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All IRB applications, appendices, post-approval submission forms and templates are listed below. Principal investigators must submit an application and required supplemental materials for research activities that meet the federal definition of human subjects research. Responses on forms may not be handwritten.
New applications must be submitted and approved prior to conducting research. Depending on the specific details of the proposed research, supplemental forms and approvals may be required. See detailed submission instructions below.
When to use
|Determination form||If you are unsure whether IRB review is required for your project or if you need documentation that IRB review is not required||June 2014|
|Health and Biological/Medical||For biomedical research requiring full committee or expedited review||Sep 2014|
|Medical Record Chart Review||For projects using medical record chart review methodologies only||Sep 2014|
|Social and Behavioral Sciences||For social/behavioral research requiring full committee or expedited review||Sep 2014|
|Research Methods Class Protocol||For professors teaching research methodology when the assigned research projects meet the federal definition of human subjects research||Dec 2012|
|Exempt Category 1: Investigational Strategies in Educational Setting||For research conducted in educational settings, involving normal educational practices||Sep 2014|
|Exempt Category 2: Surveys/Interviews, Standard Educational Tests, Observations of Public Behavior||For research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey/interview procedures or public observations||Sep 2014|
|Exempt Category 3: Public Officials, Surveys/Interviews, Educational Tests, Observation of Public Behavior||For research involving the activities in category 2 and the human subjects are elected or appointed public officials or candidates for public office||Sep 2014|
|Exempt Category 4: Existing Data, Records Review, Pathological Specimens||For research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens||Sep 2014|
|Exempt Category 6: Food Quality and Consumer Acceptance Studies||For taste and food quality evaluation and consumer acceptance studies||Sep 2014|
|Humanitarian Use Devices (HUD)||To register protocols and request approval to use a HUD||Mar 2010|
Depending on the specific details of the proposed research, supplemental forms and approvals may be required. Failure to submit required supplemental materials may significantly delay review and/or approval. Common supplemental materials include:
These are often submitted with the initial application and may be required if details of the research change. The application will highlight when these are required.
|Download||When to use||Updated|
|Appendix A: Sponsored Projects||To report funding information including type and source. Appendix A is NOT required when the only funding source is internal University of Minnesota funds. Examples of internal University funds include departmental funds, UROP funding and OVPR Grant-in-Aid Program awards.||Sep 2014|
|Appendix B: Pregnant Women, Human Fetuses and Neonates Involved in Research||
When research targets pregnant women, human fetuses and neonates of uncertain viability or nonviable neonates
|Appendix C: Prisoners As Subjects||
When prisoners are included in the subject population, either by design or incidentally
|Appendix D: Department of Defense||When research includes any component of the Department of Defense||Jul 2011|
|Appendix E: Use of Drugs||Medical only Submit when research includes the use of approved or unapproved drugs||Dec 2013|
|Appendix F: Use of Devices||Medical only Submit when research includes the use of approved or unapproved devices||Jun 2014|
|Appendix G: Genetic Testing||When research includes genetic testing, whether or not results are returned to subjects||Dec 2013|
|Appendix H: HIPAA||When research includes the use of Protected Health Information (PHI)||Dec 2013|
|Appendix I: Vulnerable Populations with additional considerations||
If your research targets minority groups or if the subject population includes:
|Appendix J: Student as PI||Submitted by Faculty Advisor to validate student PI has requisite training and knowledge to conduct proposed research||Dec 2013|
|Appendix K: International Research||If research will be conducted outside of the United States||Dec 2013|
|Appendix L: Field Work||When conducting phenomenological, ethnographic or “in the field” research||Dec 2013|
|Appendix M: Research in Schools||When conducting research in primary or secondary school settings||Dec 2013|
|Appendix N: Use of Deception||When research includes use of deceptive technique||Dec 2013|
|Appendix Q: Community Based Participatory Research||When research design incorporates a community-based participatory research approach||Dec 2013|
|Appendix T: Tissue/Sample use and storage||When research includes the use of existing biological samples and/or biological samples prospectively collected||Sep 2014|
|Appendix W: Informed Consent Waiver||To request of waiver of documentation of informed consent or a waiver of informed consent. For Social/Behavioral Research use only||Jan 2014|
|Appendix Y: Children as Subjects||When children will be included as subjects||Dec 2013|
|Scientific Review – Collegiate or Departmental Committee||To provide documentation of scientific review conducted by collegiate or departmental committee||Dec 2007|
|Additional Study Personnel||When additional personnel need to be listed with the original application. Do NOT use this form if adding personnel after initial approval. See Add/Change/Remove Personnel form in the Post-Approval forms section below.||Dec 2013|
These forms are used after the initial application has been approved. Changes to the approved project must be requested and approved before implementation. Unanticipated Problems Involving Risks to Subjects or Others must be reported in timely manner.
|Download||When to use||Updated|
|Change in Protocol||
|When adding/changing or removing a principal investigator, co-investigator or other study personnel||Sep 2014|
|When adding or removing funding associated with a project||Sep 2014|
|Use this form to report events, including Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSO), which fit the definition of promptly reportable events. The IRB defines “prompt” to be within 5 business days of discovery of the event. See the Reporting Unanticipated Problems webpage for additional guidance.||Sep 2014|
|To request copies of documents or correspondence associated with IRB record||Nov 2012|
Continuing Review (in eResearch Central)
|Submit prior to deadline indicated in the notice for renewal (expedited and full committee review of medical and social applications)|
|Five Year Renewal||When your study remains active and enrolling five years after initial approval||Nov 2012|
|Study Inactivation Request Form||Submit this form to request inactivation of IRB approval. Submit only after all study related activities/interventions have been completed.||Sep 2014|
Consent, assent, information sheets, HIPAA and protocol templates are commonly included with applications.
Consent Short forms
Additional protocol template resources are available from the NIH
|Continuing Review Event Reporting||
Template for tracking and reporting adverse events that do NOT meet the threshold for prompt reporting to the IRB. These events must be reported at continuing review or when requesting study inactivation.
PIs may submit applications and required supplemental materials electronically** via email. Electronic submissions must be sent to firstname.lastname@example.org from the PI’s official UMN email account, copying all co-investigators. If the PI is a student, the student’s academic advisor (as listed on the application) must be copied on the submission.
Within 24 hours of receipt, the application will be logged and assigned a unique IRB tracking number. An email confirmation will be sent to all PIs, co-investigators and correspondents listed on the application, along with the tracking number. This number must be included in all future correspondence to the IRB concerning the project.
**Hard copy submissions are also acceptable, though not preferred. These must be signed by the PI and either delivered to D528 Mayo Memorial Building or mailed to:
Human Research Protection Program
420 Delaware St. SE
Minneapolis, MN 55455-0392
Need help? Please contact HRPP staff at 612-626-5654 or email@example.com.