MyMedR

Displaying all 10 publications

Abstract:

Sort:

Research integrity in randomized clinical trials: A scoping umbrella review

Núñez-Núñez M, Maes-Carballo M, Mignini LE, Chien PFW, Khalaf Y, Fawzy M, et al.

Int J Gynaecol Obstet, 2023 Sep;162(3):860-876.
PMID: 37062861 DOI: 10.1002/ijgo.14762

BACKGROUND: Randomized clinical trials (RCTs) are experiencing a crisis of confidence in their trustworthiness. Although a comprehensive literature search yielded several reviews on RCT integrity, an overarching overview is lacking.
OBJECTIVES: The authors undertook a scoping umbrella review of the research integrity literature concerning RCTs.
SEARCH STRATEGY AND SELECTION CRITERIA: Following prospective registration (https://osf.io/3ursn), two reviewers independently searched PubMed, Scopus, The Cochrane Library, and Google Scholar, without language or time restrictions, until November 2021. The authors included systematic reviews covering any aspect of research integrity throughout the RCT lifecycle.
DATA COLLECTION AND ANALYSIS: The authors assessed methodological quality using a modified AMSTAR 2 (A Measurement Tool to Assess Systematic Reviews) tool and collated the main findings.
MAIN RESULTS: A total of 55 relevant reviews, summarizing 6001 studies (median per review, 63; range, 8-1106) from 1964 to 2021, had an overall critically low quality of 96% (53 reviews). Topics covered included general aspects (15%), design and approval (22%), conduct and monitoring (11%), reporting (38%), postpublication concerns (2%), and future research (13%). The most common integrity issues covered were ethics (18%) and transparency (18%).
CONCLUSIONS: Low-quality reviews identified various integrity issues across the RCT lifecycle, emphasizing the importance of high ethical standards and professionalism while highlighting gaps in the integrity landscape. Multistakeholder consensus is needed to develop specific RCT integrity standards.

Matched MeSH terms: Moral Obligations*
The Integration and Harmonisation of Secular and Islamic Ethical Principles in Formulating Acceptable Ethical Guidelines for Modern Biotechnology in Malaysia

Hasim NA, Amin L, Mahadi Z, Yusof NAM, Ngah AC, Yaacob M, et al.

Sci Eng Ethics, 2020 06;26(3):1797-1825.
PMID: 32266581 DOI: 10.1007/s11948-020-00214-4

The Malaysian government recognises the potential contribution of biotechnology to the national economy. However, ongoing controversy persists regarding its ethical status and no specific ethical guidelines have been published relating to its use. In developing such guidelines, it is important to identify the underlying principles that are acceptable to Malaysian society. This paper discusses the process of determining relevant secular and Islamic ethical principles and establishing their similarities before harmonising them. To achieve this, a series of focus group discussions were conducted with 23 knowledge experts representing various stakeholders in the biotechnology community. Notably, several principles between the secular and Islamic perspectives are indirectly or directly similar. All the experts agreed with the predominant six ethical principles of secular and Islamic philosophy and their importance and relevance in modern biotechnology. These are beneficence and non-maleficence as the main or overarching principles, the preservation of religious and moral values, the preservation of the intellect and the mind, the protection of human safety, the protection of future generations, and protection of the environment and biological diversity. Several adjustments were made to the terminologies and definitions of these six principles to formulate acceptable guiding principles for the ethics of modern biotechnology in Malaysia. These can then be adopted as core values to underpin future national guidelines on modern biotechnology ethics. These principles will be particularly important in guiding the policy makers, enforcers, industries and researchers to streamline their activities. In so doing, modern biotechnology and its products can be properly managed without jeopardising the interests of the Muslim community as well as the general public. Importantly, they are expansive and inclusive enough to embrace the religious sensitivity of diverse quarters of Malaysia.

Matched MeSH terms: Moral Obligations
Fulltext Educating future medical professionals with the fundamentals of law and ethics

Puteri Nemie, J.K., Ariff Osman, H.O., Ramizah, W.M.

