The ethical principles employed by IntegReview that govern the conduct of human research are those identified in the Belmont Report; respect for persons, beneficence and justice. IntegReview expects Sponsors to abide by these principles as well.

It is the responsibility of the Sponsor/Project Manager to:

• Follow any federal, as well as any applicable state and local laws governing research
• Provide any safety information to IntegReview, which may help to provide additional protections for research participant’s safety and well-being.
• Ensure procedures are used to maintain the confidentiality of the research data.
• Ensure the privacy of research participants is protected.
• Incorporate plans to monitor the data collected for the safety of research participants. Monitoring might occur at specific points in time, after specific numbers of participants have been recruited, or upon recognition of harms.
• Report findings detected in the monitoring process when those findings could affect the safety of participants or their willingness to continue participation, influence the conduct of the study, or alter IntegReview's approval to continue the study.
• When an IND or IDE is required, one of the following must be provided to the IRB as documentation of the IND or IDE number:
1. Approval letter from the FDA indicating the IND or IDE number
2. Letter from the sponsor indicating the IND or IDE number
3. Sponsor protocol indicating the IND or IDE number

You may obtain answers to questions, express concerns, and convey suggestions regarding IntegReview’s Human Research Protection Program (HRPP) via e-mail to or by dialing (512) 326-3001, extension 207.

We welcome you to complete IntegReview’s Customer Survey to offer suggestions or to voice any concerns regarding our processes or services. Customer surveys that reflect concerns will be reviewed by IntegReview’s Quality Systems Manager.