Bioetic Committee | National Institute of Geriatrics, Rheumatology and Rehabilitation

The Bioetic Committee of the National Geriatrics, Rheumatology and Rehabilitation Institute operates in accordance with order no. 1/2015 of the Director of the National Geriatrics, Rheumatology and Rehabilitation Institute in Warsaw. The Bioetic Committee is considering and expressing opinions on applications for the approval of studies involving people (also surveys) and studies carried out on human biological material.

The meetings of the Committee take place on the last Thursday of the month.

The next meeting will take place on 31st August 2017.

Applications for the approval of studies are to be submitted to the Committee secretary, at least two weeks before a scheduled meeting.

Members of the Committee

Members of the Bioetic Committee of the National Geriatrics, Rheumatology and Rehabilitation Institute in 2015-2017:

Prof. Piotr Głuszko, MD, PH.D. – President
Barbara Kurek – Vice-President
Associate Prof. Robert Gasik, MD, PH.D.
Att. Maria Grzeszczyk
Ewa Kujawa, PhD
Associate Prof. Brygida Kwiatkowska, MD, PH.D.
Rev. Dr. Włodzimierz Nast
Associate Prof. Marzena Olesińska, MD, PH.D.
Tomasz Pawiński, PharmD
Prof. Lidia Rutkowska-Sak, MD, PH.D.
Aleksandra Słabik-Ledóchowska, MD, PH.D.
Prof. Anna Sosnowska, MD, PH.D.
Prof. Tadeusz Styczyński, MD, PH.D.

Committee rules

RULES OF THE BIOETIC COMMITTEE

Appointed on 29.12.2011 by the Director of the Rheumatology Institute, according to the regulation of the Minister of Health and Social Care of 11th May 1999 on detailed rules of appointing and financing and the mode of operation of bioetic committees
(Polish Journal of Laws nr. 47, position 480)

1. The Board of the Bioetic Committee:

Prof. Anna Jędryka-Góral, MD, PH.D. – President
Mgr Iwona Pilichowska – Vice- President

Members:

Prof. Anna Filipowicz-Sosnowska, MD, PH.D.
Associate Prof. Lidia Rutkowska-Sak, MD, PH.D.
Associate Prof. Piotr Głuszko, MD, PH.D.
Prof. Tadeusz Styczyński, MD, PH.D.
Prof. Paweł Małdyk, MD, PH.D.
Brygida Kwiatkowska, MD, PH.D.
Ewa Kujawa, PhD
Barbara Kurek
Rev. Dr. Włodzimierz Nast
Att. Maria Grzeszczyk

2. The Bioetic Committee (hereinafter referred to as Committee) operates in accordance with the principles of the Declaration of Helsinki (2008), the Guidelines for Good Clinical Practices, the Polish Medical Profession Act, the Polish Personal Data Protection Act, the legislation on clinical trial currently applicable in Poland and Good manners in science (Polish Academy of Sciences 2001), expressing opinions in intended human experimentation projects, referred to in chapter 4 of the Polish Medical Profession Act of 5.12.96 (article 29 section 1.12 of this act and the regulation of the Minister of Health and Social Care of 11.05.1999 Polish Journal of Laws nr. 47 position 480).

3. The Committee operates independently.

4. Meetings of the Committee are held at least once a month. If a meeting is not needed, it may be canceled by the President.

5. The Committee’s meetings are chaired by the President of the Committee, in the event of his/her absence – the Deputy President.

6. All members of the Committee are obliged to keep the content of the meeting confidential and to adherence to the principles of the lack of conflict of interest.

7. The Committee initially evaluates studies, supervises them and gives its appropriate opinion after an assessment of the reviewers and a secret voting.

8. The Committee may approve/give its opinion on changes to an ongoing study – which has already obtained a positive opinion of the Committee – under accelerated procedure (in accordance with applicable rules).

9. Taking on a study, about which the Committee gives its opinion, is only possible after a written positive opinion of the Committee.

10. Deviations from and changes in the study protocol without former written consent of the Committee are unacceptable.
It is only possible to make an exception, if immediate action is necessary to eliminate risks to the participants or if the given change concerns technical or administrative issues only.

11. The researcher is obliged to inform the Committee immediately about the following:

deviations from and changes in the study protocol aiming at the elimination of sudden risks or increasing risks to the participants or changes influencing the course of the study,
any severe and unexpected adverse drug action,
any new information on adverse effects of the tested product on the security of the participants or the course of the study.

