Despite tremendous advances in pharmacotherapy over recent decades, the expectations of both medical professionals and patients towards more effective and safer therapies are even greater. This is particularly true for treatment of vascular diseases such as acute coronary syndromes (ACS) and acute stroke, considering the numerous complications that can occur. Although treatments of ACS and stroke have improved greatly with thrombolytic and percutaneous coronary interventions, both conditions still have major therapeutic needs. To satisfy these needs, much research is being conducted by both academia and industry. However, in the era of the evidence-based medicine, novel therapies, even in emergency settings, must be accompanied by essential documentation of their pre-clinical and clinical efficacy and safety to be approved for general use. Clinical research nowadays is governed by widely accepted strict ethical and quality standards, based on the Declaration of Helsinki  and Good Clinical Practice (GCP) guidelines (Good Clinical Practice standards by the International Conference on Harmonisation, ICH, 1996, also introduced into general law in most European countries over recent years by the means of two European Community directives, 2001/20/EC and 2005/28/EC). Essential to these standards are the respect of autonomy of research participants and the importance of their well-being over the interests of science and society. Therefore one of the most fundamental principles of modern clinical research is the informed consent of participants. In the case of emergency trials, however, giving appropriate oral and written information to a prospective participant is usually a challenge for researchers and treating physicians. The informed consent process has to compete with the categorical need of starting necessary diagnostic procedures as quickly as possible, short therapeutic windows, and frequently impaired or absent patient's competence to give informed consent due to poor physical or mental state, shock, neurological deficit, or even unconsciousness [2, 3]. Evidence exists that participation in acute coronary trials may delay the start of the reperfusion therapy, and at least a part of that delay might be due to a patients' involvement in the informed consent process. It has been recently demonstrated that allowing deferred consent for enrolment in a traumatic brain injury (TBI) trial reduces time to study drug administration by 50% compared to written proxy consent .
In the European countries, the ethical and legal environment for conducting biomedical research involving humans has dramatically changed over the last decade. This is due to the inflow of industry-sponsored GCP-compliant clinical trials, adoption of modern medical and pharma laws, the update of national and international ethical codes and conventions, and the implementation of relevant European Union directives. From the perspective of a Polish national, there are a number of conflicting statements in the national medical and pharma laws which have built up a nebulous environment for emergency research investigators. Specifically, these include a waiver from participant's consent, no regulations for a deferred consent, and restrictive regulations for proxy (surrogate) consent, as well as a remarkable tradition of involving patient's relatives in information and/or consent process.
Little is known about either a patients' competence to give consent, or their general opinion on emergency research [6, 7]. A recent report, written following interview of a group of 12 American stroke patients, demonstrates patients' willingness to participate in emergency research, as well as acceptance of a waiver of consent . Noteworthy evidence also exists that the public is aware of the importance of emergency research and that the normal rules for consent may not be easily applicable in these circumstances . Likewise, little is known on physicians' attitudes, especially in terms of informed consent of research participants. Only anecdotal reports are available, such as that by Ågard et al. who investigated the attitudes of Swedish cardiologists to ACS research in 2004 , or a survey among European neuro-trauma centres on TBI trials in 2005 . This has led us to investigate the problem of informed consent in emergency settings from the perspective of Polish physicians' who have frequently faced such issues in practice when conducting ACS or stroke trials.