Ethical Aspects of Vulnerable Group of Patients in Clinical Trials

Ivanova, Ekaterina A.; Getov, Ilko; Lebanova, Hristina

doi:10.5772/intechopen.70318

Cited by 3 publications

(3 citation statements)

References 2 publications

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“…Protection measures to safeguard the vulnerable and marginalised populations should be carefully scrutinised during review. Ethical considerations must be adjusted to the individual situation to protect these vulnerable subjects from exploitation and later abandonment [38].…”

Section: Location and Populationmentioning

confidence: 99%

COVID‐19 vaccine research and development: ethical issues

Wibawa

2020

Tropical Med Int Health

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The achievements of vaccine research and development bring a hope to our societies that we may cope with the COVID‐19 pandemic. There are two aspects that should be maintained in balance: the immediate necessity for speed of vaccine research and the inherent need for protection of research subjects, which is the foremost concern of research ethics. This narrative review highlights ethical issues in COVID‐19 vaccine research and development that every stakeholder needs to be aware of and to consider.

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Section: Location and Populationmentioning

confidence: 99%

COVID‐19 vaccine research and development: ethical issues

Wibawa

2020

Tropical Med Int Health

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“…Because the vulnerable population like drug/alcohol addicts, mentally challenged people, children, geriatric age people, military persons, ethnic minorities, people suffering from incurable diseases, students, employees, and pregnant women cannot make decisions with respect to participating in a clinical trial, ethical concerns, and legal issues may prop up, that may be appropriately addressed before drug trials which include such groups [50].…”

Section: Current Perspectives and Future Implicationsmentioning

confidence: 99%

Clinical Trials and Clinical Research: A Comprehensive Review

Kandi¹,

Vadakedath²

2023

Cureus

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Clinical research is an alternative terminology used to describe medical research. Clinical research involves people, and it is generally carried out to evaluate the efficacy of a therapeutic drug, a medical/surgical procedure, or a device as a part of treatment and patient management. Moreover, any research that evaluates the aspects of a disease like the symptoms, risk factors, and pathophysiology, among others may be termed clinical research. However, clinical trials are those studies that assess the potential of a therapeutic drug/device in the management, control, and prevention of disease. In view of the increasing incidences of both communicable and non-communicable diseases, and especially after the effects that Coronavirus Disease-19 (COVID-19) had on public health worldwide, the emphasis on clinical research assumes extremely essential. The knowledge of clinical research will facilitate the discovery of drugs, devices, and vaccines, thereby improving preparedness during public health emergencies. Therefore, in this review, we comprehensively describe the critical elements of clinical research that include clinical trial phases, types, and designs of clinical trials, operations of trial, audit, and management, and ethical concerns.

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“…The interviews proceeded on the terms of participants' feelings. The themes of the interview were modified by respecting the participants [33][34][35][36]. The patients' vulnerability may have been increased because of disease-related emotional issues that the participants might have had to face [37].…”

Section: Ethical Considerationsmentioning

confidence: 99%

‘I am still valuable’ – A qualitative study of incurable cancer patients coping in hospice care

Viitala

Åstedt‐Kurki

Lehto

et al. 2023

Scandinavian Caring Sciences

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BackgroundKnowledge of the experiences of coping in patients with incurable cancer is essential for high‐quality palliative and end‐of‐life care.Aim and ObjectiveTo describe the coping experiences of patients with incurable cancer in hospice care to better develop patient‐centred care.MethodsThe data for this qualitative study were collected through semi structured interviews, with patients with incurable cancer in hospice care (N = 20) and analysed with inductive content analysis. Ethical and organisational approvals were obtained, and the participants received both verbal and written information before consenting to participate.ResultsThe patients' coping was enhanced with their involvement in treatment‐related decisions. Valuing day‐to‐day living and coping with emotional stressors helped them accept their own life situations. Accepting their increasing fragility was enhanced by their self‐reappraisal. The patients found security in the possibility of receiving support when they needed it. Although the ordinariness of dying in hospice care settings was sometimes too much to bear, they understood dying to be a part of the natural cycle of life. They questioned the responsiveness of healthcare services because they felt that they were not always heard.Study LimitationsBecause this study was limited to a specific population of cancer patients in hospice care, the results might not be generalised to other patient groups with chronic diseases or other palliative care settings.ConclusionsThe experiences of patients in hospice care of coping with incurable cancer were reminiscent of the common coping process descriptions. Surprisingly, even though participants voiced that they had accepted their situation, dying itself was something they did not find crucial to discuss. The crucial aspects – without being in denial – dealt more with focusing on positive thinking and facing life.

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Ethical Aspects of Vulnerable Group of Patients in Clinical Trials

Cited by 3 publications

References 2 publications

COVID‐19 vaccine research and development: ethical issues

COVID‐19 vaccine research and development: ethical issues

Clinical Trials and Clinical Research: A Comprehensive Review

‘I am still valuable’ – A qualitative study of incurable cancer patients coping in hospice care

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