Applying for IRB Review and Approval

To better serve University of Minnesota researchers and Institutional Review Board (IRB) reviewers all human subject applications and several supporting documents have been revised. The revised forms will provide the IRB committee with more precise information for review.

The revisions affect all human subject applications: Health and Biological, Social and Behavioral and Exempt applications. Samples of revisions include Potential Biohazards, Inclusion/Exclusion of Children in research and changes to several appendices.

Use these application forms to apply for IRB approval to conduct research with human subjects that involves minimal or greater than minimal risk to human subjects or participants. (More about minimal risk.)

HRPP documents are protected since checkboxes and dropdown menus are utilized. If you are trying to use certain Microsoft Word features such as spell check, the document must be unprotected.

Health & Biological/Medical Application Form

Social & Behavioral Sciences Application Form

Medical Record Chart Review (MRCR) Form

The NEW Medical Record Chart Review (MRCR) application has been developed for researchers who plan to use medical record chart review methodologies only.  This new process has been especially tailored with medical record chart review researchers in mind.  No other types of research should be submitted on this form as they will be returned.

Research Methods Class Protocol

The NEW Research Methods Class Protocol application has been developed for researchers who plan to conduct surveys, intereviews, aobservations of public behavior.  This new process has been especially tailored with class protocols in mind.  No other types of research should be submitted on this form as they will be returned.

Applying For an IRB Exemption

There are 5 exempt application forms available for research such as educational tests; surveys; interviews; observation of public behavior; studies of existing data, documents, records, pathological specimens, or diagnostic specimens; consumer acceptance or taste testing.

Questions? Try these four steps to determine if your activity is exempt from full IRB review.

Not sure which form to use? See Which form to Use?

Exempt Screening from IRB Committee Review Application Forms

Other IRB Forms

Five Year Renewal Form

Please note that an additional scientific review is not required at the time of submission.

Five Year Renewal Form

Request IRB Approval for a Change in Protocol

Researchers are required to use this Change in Protocol Request From as of February 15, 2010. The form highlights the elements the committee requires to review your request and please note the form requires the Principal Investigator's original signature. This form is for use when the changes are initiated by the PI.  Do not use this form to respond when changes are requested by the IRB.  Please do not use this form when responding to changes requested in a stipulation letter.

Change in Protocol Request Form

Adding/Removing/Changing Personnel on an IRB Study

Complete and submit this form to request personnel changes on an IRB study.

Add/Change/Remove IRB Study Personnel (Microsoft Word)

Adding/Removing/Changing Titles on an IRB Study

Complete and submit this form to request title changes on an IRB study.

Add/Change/Remove IRB Study Titles (Microsoft Word)

Request Copies of IRB Study Documents

Complete and submit this form to request copies of documents associated with an IRB study.

IRB Request for Document Copy (Microsoft Word)

Continuing Review Forms

Continuing Review Forms

Humanitarian Use Devices (HUD)

Registration Form for Protocols Using HUD

Research Templates and Samples

Consent/Assent Form Samples

HIPAA-related Forms and Templates

Scientific Review Forms

Documentation by Collegiate or Departmental Committee

Documentation by IRB Scientific Review

Reporting Unanticipated Problems Form

UPIRTSO Form (Revised March 2010)

See also "What Every Research needs to know about unanticipated probelms"

Affiliated Research Registration Form -- In Development

An agreement allow the University of Minnesota Institutional Review Board to formally delegate research review responsibilities to the respective IRB for projects where:

• University faculty or staff hold joint appointments
• All research subjects are recruited and seen at that facility
• Funding arrangements are not managed through University of Minnesota Sponsored Projects Administration.

This form registers activities on projects where the review was conducted through the researcher's respective IRB, eliminating the duplicity of a review conducted by both review boards.

Affiliated Research Registration Form (tbd)