The following standards have been worked out complying with international guidelines formulated in the Helsinki Declaration, International Ethical Guidelines for Running Biomedical Research on Human Subjects worked out by Council for International Organization of Medical Science) guidelines of Good Clinical Practice and Directives of European Union 2001/20/WE (completed with the guidelines to the ENTRA/6422/01 Directive, and also the act of medical doctor profession and the dentist profession from 5 December 1996 (homogenous with Journal of Laws 2005.226.1943 with changes),Act of Pharmaceutical Law on 6 October 2001 (homogenous text Journal of Laws 2004.53.533 with changes), Ordinance of the Ministry of Health and Welfare on 11 May 1999 concerning detailed regulations of creating, financing and the mode of operation of bioethical commissions (Journal of Laws 1999.47.480), Ordinance of Ministry of Health on 30 April 2004 concerning the way of notifying medical incidents and further actions after their notification (Journal of Laws 2004.125.1316), Ordinance of Ministry of Health on 30 April 2004 concerning the way of notifying unexpected serious and unwanted operation of therapeutic product (Journal of Laws 2004.104.1107),Ordinance of Ministry of Health on 30 April 2004 concerning the way of running the clinical research on under aged subjects (Journal of Laws 2004.104.1108), Ordinance of Ministry of Health on 30 April 2004 concerning a model application for issuing the permission for beginning clinical research of a therapeutic product, final report on performing this research and the model of statement certifying the compliance of the therapeutic product intended for the clinical research with the safety regulations (Journal of laws 2004.120.1258), Ordinance of Ministry of Health on 30 April 2004 concerning obligatory insurance from civil liability of the researcher and the sponsor (Journal of Laws 2004.101.1034 with changes) and the Operational Guidelines of World Health Organization for Ethical Commissions Evaluating Biomedical Research.

1. Medical experiment on human subjects be run at the Medical University of Wroclaw, Independent Public Clinical Hospital no 1 in Wroclaw or Clinical University Hospital in Wroclaw exclusively after obtaining the consent of Bioethical Commission at the Medical University of Wroclaw.
2. Bioethical Commission at the Medical University of Wroclaw, called later "the Commission", is the collegial body independent in its opinion whose task is contribution to guaranteeing the rights, safety and welfare of subjects of clinical research. The Commission guards the respect for the dignity of a human being as the superior value to scientific goals of research.
3. The Commission in its opinions is directed by ethical values and the purposefulness and feasibility of the research projects.
4. The basis for the operation of the Commission are: The Helsinki Declaration, The Rules of Good Clinical Practice and referring to the sphere of ethics of research on human subjects, Directives of European Union and legal regulations binding in Poland.

1. Bioethical Commission at the Medical University of Wroclaw is appointed by Rector of the Medical University in the course of management. The members of the Commission are chosen by Rector according to professional and ethical criteria contained in the act of the medical doctor profession and the ordinance of the Ministry of Health and Welfare concerning the detailed rules of creating, financing and the mode of operation of bioethical commissions.
2. The conditions of fulfilling the function of the member of the Commission are the following:
   1. Members of the Commission are nominated for the time of term of office of the university management. The commission performs its functions until the new commission is appointed for the new term.
   2. Rector recalls the member of the Commission against whom the spokesman of professional responsibility or prosecutor came against with the motion of punishment.
   3. The member of the Commission has the right to resign from the activities because of professional or personal reasons during the term of office.
   4. In case of earlier termination of the term of office by one of the members of the Commission his successor is called by the Rector of the Medical University,
   5. A member of the Commission should voluntarily withdraw from the Commission activities concerning such an application for evaluation in the effect of which the conflict of interests appears. The chairman of the Commission should be informed in writing about the conflict of interests before the beginning of evaluation of the project. The conflict of interests should be recorded in the protocol of Commission's sitting,
   6. A member of the Commission should express his consent for publication of his name, place of work, age and sex,
   7. The height of cost return for the work in the Commission is stated in the Rector's of the Medical University ordinance,
   8. A member of the Commission before beginning of the term in office must sign the statement obliging to confidentiality concerning the applications presented to the Commission's evaluation.

