The issue of the protection of communities in clinical research first arose 10 years ago in studies conducted in technologically developing countries by scientists from technologically developed nations. The question was, which ethical standards ought to apply, those of the Western investigators or local standards?

Although for the last 50 years, ethicists dealing with human experimentation have focused primarily on the need to protect individual research subjects and vulnerable groups, biomedical research, especially in genetics, now requires the establishment of standards for the protection of communities. We have developed such a strategy, based on five steps. (i) Identification of community characteristics relevant to the biomedical research setting, (ii) delineation of a typology of different types of communities using these characteristics, (iii) determination of the range of (...) possible community protections, (iv) creation of connections between particular protections and one or more community characteristics necessary for its implementation, and (v) synthesis of community characteristics and possible protections to define protections appropriate for each type of community. Depending on the particular community, consent and consultation, consultation alone, or no added protections may be required for research. (shrink)

The objective of this module is to cover ground that was not covered in-depth in any of the other modules, including: scientific misc.

Background There is a dearth of information on the prevalence of scientific misconduct from Nigeria. Objectives This study aimed at determining the prevalence of scientific misconduct in a group of researchers in Nigeria. Factors associated with the prevalence were ascertained. Method A descriptive study of researchers who attended a scientific conference in 2010 was conducted using the adapted Scientific Misconduct Questionnaire-Revised (SMQ-R). Results Ninety-one researchers (68.9%) admitted having committed at least one of the eight listed forms of scientific misconduct. Disagreement (...) about authorship was the most common form of misconduct committed (36.4%) while plagiarism was the least (9.2%). About 42% of researchers had committed falsification of data or plagiarism. Analysis of specific acts of misconduct showed that committing plagiarism was inversely associated with years in research (Fisher exact p-value = 0.02); falsifying data was related to perceived low effectiveness of the institution's rules and procedures for reducing scientific misconduct (X2 = 6.44, p-value = 0.01); and succumbing to pressure from study sponsor to engage in unethical practice was related to sex of researcher (Fisher exact p-value = 0.02). Conclusions The emergent data from this study is a cause for serious concern and calls for prompt intervention. The best response to reducing scientific misconduct will proceed from measures that contain both elements of prevention and enforcement. Training on research ethics has to be integrated into the curriculum of undergraduate and postgraduate students while provision should be made for in-service training of researchers. Penalties against acts of scientific misconduct should be enforced at institutional and national levels. (shrink)

Background Papers retracted for fraud (data fabrication or data falsification) may represent a deliberate effort to deceive, a motivation fundamentally different from papers retracted for error. It is hypothesised that fraudulent authors target journals with a high impact factor (IF), have other fraudulent publications, diffuse responsibility across many co-authors, delay retracting fraudulent papers and publish from countries with a weak research infrastructure. Methods All 788 English language research papers retracted from the PubMed database between 2000 and 2010 were evaluated. Data (...) pertinent to each retracted paper were abstracted from the paper and the reasons for retraction were derived from the retraction notice and dichotomised as fraud or error. Data for each retracted article were entered in an Excel spreadsheet for analysis. Results Journal IF was higher for fraudulent papers (p<0.001). Roughly 53% of fraudulent papers were written by a first author who had written other retracted papers (‘repeat offender’), whereas only 18% of erroneous papers were written by a repeat offender (χ=88.40; p<0.0001). Fraudulent papers had more authors (p<0.001) and were retracted more slowly than erroneous papers (p<0.005). Surprisingly, there was significantly more fraud than error among retracted papers from the USA (χ2=8.71; p<0.05) compared with the rest of the world. Conclusions This study reports evidence consistent with the ‘deliberate fraud’ hypothesis. The results suggest that papers retracted because of data fabrication or falsification represent a calculated effort to deceive. It is inferred that such behaviour is neither naïve, feckless nor inadvertent. (shrink)

