COMPARATIVE STUDY OF BIOMEDICAL RESEARCH ETHICS CODES/ GUIDELINES AND RECOMMENDATION

society is an important but complex task for research. We know from other research on social identity that respondents are likely to report problems and coping strategies that are acceptable...

ObjectivesIn this paper we discuss the main ethical challenges related to the conduct of medicine quality surveys and make suggestions on how to address them.MethodMost evidence‐based information regarding medicine quality derives from surveys. However, existing research ethical guidelines do not provide specific guidance for medicine quality surveys. Hence, those conducting surveys are often left wondering how to judge what counts as best practice. A list of the main ethical challenges in the design and conduct of surveys is presented.Results and conclusionsIt is vital that the design and conduct of medicine quality surveys uphold moral and ethical obligations and analyse the ethical implications and consequences of such work. These aspects include the impact on the local availability of and access to medicines; the confidentiality and privacy of the surveyors and the surveyed; questions as to whether outlet staff personnel should be told they are part of a survey; the need of ethical and regulatory approvals; and how the findings should be disseminated. Medicine quality surveys should ideally be conducted in partnership with the relevant national Medicine Regulatory Authorities. An international, but contextually sensitive, model of good ethical practice for such surveys is needed.

Review by research ethics committees (RECs) is the key in medical research regulation. Data from meeting notes and project summaries were abstracted from all projects submitted in 2002 (n = 1,004) and 2007 (n = 1,045) to the official medical RECs in Finland. Data from consecutive submissions were combined per project. When comparing RECs, logistic regression was used to adjust for application characteristics. The number of projects handled varied notably by REC. In the first handling, 85% of applications in 2002 and 77% in 2007 were approved, while 13% and 20% were tabled. For 61% of the projects, the review time was <30 days, 16% had >89 days, and 6% had 6 months or longer. The variation by REC in approval rates, number of handlings, or long review times was not explained by project characteristics. In the last handling, 94% of the projects in both years were approved or concluded not to need a statement from that REC. The most common reason for tabling or not approving an application was patient autonomy, usually centered on the patient leaflet. The next most common reasons were requests for further information and dissatisfaction with the scientific aspects of the project. The reasons classified as "ethics" in the narrow sense were rare. The REC focus was to assure that researchers follow the various rules on medical research and to improve the quality of research and project documents. REC considerations could be divided into decisions based on ethics and recommendations covering other aspects.

This article discusses the methodology used in the research Education on health in the labor process of a Psychosocial Attention Center (CAPS). It is a descriptive and analytical research, qualitative approach, carried out in a CAPS of Rio Grande do Sul, as a subproject of the evaluation research of CAPS from southern Brazil-CAPSUL, based on fourth generation evaluation, and approved by the Committee of ethics in research of Faculdade de Medicina da Universidade Federal de Pelotas (of. 074/05). The study made possible to reaffirm the fourth generation evoluation as an important method of qualitative assessment of health services, and the use of Dialectical-Hermeneutical Circle for data collection, which was essential for recycling data, not only allowing update information and historical context, as well as raising relevant new issues to the study. The analysis allowed an understanding on the facts and their consensus, without leaving aside the criticism and the necessary estrangement, when the look of the researcher goes beyond description of results, but the faces with the historical context implied in reality under study. Descriptors: Fourth generation assessment; qualitative research in health; health services assessment.

Background The establishment of research ethics committees (RECs) in charge of reviewing research protocols answers the need to regulate with an ethical framework the development of clinical trials, biomedical research and technologies affecting human health. The first RECs were instituted at the national level in the 60 s, and were gradually put in place in Africa as a result of research projects development in the area of epidemics such as HIV infection, and to meet one of the major requirements of the Helsinki Declaration and the international ethical Guidelines CIOMS: ‘each research protocol involving humans has to be reviewed by an independent ethics committee’. However, RECs in Africa are still facing various challenges in the accomplishment of their missions. Among them, RECs located in the West-African French speaking area are reporting an urgent need for networking and coordinating their effort. Supported by EDCTP, AFREENET (AFRica Ethics Excellence NETwork) is a 3 year collaborative project between three RECs, respectively in Côte d’Ivoire, Guinea and Benin, and coordinated by the Ethics Unit of Institut Pasteur (France), which aims to reinforce RECs capacities. The project will lead to reinforcement of training capacities through a long-term strategy to establish mechanisms to ensure and update members’ training, and to develop a pool of ethics trainers. Based on RECs experiences, network activities will permit to share and identify valuable practices on global ethics oversight, such as monitoring, SOPs, regulatory issues and sensitisation. The preparation of Ethics Committees for the potential occurrence of outbreaks will be specifically addressed through an Outbreak preparation plan built upon lessons learnt from the Ebola crisis. Creating synergies and mutual empowerment between „African RECs will increase their visibility, their capacity for advocacy and their recognition as key actors of a responsible ethics research framework at the national, regional and international level.

