scholarly journals Ethical Regulations of Medical Research Involving Human Subjects: Exploring the Perspective of Trial Participants

2019 ◽  
Vol 9 (1) ◽  
pp. 34-49
Author(s):  
Anna Kravets
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Medical Research ◽  
Broad Spectrum ◽  
Human Subjects ◽  
Well Being ◽  
Research Protocols ◽  
Ethnographic Data ◽  
Protection Of Human Subjects ◽  
Trial Participants

In this paper I address the question of whether the existing ethical regulations of clinical research ensure protection and well-being of human subjects. Drawing on ethnographic data gathered in Berlin, Germany, I show that German institutions which are meant to ensure the ethical validity of clinical research cannot address posed issues. It appears that these institutions (Berlin Ethik-Kommission in particular) only evaluate research protocols and do not consider the broad spectrum of processes and interactions involved in clinical research. The experience of professional human subjects, as well as the consideration of the every-day life in a clinic, shows that there is much more to clinical trials. The argument of this paper is that the inability of institutions to address protection of human subjects originates from the bureaucratic logic of their organization. Drawing on Bauman’s (1992) argument that the bureaucratic machine is characterized by separation between morality and purpose, with the example of Berlin Ethik-Kommission, I argue that the bureaucratic machine cannot be sensitive to morality and ethics, even if these are its main purposes.

scholarly journals Ethical implications of procedural or protocol adjustments to clinical research involving the participation of human subjects during the COVID-19 pandemic

2021 ◽  
Vol 11 (3-4) ◽  
pp. 181-195
Author(s):  
Anetta Jedličková
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Human Subjects ◽  
Subject Matter Experts ◽  
Ethical Challenges ◽  
Wide Audience ◽  
Ethical Implications ◽  
The Subject ◽  
Research Professionals ◽  
Trial Participants

Abstract The current coronavirus disease 2019 (COVID-19) pandemic has led to essential adjustments in clinical research involving human subjects. The pandemic is substantially affecting most procedures of ongoing, as well as new clinical trials related to diseases other than COVID-19. Procedural changes and study protocol modifications may significantly impact ethically salient fundamentals, such as the risk-benefit profile and safety of clinical trial participants, which raise key ethical challenges the subject-matter experts must face. This article aims to acquaint a wide audience of clinical research professionals, ethicists, as well as the general public interested in this topic with the legal, ethical and practical considerations in the field of clinical trials during the COVID-19 pandemic and to support the clinical researchers and study sponsors to fulfil their responsibilities in conducting clinical trials in a professional way that does not conflict with any legal or ethical obligations.

scholarly journals COVID-19 challenges in clinical trials

2021 ◽  
Vol 10 (6) ◽  
pp. 769
Author(s):  
Murugan Panchatcharam ◽  
Sravanthi Lakshmi Mukku
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Human Subjects ◽  
Well Being ◽  
The Past ◽  
The Face ◽  
Current Scenario ◽  
One Year ◽  
Research Organisations ◽  
Contract Research Organisations

Clinical research involves working with human subjects to answer questions relevant to their well-being in an ethical manner. The current scenario from the past one year has drastically changed the face of the clinical trials. The present COVID prevalence and simultaneously conducting the research with all the regulations and the precautions has been the difficult task for the contract research organisations (CRO).

Medical Research Ethics: What We Need to Comply When Obtaining Informed Consent from Human Subjects?

2009 ◽  
Vol 16 (4) ◽  
pp. 271-276
Author(s):  
CSK Tay
Keyword(s):  
Patient Safety ◽  
Informed Consent ◽  
Medical Ethics ◽  
Clinical Research ◽  
Medical Research ◽  
Research Ethics ◽  
Human Subjects ◽  
Well Being ◽  
Research Subjects ◽  
Medical Research Ethics

Patient safety and well-being are very important to safeguard in medical research. A subject's life cannot be sacrificed for the benefits of future mankind, as medical ethics of autonomy dictate the respect of an individual. By reference to the Declaration of Helsinki, this article discusses the ethical principles and processes in obtaining a valid and proper informed consent from the research subjects who should freely consent and voluntarily participate in the clinical research, including the ‘contents’ of the informed consent and the ‘skills’ of obtaining informed consent.

Doubtful use of placebo following placebo in recent controlled trials of lasmiditan and ubrogepant for the treatment of migraine attacks

Cephalalgia ◽  
2021 ◽  
pp. 033310242110299
Author(s):  
Peer Tfelt-Hansen ◽  
Karsten Jørgensen ◽  
Hans-Christoph Diener
Keyword(s):  
Clinical Research ◽  
Migraine Attack ◽  
Human Subjects ◽  
Second Step ◽  
Controlled Trials ◽  
Scientific Rigor ◽  
Protection Of Human Subjects

Purpose In four large controlled trials with lasmiditan and ubrogepant placebo was administered in the first step to demonstrate an effect on migraine attack. In the same trials the investigators also asked the question: is a second dose of the drug effective in non-responders to the first dose? In this phase patients who received placebo in the first phase of the trial again after 2 hours received another dose of placebo. Conclusion To be ethical, clinical research requires balancing rigorous science with the protection of human subjects; and it is, in our view, questionable whether placebo was used with “scientific rigor” in the second step of these trials, and this design is not recommended.