International Medical Journal Malaysia, 2017;16(2):101-105.
MyJurnal

The increasing awareness amongst the society on medico-legal issues as well as the growth of consumerist
attitude towards the provision of medical services has caused the medical profession to be subjected to
vociferous criticism if they do not meet rising expectations of the society. Substandard services have not
been well tolerated and paternalistic approaches in medical treatment are considered to be outmoded and
inappropriate. Any dissatisfaction on the part of the patient towards medical services provided nowadays
may easily trigger claims in the court of law. This changing trend has also fundamentally changed the
behaviour of the courts towards the medical profession. Judicial and legislative interventions in medical
practice have created more and more rights for the patients and consequently, corresponding legal duties
for the medical profession to uphold. In the present healthcare setting, the medical profession will not be
able to provide infallible services without knowledge of the legal standards which they have to adhere.
Thus, educating future medical professionals with the fundamentals of law and ethics would ensure greater
accountability, knowledge and personal commitment in providing medical services to the society as the
ideals of professionalism not only require them to have the necessary expertise, dedication, respect,
compassion, empathy, honesty, altruism, responsibility, integrity, self-improvement and accountability but
also adherence to the demands of law and highest ethical standards.

Matched MeSH terms: Moral Obligations
Fulltext Ethical Questions Linked to Rare Diseases and Orphan Drugs - A Systematic Review

Kacetl J, Marešová P, Maskuriy R, Selamat A

Risk Manag Healthc Policy, 2020;13:2125-2148.
PMID: 33116992 DOI: 10.2147/RMHP.S260641

Background: Rare or orphan diseases have become an important target of healthcare activities all over the world. The study aims to identify ethical questions linked to rare diseases and orphan drugs and ethical principles or approaches applied to solve them.
Methods: Relevant peer-reviewed articles were identified by means of a systematic review. The literature was searched from 20 May 2020 to 20 June 2020. The search included the databases PubMed, Scopus and Web of Science (2010 - April 2020). A total of 4,139 papers related to rare diseases were identified; with 1,205 papers obtained from Scopus; 2,476 papers from PubMed; and 458 from Web of Science with keyword search "ethics" AND "rare" AND "disease", "ethical" AND "orphan", "ethical" AND "orphan" AND "drug", and "ethical" AND "rare" AND "disease". Finally, XX studies were chosen for further analysis.
Results: The main findings reveal five main ethical issues. The most essential one shows that funding research and development in the field of orphan drugs poses an almost impossible dilemma. Other issues include the significance of non-economic values like compassion and beneficence in decision-making related to orphan drugs and rare diseases; the identification of limits to labelling diseases as rare; barriers to global, supranational and international cooperation; and last but not least, determining and establishing panels of decision-makers.
Conclusions: A strictly global approach would be the most appropriate way to deal with rare diseases. Nonetheless, international, let alone global, cooperation seems to be completely beyond the reach of the current international community, although the EU, for instance, has a centralized procedure for labelling orphan drugs. This deficit in international cooperation can be partly explained by the fact that the current technologically globalized world still lacks globally accepted ethical values and rules. This is further aggravated by unresolved international and intercultural conflicts. In addition, the sub-interests of various parties as well as the lack of desire to deal with other people's problems need to be taken into account. The aforementioned problems are difficult to avoid. Nevertheless, let us be cautiously optimistic. At least, there are people who raise ethical questions about rare diseases and orphan drugs.

Matched MeSH terms: Moral Obligations
Fulltext Medical ethics: what you should know

Mohd Rizal Abdul Manaf

Int J Public Health Res, 2012;2(1):129-136.
MyJurnal

Introduction Medical ethics is a system of moral principles that apply values and judgments to the practice of medicine. As a scholarly discipline, medical ethics encompasses its practical application in clinical settings as well as work on its history, philosophy, theology, and sociology. The medical profession has long subscribed to a body of ethical statements developed primarily for the benefit of the patient. A physician must recognize responsibility to patients first and foremost, as well as to society, to other health professionals, and to self. This paper presents some information regarding medical ethics, including the values and principles of ethical conduct. Later the requirements of consent form is presented to guide the researchers before conducting a study.

Matched MeSH terms: Moral Obligations
Fulltext Principlism and neonatology: utilising the principles of medical ethics in decision-making for neonates

Tan, Mark Kiak Min

Journal of Clinical and Health Sciences, 2018;3(2):5-12.
MyJurnal

Prematurity is the leading cause of infant mortality and one of the main reasons for newborn infants to be admitted to the Neonatal Intensive Care Unit (NICU). Advancements in medicine has made the NICU a maze of sophisticated modern technology and expensive to run. These advances in technology have also resulted in an added layer of complexity to many ethical dilemmas that are encountered in the NICU. In 1977, Beauchamp and Childress introduced the principles of biomedical ethics. These four principles of (1)respect for autonomy, (2)nonmaleficence, (3)beneficence and (4)justice, form a suitable starting point for the analysis of the moral challenges of medical innovation. This article explores how the four ethical principles relate to decision-making in the NICU, and how they can be applied to the treatment of sick newborn infants in clinical practice. It also highlights the reasons why healthcare personnel need to equip themselves with good communication skills and up to date knowledge of ethical considerations in the NICU in order to make quality decisions about care for their patients. This article also suggests that a Clinical Ethics Committee can play a vital role in ensuring that the best decisions are achieved for these patients.

