If you have any questions, please contact the Research Protections staff.

1. Complete the necessary training

All faculty, staff, and students who will conduct human subject research must complete the required human subject protections training. Please refer to the training section of our website which explains the training requirements and provides the links to the online CITI training program and instructions for registering for the appropriate course(s). Completing the training before preparing the IRB submission materials may alert the researcher to issues that should be addressed in the IRB application.  The Faculty Sponsor must have documentation of Human Subject Protections Training on file with Research Protections in order for a student investigator to obtain final approval from the IRB.

2. Developing your Research

Student

Each student that conducts human subject research must have a Faculty Sponsor. The student should develop the research plan with assistance from the Faculty Sponsor. The research plan should be developed before completing the IRB application form. The first time you think about how you will conduct the research should not be as you are filling out the IRB form. 

Once you have a detailed research plan, you should review the Levels of Review page to determine which review level applies to your research: exempt, expedited, or full board. Next, discuss your determination with your Faculty Sponsor to confirm if s/he agrees. After your Faculty Sponsor and you have determined the required level of review for your research, review the Forms & Templates page and the instructions for each form to ensure that you are completing all the necessary documents for the appropriate level of review. Finally, complete the appropriate documents from the Forms & Templates page.

If you believe your research is Non-reviewable (i.e., does not involve research or humans subjects), the IRB requires that you submit an email containing a summary of your planned project to the IRB in order for the IRB to make an official non-reviewable determination. 

Faculty/Staff

Develop the research plan. The research plan should be developed before completing the IRB application form. The first time you think about how you will conduct the research should not be as you are filling out the IRB form. Once the research plan is developed, review the Levels of Review page to determine which review level applies to your research: exempt, expedited, or full board. Then review the Forms & Templates page and the instructions for each form to ensure that you are completing all the necessary documents for the appropriate level of review. Finally, complete the appropriate documents from the Forms & Templates page.

If you believe your research is Non-reviewable (i.e. does not involve research or humans subjects), the IRB requires that you submit an email containing a summary of your planned project to the IRB in order for the IRB to make an official non-reviewable determination.

**If your research involves recombinant or synthetic nucleic acid molecules, potentially pathogenic substances, select agents or toxins, or other biohazardous agents (e.g., human blood, tissue, or cells), the IBC protocol must be reviewed and approved by the IBC before submitting your research to the IRB.**

Outside collaborators are not allowed to be listed at Principal Investigators (PIs) on DePaul IRB applications.

3. IRB Process

Student & Faculty/Staff

Submit all your submission documents electronically via email to: orp@depaul.edu. If the form has not yet been converted to a fillable PDF by ORS and we require your signature or the signature of the faculty sponsor, you must send us a hard copy or scanned PDF version of just the signed IRB application form in addition to the electronic version. Please send all consent documents, information sheets, and recruitment materials in WORD, so that the IRB can manipulate or edit them, when necessary.

*STUDENT RESEARCHERS - Your Faculty Sponsor must sign your research application and the IRB must receive the version containing the Faculty Sponsor signature. 

You should receive notification of review from the IRB within 7-10 business days of the receipt of your protocol. However, at times the IRB may take up to 15 business days. If you do not hear from the IRB within this time frame contact the office regarding the protocol status at: orp@depaul.edu

4. After approval

Student & Faculty/Staff

Once the IRB has classified a project as exempt or approved a research project at the expedited or full level, the project must be conducted as approved. Any changes to the protocol personnel, methods, procedures, or documents after initial approval must be submitted to the IRB for approval via an amendment. Examples of changes that must be approved by the IRB include: changes in participant population or number, recruitment plans, research procedures, study instruments, study sites, and research personnel  

You MUST inform the IRB of any unanticipated/adverse events, or complaints. If your project received expedited or full board review your protocol MUST receive continuing review before the expiration date noted in your approval letter.

Once the project is completed you must submit the final closure report form. The final closure report form can be downloaded from the Forms & Templates page.

If  you have questions regarding the IRB review processes, please contact the Research Protections staff.