What Constitutes Research?
Research is defined as a "systematic investigation, including research development, testing, and evaluation. It is designed to develop or contribute to generalized knowledge, or a clinical investigation."
What is a Federal-wide Assurance?
The Federal-wide Assurance (FWA) is an agreement between Creighton University and the U.S. Department of Health and Human Services' Office of Human Research Protections (OHRP) that assures that Creighton University will follow OHRP and FDA regulations regarding human subjects research. Creighton University adheres to the assurance prescribed in its Federal-wide Assurance (FWA) FWA00001078. For more information about Creighton University's FWA, see IRB Policy 104, "Federal-wide Assurance/IRB Registration."
What does the Creighton University Institutional Review Board do?
The two Creighton University IRBs have sole authority to review, approve, disapprove, or require changes in research or related activities involving human subject research conducted by Creighton University Investigators and other institutions that designate review of their research to these IRBs. Creighton University has two IRBs of record registered with the Office for Human Research Protections (OHRP): Biomedical Board IRB00000155 and Social Behavioral Board TIRB20067. The Creighton University Institutional Review Board is duly constituted (fulfilling OHRP and FDA requirements for diversity), allows only those IRB members who are independent of the Investigator and the sponsor of the trial to vote/provide opinion on the trial, has written procedures for initial and continuing review of clinical trials; prepares written minutes of convened meetings, and retains records pertaining to the review and approval processes. Creighton University's IRB policies and procedures are based on federal regulations published by the U.S. Department of Health and Human Services (DHHS) Office for Human Research Protection and the U.S Food and Drug Administration.
What does "being exempt" mean?
The IRB is not required to apply all of the Codes of Federal Regulations to certain research projects. There are six specific categories of exempt research. See IRB Policy 114, "Exempt Research," for more information. The IRB at Creighton University must review this type of research.
How is the safety of research participants monitored?
When reviewing research that is more than minimal risk, the IRB is responsible to determine that the protocol includes adequate provisions for monitoring the data collected to ensure the safety of the humans enrolled. For more information, see IRB Policy 132, "Data and Safety Monitoring Plans."
Who is the responsible Institutional Official?
The responsible Institutional Official for Creighton University is the Associate Vice Provost for Research & Scholarship. He is responsible for ensuring the independence of the IRBs and their support and standing within the Institution.
Who is responsible for implementing the HRPP?
The Director of Research & Compliance is responsible for 1) implementation of the policies that govern research; 2) review and evaluation of reports and results of compliance assessment and quality improvement activities; 3) implementation of needed improvements and follow-up on actions as appropriate; and 4) monitoring changes in federal and state regulations and policies that relate to human research protections.
What is a conflict of interest?
A conflict of interest exists when commitments or obligations to Creighton University are likely to be compromised by a person's other interests or commitments, especially financial. This includes:
- an existing or potential financial interest that may affect or appear to affect the individual's independent judgment while performing his or her duties for Creighton University;
- an existing or potential non-financial interest that may affect or appear to affect the individual's independent judgment while performing his or her duties for Creighton University;
- receiving or the possibility of receiving a material, financial, or other benefit from knowledge of confidential or proprietary Creighton University information.
The Creighton University's Conflict of Interest Committee (CIRC) reviews annual Investigator disclosures and decides whether a conflict of interest exists. The CIRC will prepare a resolution plan to manage, reduce or eliminate any identified conflict of interest before the research can proceed. If the project involves human subject research, the IRB may impose additional requirements before granting IRB approval.
All conflicts of interest should be reported to the Research Compliance Office and the IRB Office.
What is the Quality Assurance Program?
The Research Compliance Quality Assurance Program is a component of Creighton University's Research Compliance Program. The purpose of the Research Compliance Quality Assurance Program is to benefit and support the research programs at Creighton University involving human subjects and animals to 1) Achieve quality, performance, and efficiency; 2) Ensure compliance with University Polices and federal laws and regulations; and 3) Identify education/training initiatives for Investigators, their research staff, and others.
What training is required before conducting human subjects research?
Creighton University requires that all individuals working with human subjects in research complete an educational program in the protection of human subjects. Creighton University has developed the Human Subjects Research Education Program to assist Investigators and staff in meeting federal regulations and University education requirements. The Human Subjects Research Education Program includes initial certification as well as ongoing education and recertification.
If you are an investigator or a member of research staff and have questions, would like to express concerns, or offer suggestions about any aspect of the Creighton University Human Research Protection Program, please contact the IRB Office at 402-280-2126 or by email at IRB@creighton.edu.
Confidential Research Hotline (402-280-3200)
Research Personnel are expected to report any known or suspected noncompliant conduct related to research or sponsored program activities conducted and/or approved through Creighton University. The confidential Research Compliance Hotline (402-280-3200) is available for any individual who wishes to remain anonymous and/or has found other available reporting mechanisms to be ineffective. Research Personnel may also address their research compliance-related questions or concerns to the Director of Research & Compliance at 402-280-2511.