Ethics of medical research and publication

Indian Journal of Child Health

M edicine is an evolving science and is an area of constant research. Although lot of things are already known, many things are yet unknown in this context. Due to the phenomenal improvement in the health-care system, there is a significant increase in life expectancy owing to non-invasive methods of the diagnosis, newer drugs, and the unprecedented technological advances in the treatment. However, drugs which are working today, might not work tomorrow due to phenomena of resistance. Hence, there is the need of applied research for developing new drugs, tests, imaging techniques, surgical modalities, etc especially, due to ever-increasing novel health issues that were not so critical earlier [1]. There is now a need for newer drugs with better efficacy and lesser side effects for the treatment and control of emerging diseases. We need newer treatment regimes for improved outcomes of diseases. Research is needed not only for identifying these new treatments or drugs but also for new devices and surgical techniques. This has to be tried and tested in the context of the disease epidemiology and healthcare delivery (health systems' research). It is well documented that acceptance to medication also depends on the medical sociology, culture and anthropology, laws (legal medicine), and ethics (medical ethics) [2,3]. Medicine differs from mathematics and physics in the way that medicine does not have any blanket principles. Although there are general guiding principles that may be valid, each patient is different and every patient is an individual entity in its own. Although it may work for the majority, it might not be valid or effective to treat all the patients. A doctor often experiments the treatments in case of those patient who may not respond to the routine medications. Thus, medicine is experimental. This is true even for the routinely accepted treatments, wherein the response to the same treatment by every individual may vary. Hence, monitoring and evaluation of the treatment regimes of well-documented effective medicines is also required. This is the core of medical research [2]. EVIDENCE BASED MEDICAL PRACTICE Physicians need to be updated about all the changes that occur continuously in the medical world. They have to keep reading and improving their knowledge of clinical research, based on the results of medical research; termed as evidence-based practice. Individual professionals need to be informed, trained, and motivated to be on the lookout of and incorporate the latest ABSTRACT Ethics in the medical research is known since many years; however, there have been new developments in this area recently. A phenomenal improvement in the health-care system, leading to increased life expectancy, and thereby, newer lifestyle and other health-related diseases has opened avenues for newer drugs and health-care technology. However, these have to be tried and tested in the context of the disease epidemiology, health-care delivery and of course, medical ethics. Monitoring and evaluation of the treatment regimes of well documented effective medicines is also required. This is the core of medical research. With the ever increasing concept of evidence-based medical system, and thereby, a rapid rise in the number of clinical trials; the role of medical ethics is potentially increasing to keep the patients' interest in mind. The physicians have to consider the health and positive outcome for the patients. This gives rise to conflicting roles and duties; however, physicians' role and patient commitment must supersede the role of researcher in such cases. The ethical principles, i.e. autonomy, beneficence, and justice apply not only to the physician but also to the medical researcher as well. To monitor the interests of the patients, the ethical review committee sees to it that the clinical trials are conducted with the correct "ethical" approach, giving due consideration to the informed consent process. Refining the regulations and guidelines, especially for individual studies is the core mechanism to strengthen the international medical ethics scenario. This has increasing importance in view of increasing funded research, research involving children, women and prisoners, research related to neurosciences, newer vaccines, organ and tissue transplant, and stem cell transplantation.

Canadian Journal of Anesthesia/Journal canadien d'anesthésie, 1999

A Practical Guide to the Conduct of Field Research in the Social Sciences, 2019

It is an exciting, vital time to be a member of the Intramural Research Program (IRP) at the National Institutes of Health. Research is increasingly multidisciplinary and relies on innovative technologies that are developing almost too quickly to count. No better example of this is the intramural response to the COVID-19 pandemic, in which the IRP led the charge in understanding pathophysiology, in diagnosis, in treatment, and in the development of safe and effective vaccines. Team science is now the expected norm. Because of the technological advances, and team-science approaches, it is more important than ever to promote a culture of research integrity on intramural campuses. A culture of integrity is one in which every individual understands how to perform research ethically and does so. These guidelines were written to provide important information about how to perform ethical research and maintain a culture of research integrity in the IRP. I would like to draw your attention to the section on our "Research Environment," and specifically to the chapter on IRP Commitment to Diversity, Equity, Inclusion, and Accessibility. The IRP is committed to carrying out its mission while breaking down barriers that prevent any member of our community from contributing their talents. We need and we value diverse perspectives, backgrounds, and skills, to be a successful program. We are committed to ensuring that every person in the IRP is welcomed, retained, and encouraged to be successful, and to experience a culture of respect and inclusion. It is essential that every investigator involved in research at NIH read, understand, and incorporate the Guidelines and Policies into everyday practice. The progress and excellence of NIH intramural research are dependent on our vigilance in maintaining the highest quality of conduct in every aspect of science. These guidelines were developed by the Scientific Directors in 2007 then revised in 2016, 2019 and 2021 by the intramural scientists serving on the Committee on Scientific Conduct and Ethics. This edition was approved on (date) by the Scientific Directors.

To present the basic principles and standards of Ethics in medical research and publishing, as well as the need for continuing education in the principles and ethics in science and publication in biomedicine. An analysis of relevant materials and documents, sources from the published literature. Investing in education of researches and potential researches, already in the level of medical schools. Educating them on research ethics, what constitutes research misconduct and the seriousness of it repercussion is essential for finding a solution to this problem and ensuring careers are constructed on honesty and integrity.

The American Journal of Bioethics, 2009

Human Reproduction, 2018

Much of the published medical research is apparently flawed, cannot be replicated and/or has limited or no utility. This article presents an overview of the current landscape of biomedical research, identifies problems associated with common study designs and considers potential solutions. Randomized clinical trials, observational studies, systematic reviews and meta-analyses are discussed in terms of their inherent limitations and potential ways of improving their conduct, analysis and reporting. The current emphasis on statistical significance needs to be replaced by sound design, transparency and willingness to share data with a clear commitment towards improving the quality and utility of clinical research.

1998

A number of developments have brought the subject of ethics in medical research to the front line of concerns of the medical profession and of the society at large. Ethical concerns should be addressed at all stages of the research process.

Journal of Hepatology, 2009

R&D of new drugs is driven by pharmaceutical companies that invest considerable amounts of money for this purpose. This may introduce bias, to emphasize the clinical value of drugs to be allowed onto the market. Bias is caused by methodological flaws including the population under study, the choice of inadequate comparators or of their dosage, the adoption of surrogate or composite endpoints, the decision to publish mainly positive findings or to overlook some safety concerns, etc. All this happens in a legal context that requires no added value for new drugs to be approved for the market. This encourages the use of placebo even when active comparators are available, or the search for non-inferiority of new products in comparison with active comparators. Superiority over placebo and non-inferiority to active comparators may allow drugs onto the market that are in fact less active (or safe, tolerable, convenient, etc.) than those already available, usually with consolidated properties and lower costs. In addition, they do not meet patients' or physicians' needs of defining the place in therapy and respective roles of new and available treatments. The current legislative and regulatory setting seems designed to meet commercial interests rather than public health needs. Ó