scholarly journals Ethical Issues of Electronic Patient Data and Informatics in Clinical Trial Settings

2006 ◽  
pp. 233-256 ◽  
Author(s):  
Dipak Kalra ◽  
David Ingram
Keyword(s):  
Clinical Trial ◽  
Ethical Issues ◽  
Patient Data

Secondary use of routinely collected patient data in a clinical trial: An evaluation of the effects on patient recruitment and data acquisition

2013 ◽  
Vol 82 (3) ◽  
pp. 185-192 ◽  
Author(s):  
Felix Köpcke ◽  
Stefan Kraus ◽  
Axel Scholler ◽  
Carla Nau ◽  
Jürgen Schüttler ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Data Acquisition ◽  
Patient Data ◽  
Patient Recruitment ◽  
Secondary Use

scholarly journals COVID-19 Pandemic in Thailand: Implementing Containment Measures and Their Ethical Challenges

2020 ◽  
Author(s):  
Hongsuda Sornklin ◽  
Thitiwan Kerdsomboon ◽  
Yongyuth Yuthavong ◽  
Prasit Palittapongarnpim ◽  
Soraj Hongladarom ◽  
...  
Keyword(s):  
Public Health ◽  
Clinical Trial ◽  
Ethical Issues ◽  
Technology Development ◽  
Research Integrity ◽  
Ethical Challenges ◽  
National Science ◽  
Office Of Research Integrity ◽  
Containment Measures ◽  
New Challenges

Abstract Containment measures have been implemented in Thailand after the country was hit by the Covid-19 pandemic. The top priority is to save people’s lives. Unavoidably, serious consequences that affected the people’s income, privacy, needs, equality, and equity emerged, presenting new challenges. In order to begin to investigate these complex ethical questions, the Office of Research Integrity of National Science and Technology Development Agency organized a meeting in order to bring together key experts in various fields related to the Covid-19 pandemic to discuss what was going on in Thailand and how to manage it properly. Three key ethical settings, each of which caused significant effects, were discussed in the meeting, namely public health, medical services, and research and clinical trial settings. Many key ethical issues were revealed during the meeting, as well as how best to address and manage them properly.

scholarly journals Assessment of Knowledge, Perception and Readiness of Nigerians to Participate in the COVID-19 Vaccine Trial

2020 ◽  
Vol 4 (1) ◽  
Author(s):  
Enitan SS ◽  
Oyekale AO ◽  
Akele RY ◽  
Olawuyi KA ◽  
Olabisi EO ◽  
...  
Keyword(s):  
Public Health ◽  
Clinical Trial ◽  
Ethical Issues ◽  
Vaccine Trial ◽  
Global Public Health ◽  
Poor Knowledge ◽  
Negative Perception ◽  
Safety Concerns ◽  
Trial Phase

Background: Developing an effective and safe COVID-19 vaccine is a global public health necessity in containing the pandemic, however, recruiting volunteers can be challenging in a clinical trial phase because of poor knowledge, negative perception, ethical issues and safety concerns.

Research in Terminally Ill Patients

2018 ◽  
Author(s):  
Sriram Yennurajalingam
Keyword(s):  
Clinical Trial ◽  
Palliative Care ◽  
Chronic Disease ◽  
Ethical Issues ◽  
Treatment Options ◽  
Terminally Ill ◽  
Symptom Burden ◽  
Terminally Ill Patients ◽  
Disease States ◽  
Key Concepts

It is important to conduct quality palliative care research so as to improve care in this distressed population. However, research in palliative care is challenging due to the high symptom burden and issues related to it, including poor accrual, and higher dropout rates compared to those of patients with chronic disease states. Additionally, patients receiving palliative care are considered a vulnerable population due to the presence of severe symptom distress and limited treatment options available. It is therefore important to address all ethical issues related to participation in a clinical trial. This chapter reviews key concepts with regard to research in terminally ill patients.

scholarly journals Obstacles and Considerations Related to Clinical Trial Research During the COVID-19 Pandemic

2020 ◽  
Vol 7 ◽  
Author(s):  
Hasan Hashem ◽  
Mohammad Abufaraj ◽  
Abdelghani Tbakhi ◽  
Iyad Sultan
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Ethical Issues ◽  
Clinical Trial Design ◽  
Cost Effective ◽  
Clinical Trial Research ◽  
External Monitoring ◽  
Treatment And Prevention ◽  
Clinical Research Trials

