IRB Frequently Asked Questions

How do I access RAMP IRB?

There are 3 ways to access the system:

1. Sign on to the myFSU portal https://www.my.fsu.edu/portal and click on the RAMP icon
2. Visit https://myramp.research.fsu.edu
3. Click on the link from an auto-generated email from ramp-irb@fsu.edu

How do I obtain assistance with using RAMP IRB?

The Help Center within the RAMP IRB contains guides and videos to aid in the use of the system. If you have questions or need further assistance, please email ramp-irb@fsu.edu. This email is checked frequently and a knowledgeable staff member will promptly assist you. We ask that you email rather than call in order for the team to document the types of questions asked to provide relevant updates to training resources and FAQs.

Where do I download the required forms?

The library section within the RAMP IRB comprises all of the required templates.

How do I request a continuing review for a study approved in HSRS that was not imported into RAMP IRB?

When a continuing review is needed, create a new study submission and on the “Local Site Document” page of the SmartForm, under question # 3, Other attachments, attach a completed “HRP-212 Form - Continuing Review” form and select “Continuing Review Form” as the category.

How do I request modification(s) for a study approved in HSRS that was not imported into RAMP IRB?

You will need to create a new study submission in RAMP IRB with a new protocol document attached.

If I am a student, how does my advisor approve my submission?

You will be asked to list your faculty advisor on the study submission. Once it is submitted, RAMP IRB will send the faculty advisor an email notification to review the submission which will appear in the advisor’s “My Inbox” page within RAMP IRB. Once the faculty advisor approves the submission, it will move to the state of “Pre-Review”. It is the student’s responsibility to monitor the submission status to ensure the workflow is progressing.

How do I close a study?

• If the study is in HSRS, the study will need to be closed through HSRS by selecting the “close” option, which will prompt the user to complete HRP-212 Form - Continuing Review
• If the study is in RAMP IRB, go to the IRB page and click on the “Active” tab, click on the protocol hyperlink to navigate to the study workspace and click on the “Create Modification/CR” button. Under the “What is the purpose of this submission?” question, select “Continuing Review” and follow the prompts on the “Continuing Review / Study Closure Information” SmartForm to close your study

How do I respond to clarification/modification requests from reviewers?

On the RAMP IRB study workspace, review the “History” tab to view the clarifications requested. To clarify information within the submission, click “Edit Study”, make any requested changes to the SmartForm and documents, and then click “Exit” on the SmartForm once all revisions have been completed. Finally, be sure to click “Submit Response” from the study workspace.

For more information on how to respond to clarification requests, please refer to the RAMP IRB Researcher's Quick Reference on the RAMP IRB Help Center page.

What is a PI proxy and how do I create one?

A proxy is a trusted team member that has been delegated authority to act on the Principal Investigator’s behalf. The proxy has the ability to create and submit studies, respond to clarification requests, modify studies and submit continuing reviews. There can be multiple proxies for a study; however, each must be listed as a study team member within RAMP IRB.

What if a team member is not listed in the person chooser?

You will need to contact your department’s Human Resources representative since this list is populated from all students, faculty and staff members affiliated with the university. It is possible that a courtesy appointment will be necessary.

What if my funding organization is not listed in the organization chooser?

The organizations are populated from OMNI and refreshed on a nightly basis; however, if your organization does not appear in the list, please email ramp-irb@fsu.edu and the Human Subjects Office will have it added as soon as possible.

How do I know if my current training is acceptable and how do I determine which training modules to complete?

The CITI program offers many different kinds of training, not all are required. The correct training is specifically called “Human Subjects Research (HSR)” training, which contains the required modules for protecting human subjects. Any other type of training from CITI will be missing required modules, therefore, your certificate must say “Human Subjects Research” training to be valid. In order to find/enroll in the correct modules, follow these instructions:

1. Register or log in to the CITI Program website
2. Affiliate with “Florida State University” and select the option to “Add a Course”
3. Nine questions will prompt you to choose which courses you’d like to register for. The first six questions are optional, supplemental training modules, please answer them accordingly. The 8th & 9th questions are also optional, but recommended
4. The 7th question asks if you are required to complete the HSR Training. Here you must select one of the “FSU Faculty, Staff, and Students” options in order to access the appropriate required training

Does the CITI training expire?

Yes, it expires every 3 years and then refresher courses are required.

Who is required to take CITI training?

The PI and study team members who are engaged* in research must complete training.

*Engaged individuals - persons who will obtain consent/assent, will have interactions (example data collection, recruitment) with research participants or have access to identifiable private research data.

Why is my CITI training not listed in RAMP IRB within the training tab?

In order for CITI training courses be to populated in RAMP IRB, the preferred email address in your CITI training profile must be a FSU-affiliate email address. Once the email address associated with your CITI training profile is updated, the completed CITI training course will appear in RAMP IRB within 24 hours.

How do I request FSU to be the single IRB or IRB of record?

Indicate this information on the “Basic Study Information” page of your study SmartForm:

• If this is a single-site study, select “no” on question #5, Will an external IRB act as the IRB of record for this study?
• If this is a multi-site or collaborative study, select “no” on question #5, Will an external IRB act as the IRB of record for this study?, and select “yes” on question #6, Will your IRB act as the single IRB of record for other participating sites?

For more information on a single-site external study, please refer to the RAMP IRB Researcher's Quick Reference on RAMP IRB Help Center page.

For more information on a multi-site or collaborative study, please refer to the RAMP IRB Multi-Site Study Researchers Quick Reference on RAMP IRB Help Center page.

How do I request to have another IRB be the IRB of record?

Indicate this information on the “Basic Study Information” page of your study SmartForm:

• If this is a single-site study, select “yes” on question #5, Will an external IRB act as the IRB of record for this study?
• If this is a multi-site or collaborative study, select “yes” on question #5, Will an external IRB act as the IRB of record for this study?

For more information on a single-site external study, please refer to the RAMP IRB Researcher's Quick Reference on RAMP IRB Help Center page.

For more information on a multi-site or collaborative study, please refer to the RAMP IRB Multi-Site Study Researchers Quick Reference on RAMP IRB Help Center page.

What is a reliance agreement and when is needed?

The regulations permit an IRB the option to rely on the review of another IRB. When this is the intention, the institutions enter into an agreement often referred to as an IRB Authorization Agreement (IAA). These agreements are executed between a Reviewing IRB and one or more Relying Institutions and delineate the roles and responsibilities of the involved parties. The agreements can be for a single research study or for multiple studies (e.g., a Master Reliance Agreement). The National Institutes of Health (NIH) and some funding agencies have required the designation of one IRB to serve as the Reviewing IRB for all participating sites in multicenter research studies.

Effective January 25, 2018 the NIH has mandated that all domestic sites participating in a non-exempt, multi-site research study (where study activities outlined in a single protocol are carried out at multiple institutions) use a single IRB (sIRB).

Effective January 20, 2020, OHRP will require a sIRB for all domestic sites participating in a non-exempt, cooperative research study (two or more institutions coordinate to complete a portion of the research outlined in a specific protocol).