HSIRB Application for Exempt or Non-Exempt Research

Beginning November 1, 2020, the HSIRB protocol application process will be managed through Submittable, an online application submission program.  All communications regarding your submission will be managed through Submittable.  Once an application has been submitted, you may log in to your Submittable account to review your application’s progress, assigned protocol number, reviewer comments, etc.  Modification requests will also be managed through Submittable.

The program will walk you through the application step by step.  If you need help determining whether your project is exempt or non-exempt, there are prompts for these questions built into the application; if you already know your expected exempt/non-exempt status, it is possible to skip directly to the application sections. 

You will be prompted to upload supporting documents – including current training certificates for the all research team members - depending on your selections in each section; you will not be able to submit your application until all required documentation has been uploaded.  If you receive a “missing information/document” error message, scroll up through the application until you find the red error message/s and make the appropriate corrections.

Applicant Tips

Review our Applicant Tips document (PDF) for important information regarding student submissions and for instructions on viewing your application and application status after submission.

Faculty Sponsor Assurance

Students must have their documents reviewed by their faculty sponsor before submitting an application. Within the application, student researchers will submit the email address of their faculty sponsor who must complete a form affirming that they have reviewed the application materials and approve the project; faculty sponsors will also need to upload their current training certificate.

Blanket Protocols for Class Projects

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.

Research in Collaboration With Other Institutions

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.

Before You Begin an Application

Gather the following documents.  These will need to be separate files.  

  1. Training certificates for the research team. Davidson College requires all investigators: faculty, students, staff (anyone named as personnel on a new or existing non-exempt research project) to complete human subjects training before submitting a protocol for approval.  Training is not required but is strongly recommended for exempt protocols; if a request for exemption is deemed to be non-exempt, training for both the investigator and faculty sponsor (if applicable) must be completed prior to approval. Please visit our CITI training page for more information. Training certificates for your research team must be submitted with each application. Faculty sponsors must submit their own training certificates with each faculty sponsor assurance. Our CITI human subjects training certificates are good for three years.
  2. Documentation of permission to conduct research in a location other than Davidson College
  3. IRB approval documentation from another institution
  4. Tests, questionnaires, interview questions, surveys, scripts, etc.  If you are interviewing or obtaining data by any type of test, survey or questionnaire, you must submit the instrument by which you intend to acquire your data.
  5. Recruiting materials, text of e-mail or web-based solicitation
  6. Consent and/or assent forms
  7. If requesting oral consent, researcher must provide a copy of the consent document that will be read to research participants and, if required, the name and address of the individual who will witness the oral consent. The oral consent document should include a statement indicating that completion of the research exercise will confirm the participants’ consent to participate.

Need Assistance?

For help with Submittable, email HSIRB@davidson.edu

For questions about human subjects research, contact our Chair (jegood@davidson.edu) or Vice Chair (tijohnson@davidson.edu), CC to HSIRB@davidson.edu.

HSIRB Application

Complete the HSIRB Application through Submittable.