Certification for IRB Professionals (CIP) Practice Exam

For how long is an investigator required to keep consent documents and research records?

1. For a minimum of one year after the study

2. For a minimum of two years after the study

3. For a minimum of three years after the study

4. Indefinitely, as long as research is ongoing

The correct answer is: For a minimum of three years after the study

The requirement for investigators to keep consent documents and research records for a minimum of three years after the completion of the study is rooted in the federal regulations governing human subjects research. This time frame ensures that data is available for audits, oversight inspections, or any potential legal actions that may arise from the study's findings. The three-year period starts after the conclusion of the study, which encompasses the final analysis and the decision to cease any ongoing research activities. Maintaining records for this duration allows for accountability in the research process, supports the integrity of the research findings, and ensures that participant rights and data can be reviewed if needed. While some options suggest shorter durations or indefinite retention, the three-year minimum aligns with the established guidelines from regulatory bodies such as the Office for Human Research Protections (OHRP) and federal regulations under the Common Rule. This standardization helps ensure consistency across studies and institutions.