Declaration of Helsinki: ethical norm in pursuit of common global goals.

The World Medical Association's Declaration of Helsinki is in the process of being revised. The following amendments are recommended to be incorporated in pursuit of the common goal of promoting health for all. 1. Data-driven research that facilitates broad informed consent and dynamic consent, assuring participant's rights, and the sharing of individual participant data (IPD) and research results to promote open science and generate social value. 2. Risk minimisation in a placebo-controlled study and post-trial access to the best-proven interventions for all who need them. 3. A future-oriented research framework for co-creation with all the relevant stakeholders.

Evaluation of the Efficacy of Turmeric-Based Lozenges for the Prevention of Postoperative Sore Throat in Surgeries Done Under Laryngeal Mask Airway Insertion.

Context: Sore throat is a common complaint to both laryngeal mask airway (LMA) insertion and endotracheal tube intubation. Its incidence in LMA has been found to vary between 5.8% and 34%. Administration of medicated lozenges in the preoperative period is also a route available for the prevention of postoperative sore throat (POST). Aim: The aim of this double-blinded randomized controlled study was to evaluate the efficacy of turmeric-based lozenges given preoperatively in patients undergoing general anesthesia (GA) under LMA insertion for the prevention of POST. Settings and Design: This study was conducted at the Department of Anaesthesiology, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Swami Rama Nagar, Dehradun, over a period of 12 months. Subjects and Methods: Two hundred and fifty patients of the American Society of Anesthesiologists classes I and II posted for elective surgeries under GA with insertion of LMA were included in our study. Randomization was done by the sealed envelope technique. Turmeric extract with menthol and eucalyptus oil lozenges was given in Group A (n = 125), while plain turmeric extract with orange flavor lozenges was given in Group B (n = 125) 30 min preoperatively. The patients were assessed for POST in the recovery room post-LMA removal at 30 min, 6 h, 12 h, and 24 h. Statistical Analysis: The data were analyzed using Chi-square test, Fisher's exact test, and Student's t-test. P < 0.05 was considered statistically significant. Results: The turmeric lozenges containing 6.4 mg eucalyptus oil and 6.3 mg menthol oil along with turmeric extract 100 mg significantly reduced the incidence of POST across all time intervals (P < 0.05) as compared to orange-flavored plain turmeric lozenges containing turmeric extract 100 mg. Conclusions: POST was reduced with preoperatively administered eucalyptus oil and menthol oil containing turmeric lozenges.

The ethical responsibility to continue investigational treatments of research participants in situation of armed conflicts, economic sanctions or natural catastrophes.

This paper discusses the effects of armed conflict, economic sanctions, and natural catastrophes on ongoing clinical trials. We suggest that • stopping the accrual of new patients in clinical trials under such extreme conditions is acceptable. • research participants already receiving trial medication in such disruptive situations are to be considered highly vulnerable due to their medical dependency for ongoing treatment according to the approved clinical study protocol. • based on the present experience in Ukraine and Russia, we conclude that finishing ongoing trial treatments according to approved or amended protocols should be considered to be an ethical obligation of trial sponsors irrespective whether trial disruption is due to war, economic sanctions, or natural catastrophes. • it is important to devote more attention to the ethical challenges raised by such fundamentally disruptive situations to clinical trials generally in any region of the world.

Linking the Declarations of Helsinki and of Taipei: Critical Challenges of Future-Oriented Research Ethics.

Expansion of data-driven research in the 21st century has posed challenges in the evolution of the international agreed framework of research ethics. The World Medical Association (WMA)'s Declaration of Helsinki (DoH) has provided ethical principles for medical research involving humans since 1964, with the last update in 2013. To complement the DoH, WMA issued the Declaration of Taipei (DoT) in 2016 to provide additional principles for health databases and biobanks. However, the ethical principles for secondary use of data or material obtained in research remain unclear. With such a perspective, the Working Group on Ethics (WGE) of the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) suggests a closer scientific linkage in the DoH to the (Declaration of Taipei) DoT focusing specifically on areas that will facilitate data-driven research, and to further strengthen the protection of research participants.

A Statement of Solidarity on COVID-19 Pandemic 2020 by the South Asian Family Physicians.

The World Organization of Family Doctors (WONCA) is a not-for-profit organization and was founded in 1972 by member organizations in 18 countries. WONCA now has 118 Member Organizations in 131 countries and territories with a membership of about 500,000 family doctors and more than 90 percent of the world's population. WONCA has seven regions, each of which has its own regional Council and run their own regional activities including conferences. WONCA South Asia Region is constituted by the national academies and colleges and academic member organizations of this region namely India, Pakistan, Bangladesh, Nepal, Sri Lanka, Bhutan, and the Maldives. In the background of the ongoing COVID 19 pandemic, the office bearers, academic leaders, practitioners, and researchers of primary care from the South Asia Region have issued a solidarity statement articulating the role of primary care physicians.

Development and Use of Gene Therapy Orphan Drugs-Ethical Needs for a Broader Cooperation Between the Pharmaceutical Industry and Society.

Gene therapy orphan medicinal products constitute a unique group of new drugs which in case of hereditary diseases are usually administered only once at an early age, in the hope to provide sufficient gene product to last for the entire life of the patients. The combination of an exceptionally large single payment and the life-long clinical follow-up needed for understanding the long-term benefits and safety of gene therapy, represent new types of scientific, financial, social and ethical challenges for the pharmaceutical industry, regulators and society. With special consideration of the uniqueness and importance of gene therapy, the authors propose a three points plan for a close cooperation between the pharmaceutical industry and society to develop orphan gene therapy. (1) In fully transparent health technology negotiations a close and long-lasting, contractually fixed cooperation should be established between the manufacturers and local health-care stakeholders for sharing the medical and scientific benefits, the financial risks as well as the burdens of the post-authorization clinical and regulatory development. (2) The parties should agree on a fair, locally affordable drug price without the usually very high premium price calculated to compensate for the low number of patients. In case of high manufacturing costs, the companies should offer prolonged, 15-20 years long payment by installment with risk-sharing, especially considering that the late outcome of the treatment is unknown. Society should assist scientifically and financially organizing a specific patient registry, treatment in specialized hospitals and adequate long-term follow-up of patients, the coordinated management of financial transactions related to the risk sharing program. (3) The post-authorization treatment and prolonged observation of additional new cases coordinated by society should provide real world data needed for the modern complex regulatory evaluation of gene therapy products by the competent authorities. We assume that fair sharing of the benefits and risks as well as a well-organized cooperation of society with the industry in collecting real world evidence might result in better drug evaluation and improved accessibility due to lower prices. The outlined concept might support gene therapy more efficiently than the presently requested outstandingly high prices.

Corrigendum: Linking the Declarations of Helsinki and of Taipei: Critical Challenges of Future-Oriented Research Ethics.

[This corrects the article DOI: 10.3389/fphar.2020.579714.].