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- Responsible Conduct of Research
IRB Review - Where Do I Start? This flowchart provides a quick snapshot of the IRB review process. It helps PIs determine whether or not they need IRB approval, and if so, which application form they should use.
Do I Need to Submit an IRB Application? This self-test allows users to determine whether or not their study requires IRB review.
Note: All key personnel listed on forms submitted for IRB approval must complete training on the protection of human research participants before a protocol will be approved.
New Application Forms
The signed original application and all accompanying materials (i.e., copies of grants for all federally funded research, advertisements, phone scripts, survey instruments, letters of information, etc.) are to be submitted for each research project involving human participants. Please submit all documents to IRB, 2420 Lincoln Way, Suite 202.
- Application for Approval of Research Involving Humans Please submit one fully signed original.
- Checklist for Application for Approval of Research Involving Humans
- Exempt Study Review Form This form should only be used for research that falls within the categories of exempt research as defined in the federal regulations at 45 CFR 46.101(b) (DHHS) and 21 CFR 56.104 (FDA).
- Information about Exempt Research
- Request for Preliminary IRB Determination (formerly Approval in Concept) This form is used only for funded projects that lack definite plans for the involvement of human subjects because time after the award is needed to develop the final protocol and related study materials. A complete copy of the grant proposal must be submitted with the request.
Informed Consent Document Templates
Using one of these templates will help ensure that all of the consent elements required by the regulations are included in your document. The template is only a guide and you may modify the document to meet the needs of your research. However, it is very important that you include all of the consent elements in your document unless your study falls into one of the categories of exempt research.
Informed consent documents should use an 11pt. font or larger. Please do not include titles such as Attachment or Appendix on the consent form, as the approved document will be stamped with the IRB approval stamp. Please leave a 1 1/2-inch margin at the top of the document to accommodate the stamp.
The stamped document should then be copied for use in your study to assure that the current IRB-approved document is being used. The IRB stamp will also serve as a reminder of the approval expiration date and will assure participants that the study has been reviewed by the IRB.
- Checklist for Easy-to-Read Informed Consent Documents Text
- Elements of Informed Consent
- Informed Consent Document Template--Q & A Format
- Informed Consent Document Template--Standard Format
- Parental Informed Consent Document Template--Q & A Format
- Parental Informed Consent Document Template--Standard Format
Note: For student submissions, the major professor's or supervising faculty member's contact information must be included on the consent form.
Under some circumstances, requirements for informed consent can be waived by the IRB. See Information about Waivers of Consent. Please note that the Waiver of Documentation of Consent and Waiver of Elements of Consent forms have been removed. These forms are no longer required because the investigator's justification is now requested in the Application for Approval of Research Involving Humans.
Adverse Event Form
- Report of Adverse Events or Unanticipated Problems Incidents that are unexpected, serious, and/or related, or possibly related, to the research must be promptly reported to the IRB using this form. (See Reporting Adverse Events and Unanticipated Problems for guidance.)
Continuing Review and Modification Forms
After initial approval, the IRB is required to review and approve all non-exempt research projects at intervals appropriate to the degree of risk. This is called continuing review. If a Continuing Review Form has not been submitted in time for review by the expiration date shown on the approval letter, IRB approval will lapse and, in accordance with Federal regulations, all research activity, including enrollment of participants, must cease pending the receipt, review, and approval of a Continuing Review Form.
Any change in the conduct of a study must be reviewed and approved by the IRB prior to implementing the change. The only exception to this is when the change is necessary to eliminate apparent immediate hazards to participants.
- Continuing Review Form
- Modification Form for Exempt Research
- Modification Form for Non-Exempt Research
- Personnel Change Only Form
- Project Closure Form This form is to be submitted when the project has been completed or canceled.
- Application for Use of Protected Health Information Form This form is required for projects using a health care provider's records and/or information about a subject. The Health Insurance Portability and Accountability Act (HIPPA) established the conditions under which protected health information may be used or disclosed for research purposes.