IRB Application

Umbrella Protocol for Pedagogical Research

The IRB approved an umbrella protocol, “Pedagogical Research at Davidson College,” also known as the “CTL Umbrella” protocol on February 11, 2019.  This protocol allows faculty to apply to the Director of CTL for inclusion under the protocol so that coursework may be used in pedagogical research.  Authorized faculty must include standard verbiage provided by the Director of the CTL, Dr. Mark Barsoum, in their syllabi for courses included under the protocol and must provide the syllabi including this language to students before they may use student coursework for pedagogical research. 

You may visit the Umbrella IRB for Pedagogical Research page or reach out to Dr. Barsoum for more information at mabarsoum@davidson.edu.

For Class Instructors

If your class will be conducting a human subjects project that is intended or likely to be published or presented publicly (outside the classroom), we ask that you apply in advance of the semester for a blanket protocol to cover exempt projects. This blanket protocol should describe the range of research topics you will be working with in class projects, a general consent document, representative survey questions (if applicable), and how you plan to protect participant identity and secure data. The IRB will review the general scope of the work, with the consent, identity, and data protection aspects. If you plan to assign the same project for multiple classes, you may list the classes in the protocol description.

Approval of a blanket protocol for class projects may carry over from year to year; substantive changes to the blanket protocol (including the list of classes) will require a modification request. 

Students completing non-exempt projects must submit their individual protocols to the IRB for review.

Training Requirements for Blanket Protocols

Instructors must submit their own training certification at the time of application.  We strongly recommend (but do not require) assigning CITI training as part of the course for your students' education and future research preparation. 

Once your students have complete CITI training, you may submit your students' training documents in a batch via Submittable's Messages function so they are attached to your approved protocol.  See the Applicant Tips document on this page.

Protocol Materials in Languages Other than English

If a student will be producing survey questions or protocol materials in a language other than English, the student should provide English translation copies of those materials to the instructor.  If you feel that the materials are outside the scope of what is covered by the approved class protocol, you may reach out to the Chair or Vice Chair that approved your class protocol for guidance; a separate protocol submission by that student may be necessary.

In certain instances, an investigator from Davidson College may be involved in a collaborative research project involving human subjects which is to be conducted at another institution, or vice versa.  In such cases, one collaborating institution typically relies on the other institution's IRB approval.  Such arrangements may require an Institutional Review Board Authorization Agreement (IAA).  The determining factors are whether a Davidson agent (faculty/staff/student) is a PI/Co-PI and whether the protocol is exempt or non-exempt.

When is an IAA required?

• If a Davidson College agent (faculty/staff/student) is a PI/Co-PI on a collaborative project being managed or administrated by another institution, a copy of the IRB approval and a short description of the project should be sent to HSIRB@davidson.edu. 
  • If the project is non-exempt, an IAA agreement is also necessary.  Email HSIRB@davidson.edu with details of the project and the contact information for the collaborating institution's IRB administrator.
• Similarly, a collaborating institution can request to rely on Davidson’s IRB, in which case the Davidson PI may provide the collaborating institution with a copy of Davidson's IRB approval. 
  • If the project is non-exempt, an IAA agreement is also necessary.  Email HSIRB@davidson.edu with details of the project and the contact information for the collaborating institution's IRB administrator.
• If a Davidson College agent (faculty/staff/student) is NOT a PI/Co-PI participating directly in the research but is assisting with distribution of a study to the Davidson College community (e.g., another institution's survey that they would like to distribute to our students), a copy of the IRB approval and a short description of the project should be sent to HSIRB@davidson.edu. 
  • Since we are not a collaborating institution, an IAA is not required, regardless of whether the project is exempt or non-exempt.

Research with human subjects at international locations can be complex and will require additional time to secure local ethics board approval or a determination that the local ethics board will rely on Davidson’s IRB to assess compliance with local ethics and data protection standards. Such approval or determination must be received prior to and submitted with your application to Davidson’s HSIRB; the IRB cannot review such projects without this approval or determination. Review timeframes for these types of projects typically run much longer than our standard review timeframe. Please plan accordingly.

Some important things to consider and plan for:

• Country-specific ethics guidelines and committees are often under the purview of the country’s health and human services department or ministry, equivalent to the US Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP).  Projects that are primarily social/behavioral without a medical or health component will still be subject to the local ethics standards, even when those standards are under the purview of the local health service.
• Country-specific guidelines may require that you establish a relationship with and work with and through a local agent or organization to apply for ethics review and/or complete your research project. 
• Once local ethics review/approval is received and you submit your protocol to Davidson’s HSIRB, a full board review may be necessary which will extend the review timeframe as the IRB must find a time to prepare for the review and convene a quorum.