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Świadoma zgoda na udział w eksperymencie medycznym. Poradnik dla badacza [Informed consent for medical research. Handbook for researchers]
Abstract
SPIS TREŚCI
Podziękowania
Słowo od autorów
Wprowadzenie
1. Istota i rodzaje eksperymentów medycznych
2. Świadoma zgoda jako warunek dopuszczalności prowadzenia eksperymentów medycznych na ludziach
2.1. Świadoma zgoda jako wymóg etyczny
2.2. Świadoma zgoda jako przedmiot regulacji międzynarodowych i europejskich
2.3. Świadoma zgoda w prawie polskim
2.4. Dopuszczalność prowadzenia eksperymentów bez świadomej zgody
3. Warunki ważności zgody na udział w eksperymencie medycznym
3.1. Zgoda musi być udzielona przez kompetentny podmiot
3.2. Zgoda musi być udzielona przez należycie poinformowany podmiot
3.3. Zgoda musi być dobrowolna
3.4. Zgodna musi być udzielona w odpowiedniej formie
4. Proces uzyskiwania świadomej zgody na udział w eksperymencie medycznym
5. Dokumentacja świadomej zgody
5.1. Druk informacji dla uczestnika eksperymentu medycznego
5.2. Wzór formularza świadomej zgody uczestnika eksperymentu medycznego
5.3. Wzór oświadczenia o przyjęciu warunków ubezpieczenia przez uczestnika eksperymentu medycznego 5.4. Wzór oświadczenia o wyrażeniu zgody na przetwarzanie danych związanych udziałem uczestnika w eksperymencie przez badacza i inne osoby lub podmioty przeprowadzające eksperyment medyczny
5.5. Dokumentacja świadomej zgody w eksperymentach medycznych z udziałem małoletnich
5.6. Dokumentacja świadomej zgody w eksperymentach medycznych z udziałem osób ubezwłasnowolnionych 6. Najważniejsze regulacje polskie i międzynarodowe dotyczące wymogu świadomej zgody [teksty dokumentów]
7. Literatura
8. Nota o autorach
... Zasada ta realizuje się m.in. poprzez obowiązek szczególnej ochrony osób niezdolnych do samostanowienia oraz osób, które ze względu na swoją sytuację zdrowotną lub życiową nie mogą samodzielnie zadbać o swoje interesy 40 . ...
The article focuses on the analysis of the parent situation (or statutory representatives) who are under legal requirement to subject their children to preventive vaccination. The main deliberations focus on answering the question of how the parents’ (or statutory representatives’) position should be treated if they, relying on the principle of autonomy and their parental rights, and pointing to their duty to exercise care of a minor and to represent a minor child, fail to take any action intended to implement the obligation imposed by law. Parents refer to the principle of child’s welfare and argue that vaccination constitutes an essential threat to the values they recognise, such as autonomy, freedom to make decisions regarding the actual situation and legal position of a child, or the child’s welfare. The issue of parents’ autonomy and implementation of child’s welfare is raised. Parents often bring up an argument of the harmful eff ects of vaccination and claim that by refusing to agree to vaccination they exercise the principle of child’s welfare. The legal character of the refusal to consent to child vaccination is also analysed. Here, deliberations are set in the context of imprecisely formulated statutory provisions and their mutual relations, especially in the context of the meeting of acts from two branches of law: administrative and civil, and within the latter family law in particular. An attempt has been made to explain doubts whether despite the mandatory requirement and resulting from it obligation threatened with an administrative fi ne statutory representatives still have a right to express or not consent for vaccination of their children or to decide about at any stage of the procedure.
... In the case of non-therapeutic interventions (e.g. medical experiments, research), renouncement of the right to information is not permitted [42]. Besides, this regulation is used only in relation to the patient. ...
The right to self-determination, including the decision on treatment, is affirmed in modern societies. Therefore, the fundamental condition of legal procedures is informed consent of a patient or an authorised person. However, to make the consent legally effective, some conditions have to be met; of these, the provision of comprehensive medical information is of the utmost importance. Thus, a patient is entitled to necessary information provided by a physician. The correlate of this right is the obligation to disclose information which must be fulfilled by a medical practitioner. The aim of this review is to examine this obligation in terms of determining the range of subjects authorised to provide information, the scope of subject information or a set of data, and the manner and time in which it should be given. Moreover, this article discusses regulations which permit limitations of information disclosure, i.e. the patient's entitlement to renounce the right to information, and therapeutic privilege. The disquisition regards achievements of legal doctrine and judicature, from the angle of which all the legal solutions and doubts arising are presented.
