Background 

This guidance pertains to Human Subjects Research collaborations between Lehigh University and Good Shepherd personnel. 

Process for submitting collaborative Good Shepherd and Lehigh University research to the joint Good Shepherd and Lehigh University (GSR - LU) Research Committee

Before research is submitted to an IRB, all collaborative Good Shepherd Rehabilitation (GSR) and Lehigh University (LU) research must be submitted to the GSR - LU Research Committee, consisting of representatives from both institutions. The PI will be invited to attend all meetings of the GSR - LU Research Committee at which their research is discussed. 

To submit to the GSR - LU Research Committee, the Lehigh University Principal Investigator (PI) must complete the Good Shepherd / Lehigh University Collaborative Research Intake Form and email it to inirb@lehigh.edu and research@gsrh.org. The committee will determine whether the project constitutes Human Subjects Research. If yes, the committee will determine: 

  1. If the project will be reviewed by LU’s IRB, or
  2. If the project will be reviewed by WCG IRB. WCG IRB will review all FDA-regulated clinical investigations.

GSR will defer IRB review to LU via an IRB Authorization Agreement for all non-exempt collaborative research that is reviewed by LU. If the LU IRB determines the study meets exemption criteria, GSR will rely on LU’s exempt determination. An Institutional Authorization Agreement is not required.

Process for submitting collaborative Good Shepherd and Lehigh University research to Lehigh’s IRB

New projects are submitted to Lehigh’s IRB following the steps described on the IRB’s webpage. An LU Principal Investigator must be appointed for all research reviewed by Lehigh’s IRB. 

Create an IRBNet account
  1. Visit: https://www.irbnet.org/release/register.do
  2. Complete the form. All fields are required.
  3. Under “Your Research Institution or Organization,” select Lehigh University, Bethlehem, PA
  4. Review and accept the terms of use.
  5. You will receive an email from IRBNet that includes a link. Click the link to verify your account.

Note that each IRBNet user must create their own account.

Sharing a protocol in IRBNet

The LU PI must share the IRBNet protocol with all project personnel who are engaged in human subjects research. GSR personnel may be included. All users with whom the PI has shared the protocol can access all study materials within IRBNet. They will be copied on all communications via IRBNet. 

  1. Log into IRBNet.
  2. Select My Projects.
  3. Select the project you wish to share.
  4. Select Share this Project in the left-side menu
  5. Select Share
  6. Select Lehigh University, Bethlehem PA
  7. Search for the user.
  8. Locate the user and select Full access.
  9. Select Save. 
Signing a protocol in IRBNet

All users with whom the PI has shared the protocol must sign the protocol in IRBNet before the project is submitted for IRB review. Your signature affirms that you agree to conduct to the IRB protocol as it is written and that you will adhere to all IRB determinations.   

  1. Log into IRBNet.
  2. Select My Projects.
  3. Select the project you wish to sign.
  4. Select Sign this Package in the left-side menu.
  5. Select a role from the drop down menu. Select Sign. You will be asked to re-enter your password to sign. 
Required training

All personnel who are engaged in human subjects research must meet their own institution’s training requirements.  LU requires all LU personnel to complete the Social and Behavioral Research CITI training.

Questions

Email inirb@lehigh.edu