HRPP Toolkit Frequently Asked Questions
What is the Human Research Protection Program (HRPP) Toolkit?
The toolkit is a comprehensive set of workflows, standard operating procedures, checklists, worksheets and templates. It is implemented by many human research protection programs of all sizes. The updated templates help research teams develop and submit compliant protocols to the IRB. The resources contained within the toolkit will be utilized with our current electronic Human Subject Research System (HSRS) to aid in the transition to the new RAMP IRB system, which will go-live in late June. Additionally, an Investigator Manual is included as an important reference that provides a general overview of Investigator responsibilities, both in terms of designing and initiating human research, and managing human research once it’s activated.
When should researchers use the toolkit templates?
Beginning April 20, 2019, all new protocols and continuing reviews (renewals) require the submission of a protocol document that is part of the HRPP Toolkit using the current HSRS. All protocol modifications (changes in protocol) will be presented with the option to either submit using the current application process, or the protocol document within the toolkit.
Any submissions that have not been updated to the toolkit templates will not be automatically imported into RAMP IRB. Protocol modifications (changes in protocol) or continuing reviews (renewal) for these submissions will require a new submission in RAMP IRB using the HRPP Toolkit templates. For this reason, the Human Subjects Office highly encourages investigators to begin utilizing the HRPP Toolkit templates as soon as possible.
Once the RAMP IRB module goes live, HSRS will no longer be used for submissions. The RAMP IRB module will be used for all submissions and HSRS will remain for researchers to access historical documents.
What training is offered for the toolkit?
Several Protocol Development Workshops were offered prior to the implementation of the toolkit. If you were unable to attend the workshop, a recorded webinar is available on the Human Subjects Office website in the Training and Education section. A second webinar, which outlines the resources available within the toolkit, is posted on the website as well. The Investigator Manual should be accessed as an additional tool which furnishes guidance on submitting compliant IRB protocols.
Why has the consent form changed?
The form is designed to cover all study types and any questions that are not applicable should be deleted from the template or marked as “N/A”. The comprehensive list of questions contained within the new template will allow the Human Subjects Office to better determine at an early stage whether the protocol should be classified as exempt, or should be routed for expedited or full committee review.
How do I submit a modification (revision or change in protocol)?
All protocol modifications (changes in protocol) will be presented in HSRS with the option to either submit using the current application process, or the protocol document within the toolkit. Maintain electronic copies of all information submitted to the IRB in case revisions are required. Please note that research must continue to be conducted without inclusion of the modification until IRB approval is received. Updates to the list of study personnel will be acknowledged unless the update represents a modification to the research.
How do I submit a continuing review?
Complete the renewal application in HSRS and attach the toolkit protocol (and consent form if applicable) in the document upload section on the last page. Maintain electronic copies of all information submitted to the IRB in case revisions are required. Before submitting the research for initial review, you must:
- Determine whether any member of the research staff has a financial interest related to the research. A “yes” or “no” answer is sufficient. There is no need to obtain additional details.
- Obtain the verbal or written agreement of each member of the research staff to his/her role in the research.
If the continuing review application is not received by the date requested in the approval letter, you will be restricted from submitting new Human Research until the completed application has been received.
If the approval of Human Research expires all Human Research procedures related to the protocol under review must cease, including recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection or analysis of private identifiable information.
How do I close out a study?
Complete the continuing review in HSRS, which also serves as the final report to close a protocol. Be sure to maintain electronic copies of all information submitted to the IRB in case revisions are required.
If you fail to submit a continuing review form to close out Human Research, you will be restricted from submitting new Human Research until the completed application has been received.
If the continuing review application for closing out a Human Research study is not received by the date requested in the approval letter, you will be restricted from submitting new Human Research until the completed application is received.
Will my protocols in HSRS transition to RAMP IRB?
All submissions (new protocols, modifications, or continuing reviews) in the HSRS that have been approved as of June 14 using the HRPP Toolkit templates will automatically be imported into RAMP IRB when the module goes live on June 21.
All submissions using the HRPP Toolkit templates that are not approved by June 14, or other approved submissions without the HRPP Toolkit templates will not be automatically imported into RAMP IRB. Modifications (changes in protocol) or continuing reviews (renewal) for submissions that are not automatically imported into RAMP IRB will require a new submission in RAMP IRB using the HRPP Toolkit templates. For this reason, the Human Subjects Office highly encourages investigators to begin utilizing the HRPP Toolkit templates as soon as possible.
Where can more information be obtained?
Please access the Human Subjects website for more information on Investigator resources, the HRPP Toolkit, training resources, policies and procedures and CITI training requirements, as well as other information related to human subjects research. Also, be sure to sign up for the IRB listserv notifications if you aren’t already receiving them (email humansubjects@fsu.edu to be added to the distribution list).
For timely information on RAMP, please visit the project website at https://ramp.research.fsu.edu and watch for updates in the monthly Research Newsletter.