What Projects Should be Reviewed by the IRB?

When faculty, staff, and students at the University conduct projects involving collecting data from or about people — say by administering surveys, observing people's actions on or off campus, or interviewing — they need to arrange to have these projects screened by the University's Institutional Review Board (URIRB) before they begin them. Questions to consider include:

  1. Is this project's purpose educational rather than research-focused? The IRB has determined that instructional activities that involve interviews, surveys, and so on require limited review by the IRB to determine if they meet the federal standard of "research." Therefore, instructors conducting class projects are asked to contact the IRB at IRB@richmond.edu and provide relevant details so that we can make a determination regarding the projects’ status as "teaching activity" or "scientific research." See the "Educational Projects" link for more information about registering educational projects with the IRB.
  2. Is this project research? 45 CFR 46 defines research as follows: "Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge." For example, program evaluations, the development of surveys for internal purposes, and commercial research activities not designed to yield scientific findings are not considered to be science so the IRB has no jurisdiction. However, the IRB has determined that such projects require limited review by the IRB to determine if they meet the federal standard of "research." For more information about registering such projects with the IRB see the "Excluded Projects" link.
  3. Is a faculty or staff member or student at the University of Richmond "engaged" in the research project? Engagement, as defined by 45 CFR 46, involves interaction with participants (including carrying out the consent process) and/or access to identifiable information about participants. If, for example, you are asked by someone outside of the University to send a survey to employees, and you do not interact with the subjects (including consenting them), then UR is not directly engaged in the research (see http://www.hhs.gov/ohrp/policy/engage08.html). In such a case, UR would not be the IRB of Record and would not be the governing body with respect to ethical conduct of research. (Note that this determination does not, in any way, sanction the sharing of confidential information about UR students or employees with external individuals or organizations. The IRB does not monitor compliance with HIPAA regulations or University policies pertaining to data-sharing/disclosure.)
  4. Has the project already been reviewed by a different IRB? For some multisite studies, one organization's IRB is identified as the IRB of Record, and other organizations taking part in the research do not need to review the work. That process, however, requires a formal IRB Authorization Agreement (IAA). If no IAA is in place, only the University of Richmond can sanction human research conducted by faculty, staff, and students.
  5. Does the project involve "human subjects?" The federal code of regulations that governs research with people (45 CFR 46) defines a human subject as a living individual the researcher studies by collecting identifiable, private information, often (but not always) through intervention or interaction with the individual
  6. Is this project research involving human participants? If the project involves studying living human beings by collecting identifiable, private information about them through some type of intervention or interaction (including administering surveys online, observation, interview, accessing private records, and so on), review by the IRB is required.

Individuals seeking additional information about this determination should contact the IRB by email.