1. The Commission's work is directed by the chairman supported by the vice-chairman and the secretary.
2. The duties of the chairman are:
   1. Representing the Commission outside,
   2. Analysis of applications and other correspondence directed to the Commission,
   3. Choice of an expert preparing the project for the commission,
   4. Preparing schedule and the agenda of the sittings of the Commission,
   5. Signing decisions and other documents on behalf of the Commission.
3. Vice-chairman of the Commission substitutes the chairman in case of temporary inability of performing the duties.
4. Secretary of the Commission prepares the protocol of the Commission's sitting.

Administrative activity is run by the secretarial staff whose duties are to keep substantial and financial documentation, sending the decisions to the movers and other bioethical commissions and running documents filing system.

1. The resolutions of the Commission are take when over the half of its members takes part in the vote, including the chairman or his vice.
2. In quorum when taking the decision about giving opinion about research project at least two medical doctors, two persons of different profession one person who is not present or ex worker of Medical University in Wroclaw and one female must be present.

1. Application for bioethical evaluation of the research proposed for realization within Medical University of Wroclaw, Independent Clinical Public Hospital no 1 in Wroclaw or University Clinical Hospital in Wroclaw can be submitted by a medical doctor or a dentist of proper professional qualifications who is responsible for scientific and ethical aspects of the research (it is the researcher or the representative of the research team appointed by him in writing).
2. The movers can be only: the sponsor of the research, employees of the Medical University in Wroclaw, the participants of stationary and non-stationary PhD studies at the Medical University and the employees of Wroclaw clinical hospitals.

The procedure of applying consists of:

1. Submitting an application to the Bioethical Commission at the Medical University of Wroclaw for issuing the opinion about the proposed research project at the secretarial office, in one copy together with other required documents. (Rectorate),
2. Application form and enclosed documents can be submitted in English if the sponsor has his premises and place of living out of Poland. Documents for the participants of the research should be submitted in Polish. All the documents should be in A4 format.
3. The mover will be informed about the missing documents as soon as their lack will be discovered but not later than ten working days after submitting the documentation in the secretarial office of the Commission.

Documentation mentioned in § 7 consists of:

1. Application form filled in Polish (available at www.bioetyka.am.wroc.pl),
2. The statement of the research sponsor about authorization of the Medical University of Wroclaw to issue a VAT invoice without the signature of the recipient,
3. Promise of the contract between the sponsor and the Medical University of Wroclaw (in case of research realized by theoretical institute of the University or between the sponsor and the clinical hospital (when the research project is realized by clinical ward) stating the condition of further contract for conducting clinical test in a given center.
4. Protocol of the proposed research (dated and with clear identification) together with attachments and supplements,
5. Graphic presentation of the test scheme ("flowchart") - if the research project can be presented in this form,
6. Exhaustive summary of all pharmacological and toxicological data together with the summary of the results of clinical tests available for the tested medicament on the day of submitting the application (current edition of the researcher brochure),
7. Current CVs of the researchers (signed and dated),
8. materials (including announcements) used for recruitment of the subjects of the test (patients and healthy volunteers),
9. information for the test subjects prepared in Polish and containing detailed data concerning the purposes and the rules of the experiment, expected therapeutic or other benefits for these people and about the risk connected with the experiment,
10. obligation signed by the researcher to obtain conscious consent from all tested persons or their legal representatives,
11. the form of conscious consent of the patient prepared in Polish containing at least the statements concerning:
    1. voluntary consent to be submitted to a medical experiment after getting acquainted with the information contained in point 9,
    2. confirmation of the possibility of asking questions to the person leading the experiment and getting them answered,
    3. getting the information about withdrawal from the participation in the experiment at every stage,
12. insurance policy of the test participant in case of damage of health,
13. model from of the statement of approval of insurance conditions by the tested person,
14. model form of the statement of the consent of the tested person to process the data connected with his participation in the test,
15. declaration that the test will be considered by Central Inventory of Clinical Research,
16. clinical research form (CRF), patients diaries and other questionnaires for the patients;
17. all important earlier decisions (e.g. rejecting the approval of the research project or changes in protocol) taken by other Bioethical Commission in relation to the evaluated research (concerning the mover or other center),
18. information about all remuneration for the patients,
19. statement of the mover that neither the researcher nor the members of his family will not take any material advantages form the results of the test.

1. If a person who cannot express his consent in a written form is to participate in the experiment it is possible to express the consent in an oral form in the presence of two witnesses what should be conformed with witnesses' signatures in the research documentation.
2. If a juvenile or completely incapacitated person takes part in the experiment the documents mentioned in § 8 p. 9, 11, 13, 14 should contain the consent of his legal representative. If the juvenile is above 16 or is under 16 but can reasonably express his opinion concerning his participation in the experiment, his written consent is also necessary.

Procedure of registration of the documents in the secretarial office of Bioethical Commission at the Medical University of Wroclaw covers:

1. Dating all the materials submitted to the Commission,
2. Storing, filing all the submitted materials in the way that will prevent them from access of other people than the member of the Commission, the researcher and the expert appointed by the Commission,
3. Checking if the application is complete in formal terms,
4. Informing the mover about the lacks in submitted documentation,
5. Informing the mover about the foreseen term of considering the application by the Commission,
6. Storing the records of all the contacts (written, oral or electronic) related to the application.

1. Bioethical Commission at the Medical University of Wroclaw based on the binding regulations accepts payment for considering the application. (see www.bioetyka.am.wroc.pl CURRENT INFORMATION; Payment).
2. The fund created from the payments for issuing the opinions is at the disposition of the chairman of the Commission.

1. The sittings of the Commission in the period form September to June take place every month in the terms fixed in advance and announced three months before at www.bioetyka.am.wroc.pl
2. The agenda of the sitting is agreed two weeks in advance.
3. The Secretary takes the minutes of the sitting of the Commission and the protocol is approved at the next sitting.
4. The mover of the project considered by the Commission for the first time is always invited to the sitting if the coordinator of the research is the worker of the Medical University of Wroclaw or of one of Wroclaw clinical hospitals. Other researchers or independent experts appointed by the Commission or the representatives of given groups of patients may be invited to the sitting when it is needed.

1. Bioethical Commission at the Medical University of Wroclaw gives its opinion about the experiment in the form of resolution.
2. When forming the opinion about the research project the Commission takes into consideration the following aspects:
   1. Exactness and completeness of submitted documentation and if on its basis it is possible to determine ethical problems arising from the context of the research.
   2. If the protocol of research and the forms for collecting data are formulated in the way proper for the goals of the test, taking into consideration binding rules and regulations, demands of statistical analysis and scientific demands - if well documented conclusions can be drawn at the least risk for the subjects of the research.
   3. If the center satisfies the demands, if it has proper personnel, equipment and the procedures of operation in emergency,
   4. If proper medical supervision and further, later observation of the subjects of the test are planned,
   5. If monitoring and auditing of the test is ensured,
   6. If the information for the subjects of the research or their legal representatives is adequate, full and understandable,
   7. What the methods of initial recruitment are, in what way the information about the research will be transferred and how conscious consent for the participation in the test will be obtained,
   8. What the content and vocabulary of the form of conscious consent of the patients are - if there is such a need - what means have been undertaken concerning the subjects of the research who are not able to express their consent personally,
   9. If obtaining all new and important information which appear in the course of the test is ensured for the subjects of the research,
   10. What actions have been undertaken to receive the questions and give answers to the patients during the test,
   11. In what way the compensation/treatment in case of damage to health/disability/death of the patient connected with his participation in the research is ensured,
   12. If the sponsor insures the researcher from civil liability concerning the necessity of paying compensation,
   13. If the family physician will be informed, with the consent of the patient, about the participation of the patient in the research,
   14. In what way the confidentiality of personal data will be kept,
   15. If remuneration and payments for the patients (healthy volunteers) are planned.
3. Evaluation mentioned in point c and d is also done in the case when the coordinator of multi-center test obtained the consent for its realization from other bioethical commission and the participation of the researcher and/or center from the Medical University or Wroclaw hospital in the project of the experiment are planned. For this purpose it is necessary to submit the protocol of the test and information about the composition of on the stationary research team.

1. After receiving the application the chairman of the Commission makes primary formal and substantial analysis and appoints an independent expert who can be a member of the Commission or other person of proper knowledge and experience allowing to analyze the project in regard with ethical and scientific aspect.
2. An independent expert in the period not longer than ten working days prepares the project of the opinion.
3. After the chairman gets acquainted with the document, the research project is implemented to agenda of the next sitting of the commission.
4. The commission gives its opinion not later than 3 months from the day of receiving complete documentation concerning the research document.

