Ethical considerations

The consenting process was thorough and participants were allowed to seek clarification or withdraw at any stage during the study. The key areas considered in planning and conduct of the study are highlighted.

3.10.1 Risks

No procedures used in this study represented a significant risk to the participants. The nasal sampling could result in mild discomfort which was explained to each participant prior to collection. Suitably trained staff performed all study procedures, and these procedures were carefully explained in advance to the older children and adults. The frequency of home visits was discussed with the household head and all individual members so that a convenient schedule was agreed upon. The scheduling was flexible and would vary from week-to-week depending on participant’s availability.

3.10.2 Benefits

There were no direct benefits accruing from the frequent nasal/oral sampling and testing since there is no established treatment for viral respiratory infections. However, the participants may well have benefited from close monitoring for any illness by the study coordinator (a nurse) during the home visits and were referred to the study clinic promptly for treatment when necessary. All costs of treatment including drugs for acute illnesses incurred in Matsangoni dispensary were paid for by the project. Expenses for referral to KDH and costs of inpatient treatment were also incurred by the project. The community, in general, benefited from enhanced supply of drugs to the dispensary. The project supported the Ministry of Public Health and Sanitation in dealing with a cholera outbreak that occurred in the area during the study period. We provided vehicle for ease of referral of severe

‘suspected’ cholera cases to KDH and more substantially provided supplies used in cleaning and covering of open water wells. Other benefits to the study households were in form of reading books and pens to the school going children but our main efforts to promote

education in the area was through supply of text books and holding of career days in each of the six public primary and one secondary school in the area. In line with local culture we recognised the household involvement by offering a gift hamper at the end of the study. This was not planned for at the outset and the CAST (while planning on the household and community exit strategy) decided on the package. This consisted of household consumables

that would last an average family ( 8 members) about 1 - 2 days.

3.10.3 Data confidentiality

Data were stored on password-protected database, accessible only to study investigators and under close monitoring by the project manager. Data were archived by the Centre’s database administrator. Project manager created the analysis databases with all personal identifiers

removed from the main study database. All the source documents were stored in cabinets under lock and key.

3.10.4 Feedback o f information

The individual test results of the nasal and oral fluid samples were not conveyed to the participants for they were not likely to affect their health care. This was clearly explained during the consenting process. A feedback meeting was organised at the end of the study to share the major study experiences and results.

3.10.5 Scientific and ethical approval

The following scientific and ethical committees approved the project:

a) The Scientific Coordinating Committee (SCC) based in KWTRP, Centre for Geographic Medicine and Research - Coast (CGMRC) in Kilifi, Kenya, reviewed and approved the study proposal on 5th June 2009. The affiliated Communications and Consent Committee (CCC) had reviewed the ethical aspects of the study and recommended for approval prior to the SCC meeting.

b) KEMRI Scientific Steering Committee (SSC), based in KEMRI headquarters in Nairobi, Kenya, approved the scientific basis of the study on 30th June 2009. The registration number for the study is: SSC no. 1651.

c) National Ethical Review Committee (NERC), which is an independent Kenyan ethics board, approved the study on 16th September 2009. Ethical approval has been since renewed twice in accordance to the local ethics guidelines. The current approval has been granted until 12th August 2013.

d) Biomedical Research Ethical Sub-Committee, University of Warwick, UK. This

committee reviewed and approved the study on 8th September 2009.

All the study approval letters are provided in Appendix P

3.10.6 Consent forms and consenting process

Informed consent documents used in this study (Appendix G) were developed and submitted for approval to the consent review committees (see the above committees) as an appendix to the proposal. The consent forms were later translated from English to Kiswahili and

Kigiriama, which are languages used by the local community. The process of translation and

back translation was done jointly by the candidate and the experienced4 field workers, who

are from the local community and are fluent in both languages. The household study field workers (as they were commonly referred) also proof read and made the final corrections in consultation with the project manager and the final documents reviewed by the CLG, whose members form part of Centre’s Communication and Consent Committee. This final review was mainly to ensure the original message in the English consent forms was preserved during the translation process.

Informed consent was obtained from the household head and all members of the household only after adequate explanation of the study procedures. The study was also explained to those aged less than eighteen years (as appropriate) and their verbal assent obtained before a signed informed consent was obtained from their parents or guardian. Specific consent was sought for storage and later use of the samples.

4 Field workers who have been working in KDH paediatric wards particularly those who were involved in the conduct o f RSV surveillance studies since 2002