Changes to Human Subjects Certificates of Confidentiality

As previously indicated in communication from the Program for the Protection of Human Subjects (PPHS), all NIH funded protocols that were active on December 31, 2016 (or commenced after that date) and involve human subjects, activities using or generating identifiable human subject data or samples, or the generation of individual level, human genomic data was automatically granted a certificate of confidentiality (CoC) by the NIH, effective October 1, 2017 (Please see the PPHS announcement for details).

In order to assure that the affected participants in qualifying protocols have been, or will be, notified, the PPHS requires that the Principal Investigator submit a copy of the Investigator’s CoC Notification Form for each protocol that received a CoC on October 1, 2017. While it is not required that the plan be fully executed at this time, it is important that the form(s) acknowledging that the plan is being implemented are sent to IRB@mssm.edu as soon as possible, if not done so already.

The PPHS has drafted a letter describing the pertinent information for participants (Spanish translation available upon request); however, research teams that choose to mail/email the letter to participants must also draft a cover letter reminding participants of the study and providing contact information for the study team in the event the participants may have questions. Please note that the original deadline for sending the letter to all participants, or notifying the PPHS that the task has not yet been completed was October 31, 2017.

If you have chosen to contact participants directly (e.g. phone, in-person), you should still complete the Investigator’s CoC Notification Form as soon as possible, if not done so already. If you have not spoken with all participants by November 30, 2017, you will need to re-contact the PPHS with an update on your progress.

If you have not already completed the above mentioned steps, please submit the Investigator’s CoC Notification Form upon receipt of this email, and reference the Guidance and Policies section of the PPHS website for additional details.

 

InfoEd Instructions For Submissions Started Prior to Upgrade

The Grants and Contracts Office conducted a major upgrade of InfoEd on Friday, November 17, 2017, and it may have affected some users’ submissions. Researchers may need to take additional steps to ensure that their submissions are properly completed.

If you started your project in InfoEd prior to the upgrade, which began at 5 pm of 11/17, and it has not already been received by the GCO, please be aware that finalizing, routing and sign off may be impaired since the old template will not convert to the new template properly without a manual intervention.  Below are the steps to fix it:

  1. Go into the Setup Questions > Please select a Submission Mechanism/Screen Template.  In this drop down, select any choice.  Then re-select yours. This refreshes the program and creates the correct InfoEd application.
  2. You must re-upload your Lay Summary, Research Plan, Progress Report, and/or Final Report in the appropriate tabs.
  3. You should now see the eForm as a stand alone tab.  If it’s new, the eForm is called “New/Competitive Renewals/…”.  For other projects, it is called “Non-Competi Cont/Supplement…”
  4. On the eForm, please answer q. 16 re: location again.

Technical support for InfoEd applications is available by opening a Ticket with Research IT.

 

Accessing Stony Brook University Cores

The CoRE administration is pleased to announce the formal agreement for Stony Brook University (SBU) to provide Proteomics and Metabolomics support to the Icahn School of Medicine at Mount Sinai (ISMMS). This agreement was presented at the recent SBU / ISMMS Scientific Symposium on October 30, 2017.

At the end of November all SBU cores, including Proteomics and Metabolomics, became available to ISMMS researchers. For more information on the proteomics services provided by SBU, please visit their Proteomics Core at http://dev-office-of-scientific-affairs.pantheonsite.io/research-core-facilities/bms.

To access SBU cores, please follow these steps:

  1. Log into iLab using ISMMS url (https://ismms.corefacilities.org/account/login)
  2. Click on the “list all cores” link on the left-hand menu
  3. Select other institutions in the dropdown menu and search for Stony Brook
  4. Select the core you want to use

If you have any questions about SBU cores, please email Shekhar Patil (shekhar.patil@mssm.edu).