Institutional Review Board (IRB)

What is an Institutional Review Board (IRB)?

An Institutional Review Board (IRB) is an administrative body charged with the protection of the rights, safety, and welfare of human subjects in research. The IRB is charged with the responsibility of reviewing and approving, prior to its initiation and thereafter on an ongoing basis, all research (whether funded or not) involving human participants. The IRB has the authority to approve, disapprove, monitor, suspend, terminate, and/or require modifications to all human subjects research activities that fall within its jurisdiction under the federal research regulations and institutional policy.
 
Institutional Review Boards are charged with ensuring that:

  • Research is conducted according to well-designed protocols likely to advance scientific knowledge
  • The participation of human subjects in research is voluntary and complies with the statutory requirements for informed consent
  • Risks to study subjects are minimized and outweighed by potential benefits to subjects and/or society

Fee Schedule & Policies and Procedures

Creighton University Institutional Review Boards

Creighton University IRB (CU IRB) is responsible for all human subjects research conducted by CU faculty or students or occurring on a CU campus. CU IRB has two review boards, a Biomedical IRB (IRB-01) and a Social and Behavioral IRB (IRB-02). Creighton’s IRBs operate under Federal Wide Assurance (FWA) FWA00001078. A Federal Wide Assurance is an assurance of compliance provided from an institution to the federal government, attesting that the institution will abide by the federal human subjects research regulations.

Members are appointed to the CU IRBs by the CU Institutional Official, Julie Strauss-Soukup, PhD.

Submitting a Research Application to the IRB

The CU IRB uses InfoEd, an electronic submission system, for all IRB submissions. Before you can submit a protocol to the IRB using InfoEd you will need to set up an InfoEd profile. If you do not have an InfoEd profile, please contact Rosa Seiffert at RosaSeiffert@creighton.edu or 402.280.3074 for assistance. In preparation for setting up your InfoEd account and profile please have ready your CU NetID, a copy of your current signed and dated resume or CV in PDF format, and a copy of your current professional license if you are a professional license holder. For additional information, please see the IRB Instructions page for information on how to access and submit through InfoEd.

Submitting Adverse Reports

Submitting Reports of Adverse Events, Unanticipated Problems, Research Study Complaints or Noncompliance to the IRB?

Reports of adverse events, unanticipated problems to subjects or others (UAPs), research study complaints, and/or noncompliance must be timely submitted to the IRB using the Reportable New Information eForm in Info Ed. Information on investigator reporting deadlines are included in the PDF document.

External (Non-CU) Investigators

External (Non-CU) Investigators Studying Creighton University Faculty, Staff, Learners, Programs, or Resources.
If you would like to conduct research involving Creighton University faculty, staff, learners, programs or resources please fill out this research form.

I have an IRB question. Who should I contact?

For InfoEd related questions, please contact Rosa Seiffert at RosaSeiffert@creighton.edu or 402.280.3074 for assistance.
For IRB submission status questions or for help with your submission, please contact an IRB analyst after reading about standard IRB turnaround times, below. Our IRB analysts are:

For IRB policy questions, contact IRB Director Kindra Cooper at KindraCooper@creighton.edu or 402.280.3208.

Standard IRB Turnaround Times

Announcement

Beginning in February 2024, the Social/Behavioral IRB meetings will now be held on the third Wednesday of the month at 9:30 a.m. Please see the updated IRB meeting schedule below for meeting dates and submission deadlines.  

The IRB aims to complete its initial review of complete IRB submissions (no missing documents or information) consistent with or faster than median turnaround times for Association for the Accreditation of Human Research Protections (AAHRPP) accredited programs, which are listed below.
 
While we endeavor to complete our review well ahead of these expected turnaround times, a faster review will not always be possible. Therefore, we encourage investigators to be aware of anticipated turnaround times and to communicate with the IRB office if priority review is requested to meet deadlines associated with a grant application, course requirements, etc. Please note that priority review is never guaranteed.
 
