Institutional Review Board

Federal regulations and policies require IRB approval for research with human subjects. You are required to submit a formal application if your project or study meets both of these conditions:

1. It constitutes “research” with the intent to develop new or expandable knowledge.

AND

2. If human subjects are involved, either directly or through use of identifiable data about them.

Does my study constitute “Research”?

According to the Code of Federal Regulations, research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge [45 CFR 46.102(d)] — i.e., “with the intent to develop new or expandable knowledge.”

A. Is your study intended to develop new or expand existing knowledge?

B. Do you expect or intend to publish or present the results of your study?

If you answered YES to (A) and (B), your study is considered to be “Research” and you do need IRB approval before you can begin your study. If you answered NO to either question, your study is considered to be “Research” but it may be exempt.

Is my study considered to be research “on Human Subjects”?

A. Are you planning to obtain information from or about living individuals?

B. Will the study involve direct interaction with individuals or data linked to personal identifiers?

C. Will you gather information that would ordinarily be private?

D. Will you observe behavior in a context where the subjects would reasonably expect privacy (e.g., their homes)?

If you answered YES to (A) AND one or more of the other questions, your study is considered to be “on Human Subjects.” If you answered NO to all the questions, then you do not need IRB approval and can begin your study.

Do I need to submit an IRB application?

A. Does your study constitute “Research”?

B. Is your study considered to be research “on Human Subjects”?

If you answered YES to both questions, then your study or activity is considered “Research on Human Subjects” and you must submit an IRB Application (Word) and review the material found on the Principal Investigator’s Requirements page  especially the IRB Investigator’s Guide (Word).

If you answered NO to either question, then you do not need IRB approval and can begin working on your study.

NOTE: IRBs do not have the option of granting “retroactive” approval after research is done, so you are strongly encouraged to submit your research proposal or consult with the IRB if you are unsure whether you need IRB approval.

You may email your questions to the WCGME–IRB Administrator at: wcgme-irb@thewrightcenter.org or call 570-343-2383, ext. 2261.

Fee Schedule for WCGME-IRB Review

The submitting Principal Investigator is responsible for the payment of all fees charged for IRB reviews.

Reductions in IRB review fees will be considered based upon documented budget limitations. Requests must be submitted in writing, with all appropriate budget documentation, to the Administrator, WCGME–IRB. The Principal Investigator will be notified in writing if the request is approved or not approved.

*All studies submitted for Expedited Initial Review must be accompanied by a check payable to The Wright Center for Graduate Medical Education Institutional Review Board in the amount listed above.

**Expedited studies submitted by Interns, Residents or Students will be charged the reduced rate of $100.00.

• Checklist Used by IRB for Review of Proposals (PDF)
• IRB Protocol Submission Form (PDF)
• IRB Protocol Submission Form (Word)
• IRB Fee Schedule (PDF)
• Combination Report Form (PDF)
• Combination Report Form (Word)
• Adverse Event and IND Safety Report Template (PDF)
• Adverse Event and IND Safety Report Template (Word)
• Addenda, Memoranda, Editorial and Administrative Changes Template (PDF)
• Addenda, Memoranda, Editorial and Administrative Changes Template (Word)
• HIPAA Waiver Request (Download and complete using Microsoft Word)
• Application to use Discarded Tissue (Download and complete using Microsoft Word)

Responsibilities

• Protecting the rights and welfare of prospective subjects: Protecting Human Research Participants NIH Office of Extramural Research
• Ensuring that pertinent laws, regulations, and institution procedures and guidelines are observed by participating investigators
• Obtaining informed consent and ensuring that no human subject is involved in the research prior to obtaining their consent
• Ensuring that all research involving human subjects receives IRB review and approval before commencement of the research
• Complying with all IRB decisions, conditions, and requirements
• Ensuring that protocols receive timely continuing IRB review and approval
• Reporting unexpected or serious adverse events to the IRB
• Obtaining IRB review and approval before changes are made to approved protocols or consent forms
• Seeking IRB assistance when in doubt about whether proposed research requires IRB
• Assure that research is performed in compliance with Federal Good Clinical Practice Consolidated Guidelines

Required Materials

• Complete copies of the protocol
• Informed consent

• IRB Protocol Submission Form (Word) or
• IRB Protocol Submission Form (PDF)

Informed Consent

• General Requirements
• University of Minnesota Informed Consent Instruction Module

Investigator’s Guide

• WCGME-IRB Investigator Guide – Complete Revision-11-21-2013

Clinical Trial Protocol Development Template and Informed Consent Development Sheet

• Investigator’s Protocol Development Template (Word)
• Informed Consent Template (PDF)