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Poland - RECs and Medical Research

History

Research ethics committees began to be established in Poland in the 1980s due to increasing cooperation with western institutions. Ethical review was necessary if researchers wanted to publish results or indeed collaborate in international projects.
RECs obtained legal recognition under the Medical Profession Act of 1996. There was more specific legislation in a Decree by the Ministry of Health 1999, which gives principles of the establishment, funding and operation of RECs. A Decree from the Minister of Health that implements Directive 2001/20 came into effect in January 2003 and this gives further regulations concerning RECs.

For a clinical trial to proceed it must have REC approval, a permit from the Ministry of Health and be registered with the Central Register of Clinical Trials, based at the Ministry of Health.

There are 3 ethics committees that promote good conduct in science and educate through publications – based at the Academy of Sciences, Academy of Arts & Sciences and the State Committee for Research.

Poland has no Central Ethics Committee although the idea has been discussed several times in Parliament.

Summary of Polish RECs

Type of REC Local RECs Local RECs Local RECs
Where situated? Medical schools Universities conducting medical research Regional Medical Chambers Medical Research & Development Institutes
Who applies to them? Medical Research & Development Institutes Drs conducting trials
Researchers at non-affiliated institutes		 Researchers at the institute
Formal/Informal Formal Formal Formal
National/Regional Regional Regional Regional
Laws Involved (see below)

Medical Profession Act 1996
Ministry of Health Decree 1999
Ministry of Health Decree 2002

 Medical Profession Act 1996
Ministry of Health Decree 1999
Ministry of Health Decree 2002		 Medical Profession Act 1996
Ministry of Health Decree 1999
Ministry of Health Decree 2002
Guidance Involved Declaration of Helsinki
ICH-GCP		 Declaration of Helsinki
ICH-GCP		 Declaration of Helsinki
ICH-GCP
Membership requirements 11-15 members including:
Medical specialists
A representative of another profession e.g.priest, lawyer, philosopher, pharmacist or nurse- all with at least 10 years experience
1 member from local Medical Chamber		 11-15 members including:
Medical specialists
A representative of another profession e.g.priest, lawyer, philosopher, pharmacist or nurse- all with at least 10 years experience
1 member from local Medical Chamber		 11-15 members including:
Medical specialists
A representative of another profession e.g.priest, lawyer, philosopher, pharmacist or nurse- all with at least 10 years experience
1 member from local Medical Chamber
Responsible/accountable to whom? Independent Independent Independent
Approval or Advisory powers Approval Approval Approval

Not submitting research or failing to follow review

There are no legally defined penalties for failure to follow review, although it is assumed that medical professionals are legally and professionally responsible for their research.
Following the 2002 Decree, it is illegal to conduct a clinical trial without REC approval.

Which body, if not the REC itself takes this action, and how do they proceed?

In cases regarding doctors, it would either be the Medical Court of the local Medical chambers or the Supreme Medical Court of the main Medical Chamber. The courts would consider the doctors' adherence to the principles of the Code of Medical Ethics. They have the power to award various penalties and/or revoke a doctor’s licence for serious breaches of the Code.
If there was a breach of the law, then the courts would deal with the case.

Impact of Directive 2001/20 EC

This directive was implemented in the legislation of 2002. Ministry of Health Act Nr.221 poz.1864.

Legal action that can be taken against RECs

Appeals against REC decisions are handled by the Bioethical Committee of Appeals which is established by the Ministry of Health in conjunction with the Supreme Medical Chamber.

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