TRAINING NEEDS ASSESSMENT IN RESEARCH ETHICS EVALUATION AMONG RESEARCH ETHICS COMMITTEE MEMBERS IN THREE AFRICAN COUNTRIES: CAMEROON,MALI AND TANZANIA

Background: As actors with the key responsibility for the protection of human research participants, Research Ethics Committees (RECs) need to be competent and well‐resourced in order to fulfil their roles. Despite recent programs designed to strengthen RECs in Africa, much more needs to be accomplished before these committees can function optimally. Objective: To assess training needs for biomedical research ethics evaluation among targeted countries. Methods: Members of RECs operating in three targeted African countries were surveyed between August and November 2007. Before implementing the survey, ethical approvals were obtained from RECs in Switzerland, Cameroon, Mali and Tanzania. Data were collected using a semi‐structured questionnaire in English and in French. Results: A total of 74 respondents participated in the study. The participation rate was 68%. Seventy one percent of respondents reported having received some training in research ethics evaluation. This training was given by national institutions (31%) and international institutions (69%). Researchers and REC members were ranked as the top target audiences to be trained. Of 32 topics, the top five training priorities were: basic ethical principles, coverage of applicable laws and regulations, how to conduct ethics review, evaluating informed consent processes and the role of the REC. Conclusion: Although the majority of REC members in the targeted African countries had received training in ethics, they expressed a need for additional training. The results of this survey have been used to design a training program in research ethics evaluation that meets this need.     

A Role for Research Ethics Committees in Exchanges of Human Biospecimens Through Material Transfer Agreements

International transfers of human biological material (biospecimens) and data are increasing, and commentators are starting to raise concerns about how donor wishes are protected in such circumstances. These exchanges are generally made under contractual material transfer agreements (MTAs). This paper asks what role, if any, should research ethics committees (RECs) play in ensuring legal and ethical conduct in such exchanges. It is recommended that RECs should play a more active role in the future development of best practice MTAs involving exchange of biospecimens and data and in monitoring compliance.     

Assessing Youth Perceptions and Knowledge of Ethics at 4-H Horse Shows in Louisiana

Due to the increased awareness of animal welfare issues and sensitized attitudes throughout society, youth animal projects provide a unique opportunity to assess and impact youth understanding and attitudes regarding animal welfare. Animal ethics training is not an uncommon requirement for participants in 4-H livestock programs. However, participants in 4-H horse projects are not universally held to the same standard. The purpose of this study was to assess youth knowledge, attitudes, and confidence in understanding of equine welfare at the 4-H state horse show, as well as to determine the beliefs and observations of unethical practices, and if differences exist between those parameters in youth competitors. The results suggest that 4-H competitors are interested in ethics and believe that unethical behavior rarely occurs within the state 4-H horse project. However, youth report observing common unethical behaviors at the show, suggesting a disconnect between what they believe is unethical and what they actually observe. Educational opportunities exist within these animal projects and should be enhanced to address the gap in understanding.     

Growth rate and oxygen regulate the interactions of group B Streptococcus with polarized respiratory epithelial cells

We investigated growth conditions that regulate the ability of group B Streptococcus (GBS) to attach to, invade, and translocate through polarized human respiratory epithelial cells (RECs). GBS grown in a chemostat at a fast cell mass doubling time (t(d) = 1.8 h), invaded RECs from both the apical and basolateral surfaces in higher numbers compared with those held at a t(d) = 11 h. With the exception of adherence from the basolateral surface, GBS reached peak adherence to, invasion of, and translocation through RECs when held at the fast t(d) with 15% dissolved oxygen compared with 0% dissolved oxygen. Growth rate and oxygen level strongly influence the interaction of GBS with polarized RECs and likely GBS pathogenicity.     

Impact of Three Years Training on Operations Capacities of Research Ethics Committees in Nigeria

This paper describes a three‐year project designed to build the capacity of members of research ethics committes to perform their roles and responsibilities efficiently and effectively. The project participants were made up of a cross‐section of the membership of 13 Research Ethics Committees (RECs) functioning in Nigeria. They received training to develop their capacity to evaluate research protocols, monitor trial implementation, provide constructive input to trial staff, and assess the trial's success in promoting community engagement in the research. Following the training, technical assistance was provided to participants on an ongoing basis and the project's impacts were assessed quantitatively and qualitatively. Results indicate that sustained investment in capacity building efforts (including training, ongoing technical assistance, and the provision of multiple tools) improved the participants’ knowledge of both the ethical principles relevant to biomedical research and how effective REC should function. Such investment was also shown to have a positive impact on the knowledge levels of other RECs members (those who did not receive training) and the overall operations of the RECs to which the participants belonged. Building the capacity of REC members to fulfill their roles effectively requires sustained effort and investment and pays off by enabling RECs to fulfill their essential mission of ensuring that trials are conducted safely and ethically.     

