University of Minnesota
Institutional Review Board
http://www.research.umn.edu/irb
612-626-5654

Institutional Review Board homeIRB


Forms

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.

Applications

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.

Download

When to use

Updated

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 Aug 2013
Health and Biological/Medical For biomedical research requiring full committee or expedited review Dec 2013
Medical Record Chart Review For projects using medical record chart review methodologies only Dec 2012
Social and Behavioral Sciences For social/behavioral research requiring full committee or expedited review Feb 2013
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 Dec 2012
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 Dec 2012
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 Dec 2012
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 Dec 2012
Exempt Category  6: Food Quality and Consumer Acceptance Studies For taste and food quality evaluation and consumer acceptance studies Dec 2012
Humanitarian Use Devices (HUD) To register protocols and request approval to use a HUD Mar 2010

Supplemental materials

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:

  • Appendices
  • Consent forms, assent forms or information sheets
  • Other committee approvals (e.g. Masonic Cancer Center Cancer Protocol Review Committee)
  • Recruitment materials including solicitation email/letters, flyers, advertisements and scripts
  • Surveys or interview questions
  • Documentation of Scientific Review (required for all greater than minimal risk medical applications)
  • Protocol or research plan (required for ALL medical applications)

Click on the topics below to open/close the panel and download forms:

Appendices +

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 Dec 2013
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

Nov 2012
Appendix C: Prisoners As Subjects

When prisoners are included in the subject population, either by design or incidentally

Jun 2011
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 Dec 2013
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:

  • Those who are mentally, emotionally or developmentally disabled or have impaired decision making capacity
  • Non-English speakers
  • Economically or educationally disadvantages populations
Dec 2013
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 Dec 2013
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

Post-approval forms +

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

Submit when:

  • making changes to study procedures or amending the protocol
  • closing study to accrual
  • changing recruitment strategy, inclusion/exclusion criteria or modifying IRB approved recruitment materials
  • updating consent form
  • notifying the IRB of an update or revised Investigator Brochure
Oct 2013

Add/Remove/Change Personnel

When adding/changing or removing a principal investigator, co-investigator or other study personnel Jul 2013

Add/Remove Funding

When adding or removing funding associated with a project Dec 2013

Unanticipated Problem Involving Risk to Subjects or Other Report (UPIRTSO)

To report an unanticipated problem or event which reflects new or increased risk to the subjects and was possibly related to the research procedures Nov 2012

IRB Study Document Request

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

Templates +

Consent, assent, information sheets, HIPAA and protocol templates are commonly included with applications.


Submission instructions

PIs may submit applications and required supplemental materials electronically** via email. Electronic submissions must be sent to irb@umn.edu 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
MMC 820
420 Delaware St. SE
Minneapolis, MN 55455-0392

Need help? Please contact HRPP staff at 612-626-5654 or irb@umn.edu.