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Ron Berghmans - One of the best experts on this subject based on the ideXlab platform.
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Inclusion of patients with severe mental illness in clinical trials: issues and recommendations surrounding informed consent.
CNS drugs, 2006Co-Authors: Sander P. K. Welie, Ron BerghmansAbstract:Modern medicine would be unthinkable without the possibility of administering pharmaceuticals and other evidence-based interventions. The development of these interventions requires scientific Research, ultimately with human subjects. This venture raises ethical, legal and human rights issues, which are addressed in numerous national and international declarations and regulations. In these documents, special attention is usually directed towards Research involving vulnerable groups, such as children, pregnant women, unemployed persons, refugees, patients with psychiatric disorders, dementia or mental retardation, and those who are dying. In relation to patients with psychiatric disorders, two important and mutually connected ethical questions can be posed. Firstly, is Research with persons who have severe psychiatric illnesses permissible? And, secondly, how can the mental capacity of prospective Research subjects be assessed? We investigate these questions using the Dutch legal system as an example. Regarding the first question, the Dutch Medical-Scientific Research on Human Subjects Act (1998) presents a detailed regulation that is in line with relevant international documents, such as the Convention on Human Rights and Biomedicine (1997). In the Dutch statute, the possibilities for Research involving subjects who lack mental capacity are limited, but not completely excluded. Under certain conditions, two types of Research are exempted from the general prohibition of Research with such subjects that is included in article 4 of the statute. These two types are (i) therapeutic Research and (ii) Non-Therapeutic Research that could not take place without the participation of subjects from the category to which the mentally incapacitated person belongs. The conditions pertain to ethical and scientific review, insurance, written proxy consent and respect for resistance by the subject. An extra condition for the permissibility of Non-Therapeutic Research is that the risks for the prospective subject are negligible and the burdens minimal. Although the Dutch regulation obviously does not solve all problems, it is relatively clear when compared with the situation in other European countries, such as Belgium, France, Germany, and England and Wales. Regarding the second question, two basic factors need to be considered when defining 'mental capacity'. These relate to the assumption of competence and to the task-specificity of capacity. The crucial issue in assessing mental capacity is not whether a psychiatric diagnosis is present, but whether the patient has the mental abilities required to make the decision at hand in a meaningful way. In establishing an appropriate standard for capacity assessment, several interests have to be weighed. The ethical demands of protection of subjects and stimulation of scientific Research may be balanced by attempting to enhance patients' mental capacity. The procedure of 'experienced consent' seems promising in this regard, although this approach entails its own ethical problems.
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Ethical issues in Research with dementia patients.
International journal of geriatric psychiatry, 1995Co-Authors: Ron Berghmans, Ruud Ter MeulenAbstract:The conduct of scientific Research involving dementia patients is an ethically complex issue. Increased insight into the causes and aetiology of this condition can be of paramount importance for future patients and society as a whole. However, the rights and interests of vulnerable and incompetent persons as subjects in Research make ethical boundaries imperative. A distinction should be made between Research that may directly be of benefit to the subject (therapeutic Research) and Research in which no direct benefit for the patient can reasonably be expected (Non-Therapeutic Research). The majority of the Research with dementia patients falls within the latter category. Several ethical issues are discussed, and special attention is paid to the ethical justification of Non-Therapeutic Research involving incompetent subjects suffering from dementia. Five conditions that should be met in order to make this kind of Research ethically acceptable are formulated.
J H Tripp - One of the best experts on this subject based on the ideXlab platform.
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Is venepuncture in neonatal Research ethical
Archives of disease in childhood. Fetal and neonatal edition, 1997Co-Authors: V S Shah, M Al-khannan, M W Quinn, J H TrippAbstract:AIM—To determine whether venepuncture accords with the accepted (BPA) criteria of not causing more than minimal physical or psychological distress during Non-Therapeutic Research. METHODS—Ninety two venepunctures were carried out in 69 neonates between days 6 and 10 of life, and in some cases, on day 28. Parents were fully informed of the need for the procedure and allowed to attend while it was performed. Ninety parents and 87 doctors completed questionnaires to assess the levels of perceived parental and child distress and anxiety before and after the procedure. RESULTS—Only three parents were very upset, and 47% reported the test as being better than they expected, compared with 10% who thought it worse than expected. Seven babies were recorded as being very upset. Doctors tended to underestimate the degree of anxiety before the procedure and the level of distress afterwards. CONCLUSIONS—Venepuncture in neonates seems to be acceptable to most parents and is associated with a favourable risk: benefit ratio using semiquantitative assessment of risk and benefit. Keywords: venepuncture; risk:benefit ratio; Non-Therapeutic Research
John H. Tripp - One of the best experts on this subject based on the ideXlab platform.