In addition, anticipated turnaround times apply to complete submissions only. If your submission is missing required information or requires revision it will be returned to you with comments via the InfoEd platform. In these cases, turnaround time calculations begin once your complete/revised submission has been successfully returned to the IRB. During periods of the academic year when the IRB is reviewing a higher-than-average volume of submissions, the IRB will post a notice about expected turnaround times to this website. If you believe that your submission is not adhering to the turnaround times below, please contact the IRB at irb@creighton.edu or 402.280.2126.

Initial Applications (Quality Improvement (QI), Not Human Subjects Research (NHSR), or Exempt submissions) 

Within 12 business days.

Initial Applications (Expedited Studies)

Within 17 business days.

Initial Application (Full Board Greater than Minimal Risk Studies) 

Are due to the IRB two weeks prior to the dates of the next convened IRB meeting. The IRB meeting schedule and information on full Board submission deadlines can be located here. Protocols received within one week prior to the next meeting may be added to the meeting agenda at the discretion of the IRB Director and IRB Chair. Protocols received with less than one week prior to the meeting agenda will be added to the meeting agenda for the following month. Please understand that compliance with the human research regulations requires that Board members have adequate time to read and evaluate submissions prior to the date of the convened meeting.

Modifications (NOT REQUIRING Scientific Review) 

Within 5 business days.

Modifications (REQURING Scientific Review) 

Within 12 business days.

  • This includes submissions with revised investigators brochures or other updated drug or device information, revisions to biomedical protocols that may increase risks to subjects or others.

Reportable New Information (Subject Death, Hospitalization, or Other Serious Adverse Events (SAEs))

Within 48 hours.

Reportable New Information (Other)

Within 5 business days UNLESS the RNI submission is limited to a single site visit monitoring report, in which case the report must be submitted within 30 days.

Closure (Routine Study Closeout)

Within 5 business days.

Continuing Review (Expedited Studies subject to FDA regulation ONLY)

Within 7 business days.

Continuing Review (Full Board Greater than Minimal Risk Studies): Are due to the IRB office no later than 30 days prior to the date of expiration for the IRB protocol to ensure that continuing reviews can be added to the next regularly scheduled IRB meeting. Late-submitted requests for continuing review may lead to a lapse in IRB approval. If IRB approval is permitted to lapse, no study activities other than those necessary to protect the rights, safety, and welfare of subjects will be allowed to continue and study enrollment must be stopped until IRB approval has been restored.

IRB Office Contact Information
Location: Dr. C.C. and Mabel L. Criss Health Sciences Complex I, Room 133
Phone: 402-280-2126
Fax: 402-280-4766
Email: IRB@creighton.edu

IRB Meeting Schedule

The Institutional Review Boards at Creighton University convene on a regular basis to review research involving human subjects.

The Biomedical Institutional Review Board and Social Behavioral Institutional Review Board meet in the Research and Compliance Conference Room, Criss 1, Room 111. IRB members and investigators attending CU IRB meetings may choose to attend either in person or via Zoom.

Questions regarding IRB meeting schedules, submission deadlines, or meeting attendance via Zoom should be directed to the IRB Office at 402-280-2126 or via email at IRB@creighton.edu.

Kindra L. Cooper, JD, MPA, MA, CIP
IRB Director
Office: Criss I, Room 133
Phone: 402-280-3208
Email: kindracooper@creighton.edu

Kindra Cooper is a bioethicist and regulatory and life sciences attorney. She is the I

RB Director at Creighton University, where she also serves as an Assistant Clinical Professor in the Department of Medical Humanities. Kindra relocated to Omaha, Nebraska from her hometown of Seattle, Washington in August of 2021 to assume responsibility for the CU IRB. 

Prior to her arrival at CU, Kindra previously served as an IRB Chairperson for Advarra and Senior Regulatory Counsel for Quorum Review IRB. She is a site visitor in training for the Association for the Accreditation of Human Research Protection Programs (AAHRPP), a member of the Consortium to Advance Effective Research Oversight (AEREO), and Regulatory Faculty for the Radiological Society of North America's Annual Clinical Trials Workshop. Kindra's areas of expertise include regulation of medical devices including mobile apps and in-vitro diagnostic devices, eConsent, and the use of End User License Agreements in human subjects research. She is a licensed attorney, admitted to practice in the State of Washington. 