12. The Committee informs the researcher or the researching institution in writing about the following:

decisions and opinions on the study,
the reasons for these decisions,
appealing procedures against these decisions,
the necessity to report the completion of the study to the Committee.

13. The Committee should store all the documentation at least 3 years after the completion of a study.

14. The researcher or the relevant authorities may address the Committee and ask for its rules and the current list of Committee members.

15. The Committee is being financed out of the fees paid by the entities planning to conduct studies and the members get paid depending on the time spent on the work of the Committee. The Committee’s financial rules are established by the Director of the Institute.

Legal basis

The Bioetic Committee of the Rheumatology Institute acts in accordance with following principles:

The Declaration of Helsinki (2008),
The Guidelines for Good Clinical Practices,
The Polish Medical Profession Act,
The Polish Personal Data Protection Act,
legislation on clinical trials currently applicable in Poland,
Good manners in science (Polish Academy of Sciences 2001),

expressing opinions on intended medical experiments, referred to in chapter 4 of the Polish Medical Profession Act of 5th December 1996 (article 29 section 1.12 of this act and the regulation of the Minister of Health and Social Care of 11th May 1999; Polish Journal of Laws 1999 nr. 47 position 480).

Calendar of meetings

Dates of previous meetings of the Bioetic Committee in 2015 – 2017:

12th March 2015
23rd April 2015
24th September 2015
29th October 2015
26th November 2015
14th January 2016
25th February 2016
7th April 2016
25th May 2016
29th June 2016
14th September 2016
27th October 2016
1st December 2016
26th January 2017
23rd February 2017
30th March 2017
27th April 2017
29th June 2017

The next meeting will take place on 31st August 2017

Dates of previous meetings of the Bioetic Committee in 2012 – 2014:

26th January 2012
23rd February 2012
29th March 2012
25th April 2012
31st May 2012
28th June 2012
20th September 2012
6th November 2012
29th November 2012
31st January 2013
28th February 2013
21st March 2013
25th April 2013
06th June 2013
27th June 2013
03rd October 2013
7th November 2013
28th November 2013
12th December 2013
23rd January 2014
27th February 2014
10th April 2014
29th May 2014
26th June 2014
27th June 2014
26th September 2014
30th October 2014
27th November 2014
18th December 2014

List of documents required when submitting an application

I. List of documents required in case of clinical trials of medicinal products:
[according to the regulation of the Minister of Health of 2nd May 2012 on standard documents submitted in connection with the clinical trial of a medicinal product and on the fee and the payment of the fee for submitting an application for starting clinical trials, Polish Journal of Laws 2012 nr. 0 position 491 – the content of the regulation and standard documents are available (here)]

cover letter;
a copy of the clinical trial protocol approved by the sponsor;
a copy of the changes of the clinical trial protocol, approved by the sponsor, if applicable and if they are not included in the clinical trial protocol;
a summary of the clinical trial protocol;
a copy of the booklet of the researcher in case of researched medicinal products not approved for marketing within the territory of any member state of the ICH;
power of attorney granted by the sponsor for the entity submitting the application to act in the name of the sponsor together with a translation done by a sworn translator, if applicable;
a copy of an agreement concerning handing over some or all duties or activities of the sponsor to a person or an organizational unit conducting the commissioned clinical trial together with a translation done by a sworn translator, if applicable;
a standard form of informed consent;
a standard form of the consent to processing personal data of the participant during the clinical trial concerning his/her participation in the clinical trial;
a standard written information for the patient;
a standard clinical observation card;
a signed and dated resume of the researcher together with a description of his/her scientific and professional activities;
a declaration of the sponsor or the entity, referred to in point 7 or the researcher on the recruitment rules for participants of the clinical trial, if not included in the clinical trial protocol;
a standard recruitment announcement for patients;
a declaration of the researcher on the equipment of the research center, to the extent necessary to conduct the study and information about the qualifications of the staff who will be involved in conducting the clinical trial;
information about the compensation referred to in article 37e Polish Pharmaceutical Law of 6th September 2001 – if not included in the written information for the patient;
information about the amount of the indemnification or compensation provided in the event of injury or death resulting from the participation in the clinical trial;
a copy of a document confirming the sponsor and researcher entering into an obligatory liability insurance, covering the entire duration of the clinical trial, for damages caused in connection with conducting the clinical trial;
copies of agreements on conducting the clinical trial between the sponsor or the entity referred to in point 7 and the researcher as well as copies of agreements between the sponsor or the entity referred to in point 7 and the research center, confirmed by the sponsor or the entity referred to in point 7 as a certified true copy;
information about the remuneration of the people conducting the study, if not included in the agreement between the sponsor and the person conducting the clinical trial;
information about financial rewards referred to in article 37e Polish Pharmaceutical Law of 6th September 2001.