CURRICULUM GUIDE FOR RESEARCH ETHICS WORKSHOPS FOR COUNTRIES IN THE MIDDLE EAST

To help ensure the ethical conduct of research, many have recommended educational efforts in research ethics to investigators and members of research ethics committees (RECs). One type of education activity involves multi‐day workshops in research ethics. To be effective, such workshops should contain the appropriate content and teaching techniques geared towards the learning styles of the targeted audiences. To ensure consistency in content and quality, we describe the development of a curriculum guide, core competencies and associated learning objectives and activities to help educators organize research ethics workshops in their respective institutions. The curriculum guide is divided into modular units to enable planners to develop workshops of different lengths and choose content materials that match the needs, abilities, and prior experiences of the target audiences. The content material in the curriculum guide is relevant for audiences in the Middle East, because individuals from the Middle East who participated in a Certificate Program in research ethics selected and developed the training materials (e.g., articles, powerpoint slides, case studies, protocols). Also, many of the activities incorporate active‐learning methods, consisting of group work activities analyzing case studies and reviewing protocols. The development of such a workshop training curriculum guide represents a sustainable educational resource to enhance research ethics capacity in the Middle East.     

Is Knowledge Regarding Tuberculosis Associated with Stigmatising and Discriminating Attitudes of General Population towards Tuberculosis Patients? Findings from a Community Based Survey in 30 Districts of India

Background

Stigmatising and discriminating attitudes may discourage tuberculosis (TB) patients from actively seeking medical care, hide their disease status, and discontinue treatment. It is expected that appropriate knowledge regarding TB should remove stigmatising and discriminating attitudes. In this study we assessed the prevalence of stigmatising and discriminating attitudes towards TB patients among general population and their association with knowledge regarding TB.

Method

A cross-sectional knowledge, attitude and practice survey was conducted in 30 districts of India in January-March 2011. A total of 4562 respondents from general population were interviewed using semi-structured questionnaires which contained items to measure stigma, discrimination and knowledge on TB.

Result

Of the 4562 interviewed, 3823 were eligible for the current analysis. Of these, 73% (95% CI 71.4–74.2) had stigmatising and 98% (95% CI 97.4–98.3) had discriminating attitude towards TB patients. Only 17% (95% CI 15.6–18.0) of the respondents had appropriate knowledge regarding TB with even lower levels observed amongst females, rural areas and respondents from low income groups. Surprisingly stigmatising (adjusted OR 1.31 (0.78–2.18) and discriminating (adjusted OR 0.79 (0.43–1.44) attitudes were independent of knowledge regarding TB.

Conclusion

Stigmatising and discriminating attitudes towards TB patients remain high among the general population in India. Since these attitudes were independent of the knowledge regarding TB, it is possible that the current disseminated knowledge regarding TB which is mainly from a medical perspective may not be adequately addressing the factors that lead to stigma and discrimination towards TB patients. Therefore, there is an urgent need to review the messages and strategies currently used for disseminating knowledge regarding TB among general population and revise them appropriately. The disseminated knowledge should include medical, psycho-social and economic aspects of TB that not only informs people about medical aspects of TB disease, but also removes stigma and discrimination.     

The mission of the Committee for Personal Protection (CPP) in France: neither ethical, nor scientific?

In France, research on human beings was first organized (and legally authorized) in 1988 by a law (so called Huriet-Séruclat). Since then, the specific mission of research ethics committees (RECs) has been heavily disputed. The legislator explained that the role of RECs is neither ethic nor scientific. It is < to control that the research protocol has been drafted according to the law >. Of course, this is clearly at odds with the common practice of RECs in France and abroad as well. The assessment of the benefit/risk balance and of the < pertinence > of the protocol cannot be achieved without a clear understanding of its scientific rationale. Origin of this French < cultural exception > is to be found in the historic context of the elaboration of the law, back in the mid Eighties.     