As genetic research increasingly focuses on communities, there have been calls for extending research protections to them. We critically examine guidelines developed to protect aboriginal communities and consider their applicability to other communities. These guidelines are based on a model of researcher-community partnership and span the phases of a research project, from protocol development to publication. The complete list of 23 protections may apply to those few non-aboriginal communities, such as the Amish, that are highly cohesive. Although some protections may (...) be applicable to less-cohesive communities, such as Ashkenazi Jews, analysis suggests substantial problems in extending these guidelines in toto beyond the aboriginal communities for which they were developed. (shrink)

Health research initiatives worldwide are growing in scope and complexity, particularly as they move into the developing world. Expanding health research activity in low- and middle-income countries has resulted in a commensurate rise in the need for sound ethical review structures and functions in the form of Research Ethics Committees (RECs). Yet these seem to be lagging behind as a result of the enormous challenges facing these countries, including poor resource availability and lack of capacity. There is thus an urgent (...) need for ongoing capacity and resource development in these regions in general, and in Africa in particular. Similarly, there is a need for research and initiatives that can identify existing capacity and funding and indicate the areas where this needs to be developed.This discussion paper argues that the Mapping African Research Ethics Capacity (MARC) project is a timely initiative aimed at identifying existing capacity. MARC provides a platform and tool on the Council on Health Research for Development's (COHRED) Health Research website (HRWeb), which can be used by RECs and key stakeholders in health research in Africa to identify capacity, constraints and development needs. MARC intends to provide the first comprehensive interactive database of RECs in Africa, which will allow for the identification of key relationships and analyses of capacity. The potential of MARC lies in the mapping of current ethical review activity onto capacity needs. This paper serves as a starting point by providing a descriptive illustration of the current state of RECs in Africa. (shrink)

What makes individuals, groups, or even entire countries vulnerable? And why is vulnerability a concern in bioethics? A simple answer to both questions is that vulnerable individuals and groups are subject to exploitation, and exploitation is morally wrong. This analysis is limited to two areas. First is the context of multinational research, in which vulnerable people can be exploited even if they are not harmed, and harmed even if they are not exploited. Second is the situation of women, who are (...) made vulnerable in cultural settings or in entire countries in which they are oppressed and powerless. (edited). (shrink)

The objective of this module is to cover ground that was not covered in‐depth in any of the other modules, including: scientific misconduct, issues concerning the publication and ownership of research results (authorship guidelines – who is eligible to be considered an author, or contributor to a scientific paper etc.), special problems occurring in social science and epidemiological research, and the problems pertaining to conflicts of interest the various players in biomedical research activities could encounter.

Although the International Committee of Medical Journal Editors has published clear guidance on the authorship of scientific papers, short-term contract research workers, who perform much of the research that is reported in the biomedical literature, are often at a disadvantage in terms of recognition, reward and career progression. This article identifies several professional, ethical and operational issues associated with the assignment of authorship, describes how a university department of primary care set about identifying and responding to the concerns of its (...) contract research staff on authorship and describes a set of guidelines that were produced to deal with the ethical and professional issues raised. These guidelines include directions on how authorship should be negotiated and allocated and how short-term researchers can begin to develop as authors. They also deal with the structures required to support an equitable system, which deals with the needs of short-term researchers in ways that are realistic in the increasingly competitive world of research funding and publication, and may offer a model for more formal guidelines that could form part of institutional research policy. (shrink)

Next SectionBackground Scientific papers are retracted for many reasons including fraud (data fabrication or falsification) or error (plagiarism, scientific mistake, ethical problems). Growing attention to fraud in the lay press suggests that the incidence of fraud is increasing. Methods The reasons for retracting 742 English language research papers retracted from the PubMed database between 2000 and 2010 were evaluated. Reasons for retraction were initially dichotomised as fraud or error and then analysed to determine specific reasons for retraction. Results Error was (...) more common than fraud (73.5% of papers were retracted for error (or an undisclosed reason) vs 26.6% retracted for fraud). Eight reasons for retraction were identified; the most common reason was scientific mistake in 234 papers (31.5%), but 134 papers (18.1%) were retracted for ambiguous reasons. Fabrication (including data plagiarism) was more common than text plagiarism. Total papers retracted per year have increased sharply over the decade (r=0.96; p<0.001), as have retractions specifically for fraud (r=0.89; p<0.001). Journals now reach farther back in time to retract, both for fraud (r=0.87; p<0.001) and for scientific mistakes (r=0.95; p<0.001). Journals often fail to alert the naïve reader; 31.8% of retracted papers were not noted as retracted in any way. Conclusions Levels of misconduct appear to be higher than in the past. This may reflect either a real increase in the incidence of fraud or a greater effort on the part of journals to police the literature. However, research bias is rarely cited as a reason for retraction. (shrink)

