Education & Resources

The goal of the IRB Education Program is to facilitate research involving human subjects from initial submission to study completion through didactic and practical education. Whether it is for investigators, research study personnel, students or other institutional representatives, information is explained in a manner that fits the audience. By using a variety of delivery methods, such as lectures, webinars, live-streams, bulletins, one-on-one meetings and department in-service, from new student to seasoned investigator, our objective is to offer education of:

- The history and regulation of research ethics
- The local submission requirements and process
- The common pitfalls to improve the efficiency of the submission process.

The IRB is here to help!

All educational options will be tailored to meet the specific needs of the target audience, whether it be one-on-one about a specific research protocol or a lecture to a class regarding a general overview of research ethics and the IRB process.

If you would like to schedule a one-on-one meeting, department in-service, class lecture, Q&A session or any other type of IRB education, please contact IRB staff for assistance at irbora@unmc.edu

HRPP Investigator Guidance Series

This page serves as a hub for all of the Investigator Guidance Series documents. Each document is an abbreviated version of one of our HRPP Policies and Procedures intended for investigators, coordinators, and other study team members. This page is a good starting point for any study team member with a question about a policy on a specific topic. A link to the full policy/procedure is included in each document.

Document Updated
Advertisements 12/13/2023
Authority of the IRB 12/13/2023
Change Requests 12/13/2023
cIRB 12/13/2023
Closure of Research 12/13/2023
Compensation 12/09/2024
Confidentiality 12/13/2023
Continuing Review 02/05/2024
Contraception Requirements 12/13/2023
Data and Safety Monitoring 12/13/2023
Data Registries 12/15/2023
Emergency Research - Waiving Consent 12/13/2023
Emergency Use of a Test Article 01/25/2024
Employees as Subjects 12/13/2023
Ethical Access 12/09/2024
Exempt Research 01/25/2024
Expanded Access to Investigational Drugs and Devices 12/14/2023
Expedited Review 12/13/2023
Financial COIs 01/25/2024
Full Board Review 12/13/2023
Humanitarian Use Device (HUD) 12/13/2023
Incidental Findings 12/13/2023
Increased monitoring, interim Continuing Review, and verification 12/15/2023
Informed Consent 12/13/2024
International Research 12/13/2023
Investigational and Marketed Devices 01/26/2024
Investigational and Marketed Drugs 12/13/2023
IRB Approval Criteria 12/15/2023
Obtaining Informed Consent for Non-English Speaking Persons 12/13/2023
Obtaining Informed Consent for Persons with Additional Needs 12/13/2023
PI Qualifications and Responsibilities (job description) 12/13/2023
Placebos 12/13/2023
Post-Approval Monitoring of Research 12/09/2024
Pregnancy Testing 12/13/2023
Privacy 01/26/2024
Recruitment 12/13/2023
Reimbursement 12/13/2023
Research Involving Children 12/13/2023
Research Involving Decisionally Impaired Persons 12/13/2023
Research Involving Neonates 12/13/2023
Research Involving Pregnant Women and Fetuses 12/13/2023
Research Involving Prisoners 01/25/2024
Research Personnel Qualifications & Responsibilities (study team job descriptions) 12/13/2023
Short Form Consent 12/13/2023
sIRB 12/13/2023
Students as Subjects 12/13/2023
Study Hold 12/13/2023
Suspension 12/13/2023
Termination 12/13/2023
Using PHI in Research 12/13/2023
Vulnerable Populations - Additional Protections 12/13/2023
Waiving Consent Process 12/13/2023
Waiving Signed Consent 12/13/2023
Wash Out 12/13/2023
What requires IRB review and approval? 01/10/2024

Investigator Resources

Regulations:

National Institutes of Health:

UNMC Links:

Food and Drug Administration:

International Standards:

Other Federal Agencies:

Organizations and Other Items of Interest:

IRB History and Principles:

Mental health considerations

MENTAL HEALTH CONSIDERATIONS FOR RESEARCHERS

DECEMBER 2023

EXPLANATION OF RISKS:

SELF-REPORT MEASURES:

INVESTIGATOR-ADMINISTERED MEASURES:

PHQ-9:

The Columbia Suicide Severity Rating Scale-Revised (CSSRS-R):

RESOURCES:

UNMC/NE MEDICINE PSYCHIATRY SERVICES:

PSYCHIATRY SERVICES FOR CHILDREN

PSYCHIATRY SERVICES FOR STUDENTS:

KEARNEY COMMUNITY RESOURCES

LINCOLN COMMUNITY RESOURCES

NORFOLK COMMUNITY RESOURCES

SCOTTSBLUFF COMMUNITY RESOURCES

NATIONAL RESOURCES

Miscellaneous Resources

Below investigators will find a variety of resources that may assist with research goals: