The plan for gaining ethical approval also should be mapped out in the protocol. This may involve a national ethics committee or university or organizational approval. It should be listed which documents (e.g. participant information sheet, protocol, and consent form) will be submitted for review.
At the end of a study, two forms are often produced: one to close the study, reporting final participant figures and any deviations from the planned protocol; and an end of study report of the findings, which may instead take the form of research papers. This section usually outlines which documents are planned and confirms which bodies, such as ethics committees, will see them, for example: An ‘end of study’ notification and final report will be submitted to all parties involved
Participant confidentiality is important for the process of recruiting people to the study. Wherever possible, studies should be carried out anonymously and medical records should not be accessed. In addition, participants should be assigned identification numbers rather than their names being used. A common way this is conducted is through linked-anonymized data, whereby participants are assigned identification codes which are used for all their data provided during the study and a separate database exists linking their name to their identification code. If the link needs to be broken and participants need to be informed about results, this can be done. This, and other methods for protecting participant confidentiality are discussed further in Chapter 12. These processes should be explained in this section, including who will have access to the linking database, in what circumstances the links will be broken, and when this database will be destroyed after the study. Documents should be stored securely and these secure processes (such as locked cabinets, password-protected computers, and authorized personnel only) should be outlined. If the study requires participants’ medical records or involves sensitive information, safeguards for these data should be carefully explained, and this information should be clearly stated to participants before they give consent to take part.