You may find the OHRP decision trees helpful in deciding if you need IRB review and at what level: OHRP Decision Trees
If you have any questions, please contact the Office of Research Services-Research Protections staff.
Whether or not you require review and approval through the Office of Research Services/IRB depends upon the answers to two questions:
1. Are you conducting research as defined in the Federal regulations, and
2. Does that research involve human subjects?
Under the revised regulations, which became effective on January 21, 2019:
Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
For the purposes of the regulations the following activities are deemed not to be research:
1. Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
2. Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential health signals, onsets of disease outbreaks, or conditions of public health importance.
3. Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely by criminal justice or criminal investigator purposes.
4. Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
If the answer is to is the activity is research, then the activity is non reviewable by the IRB and you may request a non-reviewable determination letter from ORS.
If the answer is yes, the activity is research, then we ask whether it involves human subjects. Under the revised regulations:
Human subject means a living individual about whom an investigator (whether professional or students) conducting research:
(i) Obtains information or biospecimens through interventions or interaction with the individual, and, uses, studies, or analyzes the information or biospecimens; or
(ii)Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
If you answer no, the activity does not involve human subjects, then the activity is non reviewable by the IRB and you may request a non-reviewable determination letter from ORS.
If your answer is yes, the activity does involve both research and human subjects, then the activity must be reviewed and approved by the IRB/ORS before any research activities, including recruitment, may begin.
The next steps then include the following:
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 the Office of Research Services in order for a student investigator to obtain final approval from the IRB. Please be sure that you have updated your CITI institutional profile to include your DePaul user ID, the one that you use to log into Campus Connect. This information helps our protocol system communicate with CITI and download your training into the system automatically. We do not need you to attach training for people affiliated with DePaul.
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 older paper forms on the Forms & Templates page and the separate instructions for each form (including a check list of required documents) to ensure that you are planning on completing and submitting all the necessary documents for the appropriate level of review. Beginning June 1, 2020, the paper forms will no longer be accepted, but are still on our web page as a reference. You will need to submit the application in the online eProtocol system. See the tabs on the left navigation portion of the website and follow the instructions for logging into and using the eProtocol system.
If you believe your research is Non-reviewable (i.e., does not involve research or humans subjects), beginning June 1, 2020, the IRB requires that you submit the request for a not research/not human subject/not engaged protocol using the new online eProtocol portal. The information requested is short and simple and just provides us with enough information to indicate that the activity is non-reviewable. We would then issue an official determination letter from our system. This helps the office track work load and create reporting information.
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 older paper Forms & Templates page and the separate instructions for each form to ensure that you are planning on completing and submitting all the necessary documents for the appropriate level of review. Beginning June 1, 2020, the paper forms will no longer be accepted, but are still on our web page as a reference. You will need to submit the application in the online eProtocol system. See the tabs on the left navigation portion of the website and follow the instructions for logging into and using the eProtocol system.
If you believe your research is Non-reviewable (i.e., does not involve research or humans subjects), beginning June 1, 2020, the IRB requires that you submit the request for a not research/not human subject/not engaged protocol using the new online eProtocol portal. The information requested is short and simple and just provides us with enough information to indicate that the activity is non-reviewable. We would then issue an official determination letter from our system. This helps the office track work load and create reporting information.
Please Note: 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 protocol materials (i.e., IRB application, consent/information sheet, recruitment materials, measures, scripts, etc.) via the new online eProtocol portal (see left tab on website) for all new protocols submitted on or after June 1,2020. Older protocols reviewed and approved on paper may continue to submit amendments and continuing review reports and final reports electronically via email to orp@depaul.edu . Please submit all consent documents, information sheets, and recruitment materials in WORD, so that the IRB can manipulate or edit them, when necessary. These documents are added to your protocol using the attachment page in the online eProtocol system. Please be sure each attached document has a version date in the footer and the file name also has a version date noted.
Please Note: Student Researchers - Your Faculty Sponsor must review and electronically sign your research application online in the eProtocol system. The online form has instructions for how that process needs to work.
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 and the amendment must be approved before it is initiated. 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, consent document or recruitment materials, and research personnel.
You MUST inform the IRB of any unanticipated/adverse events, or complaints. If your project received full board review, your protocol MUST receive continuing review before the expiration date noted in your approval letter. If your protocol was reviewed and approved under expedited review and if the IRB requires continuing 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 Office of Research Services, Research Protections staff.