The aim of this study was to explore the existence of moral distress among nurses in Lilongwe District of Malawi. Qualitative research was conducted in selected health institutions of Lilongwe District in Malawi to assess knowledge and causes of moral distress among nurses and coping mechanisms and sources of support that are used by morally distressed nurses. Data were collected from a purposive sample of 20 nurses through in-depth interviews using a semi-structured interview guide. Thematic analysis of qualitative data was used. The results show that nurses, irrespective of age, work experience and tribe, experienced moral distress related to patient/nursing care. The major distressing factors were inadequate resources and lack of respect from patients, guardians, peers and bosses. Nurses desire teamwork and ethics committees in their health institutions as a means of controlling and preventing moral distress. There is a need for creation of awareness for nurses to recognize and manage moral distress, thus optimizing their ability to provide quality and uncompromised nursing care.

Kass and colleagues explore the strengths and weaknesses of research ethics committees in Africa.

Background: The high disease burden of Africa, the emergence of new diseases and efforts to address the 10/90 gap have led to an unprecedented increase in health research activities in Africa. Consequently, there is an increase in the volume and complexity of protocols that ethics review committees in Africa have to review. Methods: With a grant from the Bill and Melinda Gates Foundation, the African Malaria Network Trust (AMANET) undertook a survey of 31 ethics review committees (ERCs) across sub-Saharan Africa as an initial step to a comprehensive capacity-strengthening programme. The number of members per committee ranged from 3 to 21, with an average of 11. Members of 10 institutional committees were all from the institution where the committees were based, raising prima facie questions as to whether independence and objectivity could be guaranteed in the review work of such committees. Results: The majority of the committees (92%) cited scientific design of clinical trials as the area needing the most attention in terms of training, followed by determination of risks and benefits and monitoring of research. The survey showed that 38% of the ERC members did not receive any form of training. In the light of the increasing complexity and numbers of health research studies being conducted in Africa, this deficit requires immediate attention. Outcome: The survey identified areas of weakness in the operations of ERCs in Africa. Consequently, AMANET is addressing the identified needs and weaknesses through a 4-year capacity-building project.

Limited capacity, deep mistrust pose challenges to sharing

The last fifteen years have witnessed a significant increase in investment in research ethics capacity development throughout the world. We examine nine research ethics training programs that are focused on Sub-Saharan Africa and supported by the US National Institutes of Health. We collected data from grants awards’ documents and annual reports supplemented by questionnaires completed by the training program directors. Together, these programs provided long-term training in research ethics to 275 African professionals, strengthened research ethics committees in 19 countries in Sub-Saharan Africa, and created research ethics curricula at many institutions and bioethics centers within Africa. Trainees’ leadership resulted in new national systems and policies on research ethics, human tissue storage and export, and methods of monitoring compliance with research ethics guidelines. Training programs adapted to challenges that arose due to varied trainees’ background knowledge in ethics, duration of time available for training, spoken and written English language skills, administrative obstacles, and the need to sustain post-training research ethics activities. Our report showcases the development of awareness of research ethics and building/strengthening of basic research ethics infrastructure in Sub-Saharan Africa. Nevertheless, the increasing amount and complexity of health research being conducted in Sub-Saharan Africa suggests the need for continued investment in research ethics capacity development in this region. This paper is part of a collection of papers analyzing the Fogarty International Center’s International Research Ethics Education and Curriculum Development program.

Participants' refusal to take part in research is an unpleasant experience that investigators face.. This paper highlights some of the reasons why people from resource-poor settings refuse to take part in health research. This paper also highlights standards which investigators can adopt to avoid unnecessary refusals and at the same time ensure that individuals have the right to participate and freedom to refuse. Our objective was to explore reasons why people refuse to join research studies. We conducted focus group discussions with people who had refused to take part in a number of biomedical research studies but agreed to be interviewed in this study. The study was undertaken in the peri-urban and urban areas of Blantyre district; Bangwe, Mpemba and Madziabango. We found nine key factors that influence people to refuse to participate in biomedical research. The factors are failure to follow traditional customs , lack of study benefits, superstition, poor informed consent procedures, ignorance of health research, fear of strangers, lack of cultural sensitivity, poor timing, and previous bad research experience. People refuse to participate in health research for a number of reasons which can be overcome if researchers embark on community engagement before implementing their studies.

Current literature suggests that therapeutic misconception-a belief by participants in a clinical trial that they are in fact simply being given clinical care-is common, especially among illiterate populations in developing countries. Therapeutic misconception reflects problems in informed consent, as people agree to participate in clinical trials without being aware that the trial procedures and test products may not in fact benefit them. In this study of Malawian adults who had participated in research projects of various kinds during the preceding years, we found that the majority participated in research for the sake of obtaining better quality treatment made available through the clinical trials as ancillary care. Their consent to participate was not due to a belief that the actual procedures of the trial would directly benefit their health. Respondents indicated that, government hospitals being crowded and commonly lacking drugs, they agreed to take part in research projects in the hope of obtaining access to ancillary care provided by clinical trials. We conclude that in this environment, possibly owing to inadequacy of routine health services, people make rational decisions to participate in research. We question whether the term 'therapeutic misconception' accurately describes participants' motivation under conditions of limited resources. We also discuss the relevance of these findings for understanding undue inducement in clinical trials.

BackgroundThe intervention reported in this paper was a follow up to an empirical study conducted in Malawi with the aim of assessing trial participants’ understanding of randomisation, double-blinding and placebo use. In the empirical study, the majority of respondents (61.1%; n=124) obtained low scores (lower than 75%) on understanding of all three concepts under study. Based on these findings, an intervention based on a narrative which included all three concepts and their personal implications was designed. The narrative used daily examples from the field of Agriculture because Malawi has an agro-based economy.MethodsThe intervention was tested using a sample of 36 women who had been identified as low scorers during the empirical study. The 36 low scorers were randomly assigned to control (n=18) and intervention arms (n=18). The control arm went through a session in which they were provided with standard informed consent information for the microbicide trial. The intervention arm went through a session in which they were provided with a narrative in ChiChewa, the local language, with the assistance of a power point presentation which included pictures as well as discussions on justification and personal implications of the concepts under study.ResultsThe findings on the efficacy of the intervention suggest that the 3 scientific concepts and their personal implications can be understood by low literacy populations using simple language and everyday local examples. The findings also suggest that the intervention positively impacted on understanding of trial procedures under study, as 13 of the 18 women in the intervention arm, obtained high scores (above 75%) during the post intervention assessment and none of the 18 in the control arm obtained a high score. Using Fischer’s exact test, it was confirmed that the effect of the intervention on understanding of the three procedures was statistically significant (p=0.0001).ConclusionsPotential trial participants can be assisted to understand key clinical trial procedures, their justification and personal implications by using innovative tailored local narratives.