etc.p.(None): p.(None): 3.4 Reviews of trial protocols by TUKIJAp.(None): p.(None): Meeting agendas, documents relating to the trial proposals that are to be reviewed, and other necessary documentationp.(None): are sent to all members of TUKIJA (or their personal deputies where members are unable to attend) at least one weekp.(None): prior to each meeting. One member (the person responsible for presenting each trial protocol) is given all originalp.(None): copies.p.(None): p.(None): The minutes of meetings generally specify the diary numbers of any trial proposals reviewed, the names of the personsp.(None): responsible for presenting the protocols, any necessary trial codes, and information on whether the proposals discussedp.(None): were approved, whether additional information had to be requested, or whether the proposals were rejected, as well asp.(None): the fees collected for the reviews. TUKIJA can approve proposals subject to certain conditions that must be satisfiedp.(None): before the trial can commence. Unsuccessful applicants are given detailed explanations of why their applications werep.(None): rejected.p.(None): p.(None): Applicants can expect opinions from TUKIJA within 60 days of submitting admissible applications. Applications relatingp.(None): to trials that concern medicinal product(s) aimed at gene therapy or somatic cell treatment or drugs that includep.(None): genetically modified organisms can take up to 90 days to process.p.(None): TUKIJA can extend the deadline by a further 90 days if extensive additional investigations are deemed necessary. Nop.(None): deadline has been set for opinions relating to xenogeneic cell therapy.p.(None): p.(None): TUKIJA can only make one request for additional information to investigators or sponsors. The time required forp.(None): obtaining any necessary additional information does not count towards the deadline.p.(None): p.(None): p.(None): p.(None): National Committee on Medical Research Ethics TUKIJAp.(None): Mannerheimintie 103b, 00280 Helsinki Telephone: +358 295p.(None): 209 111p.(None): PO Box 210, 00281 Helsinki E-mail:p.(None): tukija@valvira.fip.(None): p.(None): OPERATING PROCEDURES 7(11)p.(None): p.(None): October 2016p.(None): p.(None): p.(None): If additional information is required, TUKIJA defers the application in question and issues a written request to thep.(None): applicant. The case is then resumed at a later date. Requests for additional information specify the date by which thep.(None): requested information must be submitted to TUKIJA’s secretary in order for TUKIJA to be able to resume the case in itsp.(None): next meeting. Requests for additional information are addressed to the researcher in charge of the trial in questionp.(None): and to the sponsor and sent off as soon as possible and in any case no later than one week from the meeting duringp.(None): which TUKIJA began to review the case. E-mail and fax can be used to speed up communication.p.(None): p.(None): TUKIJA can also consult external experts on trial protocols. In such cases, TUKIJA notifies the sponsor and thep.(None): researcher in charge of the trial in question about its plan to consult an external expert in advance. Afterwards,p.(None): TUKIJA asks the sponsor and the investigator to inspect the expert’s opinion and to give comments.p.(None): p.(None): Opinions issued by TUKIJA include the following information:p.(None): • Datep.(None): •
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egards amendments introduced to investigators’ brochures, all that is required from applicants are brief summariesp.(None): of the contents of the updates/changes in Finnish or Swedish, accompanied by the investigator’s opinion on the effectsp.(None): of the proposed amendments. If the updates introduced top.(None): investigators’ brochures call for amendments in other documents such as the information presented to potential researchp.(None): subjects, applicants must notify TUKIJA of the same in connection with providing summaries and the investigator’sp.(None): opinion on the effects of the proposed amendments.p.(None): p.(None): Applicants can expect opinions on proposed amendments within 35 days of submitting admissible applications. The timep.(None): required for obtaining any necessary additional information does not count towards the deadline.p.(None): p.(None): As a rule and without infringement of the secrecy regulations the opinions of the amendments to trial protocols arep.