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Emergency Research without Consent under Polish Law

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Abstract

Although Directive 2001/20/EC of the European Parliament and of Council of 4 April 2001 on the approximation of the laws regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use does not contain an exception for emergency situations, and requires the informed consent of a legal representative in all cases where research is conducted on legally competent individuals who are unable to give informed consent, in Poland, emergency research can be conducted without consent. Polish regulations on emergency research can hardly be treated as a result of intentional legislative policy. Our provisions arise from multiple and sophisticated interpretations of different regulations that govern medical experiments on human subjects and clinical trials. These interpretations can be summarized as follows: (1) There are two categories of medical experiments: therapeutic and non-therapeutic experiments. Emergency research without consent may be conducted in the category of therapeutic experiment only (therapeutic experiment consists of the introduction by the physician of new or only partially proven diagnostic, therapeutic or preventive methods in order to achieve direct benefit to the health of the patients, and it can be carried out when hitherto applied methods were ineffective or their effectiveness was insufficient). (2). Emergency research may be conducted without consent if there is a situation of great urgency in which the research subject’s life is in danger and there is no possibility of obtaining immediate consent from the research subject him or herself, or from his or her legal representative or guardianship court, and the research subject has not refused to give consent for the participation in an emergency therapeutic experiment. The legal representative or guardianship court shall be provided with all the relevant information concerning subject’s participation in an experiment as soon as possible. All projects of emergency research with intent to be done without the research subject’s consent must be approved by an independent bioethics committee. Because these five requirements seem to provide insufficient protection for a subject’s autonomy and rights it is necessary to add to them two other conditions: (1) the emergency research could not be conducted using other research participants capable of giving informed consent; and (2) informed consent for continued participation in the emergency research shall be obtained from either the participant him or herself or the legally authorized representative as soon as possible (requirement of obtaining deferred consent). A consolidated single Act that will govern all aspects of medical experiments on human subjects, including emergency research, should be prepared and enacted as soon as possible.

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Notes

  1. The “Final Rule”, referred to as the Waiver of Informed Consent Requirement in Certain Emergency Research in DHSS regulations and the Emergency Exception to Informed Consent in the FDA regulations went into effect in November 1996, ending the 3-year moratorium on emergency research. The new regulations (Title 21, Code of Federal Regulations [21 CFR] Section 50.24, and conforming amendments contained in 21 CFR Parts 56, 312, 314, 601, 812, and 814) define specific circumstances under which a waiver of informed consent for emergency research can be obtained. In particular, the participants must be in a life-threatening situation in which available treatments are unproven or unsatisfactory; the participant must be unable to consent as a result of their condition and the intervention must be made before consent can be obtained from a legally authorized representative; the risks must be reasonable in the light of expected benefits; and the research must be impractical without the waiver. Other conditions include community consultation, i.e. consultation with representatives of the community from which the participants will be drawn.

  2. Poland signed the Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, on 7 May 1997, but has not ratified it. It means that the Convention has no direct legal effect in Polish legal system. Moreover, Poland has not signed the Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research.

  3. Art 4.8.15 of the ICH Harmonized Tripartite Guideline for Good Clinical Practice: “In emergency situations, when prior consent of the subject in not possible, the consent of the subject’s legally acceptable representative, if present, should be requested. When prior consent of the subject is not possible, and the subject’s legally acceptable representative is not available, enrolment of the subject should require measures describes in the protocol and/or elsewhere, with documented approval/favourable opinion by the IRB/IEC, to protect the rights, safety and well-being of the subject and to ensure compliance with applicable regulatory requirements. The subject or the subject’s legally acceptable representative should be informed about the trial as soon as possible and consent to continue and other consent as appropriate (see 4.8.10) should be requested.”

  4. Art 19 of the Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research:

    1. 1.

      The law shall determine whether, and under which protective additional conditions, research in emergency situations may take place when:

    2. i.

      a person is not in a state to give consent, and

    3. ii.

      because of the urgency of the situation, it is impossible to obtain in a sufficiently timely manner, authorization from his or her representative or an authority or a person or body which would in the absence of an emergency situation be called upon to give authorization.

    1. 2.

      The law shall include the following specific conditions:

    1. i.

      research of comparable effectiveness cannot be carried out on persons in non-emergency situations;

    2. ii.

      the research project may only be undertaken if it has been approved specifically for emergency situations by the competent body;

    3. iii.

      any relevant previously expressed objections of the person known to the researcher shall be respected;

    4. iv.

      where the research has not the potential to produce results of direct benefit to the health of the person concerned, it has the aim of contributing, through significant improvement in the scientific understanding of the individual’s condition, disease or disorder, to the ultimate attainment of results capable of conferring benefit to the person concerned or to other persons in the same category or afflicted with the same disease or disorder or having the same condition, and entails only minimal risk and minimal burden.

    1. 3.

      Persons participating in the emergency research project or, if applicable, their representatives shall be provided with all the relevant information concerning their participation in the research project as soon as possible. Consent or authorization for continued participation shall be requested as soon as reasonably possible.

    It is worth noting that the Additional Protocol explicitly allows for conducting non-therapeutic research in emergency situations without consent (Art. 19, Sec. 2, IV).

  5. Poland has not implemented yet the Commission Directive 2005/28/EC of 8 April 2005 lying down principle and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirement for authorization of the manufacturing or importing of such products.

  6. In light of Article 190 Sec.1 of the Constitution of the Republic of Poland “Judgments of the Constitutional Tribunal shall be of universally binding application and shall be final”. The judgments of all decisions concerning the review of norms are subject to immediate publication in the official journal in which the said acts were published. The decision comes into force on the date of publication, i.e. the normative act forfeits its binding force thereupon. The decision on non-conformity therefore has an erga omnes effect by abolishing the normative act; this also means that the normative act—albeit defective—is nevertheless in force until publication. The Constitutional Tribunal may also specify another date for the end of the binding force of a normative act.

  7. The independent bioethics committee should pay special attention to the risk/benefit ratio in order to ensure proper application of clinical equipoise—the sum of risks and potential benefits of therapeutic procedures in an emergency medical research are roughly similar to that which a patient would receive in clinical practice. However, since the waiver of informed consent may render emergency subjects more vulnerable than non-emergency subjects, an application of more restrictive risk threshold may be appropriate. What constitutes “a more restrictive risk threshold” is a very controversial issue which has not been discussed in Polish research ethics yet. Analysis of this issue falls outside of the scope of this paper.

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Authors and Affiliations

  1. Graduate School for Social Research, Institute of Philosophy and Sociology, Polish Academy of Sciences, Warsaw, Poland

    Joanna Różyńska

  2. 15 Inflancka Street, app. 132, Warsaw, 00-189, Poland

    Joanna Różyńska

  3. Bioethics Committee of the Warsaw Regional Chamber of Physicians and Dentists, Warsaw, Poland

    Marek Czarkowski

  4. Department of Internal Medicine and Endocrinology, Medical University of Warsaw, ul. Banacha 1A, Warsaw, 02-097, Poland

    Marek Czarkowski

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  1. Joanna Różyńska
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  2. Marek Czarkowski
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Correspondence to Joanna Różyńska.

Additional information

An earlier version of this paper was presented at The 7th International Conference on Bioethics on “The Ethics of Research in Emergency Medicine”, held on June 2, 2006, Warsaw, Poland.

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Różyńska, J., Czarkowski, M. Emergency Research without Consent under Polish Law. Sci Eng Ethics 13, 337–350 (2007). https://doi.org/10.1007/s11948-007-9023-8

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