We are writing to advise you of several changes in CHeRP. These changes are the result of an effort to streamline the review process for some new/existing ancillary reviews and reports of action. The changes are as follows: 

1) New Information Technology Forms and Ancillary Review

We have added a new Information Technology Ancillary Review to the protocol review process, within the CHeRP SmartForm. If your protocol involves mobile technologies, wearable devices, electronic recordings, conferencing, or text messaging, you will now see separate forms/questions. In addition, the forms have been revised to include detailed information about how research data will be transmitted, processed, and/or stored. Answers to specific questions will automatically trigger a review by Research Computing (Kris Bolt). Research Computing will be required to sign off and approve the protocol in CHeRP before the IRB releases approval. The IRB can simultaneously review the protocol during this ancillary review, but any changes or clarifications required by Research Computing may result in protocol revisions before approval is granted. As many of you have been already been referred to Kris Bolt during the IRB review process, we have created these questions to help streamline and track this process. Please contact Kris Bolt for any questions at Kristen.Bolt@childrens.harvard.edu .

2) New General Data Protection Regulation (GDPR) Ancillary Review

GDPR specific questions have been added to the CHeRP SmartForm for international research concerning regulations on data protection and privacy. Those that involve the European Union (EU) and the European Economic Area (EEA) will trigger an ancillary review by HIPAA Privacy Officer, James Downing. The IRB will not be able to release approval for a new protocol until GDPR issues are reviewed and considered by the HIPAA Privacy Officer. Please contact James Downing at James.Downing@childrens.harvard.edu with questions.

3) Modification of Social Work Services

The CHeRP SmartForm regarding social work services have been revised so that investigators will be required to include information about social workers and resources identified to support the research. If applicable, investigators will need to include detailed information before submitting the protocol. 

4) New COVID-19 Scientific Review

As was announced in a separate communication, any new COVID-19 related research or amendments that add populations of COVID, will be subject to scientific review by a newly developed COVID Scientific Review Committee. This new scientific review will replace your department/division scientific review process. A question has been added to all CHeRP SmartForms to identify those that will automatically be routed for this review. The only exception is research limited to the use of secondary data.

5) Reference to Documents Approved with Submission

There is a new SmartForm question requesting research teams to list the names/versions/dates of the documents that you want listed that were approved as part of new submissions and amendments. Please note: You must type the names of the documents EXACTLY the way you want them to appear in the approval letters. The name of the document that you type in the SmartForm MUST match the title of the attached document. IRB analysts will check if the documents listed are indeed part of the submission or amendment, but will not modify or alter any title. This will be part of the pre-review process, and the IRB analysts may send feedback for corrections.
Please note the following:

  • The new/revised questions will appear in all IRB applications that have not yet been submitted and/or approved, and will trigger the required ancillary reviews. This means, if you have a protocol under review, you are going to need to answer the new questions before we can approve it. When changes are made to the CHeRP SmartForms, this is the only way it can be implemented as part of the CHeRP platform. 

  • In addition, anytime you submit an amendment that requires changes on the pages with new questions, you will need to provide new information. Amendments will not automatically trigger ancillary reviews.  

  • Changes have also been made to the reliance forms. For submissions that are under review, the new/revised questions will need to be answered before the request can be 'approved.' This includes a new ClinicalTrials.Gov page in the ‘Reliance on Another IRB’ application, which will trigger the required ancillary review.  

We recognize these changes may require additional time to complete the required CHeRP forms, but we hope that the new required information will streamline the review process and provide information that many of you have requested in the approval letters. Please call your IRB analyst with any questions or concerns.