scholarly journals Evaluation of Program to Develop Communication Skills for Health Care Professionals-Role-playing Exercises Introduced for Training in Informed Consent Process in Clinical Trials-

2008 ◽  
Vol 34 (8) ◽  
pp. 727-735 ◽  
Author(s):  
Etsuko Arita ◽  
Tomomi Iioka ◽  
Atsushi Ujihara ◽  
Ryoko Omori ◽  
Satomi Koshiba ◽  
...  
Keyword(s):  
Health Care ◽  
Clinical Trials ◽  
Informed Consent ◽  
Communication Skills ◽  
Health Care Professionals ◽  
Role Playing ◽  
Informed Consent Process ◽  
Consent Process

scholarly journals Informed Consent Process in the New Millennium

2018 ◽  
Vol 5 (2) ◽  
pp. 22-24
Author(s):  
Ranabir Pal ◽  
Swapan K Paul
Keyword(s):  
Health Care ◽  
Clinical Trial ◽  
Developing Countries ◽  
Clinical Trials ◽  
Informed Consent ◽  
Emerging Market ◽  
Informed Consent Process ◽  
Consent Process ◽  
Autonomous Decision ◽  
New Millennium

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.

scholarly journals Parental perceptions of the informed consent process in pediatric oncology clinical trials

2013 ◽  
Vol 3 (11) ◽  
Author(s):  
Yvonne D Hastings ◽  
Natalie K Bradford ◽  
Liane R Lockwood ◽  
Robert S Ware ◽  
Jeanine Young
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Pediatric Oncology ◽  
Parental Perceptions ◽  
Informed Consent Process ◽  
Consent Process ◽  
Oncology Clinical Trials

Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials.

1996 ◽  
Vol 14 (3) ◽  
pp. 984-996 ◽  
Author(s):  
N K Aaronson ◽  
E Visser-Pol ◽  
G H Leenhouts ◽  
M J Muller ◽  
A C van der Schot ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Informed Consent ◽  
Cancer Patients ◽  
Intervention Group ◽  
Nursing Intervention ◽  
Informed Consent Process ◽  
Consent Process ◽  
Trial Participation ◽  
Oncology Nurse

PURPOSE Here we report the results of a randomized study undertaken to test the efficacy of a supplementary, telephone-based nursing intervention in increasing patients' awareness and understanding of the clinical trials in which they are asked to participate. METHODS During a 12-month period, 180 cancer patients who were approached to participate in a phase II or III clinical trial were randomized to undergo either of the following: (1) standard informed consent procedures based on verbal explanations from the treating physician plus written information (controls); or (2) standard informed consent procedures plus a supplementary, telephone-based contact with an oncology nurse (intervention). For purposes of evaluation, face-to-face interviews were conducted with all patients approximately 1 week after the informed consent process had been completed. RESULTS The two groups were comparable with regard to sociodemographic and clinical variables. Both groups had a high level of awareness of the diagnosis and of the nature and objectives of the proposed treatments. The intervention group was significantly (P < .01) better informed about the following: (1) the risks and side effects of treatment; (2) the clinical trial context of the treatment; (3) the objectives of the clinical trial; (4) where relevant, the use of randomization in allocating treatment; (5) the availability of alternative treatments; (6) the voluntary nature of participation; and (7) the right to withdraw from the clinical trial. The intervention did not have any significant effect on patients' anxiety levels or on rates of clinical trial participation. Patients reported high levels of satisfaction with the intervention. CONCLUSION The use of a supplementary, telephone-based nursing intervention is a feasible and effective means to increase cancer patients' awareness and understanding of the salient issues that surround the clinical trials in which they are asked to participate.

Comprehension and recall from the informed consent process by phase I healthy volunteers before dose administration

2019 ◽  
Vol 16 (3) ◽  
pp. 283-289 ◽  
Author(s):  
Rami Tadros ◽  
Gillian E Caughey ◽  
Sally Johns ◽  
Sepehr Shakib
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Phase I ◽  
Healthy Volunteers ◽  
Drug Administration ◽  
Study Drug ◽  
Informed Consent Process ◽  
Consent Process ◽  
Phase I Clinical Trials ◽  
Study Drug Administration

