This blog is closed to new posts due to inactivity. The post remains here as part of the network’s archive of useful research information. We hope you'll join the conversation by posting to an open topic or starting a new one.
International guidance and regulation on research ethics is detailed and inconsistent when it comes to information that must be provided to research participants during recruitment (see the OHRP Compilation at for links to over 1100 guidelines and regulations).  Some guidelines, such as the Declaration of Helsinki, mention a small number of general topics to be covered, other guidelines product more detailed lists of over 25 items to be included in consent forms. Topics that are consistently mentioned as being necessary to inform participants of are the purpose of the trial, research procedures, methods and duration, risks, benefits, right to to decline without penalty, right to withdraw at any time without reason, treatment  and compensation available if harm occurs, and confidentiality.
Determining what information should be provided during a consent process for a specific study is obviously not  be a ‘one size fits all’ approach. While it is necessary to tailor consent processes to specific studies and contexts, and this is recognised in the relevant guidance, the guidance does not provide detailed advice about how best to do so. Some forms of national guidance on research ethics listed in the OHRP Compilation provide some further details about the appropriate tailoring of consent processes in national contexts. Additional useful sources of information include ethics committee websites, see Further resources are produced by research teams such as The Communication and Consent Committee, KEMRI Wellcome Trust Research programme, Kilifi, Kenya, which has produced templates for five kinds of studies, clinical trials, in-patient clinical trials, interview studies, community based sampling and medical facility based sampling  - see
Determining what information should be provided to research participants may not be an easy thing to do in practice. The experience of those who have previously conducted similar studies in similar settings can be very valuable.  Additionally, some of the issues that it may be important to inform participants of may be difficult to identify prior to research and only become apparent once recruitment begins – requiring researchers and reviewers to be prepared for adaptions of the consent processes as appropriate.
Concerns have been raised in the literature that ethics committees spend a disproportionate amount of time reviewing documentation for consent processes, when compared to other ethical issues needing to be addressed.   During review significant amounts of attention may be placed on the precise wording of forms that will undergo translation when the consent process begins. Committees may also request back-translation to confirm that meaning is appropriately preserved ( In other cases committees may raise concerns about issues about consent documentation including the use of complicated and technical language, missing information about important aspects of the study or imbalanced information about risks and benefits of research.  Committees may also be asked to review consent processes that have been originally designed for use in foreign contexts and have not been amended for use in the local context.
Review committees have the challenging task of ensuring that the information provided during consent processes is appropriately tailored to the research context while ensuring that fundamental categories of information about a study, as outlined above, are explained appropriately.  As well as considering the wording of information sheets and consent forms, it may be equally important  to consider how the consent process was designed, the ways in which information will be provided and to whom during the recruitment process, and how consent processes will adapt, if necessary, once recruitment begins.