Study Team Member Only Change in Research Frequently Asked Questions
To increase efficiency, the JHM IRB has introduced a new Study Team Member Only Change In Research (STMO CIR). The STMO CIR can be used to add new study team members, make updates to existing study team members, and remove existing study team members. Using the STMO CIR, these updates can be administratively reviewed and approved through the eIRB system.
This page contains answers to key questions about the new STMO CIR functionality and links to tools and trainings to help you navigate use of this option.
Questions and Answers about the Study Team Member Only Change in Research (STMO CIR):
FAQ Table of Contents:
- General Information
- Submitting a STMO CIR
- Review of STMO CIRs
- Training Requirements for Study Team Members & PIs
- Common Error Messages
- Training & Information Sessions
1.General Information:
What is a study team member only change in research (STMO CIR)?
The STMO CIR is a change in research where the only change to the eIRB application is to add, update or remove study team members.
Are there study team changes which cannot be made with the Study Team Member Only Change in Research (STMO CIR)?
Yes, there are certain changes to a study team that are not eligible for administrative review via the STMO CIR as they may impact additional sections of the IRB application or require in-depth review to ensure additional requirements that cannot be verified by the eIRB system alone, have been addressed. Examples include:
- Changes to the Principal Investigator of the study
- Adding/changing a person that has a JHED affiliation that requires additional review and must be added or changed using a Standard Change in Research
- Additions of study team members who have not completed all the required Human Subjects Research related training (see below)
- Addition of a study team member who indicates that they have a potential Conflict of Interest
- Changes to a study team member whose response to the Conflict of Interest question has changed from “no” to “yes” or vice versa since they were added to the study team
Can I use the STMO CIR for any application type, including single IRB studies?
Yes, you can use the STMO CIR for any application type.
2. Submitting a STMO CIR
Can I submit a STMO CIR if there is another change in research in the system?
No, just like the current change in research rules only one change in research can be created for an application at any one time.
Who can create a STMO CIR?
Any member of the study team, or the PI, can create a STMO CIR.
Who can submit a STMO CIR?
Only the PI can submit the STMO CIR.
How do I know if I have any errors?
The “Validate” button in the top left of the smartform will not show all errors, you must use the “3 - Validation Summary” page or “Check for Submission Errors” activity to see all errors.
Do new study team members have to agree to participate?
Yes, when adding a new study team member, they have to agree to participate.
How will I know if the STMO CIR is complete and ready for submission?
The STMO CIR is designed to show an error if there is anything that will prevent submission. If the validation activity does not show any errors and all study team members being added have agreed to participate, the STMO CIR is complete and can be submitted by the PI.
What should I do if I created a STMO CIR and find out I have other application changes to make?
If the STMO CIR is not ready for submission, the PI can withdraw the STMO CIR and create a new CIR that includes the study team changes. If the STMO CIR is ready for submission, you can proceed with the study team changes (if unrelated to any other application changes) and submit a separate standard CIR once the STMO CIR is complete.
What should I do if I created a standard CIR and need to quickly add, delete or change a study team member?
If you have an active standard CIR and need to submit a STMO CIR, please contact the IRB staff for your committee for assistance.
3. Review of STMO CIRs
How long does it take for a STMO CIR to get reviewed?
The STMO CIR is designed to enable system review of the proposed changes in real time. The system applies a series of rules to determine if the study team member changes may proceed. If there are no validation errors and all study team members being added have agreed to participate, the STMO CIR is acknowledged/approved and the notification posted in eIRB immediately upon submission.
How is the STMO CIR reviewed?
When the STMO CIR is submitted, it will be evaluated by the eIRB system to be sure all requirements are met.
Will an Approval/Acknowledgment letter be generated?
Yes, as with all eIRB2 submissions, a letter of approval or acknowledgement will be created and may be viewed from the STMO CIR workspace. The letter will confirm the approval or acknowledgement including the date on which the approval or acknowledgement was given, the expiration date of the study, and details of the changes made.
4. Training Requirements for Study Team Members & PIs
Are there any changes to the training requirements for changes to the study team using the STMO CIR?
No, there are no changes being made to study team member training requirements. You will be presented with an error if training is incomplete, out of date or set to expire within 24 hours for study team member being added via the STMO CIR. Please review our training requirement on our website or reference the quick guide and any questions should be directed to the Help Desk.
How will I know if a study team member has not completed the required compliance training?
If training is incomplete, out of date or set to expire within 24 hours for any study team member being added as part of the STMO CIR, you will receive an error message notifying you of the issue.
For additional information on how to resolve the error, please see the section called “Addressing Error Messages” below.
Why can’t I upload training certificates in Section 2?
When training certificates are uploaded as proof of completion, an IRB staff member must review the certificate and manually update the study team member’s training date. If this is required, a standard change in research must be submitted to allow the IRB staff to review and update the training record appropriately.
5. Common Error Messages
When adding or updating a study team member using a STMO CIR, you may encounter study team member errors or study-level validation errors that will prevent the STMO CIR from being submitted.