Public involvement in pharmacogenomics research: a national survey on public attitudes towards pharmacogenomics research and the willingness to donate DNA samples to a DNA bank in Japan

To assess the attitudes of the Japanese general public towards pharmacogenomics research and a DNA bank for identifying genomic markers associated with ADRs and their willingness to donate DNA samples, we conducted a national survey for 1,103 Japanese adults from the general public, not a patient population. The response rate was 36.8%. The majority of the respondents showed a positive attitude towards pharmacogenomics research (81.0%) and a DNA bank (70.4%). Considering fictitious clinical situations such as taking medications and experiencing ADRs, the willingness to donate DNA samples when experiencing ADRs (61.7%) was higher than when taking medications (45.3%). Older generations were significantly associated with a decreased willingness to donate (OR = 0.45, CI 0.28–0.72 in 50s. OR = 0.49, CI: 0.31–0.77 in 60s). Positive attitudes towards pharmacogenomics research, a DNA bank, blood/bone marrow/organ donation were significantly associated with an increased willingness. However, the respondents had the following concerns regarding a DNA bank: the confidentiality of their personal information, the manner by which research results were utilized and simply the use of their own DNA for research. In order to attain public understanding to overcome these concerns, a process of public awareness should be put into place to emphasize the beneficial aspects of identifying genomic markers associated with ADRs and to address these concerns raised in our study. Further study is needed to assess the willingness of actual patients taking medications in real situations, since the respondents in our study were from the general public, not a patient population, and their willingness was assessed on the condition of assuming that they were patients taking medications.     

VIEWS OF THE PROCESS AND CONTENT OF ETHICAL REVIEWS OF HIV VACCINE TRIALS AMONG MEMBERS OF US INSTITUTIONAL REVIEW BOARDS AND SOUTH AFRICAN RESEARCH ETHICS COMMITTEES

Given the ethical controversies concerning HIV vaccine trials (HVTs), we aimed to understand through an exploratory study how members of institutional review boards (IRBs) in the United States (US) and research ethics committees (RECs) in South Africa (SA) view issues concerning the process and content of reviews of these studies. We mailed packets of 20 questionnaires to 12 US IRB chairs and administrators and seven REC chairs to distribute to their members. We received 113 questionnaires (76 from the US and 37 from SA). In both countries, members tended to be white males with advanced academic degrees. Compared to the US, SA members called for ‘major changes’ in HVT protocols more frequently (p = 0.004), and were less likely to think that HVT participants understood risks and benefits (p = 0.033) or informed consent forms (p = 0.000). In both countries, members were divided on several critical issues (e.g. the minimum standard for treatment for HVT participants who became infected during the HVT), but agreed that they needed more training. Of the SA respondents, 40% reported that they were ‘self‐taught’ in ethics. This study, the first we know of to offer quantitative data comparing US vs. non‐US IRBs/RECs, thus suggests key similarities and differences (e.g. compared to SA respondents, US respondents appeared to overestimate participants' understanding of informed consent), along with needs for education. These initial exploratory data in this area have important implications for IRBs, RECs, policy‐makers and scholars concerning future practice, training, policy, and investigations in research ethics, and prevention and treatment of HIV and other diseases in the developing world and elsewhere.     

An exploration of instructor perceptions of community college students’ attitudes towards evolution

Background

Faculty perception of student knowledge and acceptance of subject matter affects the choice of what to teach and how to teach it. Accurate assessment of student acceptance of evolution, then, is relevant to how the subject should be taught. To explore the accuracy of such assessment, we compared how community college instructors of life sciences courses perceive students’ attitudes towards evolution with those students’ actual attitudes towards evolution.

Results

The research had two components: (1) a survey of students of several biology classes at a community college about their acceptance of evolutionary theory and (2) interviews with the biology faculty teaching those classes about their perceptions of their students’ attitudes towards evolution. Results of the study indicate relatively high levels of acceptance of evolution among community college students at this West Coast institution. We also found that community college instructors of life sciences courses varied in accuracy of their perceptions of their students’ attitudes towards evolution–but not systematically. Although one professor assessed each class quite accurately, the other two professors frequently underestimated the acceptance of evolution among their students.

Conclusions

Errors in perception seemed independent of whether the class was composed of majors, nonmajors, or a combination. Clearly, in our sample there is much idiosyncrasy regarding community college instructor accuracy concerning student opinions about evolution.

