Biobanks and biomarkers:Their current and future role in biomedical research

The importance and utility of biobanks has increased exponentially since their inception and creation.Initially used as part of translational research,they now contribute over 40%of data for all cancer research papers in the United States of America and play a crucial role in all aspects of healthcare.Multiple classification systems exist but a simplified approach is to either classify as population-based or disease-oriented entities.Whilst historically publicly funded institutions,there has been a significant increase in industry funded entities across the world which has changed the dynamic of biobanks offering new possibilities but also new challenges.Biobanks face legal questions over data sharing and intellectual property as well as ethical and sustainability questions particularly as the world attempts to move to a low-carbon economy.International collaboration is required to address some of these challenges but this in itself is fraught with complexity and difficulty.This review will examine the current utility of biobanks in the modern healthcare setting as well as the current and future challenges these vital institutions face.

The ethics of exercise in eating disorders:Can an ethical principles approach guide the next generation of research and clinical practice?

1.Introduction Eating disorders(ED)are the most common psychiatric disorders afflicting young women^1 and contribute to great detriments in psychological,social,and physical health.^(2,3)Unfortunately,ED treatments tend to be long lasting,intensive,and expensive.~4Additionally,individuals with ED seeking treatment use healthcare services more frequently than non-ED individu-

Purpose, Composition and Function of the Research Ethical Committee in the Sarah Rehabilitation’s Hospital

Introduction: The Research Ethical Committee (REC) is responsible for the ethical evaluation of the projects presented by the scientific community to inform and train the members and researchers. Objective: To describe the purpose, composition and function of the REC of the Association of Social Pioneers (APS) located in the Sarah Rehabilitation’s Hospital (Brasilia, Brazil). Methodology: Descriptive analysis of the REC/APS based on 2013’s collected data was done. Results: The REC/APS is an independent collegiate body, which was established in 1998 in accordance with Brazilian regulation. The main objective is promoting the application of ethical principles and human rights in research involving humans. The REC was composed by chairperson and a substitute;secretary, fourteen regular members and five substitutes. We analyzed 164 projects submitted. The minimum time to a committee member who came up with the first opinion has been estimated as 14 days and the insurance of the consolidation occurred in 30 days. We approved 64 projects, of which 25 had pendencies in the first analysis, one project failed and 99 were excluded. The main problems were related to the writing of informed consent and the multicenter projects that did not include aspects such as costs, schedule and methodological limitations. We observed that the researcher could provide assistance. We considered the important role of the REC/APS to ensure trust between researchers and participants in the research. Conclusion: Despite the purpose, composition and function of the APS research ethical committee, there were encountered many obstacles in its formation, considering monitoring the progress of the research, national normative, international researches and others. The ethical committee does a vital public service with the variety of the specialized views on the meeting. We need to strike a balance and we must weigh up risks and benefits related to knowledge, in its essence, to research’s participant and its relevant social participation.

A Framework for the Assessment of Research and Its Impacts

This paper proposes a holistic framework for the development of models for the assessment of research activities and their impacts. It distinguishes three dimensions, including in an original way, data as a main dimension, together with theory and methodology. Each dimension of the framework is further characterized by three main building blocks： education, research, and innovation （theory）; efficiency, effectiveness, and impact （methodology）; and availability, interoperability, and ＂unit-free＂ property （data）. The different dimensions and their nine constituent building blocks are attributes of an overarching concept, denoted as ＂quality.＂ Three additional quality attributes are identified as implementation factors （tailorability, transparency, and openness） and three ＂enabling＂ conditions （convergence, mixed methods, and knowledge infrastructures） complete the fi-amework. A framework is required to develop models of metrics. Models of metrics are necessary to assess the meaning, validity, and robustness of metrics. The proposed framework can be a useful reference for the development of the ethics of research evaluation. It can act as a common denominator for different analytical levels and relevant aspects and is able to embrace many different and heterogeneous streams of literature. Directions for future research are provided.

Ethnography at the Turn of the Third Decade:Privilege and Challenge

The article analyzes the situation in which ethnographic studies found themselves at the turn of the third decade of the 21st century.The historical background,rooted in the past century,as well as the situation that developed by the end of the second decade,is considered at the general philosophical level,while the area that illustrates the situation was chosen taking into account the author’s professional orientation—ethnomusicology.The problems are divided into three groups.The first such group is devoted to new practices and information spaces that are constantly changing the situation.The second group concerns worldview aspects related to the perception of new ethnographers by the guild elders.A critique of the“decolonization”of ethnographic research as part of an overview of institutional and disciplinary barriers concludes the topics discussed in the article.