Tools in a clinical information system supporting clinical trials at a Swiss University Hospital

2014 ◽  
Vol 11 (6) ◽  
pp. 673-680 ◽  
Author(s):  
Michael Weisskopf ◽  
Guido Bucklar ◽  
Jürg Blaser
Keyword(s):  
Information System ◽  
Clinical Trials ◽  
Clinical Research ◽  
Hospital Admissions ◽  
Clinical Information System ◽  
Clinical Information ◽  
University Hospital ◽  
Trial Registry ◽  
Trial Participants ◽  
Year 2013

Background: Issues concerning inadequate source data of clinical trials rank second in the most common findings by regulatory authorities. The increasing use of electronic clinical information systems by healthcare providers offers an opportunity to facilitate and improve the conduct of clinical trials and the source documentation. We report on a number of tools implemented into the clinical information system of a university hospital to support clinical research. Methods: In 2011/2012, a set of tools was developed in the clinical information system of the University Hospital Zurich to support clinical research, including (1) a trial registry for documenting metadata on the clinical trials conducted at the hospital, (2) a patient–trial–assignment–tool to tag patients in the electronic medical charts as participants of specific trials, (3) medical record templates for the documentation of study visits and trial-related procedures, (4) online queries on trials and trial participants, (5) access to the electronic medical records for clinical monitors, (6) an alerting tool to notify of hospital admissions of trial participants, (7) queries to identify potentially eligible patients in the planning phase as trial feasibility checks and during the trial as recruitment support, and (8) order sets to facilitate the complete and accurate performance of study visit procedures. Results: The number of approximately 100 new registrations per year in the voluntary trial registry in the clinical information system now matches the numbers of the existing mandatory trial registry of the hospital. Likewise, the yearly numbers of patients tagged as trial participants as well as the use of the standardized trial record templates increased to 2408 documented trial enrolments and 190 reports generated/month in the year 2013. Accounts for 32 clinical monitors have been established in the first 2 years monitoring a total of 49 trials in 16 clinical departments. A total of 15 months after adding the optional feature of hospital admission alerts of trial participants, 107 running trials have activated this option, including 48 out of 97 studies (49.5%) registered in the year 2013, generating approximately 85 alerts per month. Conclusions: The popularity of the presented tools in the clinical information system illustrates their potential to facilitate the conduct of clinical trials. The tools also allow for enhanced transparency on trials conducted at the hospital. Future studies on monitoring and inspection findings will have to evaluate their impact on quality and safety.

scholarly journals Continued Access to Investigational Medicinal Products for Clinical Trial Participants—An Industry Approach

2018 ◽  
Vol 28 (1) ◽  
pp. 124-133 ◽  
Author(s):  
ARIELLA KELMAN ◽  
ANNA KANG ◽  
BRIAN CRAWFORD
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Pharmaceutical Research ◽  
Development Program ◽  
Well Being ◽  
Third Party ◽  
Clinical Development Program ◽  
Clinical Trial Evidence ◽  
Access To Medical Care ◽  
Trial Participants

Abstract:In the conduct of clinical trials for pharmaceutical research, access to investigational medicines following clinical trials is often necessary for the continued health and well-being of the trial participants; it is an ethical obligation under some circumstances, as outlined in the Declaration of Helsinki 2013 Article 34. This obligation becomes particularly important in lower-income countries, where access to medical care may be limited. Although there is agreement among global research and bioethics communities that continued access should be provided with prospectively defined parameters and procedures, the process is complex, as many responsible parties and complicated logistics are involved. Roche Pharmaceuticals developed and publicly posted the company’s policy regarding continued access to investigational medicines in 2013. This article provides insights on the policy, including the parameters that determine when continued access is and is not considered to be appropriate, along with an example from an active clinical development program. It also describes how multiple stakeholders, including those in academia, industry, government, and patient advocacy, have worked together to assess approaches to continued access. Continued access plans should be transparent and agreed to by research participants, investigators, and governments prior to the study and reassessed based on clinical trial evidence of safety and efficacy and availability of adequate treatments, along with relevant international laws and customs. Conducting responsible continued access programs requires close partnerships with investigators, health authorities, and third-party research partners.

scholarly journals A Preliminary Investigation of the Views of People With Parkinson's (With and Without Psychosis) and Caregivers on Participating in Clinical Trials During the Covid-19 Pandemic: An Online Survey