Matched MeSH terms: Moral Obligations
Disclosure of Mental Health Status to Employers in a Healthcare Context

Zolkefli Y

Malays J Med Sci, 2021 Apr;28(2):157-160.
PMID: 33958969 DOI: 10.21315/mjms2021.28.2.14

People suffering from mental health conditions are often unwilling to reveal their status and this includes health professionals. They may wrestle with the pros and cons of revealing their health status to their employer in particular as they seek to reconcile personal privacy with professional duty. There is no simple, clear consensus as to whether they have a moral duty to share the information voluntarily or explicitly to share it with the employer. Additionally, there is a concern as to whether a degree of non-disclosure is justifiable to protect the privacy of health care professionals in some circumstances. Decisions surrounding the disclosure of a mental health problem are nuanced and may require that competing needs and values be reconciled. Although self-declared mental health status is an intrinsic moral good, the healthcare professional needs to feel confident and ready to come forward.

Matched MeSH terms: Moral Obligations
Experiments and rights

Vollrath J

Bioethics, 1989 Apr;3(2):93-105.
PMID: 11649247 DOI: 10.1111/j.1467-8519.1989.tb00331.x
Matched MeSH terms: Moral Obligations*
The continuing risk of nuclear war

McCoy R

Med Confl Surviv, 2007 Oct-Dec;23(4):259-66.
PMID: 17987978 DOI: 10.1080/13623690701596668

Climate change and nuclear war are currently the most dangerous challenges to human civilisation and survival. The effects of climate change are now sufficient to persuade many governments to take effective measures to reduce greenhouse gas emissions. Today there are about 27,000 nuclear warheads, many at least ten times more powerful than the Hiroshima and Nagasaki bombs, and a meaningful medical response to a nuclear attack is impossible. Nevertheless, the threat of nuclear war does not raise public concern, and indeed the nuclear-weapon states are upgrading their capability. The only effective preventive measure is the abolition of nuclear weapons. Steps towards this include: a Fissile Material Cut-off Treaty, for the nuclear weapon states to observe their obligations under the Nuclear Non-Proliferation Treaty, and for the Comprehensive Test Ban Treaty to enter into force. The ultimate need is for a Nuclear Weapons Convention; International Physicians for the Prevention of Nuclear War have launched an International Campaign to Abolish Nuclear weapons (ICAN) to promote a NWC.

Matched MeSH terms: Moral Obligations
Fulltext An international survey of medical ethics curricula in Asia

Miyasaka M, Akabayashi A, Kai I, Ohi G

J Med Ethics, 1999 Dec;25(6):514-21.
PMID: 10635508

SETTING: Medical ethics education has become common, and the integrated ethics curriculum has been recommended in Western countries. It should be questioned whether there is one, universal method of teaching ethics applicable worldwide to medical schools, especially those in non-Western developing countries.
OBJECTIVE: To characterise the medical ethics curricula at Asian medical schools.
DESIGN: Mailed survey of 206 medical schools in China, Hong Kong, Taiwan, Korea, Mongolia, Philippines, Thailand, Malaysia, Singapore, Indonesia, Sri Lanka, Australia and New Zealand.
PARTICIPANTS: A total of 100 medical schools responded, a response rate of 49%, ranging from 23%-100% by country.
MAIN OUTCOME MEASURES: The degree of integration of the ethics programme into the formal medical curriculum was measured by lecture time; whether compulsory or elective; whether separate courses or unit of other courses; number of courses; schedule; total length, and diversity of teachers' specialties.
RESULTS: A total of 89 medical schools (89%) reported offering some courses in which ethical topics were taught. Separate medical ethics courses were mostly offered in all countries, and the structure of vertical integration was divided into four patterns. Most deans reported that physicians' obligations and patients' rights were the most important topics for their students. However, the evaluation was diverse for more concrete topics.
CONCLUSION: Offering formal medical ethics education is a widespread feature of medical curricula throughout the study area. However, the kinds of programmes, especially with regard to integration into clinical teaching, were greatly diverse.

Matched MeSH terms: Moral Obligations