Institutional Review Board Compliance with National Regulatory Body: A Successful Experience from Saudi Arabia

Background: The Institutional Review Board (IRB) or Research Ethics Committees (RECs) is established to review the research proposals and ensure that participants’ ethical standards, scientific merit, and human rights are protected. Purpose: The authors report the experience of the REC at Qassim Region, Saudi Arabia over 10 years period. Methods: All proposals submitted to Qassim REC during the period 2008-2017 were studied using a 30 items data collection form based on The National Committee of Bioethics Regulations. Data extracted included;principal investigator characteristics, numbers of proposals reviewed, applications completeness, approval decision status, reported ethical issues, classification of the ethical review, and committee review duration. The structure, workload, and review process of Qassim REC were addressed redundant. Results: During 10 years, Qassim Research Ethics Committee (QREC) witnessed a progressive increase in the number of submitted proposals, from 9 to 149 proposals. Out of 508 submitted applications, 439 (86.4%) proposals were eligible for ethical review. Of these, 50 (11.4%) proposals were incomplete due to nonresponse of the principal investigators to the QREC comments. The final decision was made for 389 (88.6%) completed proposals. The approval rate was 85.4%, while the rejection rate was only 1.1%. The median time taken for ethical review was 13 days. Proposals that underwent full board review had a long review duration (Median: 19 days) in comparison to the expedited review (Median: 10 days). Incomplete Committee requirements, unclear research methodology, or possible ethical violation opportunities were the main reasons for delayed decisions. Conclusion: The workload of the Qassim ethics committee is high and growing progressively. However, the process indicators as per National Bioethics Committee rules were satisfactory. Rejection of proposals was rare as most of the reviewed proposals were descriptive studies with infrequent ethical matters.

Responsible research and innovation training programmes:implementation and evaluation of the HEIRRI project

Responsible research and innovation,or RRI,is a concept that aims to bring together society and science for a better future.There are six key elements of RRI:public engagement,gender equality,science education,open access,ethics and governance.Higher Education Institutions and Responsible Research and Innovation(HEIRRI)project aimed to bring the concept of RRI into the educational system.Using state-of-the-art review of good practices,HEIRRI team developed 10 training programmes on RRI for different higher education institution educational levels,including a summer school and a massive open online course(MOOC).We conducted pilot of the trainings and evaluated participants’experiences.Satisfaction with HEIRRI training programmes on responsible research and innovation was high,both for participants and for the trainers,and trainings raised awareness of RRI.Participants’feedback was used to identify areas that need improvement and provided for recommendations for final versions of the HEIRRI training programmes.In order to equip researchers with skills to recognize and apply RRI values,RRI should be included in their education.HEIRRI training is suitable for a range of different disciplines,including forensic science,and is free to use and adjust for specific contexts(available from:https://rri-tools.eu/heirri-training-programmes).

Promoting Research Ethics

After some high-profile scandals, academic institutions and the government are devising measures to root out academic corruption Many in China regard scientific research as a sacred cause and scientists usually enjoy high standing. But a recent spate of academic scandals show that self-discipline alone is not enough to prevent academic corruption. Shanghai Jiao Tong University, one of the top universities in China, announced in May that Chen Jin, a professor at the university, was found to have falsely c...

Challenges in randomized controlled trials and emerging multiple sclerosis therapeutics

The remarkable global development of disease-modifying therapies （DMTs） specific for multiple sclerosis （MS） has significantly reduced the frequency of relapse, slowed the progression of disability, and improved the quality of life in patients with MS. With increasing numbers of approved DMTs, neurologists in North America and Europe are able to present multiple treatment options to their patients to achieve a better therapeutic outcome, and in many cases, no evidence of disease activity. MS patients have improved accessibility to various DMTs at no or minimal out-of-pocket cost. The ethical guidelines defined by the Edinburgh revision of the Declaration of Helsinki strongly discourage the use of placebo control groups in modern MS clinical trials. The use of an active comparator control group increases the number of participants in each group that is essential to achieve statistical significance, thus further increasing the difficulty of completing randomized controlled trials （RCTs） for the development of new MS therapies. There is evidence of a high prevalence of MS and a large number of patients in Asia. The belief of the existence of Asian types of MS that are distinct from Western types, and regulatory policies are among the reasons why DMTs are limited in most Asian countries. Lack of access to approved DMTs provides a good opportunity for clinical trials that are designed for the development of new MS therapies. Recently, data from RCTs have demonstrated excellent recruitment of participants and the completion of multi-nation and single-nation MS trials within this region. Recent studies using the McDonald MS diagnostic criteria carefully excluded patients with neuromyelitis optica （NMO） and NMO spectrum disorder, and demonstrated that patients with MS in Asia have clinical characteristics and treatment responses similar to those in Western countries.

“How Do We Actually Do Convergence”for Disaster Resilience?Cases from Australia and the United States

In recent years there has been an increasing emphasis on achieving convergence in disaster research,policy,and programs to reduce disaster losses and enhance social well-being.However,there remain considerable gaps in understanding"how do we actually do convergence?"In this article,we present three case studies from across geographies—New South Wales in Australia,and North Carolina and Oregon in the United States;and sectors of work—community,environmental,and urban resilience,to critically examine what convergence entails and how it can enable diverse disciplines,people,and institutions to reduce vulnerability to systemic risks in the twenty-first century.We identify key successes,challenges,and barriers to convergence.We build on current discussions around the need for convergence research to be problem-focused and solutions-based,by also considering the need to approach convergence as ethic,method,and outcome.We reflect on how convergence can be approached as an ethic that motivates a higher order alignment on"why"we come together;as a method that foregrounds"how"we come together in inclusive ways;and as an outcome that highlights"what"must be done to successfully translate research findings into the policy and public domains.