(None): recorded to the minutes of the meeting.p.(None): p.(None): 3.6 Annual list of serious adverse effectsp.(None): p.(None): Sponsors are responsible for compiling lists of suspected cases of serious adverse effects identified in connectionp.(None): with trials each year for the relevant ethics committee (Finnish Medical Research Act,p.(None): Section 10 (g). The lists must be accompanied by reports on the safety of subjects and the investigator’s Ethics TUKIJAp.(None): Mannerheimintie 103b, 00280 Helsinki Telephone: +358 295p.(None): 209 111p.(None): PO Box 210, 00281 Helsinki E-mail:p.(None): tukija@valvira.fip.(None): p.(None): OPERATING PROCEDURES 9(11)p.(None): p.(None): October 2016p.(None): p.(None): p.(None): protection of privacy and self-determination laid down in this act and elsewhere in law and present a justifiable viewp.(None): on the ethicality of the activities.p.(None): p.(None): Applications submitted to TUKIJA must be accompanied by the following documents:p.(None): 1. Application form published by TUKIJAp.(None): 2. Name or other identifier of the biobank;p.(None): 3. Owner of the biobank, business name of the owner and main financiers of the biobank;p.(None): 4. Location and method of storing the samples and information associated with them and an account of arranging thep.(None): management of information in the registers;p.(None): 5. Description of the biobank's area(s) of research and an account of the principles and terms to be applied in thep.(None): collection, granting of access to for the purposes of biobank research and other processing of samples and informationp.(None): associated with them and restrictions concerning the use of samples;p.(None): 6. The consent form used and a model for a written report to be submitted when requesting consent or information onp.(None): the content of the report and a description of submitting the report;p.(None): 7. An account of whether samples and related information other than those based on consent will be stored in thep.(None): biobank;p.(None): 8. An account of whether samples and related information other than those owned by the biobank will be stored in thep.(None): biobank and, if necessary, information on the owner of the samples;p.(None): 9. An action plan that outlines the planned scale of the biobanking activities, the organisation of the activitiesp.(None): and the division of responsibilities;p.(None): 10. Statement on the ethicality of the activities of the biobank, especially the objectives and the planning of thep.(None): biobank, as well as the pre-evaluation of the risks and benefits of the biobank;p.(None): 11. Statement on the realization of conditions concerning the protection of privacy and self- determination of thep.(None): individual
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"background-color: LightGray">Ethics TUKIJAp.(None): Mannerheimintie 103b, 00280 Helsinki Telephone: +358 295p.(None): 209 111p.(None): PO Box 210, 00281 Helsinki E-mail:p.(None): tukija@valvira.fip.(None): p.(None): OPERATING PROCEDURES 10(11)p.(None): p.(None): October 2016p.(None): p.(None): p.(None): Applicants/sponsors are requested to notify the invoicing address and Business Identity Code in its’ application.p.(None): p.(None): 6. CONTACT DETAILSp.(None): p.(None): Outi Konttinen, General Secretaryp.(None): National Committee on Medical Research Ethics TUKIJA National Supervision Authority for Welfare and Health Valvirap.(None): Mannerheimintie 103bp.(None): FI-00280 Helsinki Mailing address:p.(None): PL 210, 00281 Helsinkip.(None): Tel. +358 (0)295 209 111p.(None): E-mail: firstname.lastname@valvira.fip.(None): p.(None): Nina Lindqvist, Assistantp.(None): National Committee on Medical Research Ethics TUKIJA National Supervision Economic / Welfare Recipient
Searching for indicator welfare:
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by a regional ethicsp.(None): committee can be resubmitted unchanged, in which case the regional ethics committee in question is obligated to referp.(None): the case to TUKIJA. Previously rejected proposals can also be resubmitted to the ethics committee that initiallyp.(None): reviewed the case after any amendments requested by said ethics committee have been introduced.p.(None): p.(None): TUKIJA is also responsible for carrying out ethics reviews on the conditions for establishing a new biobank. Thisp.(None): evaluation is to be done before the biobank makes a notification to the National Supervisory Authority for Welfare andp.(None): Health for the purposes of the national biobank register.p.(None): p.(None): 2.2 Responsibilities of regional ethics committeesp.(None): p.(None): The responsibilities of regional ethics committees includep.(None): • Issuing opinions on proposals referred to them by TUKIJA;p.(None): • Issuing opinions on other medical studies that fall within their jurisdiction;p.(None): • Issuing opinions on the transfer of the old biological samples to a biobank;p.(None): • Issuing opinions on the change of purpose for which biological samples will be used if the consent for such usep.(None): cannot be received by the donor himself/herself.p.(None): • Monitoring and steering the processing of research
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and the division of responsibilities;p.(None): 10. Statement on the ethicality of the activities of the biobank, especially the objectives and the planning of thep.(None): biobank, as well as the pre-evaluation of the risks and benefits of the biobank;p.(None): 11. Statement on the realization of conditions concerning the protection of privacy and self- determination of thep.(None): individual donors.p.(None): p.(None): The undersigned application with its attachments shall be posted to TUKIJA.p.(None): p.(None): 4.2 Changes in the information provided to the biobank registerp.(None): p.(None): Any substantial changes in the information provided to the national biobank register must be submitted to TUKIJA for anp.(None): ethical evaluation. National Supervisory Authority for Welfare and Health shall estimate the need for ethicalp.(None): evaluation. As a rule changes must be submitted to TUKIJA in case the changes relate to the information referred to inp.(None): section 6 of the Biobank Act.p.(None): p.(None): 5. FEESp.(None): p.(None): Fees are imposed on the basis of the Decree of the Finnish Ministry of Social Affairs and Health on the Fees Chargedp.(None): for Opinions of the National Advisory Board on Health Care Ethics and Regional Ethics Committees. The decree governsp.(None): all cases that require an ethics review and an Ethics TUKIJAp.(None): Mannerheimintie 103b, 00280 Helsinki Telephone: +358 295p.(None): 209 111p.(None): PO Box 210, 00281 Helsinki E-mail:p.(None): tukija@valvira.fip.(None): p.(None): OPERATING PROCEDURES 10(11)p.(None): p.(None): October 2016p.(None): p.(None): p.(None): Applicants/sponsors are requested to notify the invoicing address and Business Identity Code in its’ application.p.(None): p.(None): 6. CONTACT DETAILSp.(None): p.(None): Outi Konttinen, General Secretaryp.(None): National Committee on Medical Research Ethics TUKIJA National Supervision Authority for Welfare and Health Valvirap.(None): Mannerheimintie 103bp.(None): FI-00280 Helsinki Mailing address:p.(None): PL 210, 00281 Helsinkip.(None): Tel. +358 (0)295 209 111p.(None): E-mail: firstname.lastname@valvira.fip.(None): p.(None): Nina Lindqvist, Assistantp.(None): National Committee on Medical Research Ethics TUKIJA National Supervision Authority for Welfare and Health Valvirap.(None): Mannerheimintie 103bp.(None): FI-00280 Helsinki Mailing address:p.(None): PO Box 210p.(None): FI-00281 Helsinkip.(None): Tel. +358 (0)295 209 111p.(None): E-mail: firstname.lastname@valvira.fi TUKIJAs email: tukija(at)valvira.fip.(None): p.(None): 7. REFERENCES National legislation:p.(None): Finnish Medical Research Act (488/1999, amended 295/2004, 794/2010, 143/2015) Finnish Medical Research Decreep.(None): (986/1999, amended 313/2004)p.(None): Finnish Government Decree on the National Advisory Board on Health Care Ethics (No 820/2010) Decree of the Finnishp.(None): Ministry of Social Affairs and Health on the Fees Charged for Opinions of the N
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General/Other / Relationship to Authority
Searching for indicator authority:
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gative opinion by a regional ethicsp.(None): committee can be resubmitted unchanged, in which case the regional ethics committee in question is obligated to referp.(None): the case to TUKIJA. Previously rejected proposals can also be resubmitted to the ethics committee that initiallyp.(None): reviewed the case after any amendments requested by said ethics committee have been introduced.p.(None): p.(None): TUKIJA is also responsible for carrying out ethics reviews on the conditions for establishing a new biobank. Thisp.(None): evaluation is to be done before the biobank makes a notification to the National Supervisory Authority for Welfare andp.(None): Health for the purposes of the national biobank register.p.(None): p.(None): 2.2 Responsibilities of regional ethics committeesp.(None): p.(None): The responsibilities of regional ethics committees includep.(None): • Issuing opinions on proposals referred to them by TUKIJA;p.(None): • Issuing opinions on other medical studies that fall within their jurisdiction;p.(None): • Issuing opinions on the transfer of the old biological samples to a biobank;p.(None): • Issuing opinions on the change of purpose for which biological samples will be used if the consent for such usep.(None): cannot be received by the donor himself/herself.p.(None):
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the biobanking activities, the organisation of the activitiesp.(None): and the division of responsibilities;p.(None): 10. Statement on the ethicality of the activities of the biobank, especially the objectives and the planning of thep.(None): biobank, as well as the pre-evaluation of the risks and benefits of the biobank;p.(None): 11. Statement on the realization of conditions concerning the protection of privacy and self- determination of thep.(None): individual donors.p.(None): p.(None): The undersigned application with its attachments shall be posted to TUKIJA.p.(None): p.(None): 4.2 Changes in the information provided to the biobank registerp.(None): p.(None): Any substantial changes in the information provided to the national biobank register must be submitted to TUKIJA for anp.(None): ethical evaluation. National Supervisory Authority for Welfare and Health shall estimate the need for ethicalp.(None): evaluation. As a rule changes must be submitted to TUKIJA in case the changes relate to the information referred to inp.(None): section 6 of the Biobank Act.p.(None): p.(None): 5. FEESp.(None): p.(None): Fees are imposed on the basis of the Decree of the Finnish Ministry of Social Affairs and Health on the Fees Chargedp.(None): for Opinions of the National Advisory Board on Health Care Ethics and Regional Ethics Committees. The decree governsp.(None): all cases that require an Ethics TUKIJAp.(None): Mannerheimintie 103b, 00280 Helsinki Telephone: +358 295p.(None): 209 111p.(None): PO Box 210, 00281 Helsinki E-mail:p.(None): tukija@valvira.fip.(None): p.(None): OPERATING PROCEDURES 10(11)p.(None): p.(None): October 2016p.(None): p.(None): p.(None): Applicants/sponsors are requested to notify the invoicing address and Business Identity Code in its’ application.p.(None): p.(None): 6. CONTACT DETAILSp.(None): p.(None): Outi Konttinen, General Secretaryp.(None): National Committee on Medical Research Ethics TUKIJA National Supervision Authority for Welfare and Health Valvirap.(None): Mannerheimintie 103bp.(None): FI-00280 Helsinki Mailing address:p.(None): PL 210, 00281 Helsinkip.(None): Tel. +358 (0)295 209 111p.(None): E-mail: firstname.lastname@valvira.fip.(None): p.(None): Nina Lindqvist, Assistantp.(None): National Committee on Medical Research Ethics TUKIJA National Supervision Authority for Welfare and Health Valvirap.(None): Mannerheimintie 103bp.(None): FI-00280 Helsinki Mailing address:p.(None): PO Box 210p.(None): FI-00281 Helsinkip.(None): Tel. +358 (0)295 209 111p.(None): E-mail: firstname.lastname@valvira.fi TUKIJAs email: tukija(at)valvira.fip.(None): p.(None): 7. REFERENCES National legislation:p.(None): Finnish Medical Research Act (488/1999, amended 295/2004, 794/2010, 143/2015) Finnish Medical Research Decreep.(None): (986/1999, amended 313/2004)p.(None): Finnish Government Decree on the National Advisory Board on Health Care Ethics (No 820/2010) Decree of the Finnishp.(None): Ministry of Social Affairs and Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| authority | Relationship to Authority |
| drug | Drug Usage |
| educational | Educational |
| health | Health |
| language | Linguistic Proficiency |
| officer | Police Officer |
| opinion | Philosophical Differences/Difference of Opinion |
| social | Social |
| special | Religion |
| vulnerable | Child |
| welfare | Welfare Recipient |
Indicator Peers (Indicators in Same Vulnerabilty)
Trigger Words
consent
ethics
protection
self-determination
vulnerable
Applicable Type / Vulnerability / Indicator Overlay for this Input