Who usually governs the authorship process in clinical research?

The authorship process in clinical research is typically governed by sponsor guidelines and Standard Operating Procedures (SOPs). In many clinical studies, the sponsors, often pharmaceutical or biotech companies, have specific guidelines that dictate how authorship is determined to ensure that contributions are appropriately recognized and ethical standards are maintained.

These guidelines are critical as they lay the groundwork for who qualifies for authorship based on their contributions to the study, encompassing aspects like data collection, analysis, writing, and critical revision of the manuscript. Adhering to these established SOPs helps prevent disputes and ensures transparency in the authorship process, aligning with ethical considerations outlined by organizations such as the International Committee of Medical Journal Editors (ICMJE).

While authors do play a role in determining authorship based on their contributions, it is the external standards set forth by sponsors that ultimately guide this process in a systematic and regulated manner. Thus, the correct choice reflects the structured approach necessary for ethical and fair authorship in clinical research.