1. Tips for Success in Navigating the Human Subjects Protection System
Human Subjects Research - Excerpt 10/9/2008
Tips for Success in Navigating the Human Subjects Protection System
Start early
Read and follow directions
Understand the process
Ask for help

2. What The IRB Wants To Know
Do you understand ethical research?
Training requirement
What are you doing?
Procedures/Protocol
Who are you doing it to?
Subject Population
Inclusion/Exclusion Criteria
What are the risks and benefits?
How will you ensure voluntary participation?

3. MSR Projects – Example #1
Med student designs a study
Study will be conducted at HMC and/or off-site
Study involves human subjects

4. MSR Projects – Example #1
IRB Requirements for Example #1
Study must be submitted to the Hershey IRB for review using the standard IRB forms
Student must complete the CITI Course training
Hershey IRB reviews and approves study and issues an approval or exemption determination memo
After receiving the IRB approval memo the student may start the research
Student must provide a copy of the IRB approval memo to the Director, Medical Student Research

5. MSR Projects – Example #2
Medical student plans to work on an IRB-approved study here at Hershey
Study has previously been confirmed exempt or received IRB approval

6. MSR Projects - Example #2
IRB Requirements for Example #2
Principal Investigator of the study must submit a Modification Request Form to add the student as a co-investigator
Student must complete the CITI Course
PI receives an IRB approval memo for the addition of the student to the study
After the PI receives this memo the student may commence work on the project
Student must provide a copy of this memo to the Director of Medical Student Research

7. MSR Project – Example #3
Example #3
Medical student plans to work as a co-investigator on a study off campus
Study has previously been confirmed exempt or received approval from another IRB

8. MSR Projects – Example #3
IRB Requirements for Example #3
Student must submit the following to the Hershey IRB office
MSR proposal
Copy of the approval memo from the other IRB
or letter from the principal investigator at the other institution stating that they agree to supervise the student’s work on the project
Student must complete the CITI Course

9. MSR Projects – Example #3
IRB Requirements for Example #3 (cont.)
IRB Chair reviews the information to decide if review by the Hershey IRB is required.
If review and approval by the Hershey IRB is required, the study must be submitted to the Hershey IRB using the standard IRB forms as in Example #1.

10. IRB approval must be obtained prospectively
MSR Projects
REMEMBER:
IRB approval must be obtained prospectively
Before you start your research.
The IRB does not grant retroactive approval for research that has already taken place.

11. Resources for Investigators
Human Subjects Research - Excerpt 10/9/2008
Resources for Investigators
Human Subjects Protection Office
Phone (717) , Academic Support Bldg. #1140
Individual Consultations
IRB/HSPO web site:
Resources/Investigator Resources
Educational requirements – CITI course access
Making an IRB Submission – instructions & templates
IRB Seminars
IRB New Investigator Series online