scholarly journals OC 8716 ENHANCING RESEARCH ETHICS REVIEW CAPACITY IN SUDAN

2019 ◽  
Vol 4 (Suppl 3) ◽  
pp. A16.3-A17
Author(s):  
Shaza Abass ◽  
Sara-Lavinia Brair ◽  
Shahd Osman ◽  
Henry Silverman
Keyword(s):  
Research Ethics ◽  
Health Research ◽  
Human Subjects ◽  
Knowledge Score ◽  
Ethics Committees ◽  
Ethical Review ◽  
Human Subjects Research ◽  
Review System ◽  
Consensus Document ◽  
Post Test

BackgroundIn Sudan, there is an increase in health research in a situation of scarce resources and limited counteractive quality assurance in research ethics. The aim of this project was to enhance the ethical review system in Sudan.MethodsOur framework for enhancing the ethical review capacity was based on the context of Sudan with emphasis on governance, coordination, feasibility, efficiency and sustainability. Activities conducted to achieve our goals included reviewing the guidelines that govern human subjects research, enhancing the governance of national authorities (National Health Research Ethics Committee and National Medicine and Poisons Board), improving coordination between the national authorities by developing a consensus clarifying their roles and functions, capacity building for the oversight bodies and institutional ethical review committees (RECs) as well as establishing a network of research ethics committees.ResultsThe guidelines that govern human subjects research in Sudan were reviewed and updated. In addition, a consensus document was endorsed to clarify the roles of the national regulatory authorities creating channels of coordination and cooperation between them and institutional RECs. Thirty-nine RECs from different parts of Sudan have been trained and the results of the pre/post test have shown an increase in the knowledge score among trainees (p<0.05). The project has also provided a platform for sharing experiences and maintaining partnerships with regional and international institutes in addition to provision of technical support for newly established RECs.ConclusionWe believe that the array of activities conducted through this project had enhanced the governance, coordination, feasibility and, efficiency of the ethical review system in Sudan.

What the ANPRM Missed: Additional Needs for IRB Reform

2013 ◽  
Vol 41 (2) ◽  
pp. 390-396 ◽  
Author(s):  
Charles W. Lidz ◽  
Suzanne Garverich
Keyword(s):  
Data Collection ◽  
Research Ethics ◽  
Human Subjects ◽  
Ethics Committees ◽  
Institutional Review Boards ◽  
Limited Time ◽  
Research Ethics Committees ◽  
Human Subjects Research ◽  
Institutional Review ◽  
The World

The federal Common Rule, which governs the conduct of research with human subjects, specifies the criteria and procedures by which Institutional Review Boards (IRBs) should review such research. Although there is wide agreement that IRBs, or Research Ethics Committees as they are called in most of the world, are essential to assuring that human subjects research meets common standards of ethics, IRBs have always come under considerable criticism. Some have critiqued IRBs for using important resources inefficiently, including the large amount of time researchers put into submitting applications, modifications, and reports and delaying the start of data collection within the limited time that grants and contracts provide. Others have critiqued the inconsistency of review of multi-site projects.

scholarly journals A review of ethics in developing country in perspective of dental research

2014 ◽  
Vol 5 (1) ◽  
pp. 11-19 ◽  
Author(s):  
Md Haider Ali Khan ◽  
Shamima Parvin Lasker
Keyword(s):  
Developing Countries ◽  
Research Ethics ◽  
Developing Country ◽  
Health Research ◽  
Ethical Issues ◽  
Ethics Committees ◽  
Ethical Review ◽  
Ethical Standards ◽  
Research Ethics Committees ◽  
Dental Research

The objectives of this review were to examine the ethical issues in research in developing country and perspective of dental research. In this review, we performed the systematic literature search, screening process through the web in existing published and unpublished articles and reports that related to our topics between1990 to 2013. In the past few decades, the research and discoveries in the discipline of dentistry have increased dramatically. Recently many dental Institutes in developing country is constantly looking for opportunities to borrow, enhance, and integrate knowledge from biomedical and technological research by using modern technology. The retrieved information in this review reflect that to make any research involving human subjects ethically acceptable, a number of key features have to be considered by the researchers. Those who conduct oral health research are compelled by regulations and convention to follow established ethical standards to protect human rights. Bioethics and in ethical review of research in developing countries reveals many major gaps and have seen that there are indeed many ethical issues to be considered to clinical trials taking place in developing countries. Professional societies have a major influence in shaping the moral tone and ethical climate for research through the adoption of standards, the development of educational programs designed to reinforce those standards. Research ethics committees or institutional ethical review committees is to ensure that studies involving human research participants are designed to conform the relevant ethical standards and that the rights and welfare of participants are protected. Research ethics committees should not function under the influence of others and should ensures the favorable balance of potential benefits and risks. In developing country it is necessary to strengthen local capacity and manpower by developing innovative training models for ethics that are cost-effective and sustainable. The actions required to move ahead in this field include strengthening bioethics capacity, linking health research to community needs in a transparent and participatory process and increasing communication between scientists and ethicists in industrialized and developing countries. DOI: http://dx.doi.org/10.3329/bioethics.v5i1.18443 Bangladesh Journal of Bioethics 2014 Vol.5(1): 11-19

A University Wide Model for the Ethical Review of Human Subjects Research

2005 ◽  
Vol 1 (2) ◽  
pp. 39-44 ◽  
Author(s):  
Bryn Williams-Jones ◽  
Søren Holm
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Human Subjects ◽  
Ethics Committees ◽  
Ethical Review ◽  
Research Ethics Committees ◽  
Ethics Review ◽  
Wide System ◽  
Tiered System ◽  
The University

