| Individually developed ICFs that miss vital information, inconsistency between ICFs from similar studies, lack of input from social science research, poor translation. |
Formation of a centralised consenting support and review structure.Development of contextualized templates for different categories of studies and their translations. |
| Failure to take context adequately into account, e.g., participants' health worries. |
Requirement of an SOP for the consenting process that takes account of context. |
| Length and structure of ICF undermines understanding key messages of study, particularly among the poorly literate who often form the majority of participants. |
CCC reviews each new ICF and suggests ways of keeping it short and simple while fulfilling all the regulatory requirements. For example, complexity is often reduced by presenting multiple procedures in a bulleted list rather than in continuous prose. |
| Difficulty in differentiating between research interventions and standard care (therapeutic misconceptions).Confusion between routine diagnostic samples and research samples with linked expectation that results will always be returned because of their assumed implications for the health of the individual providing sample. |
ICF begins with brief information about nature of research in general, the research institution, and its relationship to the District Hospital, followed by brief explanation of health condition affecting the participant, and the standard care for that condition, before delving into details of the proposed study.A statement on whether or not the study result will have direct implication on decisions for care of current illness and or the participants' health in general is inserted into the ICF. |
| Difficulty in communicating unfamiliar research concepts, e.g., randomization and controls, placebo, standard versus test intervention. |
Development of simpler terminology through discussions with researchers, field staff, and community liaison group. In addition, supplementary information for clarification where needed is provided alongside the ICF.Examples of terminology simplification:
Randomisation is a difficult concept to translate, since most translations of “chance” also imply “luck”, and are considered non-neutral. Eventually the phrase “ a sytem such that everyone has the same chance of being included in the study, without favouritism” was adopted. Confidentiality: Kiswahili word “siri” or “secret” had been in common use, but found to have negative connotations in community as well as being inaccurate. Instead the phrase “a limited number of people closely concerned with the research”, was adopted. Standard versus test intervention—“standard” is explained as the “ treatment recommended by the Ministry of Health”.
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| Confusion between reimbursements/compensations and benefits. In poor settings, even bus fare given for follow-up or surveillance visits could be seen as a benefit since it is possible to make a saving on it, e.g., by walking part of the journey. |
Compensation/reimbursements included under risks/costs, rather than under benefits, to emphasise their nature, e.g., “You will be asked to come back to the clinic after one month, which will take your time, but the costs of travelling will be refunded”. |
| Difficulty in understanding the level of risk—e.g., how much blood can be withdrawn safely, particularly from an already sick child.Anxiety over adverse events and what would happen if they occur. |
Find simpler ways of explaining risk, e.g., for blood samples, explaining sample volumes in locally understandable terms (teaspoons, bottle tops) as well as milliliters.Clear explanation on what safety monitoring structures are in place, e.g., “Your child will be continuously monitored by a doctor who may withdraw her from the study in case of any adverse events”. |
| Concerns over what will happen to samples, particularly with respect to storage and exportation. |
Explicit disclosure of all planned exportation and storage with separate consent being requested for each action.“A part of the sample will sent to labs in Oxford university in the UK for test x”.Statement on the fact the any future research on stored sample must first be approved by national ERC. |
