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The communication and Consent Committee, KEMRI Wellcome Trust Research programme, Kilifi, Kenya have developed a set of template consent tools. These have been designed to fit several types of research study. We offer them here for other groups to use and adapt to meet the specific needs of their protocols. The objective of preparing these templates was to support the varied needs of researchers conducting different types of clinical research studies. Key information and messages that do need to be strongly communicated change between different types of research study and different research settings. These templates aim to guide the investigator when they need to develop their own study specific information sheet and consent form. Each template should be carefully adapted for a protocol. In Kilifi these templates are intended for use with protocol specific standard operating procedures (SOP). These SOPs detail precisely how the information sheet and consent form are to be used and how it will be implemented. So, for example, SOPs typically contain details on who in the study team will be responsible for taking informed consent from the participants, how they will be trained and how the process of requesting consent will be overseen and monitored for quality and compliance to the SOP. Therefore we recommend that these templates are developed with a corresponding SOP and training plan. We would welcome feedback on these forms and also for any improvements and suggestions.
Download the resources from KEMRI, and some from other research programmes here:
Informed consent template - generic
Audiovisual recording of informed consent SOP
Informed consent template for clinical trials
Reviewing and obtaining informed consent SOP
Informed consent template for observational in-patient clinical trials
Informed consent template for interviewing research studies
Informed consent template sampling only
Monitoring informed consent checklist
Subject informed consent log template
AudioViual recording informed consent checklist
Informed Consent Sample only in household community
or visit Global Health Trials' extensive Templates Library to download more resources.
This article originally appears on the Global Health Trials resources. Please visit us for more resources relating to trials.
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Thanks to the team for helping me to do my senior project
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Merci et excellent travail, surtout beaucoup de courage car il en faut pour se lancer dans la recherche.
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Felicitaciones!
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Excelente trabajo para el personal de salud.
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Excelente trabajo de gran apoyo para lo Comités de Ética en Investigación. Gracias.
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Nice work for providing insights to clinical research
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Muito importante e informativo para nós que começamos a caminhada.
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Muchas gracias, por la información. Felicitaciones!!!!!
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an excellent module
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Muy Buenos modelos!!!
Excelente el recurso compartido
Los felicito!!! -
Muy bueno gracias
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excelente!!!
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Great Job team, very vital information
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See these samples to be of great help to me, as I am currently engaged into my Master in Public Health research
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A very good work done, keep it up.
But can you please have one example done (filled form) and underline the area that one needs to do changes interms of following the steps -
Congratulations for the wonderful work.
Keep it up with God help. -
Very useful,
Thank you very much -
this is a very useful information
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Congratulations,your work is very interesting.
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very useful files