Amendment & Renewal Processes

Once a HPSCRO application is reviewed and approved by the HPSCRO Committee, the application is updated to display the Approval Date and it becomes the investigator's Record of Approved Project.  The investigator will continue to work with the HPSCRO administration and Committee to:

• Amend their record before making changes to the approved research 
• Renew their record before the three-year approval period expires
• Terminate their record once the research has concluded

HPSCRO Amendment Process

As the investigator, it is your responsibility to alert HPSCRO to changes in your approved hESC or iPSC research prior to the implementation of those changes.  To submit an Amendment, update your Record of Approved Project and send it via email or fax to HPSCRO.  Changes that require an amendment submission for HPSCRO are:

• Work with hESC or iPSC lines other than those in the approved application
• Plans to obtain somatic cells for derivation of iPSC from a new source and/or of a different type
• Plans to add or alter the stem cell research in animals, including plans to allow animals to breed
• Any human use of iPSC or hESC lines
• Plans to distribute iPSC or hESC lines, or their living derivatives to other researchers

HPSCRO Renewal Process

HPSCRO approvals are active for three (3) years.  Near the expiration of your approval, you have the opportunity to renew for another three-year period or terminate the approval.  HPSCRO administration initiates the renewal process by emailing the HPSCRO Renewal Questionnaire and the current Record of Approved Project to the investigator for completion and submission.

The Questionnaire asks you to:

1. Indicate whether the approved work is continuing
2. Explain any new findings about the cell line's pluripotency ability
3. Confirm the storage location(s) of cell lines not in use, or to provide details regarding disposal of cell lines
4. List and publications or invention disclosures that have resulted from the research
5. Summarize any project changes to be made upon renewal
6. Indicate whether the cell lines you've obtained or derived have been shared outside your laboratory 

If there are project changes at the time of renewal, you are expected to sumbit an updated Record of Approved Project with the completed Questionnaire for HPSCRO review.  If the work is not continuing, the completed Questionnaire becomes your notice of termination to HPSCRO.  In this case, the expiration date of the approval will be the termination date.

Amendment & Renewal Review

The level and type of change indicated in an amendment or renewal determines the HPSCRO review process for the submission.  Under limited circumstances, these submissions are eligible for the Adminsitrative Review process.  This process does not apply to initial applications.

Administrative Review Criteria

1. For amendments & renewals:  the additon of an unrestricted NIH Registry line to approved in vitro or in vivo work, when all aspects of the experimental procedures remain the same as previously approved
2. For amendments & renewals:  the addition of a new source (e.g., patient population, tissue type) of somatic cells for iPSC derivation, when the informed consent language has been previously reviewed by the HPSCRO Committee and all aspects of the experimental procedures remain the same as previously approved
3. For renewals only:  there are no changes to the research

If the level/type of change for an amendment or renewal exceeds the Administrative Review criteria, the submission is reviewed via the Convened Committee Review or Expedited Review processes (see HPSCRO Review Process for details).