Background Medical research so flawed as to be retracted may put patients at risk by influencing treatments. Objective To explore hypotheses that more patients are put at risk if a retracted paper appears in a journal with a high impact factor (IF) so that the paper is widely read; is written by a ‘repeat offender’ author who has produced other retracted research; or is a clinical trial. Methods English language papers (n=788) retracted from the PubMed database between 2000 and 2010 (...) were evaluated. Only those papers retracting research with humans or freshly derived human material were included; 180 retracted primary papers (22.8%) met inclusion criteria. Subjects enrolled and patients treated were tallied, both in the retracted primary studies and in 851 secondary studies that cited a retracted primary paper. Results Retracted papers published in high-IF journals were cited more often (p=0.0004) than those in low-IF journals, but there was no difference between high- and low-IF papers in subjects enrolled or patients treated. Retracted papers published by ‘repeat offender’ authors did not enrol more subjects or treat more patients than papers by one-time offenders, nor was there a difference in number of citations. However, retracted clinical trials treated more patients (p=0.0002) and inspired secondary studies that put more patients at risk (p=0.0019) than did other kinds of medical research. Conclusions If the goal is to minimise risk to patients, the appropriate focus is on clinical trials. Clinical trials form the foundation of evidence-based medicine; hence, the integrity of clinical trials must be protected. (shrink)

Fieldworkers (FWs) are community members employed by research teams to support access to participants, address language barriers, and advise on culturally appropriate research conduct. The critical role that FWs play in studies, and the range of practical and ethical dilemmas associated with their involvement, is increasingly recognised. In this paper, we draw on qualitative observation and interview data collected alongside a six month basic science study which involved a team of FWs regularly visiting 47 participating households in their homes. The (...) qualitative study documented how relationships between field workers and research participants were initiated, developed and evolved over the course of the study, the shifting dilemmas FWs faced and how they handled them. Even in this one case study, we see how the complex and evolving relationships between fieldworkers and study participants had important implications for consent processes, access to benefits and mutual understanding and trust. While the precise issues that FWs face are likely to depend on the type of research and the context in which that research is being conducted, we argue that appropriate support for field workers is a key requirement to strengthen ethical research practice and for the long term sustainability of research programmes. (shrink)

To participate in health research, there is a need for well-administered informed consent. Understanding of informed consent, especially in international health research, is influenced by the participants' understanding of information and the meaning attached to the information communicated to them regarding the purpose and procedure of the research. Incorrect information and the power differential between researcher and participants may lead to participants becoming victims of harmful research procedures. Meningitis epidemics in Kano in early 1996 led to a response from drug (...) companies, especially Pfizer, as well as humanitarian workers from Médecins Sans Frontiers, which resulted in an unethical trial. Pfizer's drug trial during the epidemics has left a lasting controversy, which has yet to be resolved. This paper examines the key issues surrounding the controversy, discusses the context of informed decision-making, the ethical issues and implications of the incident, and concludes with some recommendations. Relevant texts, journals, Internet materials, newspaper articles and documentary materials on the conduct of the Pfizer's Trovan trial have been consulted. Four types of action (act intuitively, act rationally, act ignorantly, and act contextually – based on information provided) are identified as possible options for decision making. Participants most likely acted in ignorance due to poor understanding of the information contained in the verbal informed consent administered, thereby raising ethical issues. It is concluded that health research ethics committees have an important role to play nationally and locally in overseeing research, and in avoiding future occurrences. (shrink)