Study team member errors occur when the study team member that is being added, removed or updated does not meet the criteria for an administrative review. e.g. there is a conflict of interest that requires review or training has expired.
Study-level validation errors can occur when the requested change does not follow the guidelines or policies. e.g. REWards training has not been completed by the PI or there is not a physician-investigator or mid-level provider to obtain informed consent if required.
These errors will either need to be fixed in order to proceed, or the STMO CIR will have to be withdrawn.
Study-level validation errors:
- All study team members listed above have errors (No study team member updates can proceed on the Study Team Member Only CIR). Please resolve any errors, or withdraw the entire Study Team Member Only CIR.
- This message indicates there is at least one validation error for each of the individuals being added, removed or changed. Under each person’s name the error message will give an explanation of the error. All errors must be resolved in order for the STMO CIR to move forward.
- This study does not have a study team member listed as providing physician/mid-level provider consent for a study that requires this. Please ensure that any designated study team member has agreed to participate as a mid-level provider.
- Question 24 in Section 1 of the application (Does the institutional policy on physician consent require that a physician-investigator or mid-level provider obtain informed consent for this research?) is answered “yes” therefore there must be at least one person on the study team designated to fill this role. Check the individuals being removed or changed to be sure they were not the only person filling that role. If they were, another person on the study team must be selected for that role. If you are adding someone to fill this role, they must answer “yes” to the mid-level provider question when they agree to participate.
- PI must have completed REWards training by the indicated date to allow submission of the Study Team Member Only CIR.
- The PI has not completed REWards training as required; within one year of the date their first IRB application was submitted. You can contact the IRB Help Desk to request an extension in the time to complete the training then come back to submit the STMO CIR.
- This is not an active study. You cannot submit a Further Study Action.
- The application must be in the Approved or Acknowledged state to submit any further study action. You can contact the IRB Help Desk for information on how to resolve this issue.
Study team member errors:
- This person has indicated “yes” to conflict of interest, and must be added using a Standard Change in Research.
- When the person agreed to participant, they answered “yes” to the conflict of interest question. If they don’t have a conflict, they should agree to participant again and answer “no.” If they have a conflict, remove them from Section 1 Item 25 and add then to the study team using a standard CIR.
- This person has reported a change in a previously identified conflict of interest and the change must be made using a Standard Change in Research.
- A change was made to the status of this person’s conflict of interest. Remove them from Section 1 Item 25 and add them using a standard CIR.
- This person has a JHED primary affiliation that requires additional review, and must be added using a Standard Change in Research.
- This person’s primary affiliation listed in JHED is outside the covered entity and requires additional review to be added to the study team. Remove them from Section 1 Item 25 and add them using a standard change in research.
- This person has a JHED affiliation that indicates the person is neither an employee nor a current matriculated student. This requires additional review and must be added using a standard CIR.
- All individuals being added to a study team must have a paid affiliation with Johns Hopkins/affiliate or be a Johns Hopkins/affiliate student. This person does not meet either of those requirements in JHED and must be removed from Section 1 Item 25 and added using a standard change in research.
- Please ensure that the information re: Physician/Mid-Level Provider consent (Section 1, Question 25, Sub-question 5) is consistent with the Agree to Participate response for this person.
- When added to the study team in Section 1 Item 25 the answer to the Physician/Mid-Level Provider consent question is inconsistent with how this person answered the same question when they agreed to participate. Verify these answers are consistent by either changing their entry in Section 1 or changing the response when agreeing to participate.
- This person must Agree to Participate.
- Before the STMO CIR can be submitted, this person must go to the STMO CIR application workspace and agree to participate.
- No changes have been made to the study team members. Please add, update, or remove a team member, or withdraw the CIR.
- The system did not locate any study team member changes. Verify changes have been made.
- Human Subject Research training is either incomplete, will expire over the next 24 hours, or is expired. For information on the required training and to register please use this link - Human Subject Research.
- This person’s required HSR compliance training is incomplete or out of date. They must complete the required training before being added to a study team.
- Researchers (HIPAA) training is incomplete. For information on the required training and to register please use this link - Researchers.
- This person’s required HIPAA compliance training is incomplete. They must complete the required training before being added to a study team.
- Conflict of Interest and Commitment training is incomplete. For information on the required training and to register please use this link -Conflict of Interest and Commitment.
- This person’s required COI compliance training is incomplete. They must complete the required training before being added to a study team.
- Clinical Research Billing Orientation (CRBO) training is either incomplete, will expire over the next 24 hours, or is expired. For information on the required training and to register please use this link - Clinical Research Billing Orientation.
6.Training & Information Sessions
Training and information sessions on the new Study Team Member Only Change in Research (STMO CIR) will be offered twice monthly starting in November 2024 and will run through February 2025. The training will include a practical walk-through of how to complete the STMO CIR, review the types of study team member changes that may be submitted using this function and will discuss strategies for addressing errors that may arise in the submission process.
For information on dates and times of training sessions click here.