2020 ◽  
Vol 11 ◽  
Author(s):  
Katie McGoohan ◽  
Anneesa Amjad ◽  
Natasha Ratcliffe ◽  
Sagnik Bhattacharyya ◽  
Gillian Granville ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Clinical Trials ◽  
Clinical Research ◽  
Online Survey ◽  
Preliminary Investigation ◽  
Well Being ◽  
Support Network ◽  
Ongoing Research ◽  
Related Research

Background: The coronavirus pandemic is having a profound impact on non-COVID-19 related research, including the delivery of clinical trials for patients with Parkinson's disease.Objectives: A preliminary investigation to explore the views of Parkinson's disease (PD) patients, with and without experience of psychosis symptoms, and carers on the resumption of clinical research and adaptations to trials in light of COVID-19.Methods: An anonymous self-administered online survey was completed by 30 PD patients and six family members/carers via the Parkinson's UK Research Support Network to explore current perceptions on taking part in PD research and how a planned clinical trial for psychosis in PD may be adapted so participants feel safe.Results: Ninety-one percent of respondents were enthusiastic about the continuation of non-COVID-19 related research as long as certain safety measures were in place. Ninety-four percent stated that they would be happy to complete assessments virtually. However, they noted that care should be taken to ensure that this does not exclude participants, particularly those with more advanced PD who may require assistance using portable electronic devices. Regular and supportive communication from the research team was also seen as important for maintaining the psychological well-being of participants while taking part in the trial.Conclusions: In the era of COVID-19 pandemic, standard approaches will have to be modified and rapid adoption of virtual assessments will be critical for the continuation of clinical research. It is important that alongside the traditional methods, new tools are developed, and older ones validated for virtual assessments, to allow safe and comprehensive assessments vital for ongoing research in people with Parkinson's.

Protection of human subjects' rights in HIV-preventive clinical trials in Africa and Asia: experiences and recommendations

AIDS ◽  
2001 ◽  
Vol 15 ◽  
pp. S73-S79 ◽  
Author(s):  
Peter H. Kilmarx ◽  
Gita Ramjee ◽  
Dwip Kitayaporn ◽  
Prayura Kunasol
Keyword(s):  
Clinical Trials ◽  
Human Subjects ◽  
Protection Of Human Subjects

Bodies and Buildings

2020 ◽  
pp. 393-415
Author(s):  
Corinna Wagner
Keyword(s):  
Medical Research ◽  
Human Subjects ◽  
Well Being ◽  
Urban Environments ◽  
The Body ◽  
Victorian Culture ◽  
The Past ◽  
Research On Human Subjects ◽  
The Dead ◽  
Health And Well Being

Issues around the body have tended to be seen as the concerns of medical materialists and utilitarians, but rarely medievalists. This perception is reflected in the fact that the body only features occasionally in scholarship on Victorian medievalism. However, this chapter makes the claim that medievalists were deeply invested in issues of health and death, as well as anatomy and other branches of medicine. Moreover, medievalists often evoked the past in support of views about the ethics and care of the body that were surprisingly comparable to that of their supposed sworn enemies, materialists and utilitarians. There is a strain of thought, and an aesthetics, that runs through Victorian culture, which could be called ‘materialist medievalism’. I argue that the view of a bifurcated Victorian society has obscured how often opinions between seemingly incompatible thinkers overlapped on aesthetic, philosophical, and ‘condition of England’ questions that focused on the body. It is my hope that this reconsideration will help us better understand the Victorian foundations of our modern concerns with surveillance, medical research on human subjects, health and well-being in urban environments, and memorialization and care of the dead.

Diversifying Clinical Research Participants

2016 ◽  
pp. 234-258
Author(s):  
Saliha Akhtar ◽  
Cynthia Israel ◽  
Michelle Lee D'Abundo
Keyword(s):  
Clinical Trial ◽  
Information Technology ◽  
Clinical Trials ◽  
Clinical Research ◽  
Health Information Technology ◽  
Health Information ◽  
Research Process ◽  
Use Of Technology ◽  
Online Strategies ◽  
Trial Participants

The diversification of clinical trial participants to include women and minorities is one of the biggest challenges for the clinical research industry. The lack of diversity in clinical trials prevents the tailoring of healthcare interventions specifically for women and minorities. The purpose of this chapter is to explore how health information technology and online strategies can be applied in the clinical trial research process to increase the recruitment and retention of women and minorities in clinical trials. By examining this issue from both the individual (participant) and clinical stakeholder perspective, appropriate strategies utilizing available technology are proposed. In the health care environment, strategies to diversify clinical trial participants include the secondary use of Electronic Health Records, and disease registries, as well as e-learning to raise awareness and train health professionals and clinical trial staff. In order to recruit diverse participant populations, the use of online advertising, social media, e-newsletters, tablets, smartphones, and apps are detailed. Lessons from previous use of technology in recruitment are outlined as well as future trends. In summary, while there are recognized challenges to implementation, the current health information technology and online strategies available seem promising as methods of increasing the participation of women and minorities in clinical trials.

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