The response to the COVID-19 pandemic from the research and science community has been vigorous, with information being released faster than that of any other event in human history. Articles related to the virus were being rapidly published by January 2020. A small fraction of these publications comprised reports of prospective clinical trials (0.25%), and many of these trials have imparted conflicting conclusions, leading to confusion among the public and the scientific community. Additionally, the pandemic has raised many serious scientific and ethical concerns related to clinical research. In this review, we divided the conduct of clinical research trials into three steps and critically reviewed each step, along with the challenges and obstacles arising amid the ongoing crisis. The clinical research steps we reviewed include (1) clinical trial design factors such as social and scientific value, feasibility, single vs. multicenter trials, randomization, control groups, endpoints, off-label and compassionate use of medications, data analysis, and verifying the integrity of data; (2) ethical issues such as committee approvals, efficiency, virtual visits and remote monitoring, informed consent, shipping investigational products, and external monitoring and audits; and (3) publication and sharing of preprints, press releases, social media, and misinformation. The COVID-19 pandemic is adversely affecting existing clinical trials for other ailments and diseases, including cancer, with most trials being delayed or deferred. Although urgency is needed to communicate effective treatment and prevention strategies for COVID-19, research efforts should maintain the same high-quality core ethical principles that governed human subject research before the pandemic. Despite the catastrophic devastation caused by the pandemic, the adoption of more flexible, cost-effective methods of conducting clinical trials (without compromising ethical conduct, safety, or data integrity, while maintaining research efficiency) represents a potential silver lining. Streamlining clinical research will help to congruently address other important health issues, despite the ongoing COVID-19 crisis.

Patient Access to Experimental Drugs and AIDS Clinical Trial Designs: Ethical Issues

1996 ◽  
Vol 5 (3) ◽  
pp. 400-409 ◽  
Author(s):  
Udo Schüklenk ◽  
Carlton Hogan
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Alternative Treatment ◽  
Ethical Issues ◽  
Treatment Strategies ◽  
Patient Access ◽  
Principal Investigators ◽  
Experimental Drugs ◽  
Trial Protocols ◽  
Clinical Trial Designs

Today's clinical AIDS research is in trouble. Principal investigators are confronted with young and frequently highly knowledgeable patients. Many of these people with AIDS (PWAs) are often unwilling to adhere to the trial protocols. These PWAs believe they are ethically justified in breaching trial protocols because they do not consider themselves true volunteers in such trials. PWAs argue that they do not really volunteer because existing legislation prevents them from buying and using experimental drugs or from testing alternative treatment strategies. Their only access to such agents is participation in clinical trials.

scholarly journals EMR2vec: Bridging the Gap Between Patient Data and Clinical Trial

2021 ◽  
pp. 107236
Author(s):  
Houssein Dhayne ◽  
Rima Kilany ◽  
Rafiqul Haque ◽  
Yehia Taher
Keyword(s):  
Clinical Trial ◽  
Patient Data

scholarly journals The ethics of explantation

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Sven Ove Hansson
Keyword(s):  
Clinical Trial ◽  
Quality Assurance ◽  
Medical Devices ◽  
Ethical Issues ◽  
Body Parts ◽  
Medical Implants ◽  
Ethical Problems ◽  
Manufacturing Defects ◽  
Wide Range ◽  
Implanted Medical Devices

Abstract Background With the increased use of implanted medical devices follows a large number of explantations. Implants are removed for a wide range of reasons, including manufacturing defects, recovery making the device unnecessary, battery depletion, availability of new and better models, and patients asking for a removal. Explantation gives rise to a wide range of ethical issues, but the discussion of these problems is scattered over many clinical disciplines. Methods Information from multiple clinical disciplines was synthesized and analysed in order to provide a comprehensive approach to the ethical issues involved in the explantation of medical implants. Results Discussions and recommendations are offered on pre-implantation information about a possible future explantation, risk–benefit assessments of explantation, elective explantations demanded by the patient, explantation of implants inserted for a clinical trial, patient registers, quality assurance, routines for investigating explanted implants, and demands on manufacturers to prioritize increased service time in battery-driven implants and to market fewer but more thoroughly tested models of implants. Conclusion Special emphasis is given to the issue of control or ownership over implants, which underlies many of the ethical problems concerning explantation. It is proposed that just like transplants, implants that fulfil functions normally carried out by biological organs should be counted as supplemented body parts. This means that the patient has a strong and inalienable right to the implant, but upon explantation it loses that status.

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