Funder

The funder is the individual or organization providing the money for the research project. They should be listed on the protocol to make it clear if there are any competing interests. Any grant reference numbers are normally included on protocols.

Conflict of interest statement

All the investigators named in this initial section of the protocol should declare if they have any affiliations or involvement with any organization with any financial interests or non-financial interests in the research, for example if a researcher has shares in the organization funding the research, or if there are any professional or personal relationships with the sponsor or funder. They will not necessarily cause any problems with the project, but ethics boards and other people involved in the project have a right to know. If there is no known conflict of interest, you may write:

The investigators declare no known conflict of interest

Confidentiality statement

Many research protocols also contain a confidentiality statement. This makes it clear to anybody who might be reading the protocol that it is not for public discussion or dissemination or that it may include sensitive information. This can help to protect protocols in their early stages of development from being copied by other people. Confidentiality statements may take a form similar to this:

This document contains confidential information that must not be disclosed to anyone other than the sponsor, the investigator team, host organization, and members of the Research Ethics Committee, unless authorized to do so

Chief investigator signature

Once the protocol has been approved by those involved, the chief investigator should sign it and date it as confirmation of its high-level approval.

 
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