The article by Morris Brown on the impact of clinical trials legislation on clinical pharmacology [1]makes very sorry reading, as does the editorial appearing in the same issue, although less so than the Brown article. There is so much that is inaccurate in this article that it compromises the legitimate validity of his argument that bureaucracy in this country hampers clinical research. It so happens that, in my so-called retirement, I am closely involved with the research ethics review process throughout Europe, being co-chairman of the European Forum for Good Clinical Practice (EFGCP) Ethics Working Party and the EFGCP Ethics Officer, as well as having served on UK research ethics committees (RECs) for over 12 years, now being the alternate vice-chairman of Cambridgeshire 4 REC, which used to be the former East of England MREC. I was responsible for initiating the report on the structure and function of RECs published in the International Journal of Pharmaceutical Medicine in February 2007 and kept up to date on an annual basis on our EFGCP website (http://www.efgcp.be). I am therefore in a very strong position to maintain that the UK can be proud that it has as good a grasp of research ethics as any other European state, and I would be willing to debate that vigorously in public. Sadly, Brown has not acknowledged the efficiency that now demonstrably pervades the research ethics review system in this country, allowing himself to be overwhelmed by the deficiencies of the R&D Governance process in this country, with which the National Health Service has lumbered itself. This, I freely acknowledge, is a nightmare that only recently might have shown a first sign of waking itself up. Coupled with academic regulations, with which clinical pharmacologists might well be encumbered, too, I can therefore understand the frustration that Brown demonstrates, though it is partially misdirected. Without wishing to be personal in a letter to the Journal, I would remind Brown and his clinical pharmacology colleagues that one of the most irritating aspects of an application to a REC is the inadequacy of many patient information sheets, whether they come from pharmaceutical companies or academic departments. By and large, clinical pharmacologists ought to be as good as any group in the production of comprehensive yet comprehensible patient information sheets that, above all, are able to be understood by the patients who are the intended subjects of research projects. Time taken to produce a really good patient information sheet must be time well spent, as the time needed to take on board the concerns of a REC may well be much greater than for the drafting of a decent document in the first place. Referral back by a REC must be frustrating to an investigator, but the time taken to deal with the REC concerns can be minimized, and it is not right to accuse RECs of delaying tactics when the time taken for a response by an investigator may well be very protracted. Of more fundamental concern is Brown's clear lack of understanding of what research ethics are all about. No doubt Brown is a very sound medical ethicist and he tells us that medical ethics was his first academic interest. But research ethics is quite different from mainstream medical ethics. It is because RECs are established to look after the interests of patients who are the subjects of clinical research projects that they include in their membership lay persons as well as experts. The National Research Ethics Service (NRES) has ensured that all the members of RECs are properly trained in the principles of research ethics, and Brown's comments on the membership of RECs in his article are insulting in the extreme. It is the intelligent lay persons as well as the doctors, nurses, lawyers, statisticians, pharmacists, teachers and so on who are found on RECs that safeguard the interests of patients—and at Cambridgeshire 4 we operate to strict deadlines. I hope that readers of your Journal will recognize the efficiency with which research projects are dealt with by the NRES, through its research ethics committees, and will all contribute to putting pressure on other aspects of the research approval process that are still deficient. None declared.

There are disagreements among ethicists on what comprises an “appropriate” good to offer research participants. Debates often focus on the type, quantity, timing, and ethical appropriateness of such offers, particularly in settings where participants may be socio-economically vulnerable, such as in parts of Zambia. This was a Cross-sectional online survey of researchers and Research Ethics Committees (RECs) designed to understand practices, attitudes and policies associated with provision of goods to research participants. Of 122 responding researchers, 69 met eligibility criteria. Responses were also received from five of the six Zambian RECs involved in reviewing research proposals. Forty-nine researchers (71.0%) confirmed previous experience offering goods to participants. Of these, 21 (42.9%) offered participants money only, 18 (36.7%) offered non-monetary goods, while the rest offered both monetary and non-monetary goods. Generally, goods were offered and approved by RECs to compensate for time, lost wages and transportation. One REC and 34.8% of researchers reported being subject to an institutional policy on offering goods to participants. While reimbursement is the main reason for offering goods to participants in Zambia, caution is required when deciding on the type and quantity of goods to offer given the potential for community mistrust and manipulation.

