Informed consent and collaborative research: perspectives from the developing world.

INTRODUCTION: Informed consent has been recognized as an important component of research protocols and procedures of disclosure and consent in collaborative research have been criticized, as they may not be in keeping with cultural norms of developing countries. This study, which is part of a larger project funded by the United States National Bioethics Advisory Commission, explores the opinions of developing country researchers regarding informed consent in collaborative research. METHODS: A survey of developing country researchers, involved in human subject research, was conducted by distributing a questionnaire with 169 questions, which included questions relating to informed consent. In addition, six focus group discussions, eight in-depth interviews and 78 responses to open-ended questions in the questionnaire provided qualitative data. RESULTS: 203 surveys were considered complete and were included in the analysis. Written consent was not used by nearly 40% of the researchers in their most recent studies. A large proportion of respondents recommended that human subject regulations should allow more flexibility in ways of documenting informed consent. 84% of researchers agreed that a mechanism to measure understanding should be incorporated in research studies as part of the process of informed consent. DISCUSSION: This paper is an empirical step in highlighting the ethical issues concerning disclosure. Health researchers in developing countries are well aware of the importance of consent in health research, and equally value the significance of educating human subjects regarding study protocols and associated risks and benefits. However, respondents emphasize the need for modifying ethical regulations in collaborative research.

The burden of disease from neonatal mortality: a review of South Asia and Sub-Saharan Africa.

OBJECTIVE: To assess the burden of neonatal mortality in two developing regions. DESIGN: Review of secondary data collated through literature review. SETTING: Community and facility based studies and national health surveys. POPULATION: Neonatal (<28 days) population of South Asia and Sub-Saharan Africa. METHODS: Data on neonatal mortality were gathered from peer-reviewed literature, reports of the Demographic and Health Surveys and websites of country-based organisations. The base year for this study is 1995. For each country, a weighted mean neonatal mortality rate was calculated and the total number of neonatal deaths estimated. Country data were summarised over each region to estimate annual regional neonatal deaths and rates. The burden of disease from neonatal mortality was determined using a summary measure of health--healthy life years. MAIN OUTCOME MEASURES: Numbers of deaths and healthy life years (HeaLYs). RESULTS: Neonatal mortality rate for South Asia ranged from 41.9 to 56.9 per 1000 live births for 1995. Sri Lanka was an exception with a neonatal mortality rate between 16.3 and 18.6 per 1000 live births. The estimated regional neonatal mortality rate for South Asia was 46.27 per 1000 live births for 1995. There was a significant lack of data from Sub-Saharan Africa, resulting in highly variable neonatal mortality rates, ranging from 13 per 1000 live births in Kenya to 108 per 1000 live births in Senegal. The mean regional neonatal mortality for Sub-Saharan Africa for 1995 was estimated at 38.8 per 1000 live births. CONCLUSION: The burden of neonatal mortality in only these two regions of the developing world represents more than 2 million annual deaths. A call for greater investments in neonatal research and health programs is a logical extension to this review of evidence.