The practices on informed consent among research stakeholders (PICS Study)
Dear participant,
My name is Charles Okwii, I am carrying out research on the practices on informed consent among research stakeholders. Informed consent has been studied for a long period of time; however, there is no consensus on a number of things including length, details, timing and contents of an informed consent. Most published data is on the minimum content that every informed consent must have, but data remains scanty on whether all research stakeholders agree on the contents and practices on informed consent. The details have been left to researchers to fill in. In this study we would like to assess practices on informed consent among research stakeholders to understand the content, practice and the use of informed consent commonly practiced currently. You are kindly requested to participate in this study by giving in your response. Your responses are completely anonymised by the online survey and none of your identifier information will be made public. In addition, even the information you supply will be used for this research purposes only. If you choose to participate you will be asked to fill in this questionnaire containing questions regarding the practices on informed consent, it will take you about 5 – 15 minutes to finish depending on your speed. Your participation in this exercise is voluntary, there will be no direct benefits given to you for participating, but the information will be used to identify areas of strengths and weaknesses so as to improve the entire practice on informed consent. If you change your mind at this stage and decide you would not like to participate it will not affect you in any way. This study has been reviewed and cleared by the Mbale Regional Referral Hospital Research and Ethics Committee (MRRH-REC). In case you would like the ask anything from this regulatory authority, you may contact the Chairman, JSO Obbo on Tel. +256 772 437 407 or email: mrrhrec@gmail.com.
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1. What is your gender?
2. What is your age bracket?
3. What is your highest education status?
4. What is your occupation status?
5. What is your category of work (select only the most applicable one)?
6. Which of the following would you want included in the consent form in order to provide the participants with a quick impression of what the study is all about?
7. By signing the consent form, the participant will have agreed to participate in the study that they are being recruited into.
8. The Informed consent form should state the main reason(s) as to why the research is being done?
9. In the informed consent, the study duration should be indicated.
10. The entire procedures that the participants are expected to undergo if they choose to be part of the study should be included.
11. The benefits and none benefits for participation should be indicated in the consent form.
12. The participant’s privilege to withdraw from the study at any time during the study should be indicated in the consent form
13. In a medical emergency, consent should be deferred and a such a patient should not be recruited until is stable
14. The researcher should spend adquate time explaining the research procedure before consenting the participant. How much time on average do you recommend for the initial consent?
15. Participants should be given adequate time to understand and think about the study before they can consent
16. The use of illustrations (pictures and video clips) rather than only written information is a better way of transmitting information about research to the study participants.
17. Designated person(s) / investigators / researchers and their contacts should be indicated in the consent form to enable participants who have questions to seek further information
18. Informed consent form should provide information and contacts of the institutions, which approved this study, and emphasizing participants right to contact them at will.
19. Participants should be provided with the choice to decline to sign the consent form without being segregated against?
20. Local language must be used in consenting
21. Participants should be made aware that by participating in a given research, it’s possible that the study sponsors, various government agencies or others who are not directly involved with the study could review the information obtained from them.
22. The consent form used in the study should contain a description of who is responsible for the participant’s treatment incase they get injured or become ill as a result of participating in the research?
23. Do the researchers required to seek for further permission from the Host institution after IRB Approval?
24. Informed consent should describe the foreseeable risk associated with participation in the study.
Thank you for participating in this survey!
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