Step by Step Instructions for Protocol Submission

Step by Step Instructions for Obtaining IRB Approval for Human Subjects Research

1. Determine if your research is covered by these rules

. Definition of Human Subjects Research
. Exempt Research Requires IRB Review

. Student Research
. Existing Datasets
. Coded Information and Biological Specimens

2. Check your eligibility for Principal Investigator (PI) status

. PI Status Policy and Request Form

. Student Research

3. Take required training

. Human Subjects Training Requirement
. Human Subjects Tutorial (on-line)
. Training Completion Certificates

. Grant Certification Letter
. HIPAA Privacy Rule Training
. NIH Online Human Subjects Training

4. Find the approriate Institutional Review Board (IRB)

. UW-Madison IRBs

5. Determine what type of IRB review applies to your research

Guidance	Forms and Submission Deadlines
. Full IRB Review . Expedited Review . Exempt Research	See IRB Websites for links to protocol submission forms and deadlines for each IRB.

6. Issues to consider when planning your research

. Applying State Law
. Certificates of Confidentiality
. Conflict of Interest
. Data and Safety Monitoring Plans
. Genetics Research/Storable Tissue Use
. International Research

. Multisite Research
. Privacy and Confidentiality Protections
. SBS Genetics Research Guidance
. Requesting Student Records Information for Research
. Submitting Genome Wide Association Studies Data to NIH

7. Plan for selection and recruitment of participants

. Equitable Selection of Participants
. Recruitment of Participants
    . Email Recruitment (HS IRBs)
    . Recruiting Relatives, Employees, Students
    . Telephone Recruitment (ED & SBS IRB)

. Vulnerable Populations
. Payments to Subjects

8. Plan for informed consent and HIPAA authorization

Consent Guidance	Consent Forms and Wizards
. Informed Consent . Oral Consent/Waiver of Documentation . Waiver of Informed Consent . Assent by Children . Vulnerable Populations . Deception in Research . Research with Adults Lacking Consent Capacity . OHRP's Informed Consent FAQs	Wizards . Consent Form Wizard (for SBS & ED IRBs) . Combined Consent/Authorization Form Wizard Forms . Consent Forms for Health Sciences Protocols . Power of Attorney for Research . Advance Directive for Research
HIPAA Guidance	HIPAA Forms and Wizards
. HIPAA Research Guidance	. HIPAA Authorization Forms . Authorization Form Wizard . Combined Consent/Authorization Form Wizard . Parent/Guardian Authorization Form Wizard

9. Changes to and continuing review of approved research

Guidance	Forms and Submission Deadlines
. Continuing Review . Change of Protocol Review	See IRB Websites above for links to protocol submission forms and deadlines for each IRB.

10. Incident reporting

Guidance	Forms
. Reporting Noncompliance . Reporting Unanticipated Problems	. Non-Compliance Report Form (HS & MR IRBs) . Unanticipated Problem Report Form (SBS & ED IRBs) . Unanticipated Problem Report Form (HS & MR IRBs)

The Graduate School | UW Home

Last update: 7 October, 2009
Feedback, questions or accessibility issues: gswebmaster@bascom.wisc.edu
Copyright © 2009 The Board of Regents of the University of Wisconsin System.