1. The chairman of the Commission is entitled to approve, between the sittings of the Commission, without the necessity of directing to the reviewer, the projects realized within the own research and statutory operations of the University, doctoral theses and habilitations and amendments of technical and administrative character to sponsored projects.
2. All the decisions of the chairman within this range require approval at the sitting of the Commission.

1. Proceedings concerning the preparation and expressing the opinion by the Commission is confidential. The Commission takes decisions on the opinion of the evaluated research project after being left by the third parties and after devoting sufficient time for discussion.
2. Before taking the decision the Commission makes sure that the documentation is complete.

1. The decisions of the Commission concerning expressing opinion about the research projects are taken in the form of the resolution made during a secret ballot at which the rules of quorum stated in 5§ p. 1 are binding. During the ballot only the votes for accepting the project or against it can be cast.
2. In the case of controversy each of the members of the Commission has the right of attaching his opinion to the decision of the Commission.
3. To its decision Commission can attach the proposal of proceeding in a given case. The proposal is not binding.
4. The Commission can issue a conditional consent in which precise conditions to be fulfilled are presented in order the project could be implemented to realization.
5. Negative opinion of the commission requires a detailed justification.
6. The resolution of the Commission is signed by the members participating in its taking.

1. The decision of the Bioethical Commission at the Medical University of Wroclaw is given to the mover in a written form within two weeks from the day of sitting of the Commission at which it was taken.
2. In case of multi-center research, the coordinator of which is the worker of the Medical University of Wroclaw, the chairman informs about the decision these bioethical commissions in the area of which the remaining centers engaged in the operation are present.

1. The decision of Bioethical Commission at the Medical University of Wroclaw includes:
   1. title of the evaluated research project,
   2. identification number and the date of the protocol of the investigation on the basis of which the decision was taken,
   3. name and (where it is possible) identification numbers of the evaluated documents,
   4. name and the scientific degree of the mover,
   5. date and the place of taking the decision,
   6. name of the Commission,
   7. name of the chairman of the Commission,
   8. names of the members of the Commission taking the decision,
   9. Precise description of the decision taken,
   10. All advice, opinions or necessary conditions to be satisfied attached to the decision of the Commission,
   11. When the opinion is positive - the demand of proposing all the amendments to the protocol of the investigation, informing the Commission about difficult or unexpected unwelcome events, information about completing the investigation, information about the result of the investigation, information about important decisions of other bioethical commissions,
   12. When the opinion is negative - exactly defined reasons of the negative opinion concerning the application,
   13. Date and signature of the chairman of the Commission.

1. The mover realizing the research project is obliged to inform the Commission urgently about unexpected serious and unwelcome effects of the examined medical product (within 7 days form obtaining the information from the sponsor about the death or the threat to life and within 15 days since getting the information qualified as crucial because of other reasons).
2. The description of an unwelcome operation is quoted in original version given by the reporting person.
3. When the description is made in a language different than Polish, English or Latin the reporting person presents the description in the translation into Polish or English.
4. The description is made according to the attachment to the ordinance of the Ministry of Health on 30 April 2004 (Journal of Laws 2004.104.1107).
5. Once a quarter the specification of all the unwelcome effects together with their short description should be sent to the Commission.

1. The mover is obliged to submit to the Commission at the Medical University of Wroclaw the annual report on the realization of the research project on the state of 31 of December of each calendar year.
2. The report should be submitted to the commission till the end of the following year.
3. On the basis of this report and other documentation concerning the research (e.g. the amendments to the protocol, modification of the brochure of the researcher and notifying of the unwelcome events) the Commission makes the evaluation of the progress of the research.

1. In the result of the evaluation made, mentioned in § 21 p. 3 the Commission takes the decision if the consent issued before is or is not in power. The Commission informs the mover about the decision taken.
2. The Bioethical Commission can withdraw the consent for conducting the research if new information show the unwelcome changes in the proportion of the profits to the risk assumed in the protocol,

1. The Commission requires the information about completing the test in the moment of its end from the mover.
2. In case of untimely finishing of the research the information should contain the reasons of termination and Commission should be informed about the summary of results of the untimely finished test.

The researchers do not have any access to the documentation sent to the Commission by the sponsor.

1. The Commission requires the information about completing the test in the moment of its end from the mover.
2. In case of untimely finishing of the research the information should contain the reasons of termination and Commission should be informed about the summary of results of the untimely finished test.

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