Practice variation in the informed consent procedure for thrombolysis in acute ischemic stroke: a survey among neurologists and neurology residents

Background Obtaining informed consent for intravenous thrombolysis in acute ischemic stroke can be challenging, and little is known about if and how the informed consent procedure is performed by neurologists in clinical practice. This study examines the procedure of informed consent for intravenous thrombolysis in acute ischemic stroke in high-volume stroke centers in the Netherlands. Methods In four high volume stroke centers, neurology residents and attending neurologists received an online questionnaire concerning informed consent for thrombolysis with tissue-type plasminogen activator (tPA). The respondents were asked to report their usual informed consent practice for tPA treatment and their considerations on whether informed consent should be obtained. Results From the 203 invited clinicians, 50% (n = 101) completed the questionnaire. One-third of the neurology residents (n = 21) and 21% of the neurologists (n = 8) reported that they always obtain informed consent for tPA treatment. If a patient is not capable of providing informed consent, 30% of the residents (n = 19) reported that they start tPA treatment without informed consent. In these circumstances, 53% of the neurologists (n = 20) reported that the resident under their supervision would start tPA treatment without informed consent. Most neurologists (n = 21; 55%) and neurology residents (n = 45; 72%) obtained informed consent within one minute. None of the respondents used more than five minutes for informed consent. Important themes regarding obtaining informed consent for treatment were patients’ capacity, and medical, ethical and legal considerations. Conclusion The current practice of informed consent for thrombolysis in acute ischemic stroke varies among neurologists and neurology residents. If informed consent is obtained, most clinicians stated to obtain informed consent within one minute. In the future, a shortened information provision process may be applied, making a shift from informed consent to informed refusal, while still considering the patient’s capacity, stroke severity, and possible treatment delays.

Intention, perception and trust: Comment on “Challenges of informed consent during a political crisis” by Mishra and Gaitonde

This note explores the relevance of the ethics requirement of having a “study­independent observer/impartial witness” signing off on the informed consent procedure when the community under study is unwilling to do so. It shows how the community's distrust of the researcher as an agent of a malevolent government (expressed in a refusal to sign the consent form) is reflected in the researcher's objective links to government through education and advanced academic research. The note argues that research ethics, rather than blindly following rules, means thinking about context. It reverses the question of relevance of the ethics protocol, to questioning the relevance of the research to the community. It suggests that thinking this through will clarify the position of the researcher and contribute to research ethics

Recommendations for clinical research in children presenting to primary care out-of-hours services

Background: Research in primary care is essential, but recruiting children in this setting can be complex and may cause selection bias. Challenges surrounding informed consent, particularly in an acute clinical setting, can undermine feasibility. The off-protocol use of an intervention nearing implementation has become common in pragmatic randomized controlled trials (RCTs) set in primary care. Aim: To describe how the informed consent procedure affects study inclusion and to assess how off-protocol medication prescribing affects participant selection in a paediatric RCT. Design: A pragmatic RCT evaluating the cost-effectiveness of oral ondansetron in children diagnosed with acute gastroenteritis in primary care out-of-hours services and a parallel cohort study. Method: Consecutive children aged 6 months to 6 years attending primary care out-of-hours services with acute gastroenteritis were evaluated to assess the feasibility of obtaining informed consent, the off-protocol use of ondansetron, and other inclusion/exclusion criteria. Results: The RCTs feasibility was reduced by the informed consent procedure because 39.0% (325/834) of children were accompanied by only one parent. General practitioners prescribed ondansetron off-protocol to 34 children (4.1%), whereof 19 children were eligible for the RCT. RCT-eligible children included in the parallel cohort had fewer risk factors for dehydration than children in the RCT despite similar dehydration assessments by general practitioners. Conclusion: The informed consent procedure and off-protocol use of study medication affect the inclusion rate but had little effect on selection. A parallel cohort study alongside the RCT can help evaluate selection bias, and a pilot study can reveal potential barriers to inclusion.

Ethical issues of the informed consent procedure in schizophrenia patients in view of cognitive dysfunction

Te procedure of obtaining the informed consent plays the crucial role in biomedical studies. Psychiatric patients refer to the vulnerable category of subjects, as there is an obvious conflict exists between the necessity of compliance to the subject’s autonomy rules and the restrictions of this autonomy caused by the illness. Schizophrenia patients suffer from cognitive dysfunction in different domains, which influence their ability to comprehend the information and to make decisions. From the other hand, arguing the appropriateness of informed consent obtaining in patients with severe mental disorders (e.g. with schizophrenia) and, thus, limitation of their ability to participate in clinical trials, can be considered as an equitable limitation of their access to the latest achievements of medical science. Potential difculties in obtaining informed consent in schizophrenia subjects can be divided into three categories: 1) subject related; 2) protocol related; 3) investigator/physician related; Both the investigators and the physicians must be acquainted with the potential ethical issues that can influence the decision making ability in schizophrenia subjects due cognitive dysfunction and the decline in subject’s autonomy level.

IMPLEMENTASIROTTERDAM CONVENTION ON THE PRIOR INFORMED CONSENT PROCEDURE FOR CERTAIN HAZARDOUS CHEMICALS AND PESTICIDES IN INTERNATIONAL TRADEBAGI PERKEMBANGAN HUKUM LINGKUNGAN DI INDONESIA

Konvensi ini memang tidak langsung memberikan efek yang signifikan namun dengan meratifikasi konvensi ini akan memberikan pengaruh terhadap kelangsungan ekspor bahan mentah terlebih sumber daya alam seperti bahan obat-obatan, bahan pangan dan bahan lainnya yang terkontaminasi oleh bahan kimia dan pestisida berbahaya. Ratifikasi konvensi ini akan mempersempit kemungkinan menurunnya kualitas keanekaragaman hayati yang sering dimanfaatkan untuk kebutuhan hidup. Selain itu adanya konvensi ini akan mencegah munculnya masalah terhadap lapangan pekerjaan bagi pihak-pihak yang terkontaminasi limbah maupun bahan kimia dan pestisida yang berbahaya seperti para petani, nelayan dan masyarakat pada umumnya. Jika ditelaah secara mendalam jumlah ekpor pada sektor pertanian setiap tahun terus mengalami penurunan, hal ini disebabkan oleh menurunya kualitas ekosistem persawahan akibat pemakaian pestisida yang berlebihan. Kata kunci : Konvensi Rotterdam, ratifikasi, hukum lingkungan.

Informed Consent in Social Sciences Research: Ethical Challenges

Informed consent is a critical procedure for the fulfilment of the ethical dimension in scientific research in social sciences. On the basis of a stance centred in Sociology research practices developed by the authors, this paper reflects on informed consent, its relevance in research, and procedures involved in its production and its concomitant implications. The reflection on the research process is stressed, emphasising the need to not consider the informed consent procedure as something that is fulfilled only once, but rather as something that integrates both the research process and its product and that, therefore, should be continuously considered and assessed throughout research.