Templates for Informed Consent and Participant Information Sheet
by Donna RussellCollecting biospecimens for research from your community is a long-term commitment. It requires earning and keeping their trust by being as transparent as possible. It requires following the highest ethical, regulatory and legal standards.And it should include a mechanism for providing feedback to the community on the research that has been done using their samples. In some cases, there may be risks to ethnic and social groups or communities due to the release of aggregate research findings even when no individually identifiable information has been revealed. In addition, some populations or groups have specific beliefs about the disposition and use of their specimens, which should be respected. We provide the following templates:
- informed consent to collect biospecimens during pregnancy
- participant information sheet
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.
Novel coronavirus sampling plan
by Ken BaillieA sample plan for sample collection with regards to a potential novel coronavirus outbreak, developed by Kenneth Baillie and ISARIC's Working Group 3.
Essential Interventions, Commodities and Guidelines for Reproductive, Maternal, Newborn and Child Health
by Jai K DasResearch 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)
Point of Care Testing for Infectious Diseases: Diversity, Complexity and Barriers in Low- and Middle Income Countries
by Nitika Pant Pai, MD MPH PhD, Caroline Vadnais, Claudia Denkinger, Nora Engel, Madhu PaiAssessing 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.
Requirements for high impact diagnostics in the developing world
by Mickey Urdea, Laura A. Penny, Stuart S. Olmsted, Maria Y. Giovanni, Peter Kaspar, Andrew Shepherd, Penny Wilson, Carol A. Dahl, Steven Buchsbaum, Gerry Moeller, Deborah C. Hay BurgessThis article is an introduction to cluster randomised trials.