Human Subjects Research Determination Procedures

Purpose

All DNP students complete a final project as part of their qualifications for completion of the program and graduation from The Ohio State University. These projects are evidence-based practice (EBP), quality improvement, policy or evaluation projects and meant to apply evidence to practice and improve practice or a policy*. Thus, for the vast majority of student projects, completion of the Human Subjects Determination form (which was created by the direction of the OSU IRB) is sufficient to ensure research is not being conducted with humans. Students must also check with and adhere to their project site organizational policies/procedures, which, in some cases, may require students to submit to IRB for exempt or expedited review approval.

*NOTE: This does not mean the student can’t publish on the project outcomes or even write about lessons learned that other organizations may want to transfer to their organization The Intent of these projects are not to create generalizable knowledge, which is the purpose of research.

Procedure

Completion of the Human Subjects Research Determination Form is required, not optional. Moreover, both the student and advisor must answer/review the questions and sign the form. This process is strongly recommended to be completed at the conclusion of the professional examination with the advisor. This can be done through Zoom or in person. Implementation cannot start until this form is completed. Steps to complete the form include:

  1. Access the following link and answer the 6 questions together. Also, answer the question about permission to use data from authorized personnel from the project site.
  2. Student adds their signature and then clicks on the Save and Return Later button (Not Submit).
  3. The student then records the ID# of the form that pops up when clicking the Save and Return Later button and provides this ID# to the advisor. The student exits out of the form.
  4. The advisor then accesses the link and clicks on the “returning” link in the top right-hand corner.
  5. The advisor will be prompted to enter the ID# and this will bring up the student form.
  6. The advisor reviews the questions/answers selected, enters the student email for the confirmation, and signs the form.
  7. The advisor submits the form.
  8. The student will get the email confirmation with the PDF of the completed/signed form and retains it to include in the appendix of the final project document.

This process will assure that the completion of the form signed by student and advisor is tracked in REDCap for monitoring and reports for DNP Program leaders.

DNP program designated support staff will run routine audits to ensure forms are being completed by all students with advisor approval. These audits will be conducted for all students who have successfully completed their professional examinations since the last audit.

Approved: DNP Sub-committee 11.5.20

Graduate Studies Committee 11.12.20