Getting Started

Human subjects research requires IRB approval or a determination that the research is “exempt” from the federal regulations.  Depending on the particulars of your project, you may not need to submit an IRB application at all.  Whether or not IRB review is required is determined by going through a few key questions based on some regulatory definitions.

Research may self-determine that their project does not meet the definition of “human subjects research” using the Human Subjects Determination Form.  Even if you determine that your project does not meet the definition, you may still wish to submit an application to request a formal determination letter, for example to obtain or access data from a source or if you have a complicated project.  For more information:

• Step 1: Is your project considered research?
• Step 2: Does your research involve human subjects?

Determinations that the human subjects research is “exempt” from the federal regulations must be made by Research Integrity & Compliance (RIC).  If you believe your research may qualify for exempt status, submit an application through Axiom Mentor, SMU’s electronic submission portal.

• Step 3: Is your human subjects research “exempt” from regulations?

Visit Do I Need IRB Review section to go through the steps in order to determine if you need to submit an application for your project.

Human Subjects Protection Training: SMU and RIC requires that all researchers who conduct research involving human subjects complete training in the basic ethical principles for working with human research subjects.  Many funding organizations and collaborating institutions require valid human subjects protections training before an IRB application will be issued final approval.

Good Clinical Practice Training: Researchers working in behavioral or biomedical clinical research may be required complete training in Good Clinical Practice (GCP) to meet the requirements of the organizations they are affiliated with, funding agencies, or study sponsors.  GCP training educates researchers on the fundamental principles of conducting high quality clinical trials.

Both of these trainings are offered through the SMU’s Collaborative Institutional Training Initiative (CITI) Program.  For additional information go to the Training and Education section or for further assistance contact RIC at researchcompliance@smu.edu.

Is your study eligible for SMU IRB review?  IF your research is happening at SMU, then it’s SMU research, right?  It’s not that simple, and whether a project is considered “SMU” research has nothing to do with physical location.  It depends on whether SMU is considered “engaged” in the research through direct federal funding or human subjects activities.  For more information:

• Step 4: Is your research considered to be “SMU” research”

Is the SMU IRB the right IRB?  

While the SMU IRB is usually the right choice for most SMU research in which SMU is conducting all or most of the research activities, there are many circumstances in which an external, or non-SMU IRB must review SMU research instead of the SMU IRB.  The RIC staff must authorize the use of a non-SMU IRB in advance.  For more information on using a Single IRB or initiating a reliance agreement, go to the Collaborative Research section or contact RIC at researchcompliance@smu.edu.

Human subjects research must be reviewed and approved in advance.  Review times can vary widely depending on the type of review that is needed.  Applications that require review by the full convened IRB generally take the longest. Situations that typically require longer review times include:

• Complex studies involving many different study procedures
• The SMU reviewing for multiple institutions

Student investigators serving as the Principal Investigator on an SMU IRB application must meet the following requirements:

Faculty Advisor Review Requirement: You must have a faculty advisor sign off on your project.

1. List your faculty advisor by name in the IRB protocol application.
2. List your faculty advisor by name on any recruitment or consent documents that will be utilized during the research.
3. Grant access to your faculty advisor to review data collection and study-related materials associated with the proposed research.
4. Your faculty advisor is required to review, conduct a preliminary review, and provide feedback of your proposed research prior to submitting it formally to the IRB.
5. Once your faculty advisor has reviewed and electronically signed the submission, the review will show as “Accepted” on the Main Protocol Page in Axiom Mentor. A notification will be automatically generated by the Axiom Mentor system to RIC that a new IRB application has been submitted for IRB review.

Obtaining informed consent from research participants is one of the key criteria for IRB approval.  Informed consent must include:

• Key information that the specific subject population would need to make an informed decision about participation;
• Presentation that aids comprehension of the information and allows for dialogue; and
• Voluntary participation without coercion or undue influence.

Research Integrity & Compliance (RIC) provides extensive guidance on informed consent, including:

• Consent overview with 5 key considerations which must be part of a meaningful consent process and form
• Consent tip sheets that summarize the full consent guidance
• Consent templates to help you create a consent process and form

If IRB review is required for your study, you must include consent materials in your IRB application unless the consent requirement is waived.  For example, the informed consent requirement is commonly waived for records review studies that do not involve contacting subjects.

All applications must be submitted electronically via Axiom Mentor.  Axiom Mentor applications include:

• Web-based forms with basic questions; and
• Features to upload attachments that contain most of the information about the study, such as the IRB application form, recruitment, and consent materials.

The review process in the electronic submission portal involves having a preliminary review conducted initially and receiving and responding to stipulations, as needed.  When a notice is issued to you for additional information or revisions, the project cannot move forward with the review process until a response is received and all requests have been adequately addressed.  Similarly, once you respond to any requests, you are no longer able to make any additional changes to the application.  There can be many rounds of back and forth as needed.

If a stipulation letter is issued to you, you will receive an email notification sent to your SMU email.  A copy of the stipulation letter is also posted directly in your project in Axiom Mentor.  The application status will show as “Revisions Requested”.

The general process you should follow to respond is the same:

If you receive a formal stipulation letter, you’ll need to make edits directly in the protocol application and in any other documents that may be posted with your application (i.e., recruitment flyer, consent).  Providing a tracked, red-lined version will help the reviewer identify any changes or revisions that have been made, assisting in conducting a timely re-review and approval.

The Principal Investigator will need to select the “Submit Revisions for Review” tab to notify the RIC staff that a response has been made to the IRB application.

Manage Study Access:

There are many different user roles in Axiom Mentor, and each provides a different level of access to the study.  Review the Managing Study Access table for a summary of the different user roles and step by step directions on making the changes in Axiom Mentor.

Makes Changes to Your Study:

Exempt Research: Some changes always require RIC to review a modification and make re-determination of exempt status.  Many other changes do not.  Review the exempt research guidance for more information.

IRB Reviewed Research: Submit an amendment/modification application to your IRB project.  The modification must be approved by the IRB before you make the change.  Common types of modifications that occur in most studies:

• Administrative changes to update or remove study team members;
• Update or revise consent documents and recruitment materials;
• Modify protocol to add or remove study procedures, add new study sites, increase recruitment numbers, etc.

Axiom Mentor only allows one open modification/amendment to be submitted and reviewed at a time.  Review the resources below for more information.

Report to the IRB:  Regulations require certain information to be reported to the IRB, including information about new or increased risks to subjects and problems that have occurred, such as data breaches resulting from a stole laptop.

Consult RIC’s Report Safety/Compliance Information for more information about what needs to be reported, the timeline for reporting, and how to report.

Send an email to researchcompliance@smu.edu f you have questions or need help.

Renew IRB Approval (if required):  Your IRB approval letter will tell you if an annual re-review, called continuing review, is required for your study.  Most expedited studies do not require continuing review, while studies reviewed by the full board are more likely to require continuing review.

Review Renew Your IRB Approval for more information.

Close IRB Application:  Submit a continuing review to close your IRB application when your human subjects research is complete. Applications may be closed when:

• All subjects have completed all study-related interventions and procedures, including any follow-up.
• You have obtained all private identifiable data and/or specimens from all subjects.
• You have completed your analysis of all private identifiable data and specimens, as described in your IRB application