1. IRB BASICS Ethics and Human Subject Protections Summer 2016
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Viterbo University
IRB

2. IRB Function
The purpose of an IRB is to review human subjects research and ensure the rights and welfare of those involved in research are protected.
IRB is a federal mandate.
The Viterbo University IRB website is found at
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3. Rules Derived from Belmont Report http://www. hhs
Respect
Informed Consent Process/ Autonomous decision making
Respect for Privacy
Beneficence
Do no harm
Competent investigators/researchers
Provide resources for participants
Justice
Equitable selections of subjects
Fair distribution of risks and benefits

4. IRB Review Responsibilities
Initial Reviews and Approvals
Continuing Review for ongoing studies
Amendments/ Changes to studies
Safety Information or Unanticipated Problems to Subjects or Others
Study Closure
Compliance (most institutions have designated compliance officers)

5. IRB Review of Research Full Expedited Exempt
All research projects are categorized into one of three categories for the IRB review process. Each category is different in the level of scrutiny and submission procedures. The IRB is responsible for making the final decision of which category a research project falls under. Research that does NOT involve human subjects is not reviewed by the IRB.
Full
Expedited
Exempt

6. Exempt Review
Committee review is not required for certain categories of research activities that involve no risk to human subjects. 
Exempt does not mean the study needs no submission to the IRB. It means it can be exempt from multiple reviewers review.
Exempt reviews are reviewed by one member of the IRB committee
Exempt reviews turned around in one week.

7. Expedited Review
The complete application, consent form, and any other materials receive review and approval by the IRB chair and one other committee member.
Expedited does not mean “fast” it is a federal term used for research that must meet specific criteria (DHHS 45 CFR )
Expedited reviews are turned around in a 2 week timeframe.

8. IRB has the authority to:
Approve
Require modifications prior to approval
Table
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Disapprove all research activities including proposed changes in previously approved human subject research.

9. IRB Review and Determination of “Research Not Involving Human Subjects”
Certain forms of research do not involve human subjects or do not meet the definition of research according to the federal guidelines.  
Oral histories
Case studies (certain conditions)
Quality improvement
Historical, anonymous data sets
See details on oral history, case study, and class projects posted on the IRB website.

10. Criteria for IRB Approval (Checklist on the Website)
Risks are Minimized (Consistent with a sound research design and does not unnecessarily expose subjects to risk)
Risks are Reasonable in Relation to Benefits
Selection of Subjects is Equitable
Informed Consent will be Sought for Each Prospective Subject
Informed Consent will Be Documented
Agency permission provided for off campus studies
IRB Application identifies data collection, study procedures, data storage, and informed consent processes.
Informed Consent Templates are on the website.
When some or all of the subjects are likely to be vulnerable to coercion or undue influence, additional safeguards need to be included in the protocol to protect the rights and welfare of these subjects.
Researcher submits NIH Training obtained within last 3 years.

11. Informed Consent
Information – includes research procedure, purpose, risks, benefits, alternatives, etc.
Comprehension – function of intelligence, rationality, maturity and language, presentation of information must be adapted to the subject’s capacity
Voluntariness –requires conditions free of coercion and undue influence
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12. Application Process
Apply through the Virbatim software program. User guide on the website.

13. Information
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Chair: Dr. David Bauer ,