Fraud and Deceit in Medical Research

Objective: to identify social representations about health and disease construed by the indians Potiguara. Methodology : it is a qualitative study. 55 interviews had been carried out in Baia da Traicao/PB. The corpus was processed by the software Alceste. The research project was approved by the Committee of Ethics in Research, protocol no 05/2008. Results: the Potiguaras’ social representations related to the health/disease process indicate as a whole (66,7%) two dimensions: one, organic-physiological, in which the indians associate health/disease with the biomedic concept; and other, sociocultural that stands for the relationships among work, food and health, responsible for the involvement of the indians in their practices. Conclusion : the importance of the study is demonstrated in the field of public health, since social representations can provide theoretical foundations socially contextualized for the formulation and evaluation of strategies and/or health policies adopted by the responsible institutions for the health of indians in Brazil.

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Background: Recent articles have presented a bleak view of career prospects in biomedical research in the US. Too many PhDs and postdocs are trained for too few research positions, creating a “holding-tank” of experienced senior postdocs who are unable to get a permanent position. Coupled with relatively low salaries and high levels of pressure to publish in top-tier academic journals, this has created a toxic environment that is perhaps responsible for a recently observed decline in biomedical postdocs in the US, the so-called “postdocalypse”. Methods: To address the gulf of information relating to working habits and attitudes of UK-based academic biomedical researchers, a link to an online survey was included in an article published in the Guardian newspaper. Survey data were collected between 21st March 2016 and 6th November 2016 and analysed to examine discrete profiles for three major career stages: PhD, postdoc and principal investigator. Results: Overall, the data presented here echo trends observed in the US: The 520 UK-based biomedical researchers responding to the survey reported feeling disillusioned with academic research, due to the low chance of getting a permanent position and the long hours required at the bench. Also like the US, large numbers of researchers at each distinct career stage are considering leaving biomedical research altogether. Conclusions: There are several systemic flaws in the academic scientific research machine – for example the continual overproduction of PhDs and the lack of stability in the early-mid stages of a research career - that are slowly being addressed in countries such as the US and Germany. These data suggest that similar flaws also exist in the UK, with a large proportion of respondents concerned about their future in research. To avoid lasting damage to the biomedical research agenda in the UK, addressing such concerns should be a major priority.

Ethics of healthcare research in developing countries

Abass Alavi: A giant in Nuclear Medicine turns 80 and is still going strong!

Beginning during the last decades of the twentieth century Research Ethics Committees (RECs) have spread to many regions of the World. The initiative to set up those committees is linked to an analysis of ethical aspects in medical research projects as published in an American medical journal of high reputation. The results prompted the National Instituts of Health (NIH) to require an assessment of research projects by an Institutional Review Board (IRB) as condition for granting that research. Authorities of other States followed this example. The World Medical Association by revising its Declaration of Helsinki in Tokyo (1975) introduced the obligation for physicians to present research projects before starting to an independent committee for ‘consideration, comment and guidance’. RECs feel responsible for the protection of human rights and fundamental freedoms of research participants. In accordance with national legislation they may work as kind of an authority or as an advisory board. More and more national and/or international legally binding instruments give the frame for decisions to be taken by RECs. International Guidelines of Non Governmental Organisations may assist the RECs in their decision finding.

A research ethics committee (REC) is an appropriately constituted group that reviews and monitors biomedical research in order to protect the rights and welfare of human subjects. Although a number of studies have reported that Japanese institutions conducting biomedical research have established RECs, little is known about the quality of research protocols and the review process in these institutions. Using a checklist of 67 items, we reviewed 75 protocols that had been evaluated by the REC of an institution. Forty-six of 75 protocols did not clearly state the background of the study. In 25 of the 46 protocols, no committee members identified the absence of a stated background. Interviews with 18 investigators and 27 REC members revealed that some investigators and committee members did not understand the role of the REC. The results of this study suggest that about one-third of REC-approved protocols may contain shortcomings. The study implies that REC does not always function effectively to ensure that the research to be conducted is ethically sound. We suggest the following improvements: 1) education and training of investigators and committee members on how to conduct clinical research, 2) establishment of a research center to support and manage the conduct of clinical research, 3) improvement of relationship and communication between committee members, 4) introduction of a procedure whereby all committee members discuss each protocol until a consensus is reached, and 5) establishment of an organization to support efficient and effective operations of the RECs.