Ethics and Human Research Protection

Financial Conflict of Interest

Our Financial Conflict of Interest policy helps ensure that RTI personnel avoid situations in which personal interests may affect, or have the appearance of affecting, their professional judgment in exercising their duties or responsibilities, or in conducting or reporting research. This policy provides guidance to help personnel manage situations in their personal affairs, employment outside RTI, and financial activities that may appear to conflict with their responsibilities to RTI and our clients. RTI personnel should promptly disclose the circumstances of any situation that might be covered by this policy. For the purpose of this policy, “RTI personnel” is defined to include RTI governors, officers, and employees. Failure to comply with this policy and associated procedures may result in disciplinary action, up to and including termination of employment with RTI. RTI contractors are required to provide evidence that they comply with their own policy. If a contractor does not have a policy in place, RTI provides training and reviews as needed.

Investigators should complete the required FCOI training and complete and submit the SFI Disclosure Form.

Human Research Protection

RTI is committed to protecting the rights, welfare, and privacy of individuals who participate in our research studies, as well as the confidentiality of biologic sample and other data collected during these studies.

Our approach to protecting human subjects is guided by the ethical principles and guidelines outlined in the Belmont Report: respect for persons, beneficence, and justice. The RTI Office of Research Protection maintains three in-house Institutional Review Boards (IRBs) with relevant and required expertise, which meet regularly. We also have broad experience in collaborating with other institutions and interacting with their IRBs.

RTI maintains a Federalwide Assurance (FWA No. 3331) from the Department of Health and Human Services’ Office for Human Research Protections (OHRP) for the protection of human subjects in research. Pursuant to the FWA, federally funded human subjects research should conform to 45 CFR 46 and any other applicable guidance documents. In addition, RTI complies as needed with specific federal regulations and policies of other agencies. These include, but are not limited to, the Food and Drug Administration, Department of Defense, Department of Navy, National Science Foundation, Public Health Service, Environmental Protection Agency, Department of Education, Department of Energy, and Department of Justice. Our IRB committees are also registered with OHRP for research regulated by the Department of Health and Human Services and the Food and Drug Administration.

The RTI IRBs are responsible for ensuring that the rights of research participants are protected and that studies conducted by our researchers comply with applicable federal regulations governing research with human subjects. This includes fully informing research subjects of the risks and benefits of participation, and obtaining legally effective, informed consent from subjects prior to their participation and documenting consent in accordance with applicable regulations.

Our Office of Research Protection requires that designated RTI researchers, as well as all IRB members and IRB staff, complete the Collaborative Institutional Training Initiative's web-based training on the protection of human research subjects.

Questions about a Study or Your Rights as a Research Participant

If you have been contacted to participate in a study and have questions, please contact the study’s research team. Contact information is included in the invitation or request to participate in the study.

If you have any questions about your rights as a study participant, contact our Office of Research Protection at 1 866 214 2043 or email us.

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