Kindra is the co-author of one CITI learning module on regulation of mobile applications and the lead author of eConsent, a chapter in the third edition of IRB Management and Function (published by PRIM&R). Kindra has presented at local and national conferences and via online webinars on topics including IRB Myths, eConsent, remote technology in clinical trials, IRB review of products with Emergency Use Authorization, sIRB, and IRB review of medical device research. 

Kindra earned her law degree from the University of Washington School of Law. She also holds a Master of Arts in Bioethics and Health Policy from the Stritch School of Medicine at Loyola University Chicago and a Master of Public Administration from The George Washington University. When she is not in the office, Kindra enjoys getting outside and exploring her new home state of Nebraska with the love of her life – a 62-pound Great Dane/Pit Bull mix named Annie.
 

 

 

Betsy Dancisak
Senior IRB Administrator
Email: betsydancisak@creighton.edu

Betsy Dancisak, received her MPH from Louisiana State University in New Orleans. Prior to joining the Creighton IRB team, she worked as an IRB administrator at the LSU Health Sciences Center - Office of Research. She gained extensive experience in public health during her time at the Louisiana Department of Health, working with a quality improvement program designed to improve maternity care practices and patient-centered care at birthing facilities. She enjoys the outdoors, yoga, and time with her husband and two daughters.

 

 

Meg Rayner
Senior IRB Administrator
Email: megrayner@creighton.edu

Meg Rayner joined the Research Compliance Office at Creighton University as a Senior IRB Administrator in January of 2023. Meg has nearly a decade of experience working in research and prior to becoming part of the team at Creighton, worked as an IRB administrator for the University of Nevada Las Vegas for just over five years. Before moving into the IRB world, Meg worked as a clinical research coordinator at the Cleveland Clinic Lou Ruvo Center for Brain Health, and as a health promoter and researcher for Women’s Health Action in New Zealand, where she focused on women’s health and youth development. She received her Bachelor of Arts in Psychology from UNLV and her Master’s degree in Public Health from the University of Auckland in New Zealand. Meg received her Certified IRB Professional (CIP) certification in March of 2020.

 

 

Teri Prentis, BA
IRB/IBC Administrator
Phone: 402-280-2126
Email: IRB@creighton.edu

Teri Prentis joined Creighton's Research Compliance Office in May 2023. Teri has a background in working directly with and advocating for individuals with developmental disabilities for nearly a decade. Teri has worked in day center, educational, clinic, and in-home settings, and has ample experience working in child welfare as part of many multidisciplinary teams. Additionally, she has worked as a part of research teams in the Omaha area – a summer research program at Bellevue University that later presented at the 2018 Psychological and Educational Research in Kansas/Nebraska Psychological Society conference, and multiple research projects led by doctoral candidates and faculty at the University of Nebraska Medical Center's (UNMC) Munroe-Meyer Institute (MMI) in the integrated Center for Autism Spectrum Disorders' (iCASD) Early Intervention Program. In 2020, Teri received her Registered Behavior Technician certification in order to provide therapeutic services to children with autism in the community and worked in an in-home setting, then at UNMC's MMI - iCASD for nearly two years. 

When she's not in office, Teri serves as the Vice President of the Bellevue, NE Lions Club, auntie to many kiddos, and wife and dog mom while at home. She likes hosting and attending events, volunteering, and exploring new places in the community.

AAHRPP Accreditation

Creighton University Earns Full AAHRPP Accreditation
Creighton joins an elite group of organizations in achieving full accreditation from the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). In achieving full AAHRPP accreditation, Creighton University has demonstrated its commitment to rigorous standards that help protect research participants while ensuring that society continues to reap the benefits of research.

Close SidebarClose Sidebar