II. List of documents required in the case of a Bachelor, Master, doctoral, habilitation thesis:

an application of the main researcher addressed to the Bioetic Committee for issuing an opinion about the thesis (please provide the topic of the thesis and the surname of the thesis supervisor; the application should be approved by the head of the clinic, where the study will take place as well as by the Director of the Institute);
a description of the study program:
- the title of the study,
- the test group (the amount of people, age, sex),
- inclusion and exclusion criteria,
- recruitment rules,
- the aim of the study,
- the research methodology as well as information about the range of activities beyond routine and the level of discomfort that the study causes to the patient,
- the assessment of risks and benefits for the patient,
- an information about anonymity or the coding of the study as well as about personal data protection,
- rules for creating and securing databases in the study,
- the contact person and his/her contact details (for the patient and the Bioetic Committee);
information for the patient(open);
form of informed consent (a standard form prepared on the basis of „Informed consent to participate in a medical experiment. A guide for the researcher” ed. M. Czarkowski, J. Różyńska; Supreme Medical Chamber, Warsaw 2008) (open);
standard surveys to be used.

III. List of documents required in the case of planned, unplanned works, grants:

application of the main researcher addressed to the Bioetic Committee for issuing an opinion about the work (the application should be approved by the head of the clinic, where the study will take place as well as by the Director of the Institute);
a description of the study program:
- the title of the study,
- the test group (the amount of people, age, sex),
- inclusion and exclusion criteria,
- recruitment rules,
- the aim of the study,
- the research methodology as well as an information about the range of activities beyond routine and the level of discomfort that the study causes to the patient,
- the assessment of risks and benefits for the patient,
- an information about anonymity or the coding of the study as well as about personal data protection,
- rules for creating and securing databases in the study,
- the contact person and his/her contact details (for the patient and the Bioetic Committee);
information for the patient (open);
form of informed consent (a standard form prepared on the basis of „Informed consent to participate in a medical experiment. A guide for the researcher” ed. M. Czarkowski, J. Różyńska; Supreme Medical Chamber, Warsaw 2008) (open);
standard surveys to be used.

IV. List of documents required in case of retrospective studies conducted on human biological material collected in standard procedures:

an application of the main researcher addressed to the Bioetic Committee for issuing an opinion about the work (the application should be approved by the head of the clinic, where the biological material comes from as well as by the Director of the Institute);
a description of the study program:

the title of the study,
the test group (the amount of people),
the aim of the study,
the research methodology,
rules for creating and securing databases in the study,
the contact person and his/her contact details (for the Bioetic Committee).

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The Bioetic Committee approves genetic research separately.

Fees

Under the Order nr. 39/2015 of the Director of the Prof. Eleonora Reicher National Geriatrics, Rheumatology and Rehabilitation Institute of 24th November 2015 on the fees charged by the Bioetic Committee of the Institute the following price list applies:

consideration of a new application for clinical trial of a single center – 8000 PLN;
consideration of a new application for clinical trial of several centers – 10000 PLN, plus an additional fee (1200 PLN) for every other center taking part in the study in case a fee must be paid to a local Bioetic Committee of another center;
making amendments (changes) in the study protocol and adding a new center to the study – 3500 PLN;
consideration of an application of the applicant/sponsor for the extension of a sponsored study – 2000 PLN;
issuing an opinion about non-commercial research projects, in particular surveys, studies using biological material conducted as scientific studies following fees are charged:

students conducting research as part of their Bachelor or Master thesis, who do not have any supervisors among the employees of the Institute – 100 PLN,
others, not employees of the Institute – as their own work, scientific work financed by the state (grants) and habilitation, doctoral thesis – 350 PLN.

These are net prices, VAT tax (23%) is to be added.
Applications of organizational units or employees of the Institute may be exempt from fees. An exemption from fees may take place if the Committee possesses financial resources to cover operating costs.

The order came info force on 24.11.2015.

In case of clinical trials the applicants pay fees on the basis of invoices issued by the Institute, in case of other research projects the fees may be paid as follows:

via transfer to the account of the Institute – Alior Bank SA 37 2490 0005 0000 4530 4468 0720
or in cash at the box office of the National Geriatrics, Rheumatology and Rehabilitation Institute, every day on weekdays from 8.00-13.00 (room 015B ground floor).