The article analyzes the scope of the minor’s decision-making independence within medical procedures. As the child, who is the patient, does not have actual and formal possibilities to make independent decisions and give consent, the legal system has developed instruments for the protection of the minor’s health interest, and the implementation of health-related well-being was entrusted to parents (statutory representatives). The provisions of the applicable law provide for the existence of age limits for making decisions within the patient’s health situation. This fact is criticized. Proposals for changes and lowering the age of the minor’s decision-making independence are presented. The author analyzes the assumptions of the draft amendments to the Act on doctors and dentists professions and addresses the problem of a minor’s independence in gynecological, dermatological, and urological procedures. Considerations are carried out both under Polish medical law and family law, and the author accuses the authors of the project of lack of knowledge of system solutions and proposes de lege ferenda postulates.
The article covers the issue of providing information on the state of health in a situation where the patient is a minor. The child does not have actual and formal possibilities to make decisions independently. The child cannot make decisions regarding treatment, but he/she may make other decisions as part of informative self-determination. The purpose of the work is to show situations where a child, regardless of age, may agree to inform other people about his or her health. The author also presents instruments to secure the right to intimacy and privacy of minor patients.
This paper queries the pharmaceutical industry's concept of "ready-to-recruit" populations by examining its recruitment strategies for clinical trials and the types of human subjects who participate in these drug studies. The argument is that the pharmaceutical industry has profited from a system comprised of what can more aptly be characterized as ready-to-consent populations, meaning populations who do not have better alternatives than participation in clinical trials. Further, through qualitative research, this paper aims to highlight some of the limitations of current U.S. federal regulation and to show how these limits signal problems that are not normally discussed in the medical ethics literature about research on human subjects. It does this by examining the impotence of informed consent - both as a concept and as a practice - in light of recruitment strategies and the structural reasons motivating individuals to participate in clinical trials.
The difference between research and innovative therapy is based on the goals rather than the risks or newness of the therapy. The threat to patients from research is not that an untested treatment may be hazardous. Instead, the danger is that the loyalty of their physician may be compromised by the goals of research. In the traditional conception of research, it is assumed that we know what constitutes standard therapy and how effective it is. The goal of research is to compare the effectiveness of an innovation with the standard therapy. However, when rapid progress is being made, it becomes difficult to measure improvements due to introduction of new therapies. It is difficult to determine which of many successful therapies is "best." As a result, rapid progress makes all therapies, including both new ones and old ones, nonvalidated therapies. In such situations, scientific norms about the degree of certainty that we must have in order to judge a therapy as being efficacious are based on the values of the individuals involved; rather than on any value-free statistical or scientific calculations. There are identifiable communities (ethnic groups) that are specifically effected by certain genetic diseases, as well as communities consisting of patients who have certain nongenetic diseases. When these groups (patient advocates) and communities are politically organized, they should be consulted and allowed to participate in the process of devising strategies to evaluate new therapies.
The CRASH Trial (Corticosteroid Randomisation After Significant Head injury), which started in April 1999 hopes to answer the question of whether or not there is any benefit to giving high dose corticosteroids after significant head injuries. To do this patients are randomised to receive either the standard care for head injuries, as defined by the receiving hospital, or standard care plus a 48 hour infusion of corticosteroids. This is to be started within eight hours of injury, preferably as soon as possible. As all eligible patients will have a reduced level of consciousness informed consent has been deemed unnecessary. In this review the issue of consent in human experimentation is presented with a special emphasis on the problems faced in emergency medicine research, and the way these have been tackled.
Clinical research with adults who are unable to provide informed consent has the potential to improve understanding and care of a number of devastating conditions. This research also has the potential to exploit some of society's most vulnerable members. Recently, a number of task forces and individual writers have proposed guidelines to ensure that such research is both possible and ethical. Yet, there is widespread disagreement over which safeguards should be adopted. In the present paper, I consider to what extent these disagreements can be resolved by appeal to a general account of the interests of subjects who are unable to consent and the conditions that must be satisfied for research enrollment to constitute exploitation of their inability to make their own decisions.