Clinical Trials in East Africa: a One-Day Skills Sharing Workshop Report
by George Mukalazi Miiro, Emily N KabuyeReport on a one-day skills sharing workshop for improved clinical trials and research in East Africa, hosted by UVRI/MRC, EACCR and Global Health Trials and held on 15th February 2013.
The universal coverage with the full package of these proven interventions at observed levels of program effectiveness could prevent about one quarter of child deaths under 36 months of age and reduce the prevalence of stunting at 36 months by about one third. I attach my recent review on the possible strategies to combat malnutrition include promotion of breastfeeding, dietary supplementation of micronutrients, prevention of protein-energy malnutrition, and hygiene of available weaning foods and how best topackage these intevrentions for universal scale-up.
Clinical Data Management: Current status, challenges and future directions from industry perspectives.
by Harry van LoenCould an Open-Source Clinical Trial Data-Management System Be What We Have All Been Looking For?
by The Editorial TeamThis publication discsusses whether or not open-source clinical trial data management will improve the likelihood that good clinical trials are conducted in resource-constrained settings.
Repository on maternal child health: Health portal to improve access to information on maternal child health in India
by Jai K DasThis article describes a health portal developed in India aimed at providing one-stop access to efficiently search, organize and share maternal child health information relevant from public health perspective in the country.
Challenges of non-commercial multi-centre North-South collaborative clinical trials
by Raffaella Ravinetto , on behalf of the 4ABC Study GroupThe last decade has witnessed a substantial increase of multi-centre, public health-oriented clinical trials in poor countries. However, non-commercial research groups have less staff and financial resources than traditional commercial sponsors, so the trial teams have to be creative to comply with Good Clinical Practices (GCP) requirements. This article hopes to feed the reflection on the methodological and ethical aspects of clinical trials carried out in developing countries by North-South collaborative research groups.
This guidance article aims to provide a fully comprehensive, pragmatic guide for researchers of all roles, but especially ethics reviewers, to explain the details of each type of ethics review. The article is available in English, Spanish, Portuguese and Chinese, and has been kindly provided by www.ctmagnifier.org.
Whether breast cancer screening does more harm than good has been debated extensively. The main questions are how large the benefit of screening is in terms of reduced breast cancer mortality and how substantial the harm is in terms of overdiagnosis, which is defined as cancers detected at screening that would not have otherwise become clinically apparent in the woman's lifetime.
Research reporting guidelines are standard statements that provide guidance on how to report research methodology and findings. These are in the form of checklists, flow diagrams or texts. Most of the biomedical journals require authors to comply with these guidelines. Guidelines are available for reporting various study designs:
- CONSORT Statement (reporting of randomized controlled trials)
- STARD (reporting of diagnostic accuracy studies)
- STROBE (reporting of observational studies in epidemiology)
- PRISMA (reporting of systematic reviews)
- MOOSE (reporting of meta-analyses of observational studies)
Assessing the quality of informed consent in a resource-limited setting: A cross-sectional study
by Ronald Kiguba, Paul Kutyabami, Stephen Kiwuwa, Elly Katabira, Nelson K SewankamboThe process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University.
A range of downloadable templates and tools for Clinical Research, including monitoring checklists, budget spreadsheets, informed consent forms, SOPs and so on.
This article is an introduction to cluster randomised trials.
Towards a more pragmatic approach to trial regulation
by The EditorsThe border between Thailand and Burma (Myanmar) is at the forefront of the global battle against malaria, and is an important site for research.
This bibliography is a work in progress and is regularly revised. We are currently updating it to link to any listed papers that are available via open access. If there are papers we're missing, or if you have other comments, please let us know by writing to info@globalhealthbioethics.org.
Health Researchers’ Ancillary Care Obligations in Low-Resource Settings: How Can We Tell What Is Morally Required?
by Maria W. MerrittHealth researchers working in low-resource settings often encounter serious unmet health needs among participants. What is the nature and extent of researchers’ obligations to respond to such needs? Competing accounts have been proposed, but there is no independent standard by which to assess them or to guide future inquiry. I propose an independent standard and demonstrate its use.
Physician-researchers’ experiences of the consent process in the socio-cultural context of a developing country
by Aisha Y. MalikThis paper draws on empirical data obtained from interviews with physician-researchers in teaching hospitals of Lahore, Pakistan. The data identify social and cultural factors that affect the consent process for participants in research.
One fundamental ethical principle underpinning research ethics is that of respect for persons. It requires that researchers respect research participants’ autonomy, interests, and wishes, and act on the presumption that participants are the best judges of what their interests are (Nuffield Council on Bioethics 2002). This presumption obliges us to design consent processes for research that facilitate prospective participants’ free and informed decisions as to whether or not to participate in a study.