     

Environmental issues in relation to agricultural practices and attitudes of farmers: A case study from Saudi Arabia

PurposeThe Kingdom of Saudi Arabia is continuously in search of environment-friendly farming practices since mass-scale agriculture was initiated. It is imperative to gauge to the level of awareness of the farmers on the agricultural practices causing environmental issue in order to devise new agricultural extension programs. This research aims to identify the attitudes of farmers towards agriculture and environment in Al-Ghat area of Saudi Arabia.MethodologyA simple random sample of 110 farms truly representing the farming community was drawn to meet the objectives of the study. Data were collected by using the pre-tested questionnaire during the face-to-face interviews. In order to understand the message of study, data were analyzed for percentages, arithmetic average and standard deviation in addition to the simple Pearson correlation coefficient.ResultsThe results showed that the high proportion (87.3%) of farmers was interested in continuing to work farm and 77.3% of farmers did not consider adopting agriculture their main occupation. The findings of the survey reveal that some 55.5% of the respondent farmers were aware of the agricultural practices and their relation to the environment. Some 57.3% of the surveyed farmers are aware of potential benefits of enhanced utilization of agricultural organic wastes. However, main profession, farm employment (as the independent variables) showed a significant positive correlation with the attitudes of farmers towards their working in agriculture (as a dependent variable). Also a significant negative relationship between the educational levels and the attitudes of the farmers towards working in agriculture was noticed. The study also indicated a significant correlation between education and the degree of awareness of agricultural practices related to the environment and maximizing the optimum utilization of agricultural waste i.e. organic residues.ConclusionsThe study suggested the need for new awareness and orientation programs to educate farmers and extension workers, highlighting the environment- friendly agricultural practices.Recommendation: There is need to offer incentives and facilities to keep the farmers stay in the farming business. Extension staff must keep educating them on beneficial features of organic farm waste and crop residues as organic fertilizers.     

Attitude toward depression, its complications, prevention and barriers to seeking help among ethnic groups in Penang, Malaysia

This study aims to explore attitudes towards, complications of and preventive measures for depression and the barriers that result in delays in seeking help among the various ethnic groups in Penang, Malaysia. In June 2007 a questionnaire-based survey was undertaken in Penang. Face-to-face interviews were conducted, and 1855 respondents were approached to participate in the study by adopting a cluster random sampling method. A 25-item questionnaire was used to explore public attitudes towards, complications of and preventive measures for depression and delays in seeking help. A total of 1149 (61.94%) showed willingness to participate in the survey. Ethnically, 490 (42.6%) of the respondents who participated in the survey were Malay, while 413 (35.9%) were Chinese, 149 (13%) Indian and 97 (8.4%) from other ethnic minorities. The mean age of the respondents was 30 years (SD ± 11.5). In evaluating public attitudes, the majority (n = 910, 79.2%) agreed with the statement that family and friends can enhance the depression recovery process by providing more care and attention to the patient and this was found to be statistically significant (P ≤0.001). More than one-third of the respondents (n = 437, 38.0%) perceived depression as a normal medical condition and believed that it subsides automatically. The majority (n = 830, 72.2%) stated that depression results in social problems, while some felt that it can lead to raised blood pressure (n = 518, 45.1%). In terms of prevention, most of the respondents indicated that one can prevent depression by maintaining a good social life. In evaluating the barriers to seeking professional help, the majority (n = 582, 50.7%) stated that they did not believe they were at risk, with the next largest group identifying a lack of awareness regarding the signs and symptoms. However, a positive attitude was observed towards the complications and prevention of depression. Initiatives to increase mental health literacy will prove fruitful in neutralising the negative public perceptions towards the treatment of depression and barriers to seeking professional help.     

Focus group interviews examining attitudes toward medical research among the Japanese: a qualitative study

Objectives: the purpose of ths study is to explore laypersons' attitudes towards and experiences of medical research, and to compare them with those of physicians in Japan. Designs and Participants: fourteen Japanese adults from the general public and seven physicians participated in one of three focus interviews. Setting: Osaka, Japan. Results: trust and distrust in the physician by whom the participants were invited to participate in research played a considerable role in their decisions about participation. That the participants felt an obligation to participate was also expressed. The lay participants perceived medical research as something entirely outside of their world. A greater willingness to volunteer for research was expressed if there were direct benefits to themselves or their families. Research methods such as use of placebos, double blinds, and randomisations seemed to cause negative attitudes to medical research. All physicians were convinced of the need for medical research, including double-blinded randomised control trials, and its significant role in medical progress. Most physicians thought that the greater awareness of the need for medical research in the community and a better understanding of the psychology of potential research participants were necessary and urgent. Conclusions: there is a good possibility that the lay public and medical professionals have sharply different beliefs about and attitudes towards every aspect of medical research. Building up a better and equal patient-doctor relationship based on trust is a key issue in medical research, and it is mandatory to fill the gap in perception regarding medical research between them through fully informed debates.     