In the United Kingdom (and elsewhere), there are moves to extend formal ethical review of research involving human subjects beyond the traditional oversight by NHS local or multi-centre research ethics committees of medical or clinical research, to also encompass all ‘non-clinical’ research involving human subjects. This paper describes and analyses the development and implementation of a model for ethical review within the university sector. At Cardiff University, a devolved or two-tiered system of ethics review has been created in which a top-level university research ethics committee provides policy advice to and oversight of school-based research ethics committees that engage in formal ethics review of research conducted in their respective schools. We describe the system and reflect on the challenges and benefits of implementing such a coordinated and comprehensive university-wide system of ethics review.

Human research ethics committees members: ethical review personal perceptions

2021 ◽  
Author(s):  
Boris Handal ◽  
Chris Campbell ◽  
Kevin Watson ◽  
Marguerite Maher ◽  
Keagan Brewer ◽  
...  
Keyword(s):  
Research Ethics ◽  
Ethics Committees ◽  
Ethical Review ◽  
Research Ethics Committees ◽  
Human Research ◽  
Human Research Ethics ◽  
Personal Perceptions

Donor-funded research: permissible, not perfect

2018 ◽  
Vol 45 (1) ◽  
pp. 36-40 ◽  
Author(s):  
Mike King ◽  
Angela Ballantyne
Keyword(s):  
Health Research ◽  
Human Subjects ◽  
Trial Participation ◽  
Ethical Standards ◽  
Human Subjects Research ◽  
The Public ◽  
Funded Research ◽  
Personal Liberty ◽  
Institutional Review ◽  
Trial Intervention

Donor-funded research is research funded by private donors in exchange for research-related benefits, such as trial participation or access to the trial intervention. This has been pejoratively referred to as ‘pay to play’ research, and criticised as unethical. We outline three models of donor-funded research, and argue for their permissibility on the grounds of personal liberty, their capacity to facilitate otherwise unfunded health research and their consistency with current ethical standards for research. We defend this argument against objections that donor-funded research is wrongly exploitative, unfair and undermines the public good of medical research. Our conclusion is that, like all human subjects research, donor-funded research should be regulated via standard health research legislation/guidelines and undergo Research Ethics Committee/Institutional Review Board and scientific peer-review. We expect that, measured against these standards, some donor-funded research would be acceptable.

scholarly journals Justice: a key consideration in health policy and systems research ethics

2020 ◽  
Vol 5 (4) ◽  
pp. e001942 ◽  
Author(s):  
Bridget Pratt ◽  
Verina Wild ◽  
Edwine Barasa ◽  
Dorcas Kamuya ◽  
Lucy Gilson ◽  
...  
Keyword(s):  
Health Policy ◽  
Research Ethics ◽  
Ethics Committees ◽  
Ethical Review ◽  
Research Ethics Committees ◽  
Systems Research ◽  
The Social ◽  
Principle Of Justice ◽  
The Rich ◽  
Health Policy And Systems

Health policy and systems research (HPSR) is increasingly being funded and conducted worldwide. There are currently no specific guidelines or criteria for the ethical review and conduct of HPSR. Academic debates on HPSR ethics in the scholarly literature can inform the development of guidelines. Yet there is a deficiency of academic bioethics work relating to justice in HPSR. This gap is especially problematic for a field like HPSR, which can entail studies that intervene in ways affecting the social and health system delivery structures of society. In this paper, we call for interpreting the principle of justice in a more expansive way in developing and reviewing HPSR studies (relative to biomedical research). The principle requires advancing health equity and social justice at population or systems levels. Drawing on the rich justice literature from political philosophy and public health ethics, we propose a set of essential justice considerations to uphold this principle. These considerations are relevant for research funders, researchers, research ethics committees, policymakers, community organisations and others who are active in the HPSR field.

Making Ethics Work in Collaborative Projects

2005 ◽  
Vol 11 (3) ◽  
pp. 101
Author(s):  
Emily Mauldon
Keyword(s):  
Health Care ◽  
Primary Health Care ◽  
Research Ethics ◽  
Health Care Professionals ◽  
Ethics Committees ◽  
Research Process ◽  
Ethical Review ◽  
Ethical Research ◽  
Team Members ◽  
Primary Health

This article discusses problems a research team had managing their ethical obligations during a short project, and considers the implications of these problems for better understanding and carrying out ethical research in the future. Two key points will be proposed. Initially, it will be argued that the culture of ethical research as articulated within the research community may not be universally accepted within the primary health care sector. The nature of "ethical conduct" within clinical practice, service provision and research is not the same. Further, practical difficulties the researchers experienced while trying to gain approval from ethics committees and implement the proposed research plan highlight some ways in which institutional ethical review processes are structurally unsuited to the requirements of small collaborative projects. Understanding the different ways in which the term "ethics" is used will allow for a more expedient translation of concepts between different health professionals. Recognising the practical constraints ethical review places on the research process may help reduce some of the frustration primary health care professionals can experience when faced with the requirements of research ethics committees. Due to the history of, and cultural commitment to, ethical research within the university sector, those with formal academic training in research are well placed to assume responsibility for managing the ethics process when involved in cross-sectoral research. This responsibility may include the need to educate team members and study participants about the importance of research ethics.

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