Forms

Applications, Consent Forms etc..

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New editing software for IRB electronic application system was launched on April 9, 2014.  The new editing software is compatible with all internet browsers.  If you have any questions or issues, please contact Sue Logsdon at (402) 559-3779 or EMAIL.

NOTE: THE PAPER FORMS ON THIS PAGE ARE ONLY TO BE USED FOR STUDIES THAT HAVE NOT BEEN TRANFERRED TO THE ELECTRONIC SYSTEM (I.E. THEY ARE STILL IN PAPER FORMAT).

The IRB has an electronic IRB submission system which can be accessed at https://net.unmc.edu/rss/.

Instruction Manual for Electronic IRB Submission System: IRB Instruction Manual (pdf file)

NOTE: If you have a full board submission, paper copies will need to be submitted for initial and previously tabled studies.  DO NOT submit the paper copies until the IRB# has been assigned.  Submissions made without the IRB# will not be accepted. 

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WHICH RESEARCH APPLICATION DO I USE?

There are 12 main applications to choose from depending on the type of research that is planned.

  1. Biomedical Application: This application is used for studies involving: drugs and devices, exercise interventions/tests, clinical tests (ie., x-rays and MRIs) 
  2. Pediatric Biomedical Application:This application is used for pediatric studies involving: drugs and devices, exercise interventions/tests, clinical tests (ie., x-rays and MRIs) 
  3. Social and Behavioral Science Application:  This application is used for studies involving: survey research involving sensitive topics (eg., illegal drug use), focus groups and interviews.  NOTE: Some of this research may be categorized as Exempt per the federal regulations.  Therefore, it is always best to contact the IRB office when you have questions.
  4. Pediatric Social and Behavioral Science Application:  This application is used for pediatric studies involving: survey research involving sensitive topics (eg., illegal drug use), focus groups and interviews.  NOTE: Some of this research may be categorized as Exempt per the federal regulations.  Therefore, it is always best to contact the IRB office when you have questions.
  5. Human Biological Material Application:  This application is used for research involving: ONLY the collection of biological specimens (eg., blood, urine, tissue biopsies etc..) whether or not the samples are already existing or will be collected.  NOTE: Studies which would also include the collection of medical information via surveys or by chart review, would also be submitted using this application.
  6. Exempt Application:This application is used for research involving: educational settings, survey research that is not sensitive in nature, the observation of subjects, existing data that is not from medical records, focus groups and interviews.
  7. Medical Records Application: This application is used for research involving: the collection of information from medical records whether or not the information already exists or will be recorded in the future.  NOTE: medical records research should never be submitted using the Exemption Application.
  8. Human Biological Material Tissue Banking Application:  This application is used only for the collection of biological specimens (eg., blood, urine, tissue biopsies etc..) for the sole purpose of creating a tissue bank.  NOTE: Banks which also include the collection of medical information via surveys or by chart review to create a registry, would also be submitted using this application.
  9. Humanitarian Use Device: This application is used for the sole purpose of using a Humanitarian Use Device (HUD) which is a device that is intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect fewer than 4,000 individuals in the United States per year.
  10. Adult NCI CIRB: This application is to be used only for adult oncology protocols where the UNMC IRB is being requested to utilize the facilitated review process to accept the review and oversight of the National Cancer Institute (NCI) Central IRB.
  11. Pediatric NCI CIRB: This application is to be used only for pediatric oncology protocols where the Joint Pediatric IRB is being requested to utilize the facilitated review process to accept the review and oversight of the National Cancer Institute (NCI) Central IRB.
  12. Data Registry Application: This application is used for the sole purpose of collecting medical information to create a data registry.  This information will then be used in future research studies.    

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