Knowledge and Attitudes towards Antibiotic Use and Resistance - A Latent Class Analysis of a Swedish Population-Based Sample

BackgroundIn 2006, a study investigating knowledge and attitudes regarding antibiotic use and resistance in Sweden, indicated high level of knowledge but also areas in need of improvement.Objective(i) To provide an update on the knowledge and attitudes to antibiotic use and resistance of the Swedish population, and (ii) to identify which groups within the population are in particular need of improved knowledge or attitudes.MethodsA questionnaire was sent by post in 2013 to 2,500 randomly-selected individuals aged 18–74, living in Sweden. Latent class analyses were conducted to group respondents based on their responses. The association between socio-demographic characteristics and the probability of belonging to each latent class was assessed.ResultsThe response rate was 57%. Ninety-four per cent of the responders knew that bacteria could become resistant to antibiotics and the majority answered correctly to the questions regarding antibiotic resistance development. The respondents expressed confidence in doctors who decided not to prescribe antibiotics. Three latent classes related to ‘knowledge regarding antibiotic use and resistance’, two regarding ‘attitudes towards antibiotic accessibility and infection prevention’ and three regarding ‘attitudes towards antibiotic use and effects’ were revealed. Men, younger and more educated people were more knowledgeable but males had a less restrictive attitude. Respondents with high levels of knowledge on antibiotics were more likely to have appropriate restrictive attitudes to antibiotics.ConclusionKnowledge on antibiotic use and resistance is maintained high and has improved in Sweden compared to 2006. People with lower education and elderly are especially in need of improved knowledge about antibiotic use and resistance.     

Interpersonal contact and attitudes towards indigenous peoples in Canada's prairie cities

Research finds that non-indigenous peoples often hold negative racial attitudes towards indigenous peoples. Contact theory suggests that interpersonal contact can positively influence majority group members’ attitudes regarding minority group members, raising the question of whether indigenous population growth in cities will alter non-indigenous peoples’ attitudes. Using original 2014 survey data, this paper examines the relationship between interpersonal contact and racial attitudes in Canadian prairie cities. The analysis finds that while personal ties to aboriginal peoples are correlated with lower new and old-fashioned racism scores, general contact with aboriginal peoples only correlates with old-fashioned racism scores. As such, growing urban indigenous populations – and thus increased aboriginal-non-aboriginal general contact – alone should not be expected to result in positive racial attitudes. This research advances understanding of contact theory by considering how education interacts with interpersonal contact, and informs on-going dialogue about current racial relations between non-indigenous and indigenous peoples in Canadian prairie cities.     

Extent of Non-Publication in Cohorts of Studies Approved by Research Ethics Committees or Included in Trial Registries

Background

The synthesis of published research in systematic reviews is essential when providing evidence to inform clinical and health policy decision-making. However, the validity of systematic reviews is threatened if journal publications represent a biased selection of all studies that have been conducted (dissemination bias). To investigate the extent of dissemination bias we conducted a systematic review that determined the proportion of studies published as peer-reviewed journal articles and investigated factors associated with full publication in cohorts of studies (i) approved by research ethics committees (RECs) or (ii) included in trial registries.

Methods and Findings

Four bibliographic databases were searched for methodological research projects (MRPs) without limitations for publication year, language or study location. The searches were supplemented by handsearching the references of included MRPs. We estimated the proportion of studies published using prediction intervals (PI) and a random effects meta-analysis. Pooled odds ratios (OR) were used to express associations between study characteristics and journal publication. Seventeen MRPs (23 publications) evaluated cohorts of studies approved by RECs; the proportion of published studies had a PI between 22% and 72% and the weighted pooled proportion when combining estimates would be 46.2% (95% CI 40.2%–52.4%, I² = 94.4%). Twenty-two MRPs (22 publications) evaluated cohorts of studies included in trial registries; the PI of the proportion published ranged from 13% to 90% and the weighted pooled proportion would be 54.2% (95% CI 42.0%–65.9%, I² = 98.9%). REC-approved studies with statistically significant results (compared with those without statistically significant results) were more likely to be published (pooled OR 2.8; 95% CI 2.2–3.5). Phase-III trials were also more likely to be published than phase II trials (pooled OR 2.0; 95% CI 1.6–2.5). The probability of publication within two years after study completion ranged from 7% to 30%.

Conclusions

A substantial part of the studies approved by RECs or included in trial registries remains unpublished. Due to the large heterogeneity a prediction of the publication probability for a future study is very uncertain. Non-publication of research is not a random process, e.g., it is associated with the direction of study findings. Our findings suggest that the dissemination of research findings is biased.