scholarly journals Consensus on Language for Advance Informed Consent in Health Care–Associated Pneumonia Clinical Trials Using a Delphi Process

2020 ◽  
Vol 3 (5) ◽  
pp. e205435
Author(s):  
Amy Corneli ◽  
Sara B. Calvert ◽  
John H. Powers ◽  
Teresa Swezey ◽  
Deborah Collyar ◽  
...  
2016 ◽  
Vol 44 (3) ◽  
pp. 445-461 ◽  
Author(s):  
Ruqaiijah A. Yearby

American bioethics has served as a safety net for the rich and powerful, often failing to protect minorities and the economically disadvantaged. For example, minorities and the economically disadvantaged are often unduly influenced into participating in clinical trials that promise monetary gain or access to health care. This is a violation of the bioethical principle of “respect for persons,” which requires that informed consent for participation in clinical trials is voluntary and free of undue influence. Promises of access to health care invalidate the voluntariness of informed consent not only because it unduly induces minorities and the economically disadvantaged to participate in clinical trials to obtain access to potentially life saving health care, but it is also manipulative because some times the clinical trial is conducted by the very institutions that are denying minorities and the economically disadvantaged access to health care. To measure whether consent is voluntary and free of undue influence, federal agencies should require researchers to use the Vulnerability and Equity Impact Assessment tool, which I have created based on the Health Equity Impact Assessment tool, to determine whether minorities and the economically disadvantaged are being unduly influenced into participating in clinical trials in violation of the “respect for persons” principle.


2014 ◽  
Vol 3 (1) ◽  
pp. 1-16
Author(s):  
P C Harigovind

Experimenting new drugs on human beings, is one of the crucial human right issues faced by the third world countries in the present century. It is true that the international law had taken high concern of this social issue after the Nuremberg Trials. The international law mandates informed consent to be obtained from the participants of clinical trials and this is the sole mechanism through which the rights of the trial subjects are being protected. The public health issues caused by illegal and unethical trials over patients are now evident in Indian health care system. The issue has come up for consideration before the Supreme Court of India recently. In India the law runs in tune with the international parameters for conducting human experimentation. The law on informed consent has a fatal impact over public health care issues, especially over the matter of clinical trials. Recent experiences in India reveal the threats caused to the society by clinical experimentations. Clinical trials and allied health issues are also brought to the notice of the judiciary. The law on informed consent in India is in its infant state. Exploring the doctrine of informed consent is crucial to this study. The present issue of clinical research which threatens the health care system is analysed and the doctrine of informed consent to regulate the system is assessed to check its efficacy and veracity. Analysis of the issue will help to communicate to the public about the need for better exercise of the rights of those who are subjected to clinical researches. The law of informed consent is in many ways inadequate to deal with the issues relating to clinical trials in India. The doctrine of informed consent has to be redefined to a great extent. The institutional review boards and Non- Government Organisations (NGO) can play a vital role in assuring proper observation of rules relating to regulation of human trials.


2018 ◽  
Vol 5 (2) ◽  
pp. 22-24
Author(s):  
Ranabir Pal ◽  
Swapan K Paul

ABSTRACT In this new millennium, the clinical trial is inseparably linked with an upgrade of health care by generating invaluable data in preventive, promotive and curative health. Globally research experts have concerns regarding ensuring financial and other compensations along with optimum health benefits for research participants in clinical trials in the emerging market economy. A significant number of human healthy volunteers (participants) take part in researches in both developed and developing countries. Participants are frequently unaware that the informed consent process is mandatory for investigators, funders and participants and their free will must be documented. There are sparse published medical works of literature that attempted to assess the extent to which all the norms of the informed consent process are followed in Indian settings in this area to the best of our knowledge. We need to conduct researches on the preparedness of the clinical trials participants towards their awareness of the criticality of the informed consent process and their motives for participation. This narrative review enlightened the facts that very patient, extensive and careful transparent narration and dissemination of the information can only ensure truly informed and autonomous decision improving the validity of the study.


2006 ◽  
Vol 67 (S1) ◽  
pp. S14-S29 ◽  
Author(s):  
Paula Brauer ◽  
Linda Dietrich ◽  
Bridget Davidson ◽  

Purpose: A modified Delphi process was used to identify key features of interdisciplinary nutrition services, including provider roles and responsibilities for Ontario Family Health Networks (FHNs), a family physician-based type of primary care. Methods: Twenty-three representatives from interested professional organizations, including three FHN demonstration sites, completed a modified Delphi process. Participants reviewed evidence from a systematic literature review, a patient survey, a costing analysis, and key informant interview results before undertaking the Delphi process. Statements describing various options for services were developed at an in-person meeting, which was followed by two rounds of e-mail questionnaires. Teleconference discussions were held between rounds. Results: An interdisciplinary model with differing and complementary roles for health care providers emerged from the process. Additional key features addressing screening for nutrition problems, health promotion and disease prevention, team collaboration, planning and evaluation, administrative support, access to care, and medical directives/delegated acts were identified. Under the proposed model, the registered dietitian is the team member responsible for managing all aspects of nutrition services, from needs assessment to program delivery, as well as for supporting all providers’ nutrition services. Conclusions: The proposed interdisciplinary nutrition services model merits evaluation of cost, effectiveness, applicability, and sustainability in team-based primary care service settings.


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