Scoping available resources and tools

Scoping available resources and tools used by investigators to set up and conduct malaria clinical trials in low and middle income countries within malaria endemic settings. Participate in the survey.

To participate and complete the survey questionnaire follow this link: https://www.surveymonkey.co.uk/r/HWLJPCQ

1. What’s the study about?

As part of streamlining efforts towards improving quality of data from malaria clinical trials by supporting investigators in malaria endemic settings, the WorldWide Antimalarial Resistance Network (WWARN) has planned this survey to scope available tools and resources that are commonly utilised by investigators in low/middle income countries when setting up and conducting trials; and to evaluate the resource needs of malaria trialists in low and middle income countries. Findings from the study will help to inform development of a malaria clinical trials toolkit. This toolkit will therefore contain tools and resources that malaria investigators have highlighted (in this survey) as important.

2. What’s involved for me?

The study will involve completing an electronic questionnaire which should take 5-7 minutes. Details of your role within the research team that you work in, country where you work and the type of institution that you are currently based at, will be required. Depending on your post, the questionnaire will automatically direct you to the section relevant to your role. Specific information on the tools and resources that you use, the resources and tools that you use in designing clinical trials and any tools/resources that you are aware of will be asked. You will also be asked to provide information on how we should contact you if there is any need for clarification.

3. What will happen to my data?

Once you complete the relevant sections of the questionnaire and have submitted the form, your data will be securely extracted from the questionnaire by the researchers who are currently based in Oxford at the WWARN Secretariat. Only the investigators will have access to the data during the study. As soon as possible and in a practical way, your personal identifiers will be separated from the rest of the data. The data will be stored in a repository within WWARN and could potentially be used for further analyses and research.

Findings of this survey, including your contribution through your data, are mainly aimed at informing efforts within WWARN to streamline available tools into a toolkit that can help improve the quality of data from malaria clinical trials. The results will be presented at seminars within the Tropical Medicine Centre at University of Oxford, at other scientific conferences that are likely to be attended by scientists from low/middle income countries (this would be one way of providing feedback) and at seminars organised as part of training and engagement with the malaria community in low and middle income countries. The results will also be published in an open source scientific journal to help inform a wider community of research scientists on commonly available tools in low income settings and investigators’ needs.

Although every reasonable effort has been taken, confidentiality during actual internet communication procedures cannot be guaranteed

4. Are there any risks in taking part?

An apparent potential risk for your participation in the study is confidentiality, especially in an unlikely circumstance where de-identification of the data is not done before sharing it with other researchers. The study team will prevent this by de-identifying the data in the most practical way possible while maintaining the meaning/value of the data.

5. What are the benefits of taking part?

There are no direct benefits to you as a result of your time in completing the survey. However, there are wider benefits to the malaria science communication as the results of the study will potentially inform several efforts aimed at improving the experience of malaria clinical trialists in low/middle income countries by providing information on what is needed to help improve the quality of data.

6. Do I have to take part?

Your participation in this survey will greatly be valuable. At any point before completing the questionnaire or while completing it, you are very welcome to ask the investigators any questions you may have regarding the survey or particular questions by sending them an email. The choice to take part in the study rests with you and there will not be a penalty at any time should you decide to not take part or withdraw the information you have provided in this survey.

Should you decide to withdraw consent after you have submitted the questionnaire, or have consented to any part of the survey, you are encouraged to inform the Principal Investigator by sending an electronic mail(email). The Principal Investigator will respond to your request by confirming, through email, that your data and all submitted information will not be used in the analysis or shared. A copy of your responses will be attached to this confirmatory email (for your records). To maintain an audit trail, the already submitted data and your instruction to withdraw consent will be stored in a safe repository (separate from the rest of the data) until at least 3 years following publication/release of the data to the public. This is for audit trail purposes. Be assured that your data will not be used in anyway once you inform us of your intention to withdraw consent.

If the decision to withdraw is made before submitting the form, you can withdraw by closing the window of your browser, information will not be sent to us if you close your browser without submitting the form.

7. Has the study been reviewed by an ethics committee?

The study protocol was reviewed by the Oxford Tropical Research Ethics Committee.

8 What if I have any questions or want to raise a concern?

You are welcome to ask any questions regarding this survey at any point. Your questions can be directed to the Principal Investigator of this survey:

Dr Clifford George Banda

WorldWide Antimalarial Resistance Network

Centre for Tropical Medicine and Global Health

Nuffield Department of Medicine Nuffield Department of Medicine Research Building University of Oxford Old Road Campus, Roosevelt Drive Headington, OXFORD, OX3 7FZ

cgbanda [at] mlw [dot] mw or clifford [dot] banda [at] wwarn [dot] org

Further information can be obtained from the Secretariat of the Oxford Tropical Research Ethics Committee

To participate and complete the survey questionnaire follow this link: https://www.surveymonkey.co.uk/r/HWLJPCQ