|Old framework||New framework|
|1) Involve the study community in establishing appropriate recruitment procedures and incentives for the participants.||
(2.2) What are your plans for obtaining consent?
A requirement to inform participants is often seen as being an important way to show respect and promote patient autonomy and welfare.
|2) Ensure that consent procedures are acceptable within the study community (may include supplementary community and familial consent procedures).|
|a. What information ought to be provided? This will usually include the following elements: the reasons for doing research, details about who is doing the research, why the potential participant is being asked to be involved, details about what any intervention might involve and any on-going commitments of participation, details about anticipated risks and benefits, the fact that participants are free to refuse or withdraw, that any findings will be communicated back to the participants etc. The information given should be proportionate to any risks, but this does not mean that the higher the risk, the more information ought to be provided. Sometimes, calling attention clearly to a common or significant particular risk is more important than listing every possible remote risk.|
|3) Disclose information in culturally and linguistically appropriate formats. This implies that|
|• any information given during the informed consent process must be pretested with people of a similar cultural and educational background as potential study participants;|
|• the information provided on the consent form must be in simple language, avoiding technical terms;||b. Providing information does not guarantee it has been understood. How can information be provided at an appropriate linguistic level, without jargon or technical terms, and appropriate to the local language and culture?|
|• the consent form must be translated into the local language and then back-translated into the “international” language used to get a sense of the accuracy of the translation and correct mistakes;||c. Should information be provided in oral and/or written form?|
|4) Ensure that participants fully comprehend the research objectives and procedures:||d. How will the consent process be conducted? You may want to consider issues such as: who will consent, where they will do so (is the place appropriate to allow a confidential discussion), will a witness to the consent be required, how much time will be offered to consider whether to be involved? Prior engagement with communities can be a useful way to ensure that the consent process meets local expectations and sensitivities. How will the act of consent be recorded (e.g. signed and witnessed document, thumb print etc.)?|
|• if needed, the person should get time to discuss the information received with members of the community or family before deciding on consent;||e. Alternative or additional consent procedures may need to be developed where potential participants are minors, minor parents, or suffering from short or long-term incapacities etc.|
|• in addition, community information or “schooling” on the research to be done and on the purpose and process of seeking informed consent will raise pre-enrolment awareness and thus help people to decide if they want to participate in the study.||f. It should not be assumed that a long and complicated information sheet is always necessary and in exceptional cases it may be justifiable not to seek informed consent. Where researchers believe that this is appropriate, they should be careful to providereasons for this in the protocol.|
|5) Obtain consent in culturally and linguistically appropriate formats.|
|6) Ensure that potential participants are free to refuse or withdraw from the research at any stage without penalty..|