Annual HRPP Progress Updates
What is the purpose of the Annual HRPP Progress Update submission?
Some studies have expiration dates and some do not. Expiration dates indicate that the study must meet the regulatory requirement of Continuing Review, to report back and seek reapproval from the IRB.
For studies without an expiration date, there is no regulatory requirement to report back and seek reapproval. However, the institution still needs information about the status of the study reported back periodically. For example:
- If a study is still open, the HRPP needs to verify that the training requirements for study personnel are still up to date.
- If a study is still open, the HRPP needs to verify that COI dislosures and management plans are still up to date.
- The HRPP needs to verify that enrollment numbers and the included population are appropriate.
- If a study is eligible to be closed, the HRPP and IRB need the closure to occur so that they can make an accurate accounting of all active research.
Which types of studies do not require an expiration date in ERICA?
- Studies that receive an Exemption Determination from the IRB.
- The majority of studies that are IRB-approved as minimal risk, expedited research.
- For studies using an external IRB, the expiration date requirement is managed by the external IRB. You must continue to submit continuing reviews and information to the external IRB as required. Because an expiration date for these studies is not managed in ERICA, these studies will require an Annual HRPP Progress Update as well.
This information about the study can be found
- on the IRB's initial determination letter, and
- on the workspace of the study in ERICA.
When is the HRPP Progress Update due?
The HRPP Progress Update is due by the annual anniversary date of the study's initial approval or exemption determination from the ERICA system. An HRPP Progress Update submission is required annually for as long as the study is open.
Will I be prompted to submit an HRPP Progress Update?
Yes. You will receive two email reminders from the ERICA system that the Annual HRPP Progress Update submission is coming due.
Can I submit the HRPP Progress Update early, before the anniversary day?
Yes. You can submit the Annual HRPP Progress Update up to 60 days in advance of the anniversary day. This will not change the anniversary day for the next year.
What happens if I do not submit the HRPP Progress Update by the due date each year?
If the Principal Investigator does not submit the HRPP Progress Update by the annual anniversary date of the study's initial approval/exemption, the study will be administratively closed. Investigators will be given a 10-day grace period after the due date before the automatic closure occurs.
If a study is closed before the study is complete, a New Study application must be submitted to the IRB to continue research activities. The investigator must wait until that new application is approved to continue research activities.
What information is required in the HRPP Progress Update?
The HRPP Progress Update application requests the following information:
- progress of the study
- enrollment and withdrawals
No new forms or documents will be reviewed or approved without an amendment application.
The HRPP Progress Update application includes the option to add on an Amendment. Fill out the Amendment pages as prompted.
When an amendment is added, the HRPP Progress Update is not automatically acknowledge by the ERICA system. The combined HRPP Progress Update and Amendment application will go through the regular amendment review process. The amendment should not be initiated until IRB approval is received.
How do I fill out the HRPP Progress Update in ERICA?
The HRPP Progress Update is built as a pathway in the existing Continuing Review application. The ERICA application automatically determines which pages of the application you need, based on whether you need a Continuing Review or HRPP Progress Update.
To start an HRPP Progress Update application,
- Open the study.
- Click on the Continuing Reviews tab.
- Click on the Create button.
What is the review process for an HRPP Progress Update submission?
For HRPP Progress Updates without an Amendment
Investigators do not need to wait for IRB acknowledgement of the HRPP Progress Update. Because your study does not expire, your approval has not ended and you may continue on with your study as normal.
The HRPP Progress Update application will be automatically acknowledged by the ERICA system if all training and COI disclosures for study personnel are up-to-date. The IRB and HRPP staff will not review the submission immediately.
If training and COI disclosures for study personnel are not up-to-date, then the HRPP Progress Update will go into a pending state and prompt you via email to update these items. You may be contacted by IRB and HRPP staff to ensure completion of these requirements. Failure to complete these requirements in a timely way will result in administrative closure of the study.
For HRPP Progress Updates + Amendments
When an amendment is included, the HRPP Progress Update is not automatically acknowledged by the ERICA system. The combined HRPP Progress Update and Amendment application will go through the regular amendment review process, which includes verifying that training and COI disclosures for study personnel are up-to-date.
The amendment should not be initiated until IRB approval is received.
Will Industry or Single IRB fees be charged for HRPP Progress Update submissions?
Yes, but indirectly. For-profit and/or industry sponsored studies and single IRB studies must pay annual IRB fees, which will be invoiced separately from the HRPP Progress Update application. This fee covers the cost of ongoing oversight responsibilities of the IRB and HRPP.