The Institutional Review Board and You: An Interview with UNL's Research Compliance Staff

The safety and well being of human research participants is taken very seriously at UNL. The Institutional Review Board, which is overseen by UNL’s Office of Research, handles approval of human research. From providing a Collaborative Institutional Training Initiative (CITI) course to maintaining knowledge of all federal, state and local regulations related to research, the IRB provides necessary support to UNL’s research community. To better understand the purpose of the IRB, we sat down with Dan Vasgird, director of the Office of Research Compliance Services, and Becky Freeman, IRB and Research Compliance Manager, and asked them a few questions.

Could you tell me about what the IRB does for the university?

Dan: The IRB reviews all research projects involving human participants. The mission of the HRPP [human research protections program] is to ensure the protection of humans who choose to participate in research conducted by investigators at UNL and its affiliates. IRB members and staff keep abreast of the latest developments in the ethics and regulation of human participant research and perform thorough and consistent review of research proposals.

What is expected of UNL investigators?

Becky: Investigators are expected to conduct research with the highest degree of thought, technical skill, and care. It is important that investigators adhere to high standards of research ethics, comply with all applicable federal, state, and local laws and regulations, and always consider the rights and welfare of research participants.

Why is this important to research?

Dan: We need to ensure that research conducted at UNL is quality research, carried out with scientific integrity and in an ethical manner. We also need to insure that investigators respect all individuals and groups served by UNL. The IRB makes sure investigators follow federal, state and local regulations for research involving human participants. If the laws are not followed, research at UNL could be halted.

What happens when investigators violate IRB policies?

Dan: Violations of IRB policies are classified as noncompliance, which is defined as the failure to comply with federal regulations and/or IRB  requirements. Noncompliance is assessed by the IRB as non-serious, serious or continuing.

Non-serious noncompliance might be a one-time failure by a researcher to sign and date the informed consent form. Serious noncompliance could be
exemplified by failure to have the participant sign the consent form or conducting a study after IRB approval expiration. Continuing noncompliance is defined as a pattern of noncompliance. A finding of serious and/or continuing noncompliance could lead to consequences such as suspension or termination of the study; suspension of all of the principal investigator’s studies pending the completion of an audit; or a recommendation to the Institutional Official that the principal investigator’s privilege to conduct research be suspended for a specific period of time or terminated. There are other actions that could be taken depending on the noncompliance issue.

If the research is conducted without IRB approval, it is possible they would have to turn over their data and not be allowed to use any of it. They would have to start their research over which could significantly delay the student's graduation.

What is the relationship between NUgrant and IRB?

Becky: NUgrant is the electronic system that is used to route proposals, submit IRB applications and Disclosure of Interest forms and will be expanded to include applications for research using animals and patents. For IRB matters, the protocol submission and review process is completed via NUgrant. This includes new applications, requests for changes, continuing reviews, and final reports. NUgrant has enabled the Office of Research Responsibility to respond to investigators submitting projects to the IRB in a much more timely and efficient manner.

Who benefits from the training available through IRB? Is it mandatory for investigators on campus?

Becky: CITI training allows UNL to conduct research at a high ethical standard. It is mandatory for all principal investigators, supervising investigators, and key project personnel. This could include undergraduate students, graduate students, faculty, staff, and people not affiliated with UNL. Most people will need to complete the CITI Basic Course for Investigators and Key Personnel. The training provides investigators and key personnel with a background in conducting ethical research and how to protect study participants. The project personnel, the participants, and UNL all benefit from the training.

Your Web site provides an easy to follow flow chart of when students would need an IRB review. What should investigators do when they have additional questions about your services?

Dan: All investigators should contact the office if they have questions. Our main office phone number is 472-6965. They may also send an email to the Human Research Protections Program staff. The names and contact information are listed at http://research.unl.edu/orr/staff.shtml.