Tips for Success in Navigating the Human Subjects Protection System

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Presentation transcript:

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

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?

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

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

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

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

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

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 Email 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

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.

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.

Resources for Investigators Human Subjects Research - Excerpt 10/9/2008 Resources for Investigators Human Subjects Protection Office Phone (717) 531-5687, Academic Support Bldg. #1140 Individual Consultations IRB/HSPO web site: www.pennstatehershey.org/web/irb Resources/Investigator Resources Educational requirements – CITI course access Making an IRB Submission – instructions & templates IRB Seminars IRB New Investigator Series online http://media1.hmc.psu.edu/mediasite/Catalog/