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 Principal Investigators to abide by these principles as well.

It is the responsibility of the Principal Investigator to:

• Follow any federal, as well as any applicable state and local laws governing research and the consent process.
• Provide any safety information to IntegReview, which may help to provide additional protections for research participant’s safety and well-being.
• Respond to research participants complaints or requests for information in a timely manner.
• Ensure that research participants are provided adequate time with study personnel to address questions during the consent process.
• Ensure that the informed consent process is free from coercion or undue influence.
• Ensure that procedures are in place to guarantee that consent has been voluntarily obtained and properly documented.
• Establish an informed consent process and method of documentation appropriate to the type of research and the study population, concentrating on the importance of participant comprehension and voluntary participation.
• Ensure that additional safeguards are in place to protect any vulnerable populations involved in research.
• Ensure procedures are used to maintain the confidentiality of the research data.
• Ensure the privacy of research participants is protected.
• Understand the importance of the plan for monitoring data for the safety of participants, and comply with that plan.
• Notify IntegReview upon learning that a research participant has become incarcerated while participating in a research study. Also, all research interactions and involvement with, as well as obtaining identifiable private information about the incarcerated participant, must stop until the requirements of Title 21, CFR 45, Part 46, Subpart C have been fulfilled.
• Consider, disclose, and manage conflicts of interests that might affect the relationship with the research participant or the outcome of the research.
• Commit enough time and personnel to adequately conduct the study in a way that will protect the rights and welfare of research subjects and to have adequate space and appropriate equipment to conduct this research 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.