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ACCEPTABILITY BY PARENTS OF VENEPUNCTURE IN NON THERAPEUTIC NEONATAL Research. 1045
Pediatric Research, 1997Co-Authors: Vibhuti S. Shah, Mahmood Al-hannan, Michael Quinn, John H. TrippAbstract:Background: The acceptability of blood sampling in children for Research purposes is determined, in part, by whether or not children are harmed. The British Paediatric Association guidelines for Research involving children currently categorize venepuncture as low, rather than minimal risk and state that it is unethical to submit children to greater than minimal risk for non therapeutic Research. Objective: To assess the acceptability, the risks and feasibility of venepuncture as a procedure by parents. Method: 92 venepunctures were carried out by 1 of 2 physicians on 69 neonates enrolled in a project on the use of a new oral Vitamin K preparation approved by local ethics committee. Blood sampling was performed between day 6 and 10 and 23 newborns underwent a 2nd blood test on day 28 of life. Mothers were present at the time of venepuncture in all cases. At the end of the proce-dure, mothers and doctors were given a questionnaire to assess maternal anxiety, perce-ption of baby's discomfort and the ease of procedure. Results: 90 parent questionnaires and 87 doctor questionnaires were returned. 33(37%) parents were noted to be upset, of which 3 stated that they were very upset after seeing the procedure as compared with 42 (46%) who were worried before the procedure. Of these 3 parents, 2 stated that they were very worried before the procedure. 11 of the 33 mothers who were upset felt that their baby was not. 14 of the 36 mothers whose babies were upset were not upset themselves. Of the 7 babies who were described as a lot upset only 1 mother was a lot upset. 10% of mothers thought that the blood test was worse than expected, while 47% found that it was better. Parents-with previous experience of neonatal heel stick felt that it was a better way of collecting blood, 5 of 7 babies who were a lot upset had straightforward vene-punture at the first attempt, while in 15 babies where difficulty was experienced, only 2 were a lot upset. 23 out of 25 parents agreed to participate for a 2nd blood test.
Bartha Maria Knoppers - One of the best experts on this subject based on the ideXlab platform.
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Recruiting Terminally Ill Patients into Non-Therapeutic Oncology Studies: views of Health Professionals
BMC Medical Ethics, 2012Co-Authors: Erika Kleiderman, Denise Avard, Lee Black, Zuanel Diaz, Caroline Rousseau, Bartha Maria KnoppersAbstract:Background Non-Therapeutic trials in which terminally ill cancer patients are asked to undergo procedures such as biopsies or venipunctures for Research purposes, have become increasingly important to learn more about how cancer cells work and to realize the full potential of clinical Research. Considering that implementing Non-Therapeutic studies is not likely to result in direct benefits for the patient, some authors are concerned that involving patients in such Research may be exploitive of vulnerable patients and should not occur at all, or should be greatly restricted, while some proponents doubt whether such restrictions are appropriate. Our objective was to explore clinician-Researcher attitudes and concerns when recruiting patients who are in advanced stages of cancer into Non-Therapeutic Research. Methods We conducted a qualitative exploratory study by carrying out open-ended interviews with health professionals, including physicians, Research nurses, and study coordinators. Interviews were audio-recorded and transcribed. Analysis was carried out using grounded theory. Results The analysis of the interviews unveiled three prominent themes: 1) ethical considerations; 2) patient-centered issues; 3) health professional issues. Respondents identified ethical issues surrounding autonomy, respect for persons, beneficence, non-maleficence, discrimination, and confidentiality; bringing to light that patients contribute to science because of a sense of altruism and that they want reassurance before consenting. Several patient-centered and health professional issues are having an impact on the recruitment of patients for Non-Therapeutic Research. Facilitators were most commonly associated with patient-centered issues enhancing communication, whereas barriers in Non-Therapeutic Research were most often professionally based, including the doctor-patient relationship, time constraints, and a lack of education and training in Research. Conclusions This paper aims to contribute to debates on the overall challenges of recruiting patients to Non-Therapeutic Research. This exploratory study identified general awareness of key ethical issues, as well as key facilitators and barriers to the recruitment of patients to Non-Therapeutic studies. Due to the important role played by clinicians and clinician-Researchers in the recruitment of patients, it is essential to facilitate a greater understanding of the challenges faced; to promote effective communication; and to encourage educational Research training programs.
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Recruiting Terminally Ill Patients into Non-Therapeutic Oncology Studies: views of Health Professionals
BMC medical ethics, 2012Co-Authors: Erika Kleiderman, Denise Avard, Lee Black, Zuanel Diaz, Caroline Rousseau, Bartha Maria KnoppersAbstract:Background Non-Therapeutic trials in which terminally ill cancer patients are asked to undergo procedures such as biopsies or venipunctures for Research purposes, have become increasingly important to learn more about how cancer cells work and to realize the full potential of clinical Research. Considering that implementing Non-Therapeutic studies is not likely to result in direct benefits for the patient, some authors are concerned that involving patients in such Research may be exploitive of vulnerable patients and should not occur at all, or should be greatly restricted, while some proponents doubt whether such restrictions are appropriate. Our objective was to explore clinician-Researcher attitudes and concerns when recruiting patients who are in advanced stages of cancer into Non-Therapeutic Research.
Nancy E. Kass - One of the best experts on this subject based on the ideXlab platform.
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Participants' perceptions of Research benefits in an african genetic epidemiology study
Developing world bioethics, 2011Co-Authors: John Appiah-poku, Sam Newton, Nancy E. KassAbstract:Background: Both the Council for International Organization of Medical Sciences and the Helsinki Declaration emphasize that the potential benefits of Research should outweigh potential harms; consequently, some work has been conducted on participants' perception of benefits in therapeutic Research. However, there appears to be very little work conducted with participants who have joined Non-Therapeutic Research. This work was done to evaluate participants' perception of benefits in a genetic epidemiological study by examining their perception of the potential benefits of enrollment. Methods: In-depth interviews lasting between 45 and 60 minutes were conducted with a convenient sample of 25 ill patients and 25 healthy accompanying relatives enrolled in a genetic epidemiological study of tuberculosis. Recorded interviews were transcribed and analyzed using content analysis. Results: Participants perceived that Research was beneficial and some of the benefits included the generation of new knowledge, finding the cause of diseases, as well as the control, eradication and prevention of disease. Some thought that Research was risky whilst others thought that the benefits outweighed the risks. Conclusion: Participants perceived Research to be beneficial and most of them thought that, though it was risky, the benefits outweighed the risks. It is our view that Researchers need to give serious consideration to participant's perception of benefits in designing their consent forms, to see to the fulfillment of achievable goals.