Aims/Background A fundamental part of all clinical trials is informed consent, reflecting the respect for the volunteer’s autonomy. Research participation is voluntary; therefore, certain aspects of the proposed study must be disclosed so that volunteers can make an informed decision. In this study, we aimed to examine the level of comprehension and recall of healthy volunteers from the informed consent process. Methods The study was carried out at a single phase I clinical trials unit. A questionnaire was administered to each volunteer to assess recall of important aspects of the study at the day-1 visit following the informed consent process. The questionnaire contained seven questions regarding study objectives, route, frequency and type of drug administration, adverse effects, number of subjects previously exposed and remuneration. One point was awarded for each correct answer. Results A total of 266 volunteers were administered the questionnaire. The mean total score (±standard deviation) for all volunteers was 4.5 ± 1.1 points out of 7, with a range of 0.8–6.7. For all 10 studies, 91% of volunteers responded correctly when answering about the route of administration, and 90% were able to accurately state the correct payment amount. Only 7% were able to repeat the aims of the study correctly. Conclusion The poor performance of our study volunteers raises concerns about recall of information prior to study drug administration. This has implications for the volunteer’s safety and ability to provide true informed consent. Interventions to improve recall prior to dosing should be undertaken.

Survey of risks and benefits communication strategies by research nurses

2017 ◽  
Vol 26 (3) ◽  
pp. 937-950 ◽  
Author(s):  
Lika Nusbaum ◽  
Brenda Douglas ◽  
Neenah Estrella-Luna ◽  
Michael Paasche-Orlow ◽  
Karla Damus
Keyword(s):  
Informed Consent ◽  
Research Question ◽  
Role Playing ◽  
Informed Consent Process ◽  
Consent Process ◽  
Attitudes And Practices ◽  
Work Related ◽  
Risks And Benefits ◽  
Research Nurses ◽  
And Training

Background: An ethical, informed consent process requires that potential participants understand the study, their rights, and the risks and benefits. Yet, despite strategies to improve communication, many participants still lack understanding of potential risks and benefits. Investigating attitudes and practices of research nurses can identify ways to improve the informed consent process. Research question: What are the attitudes, practices, and preparedness of nurses involved in the informed consent process regarding communication of risks and benefits? Research design: A survey was developed and administered online to a national purposive sample of 107 research nurses with experience obtaining informed consent for clinical trials. Survey responses stratified by selected work-related characteristics were analyzed. Ethical considerations: Participants were instructed they need not answer each question and could stop at any time. They consented by clicking “accept” on the email which linked to the survey. The study was approved by the Northeastern University Institutional Review Board, Boston, Massachusetts (NU-IRB Protocol #: 13-06-17). Findings: Most research nurses (87%) used a teach-back method to assess participant comprehension, while 72% relied on their intuition. About one-third did not feel prepared to communicate related statistics. About 20% did not feel prepared to tailor information, and half did not feel competent using supplemental materials to enhance risks and benefits comprehension. Only 70% had received training in the informed consent process which included in-person training (84%), case studies (69%), online courses (57%), feedback during practice sessions (54%), and simulation, such as role playing (49%) and viewing videos (45%). Perceived preparedness was significantly associated with greater informed consent experience and training. Conclusion: Research nurses may have inadequate training to encourage, support, and reinforce communication of risks and benefits during the informed consent process. Relevant purposeful education and training should help to improve and standardize the ethical informed consent process.

scholarly journals Regulatory developments in the conduct of clinical trials in India

2016 ◽  
Vol 1 ◽  
Author(s):  
R. Roy Chaudhury ◽  
D. Mehta
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Clinical Research ◽  
Supreme Court ◽  
Large Scale ◽  
Ethics Committees ◽  
Informed Consent Process ◽  
Consent Process ◽  
Regulatory Institutions ◽  
Indian Supreme Court

There has been a drop in clinical research in India following stringent conditions put in place by the Indian Supreme Court in 2013. The Court's orders came in the wake of irregularities highlighted in the conduct of clinical trials in the country. This paper highlights the steps taken by the Indian regulator, the Central Drugs Standard Control Organisation to comply with these directions. These are of three kinds: strengthening regulatory institutions, protecting participant safety and creating regulatory certainty for sponsors and investigators. Examples include the large-scale training of Ethics Committees, framing detailed guidelines on compensation and audiovisual recording of the informed consent process, as well as reducing the time taken to process applications. It is expected that these measures will inspire confidence for the much-needed resumption of clinical research.

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