Obtaining IRB Approval for Human Subjects Research–Step by Step
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. Take required training
| .
Human
Subjects Training Requirement . Human Subjects Tutorial (on-line) |
.
Training
Completion Certificates . Grant Certification Letter . HIPAA Privacy Rule Training |
3. Find the approriate Institutional Review Board (IRB)
| .
Role
of IRBs |
. UW-Madison IRBs |
4. Determine what type of IRB review applies to your research
| Guidance |
Forms and Submission Deadlines |
See IRB Websites above for links to protocol submission forms and deadlines for each IRB. |
5. Issues to consider when planning your research
6. Plan for selection and recruitment of participants
|
.
Equitable
Selection of Participants |
7. Plan for informed consent and HIPAA authorization
| Consent Guidance |
Consent Forms and Wizards |
| .
Informed
Consent |
Wizards . Consent Forms for Health Sciences Protocols . Power of Attorney for Research . Advance Directive for Research |
| HIPAA Guidance | HIPAA Forms and Wizards |
.
HIPAA
Authorization Forms |
8. Changes to and continuing review of approved research
| Guidance |
Forms and Submission Deadlines |
See IRB Websites above for links to protocol submission forms and deadlines for each IRB. |