In July, the Office of Research Services launched a new tool called the “Agreement Navigator.” If you ever have had an agreement and you weren’t sure where it was supposed to go for processing and signature, (was it GCO or maybe MSIP or was it the FACTS office?), this new resource will help you. Confidentiality Agreements, Data Use Agreements, Subaward Agreements, and Grant Agreements are some of the categories you will find. Click here to open the Navigator. The Grants and Contracts Office posted a link in the Getting Started section of the GCO Application Info webpage and the Policies and Procedures section as well.
In response to a growing interest in the Good Clinical Practice (GCP) Refresher course, the Program for the Protection of Human Subjects (PPHS) has now made a refresher course available via the CITI program for Icahn School of Medicine at Mount Sinai. Although there has been no change in institutional requirements, the PPHS wanted to make it easier for those who work on studies with external sponsors who require completion of a GCP Refresher every three years to conveniently get it.
What you need to know:
- The GCP basic course name has been updated to GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus), which is the necessary precursor for the GCP Refresher.
- All credits transferred from the GCP course, so no one lost any credits due to this change.
- The GCP course now indicates that it expires every three years, enabling one to take the GCP Refresher course to comply with sponsor requirements.
- The PPHS office is not mandating this additional course (the refresher).
If you completed the GCP course over three years ago, when you log in to https://www.citiprogram.org/ your main page will indicate that you have incomplete coursework. If your sponsor requires a refresher every three years you can access it here. If your sponsor does not require the Refresher course, you can confirm your training status by clicking “View Previously Completed Coursework” under “My Learner Tools for Icahn School of Medicine at Mount Sinai.” You will be directed to a screen that includes the Basic Course. By clicking on “View” in the “Completion Report” column, you can print or save proof of your completion.
If you have any questions about this new resource or PPHS training requirements, contact the PPHS at email@example.com.
In July, the Program for the Protection of Human Subjects (PPHS) announced that all sites within the Mount Sinai Health System can use commercial IRBs in accordance with the Icahn School of Medicine at Mount Sinai’s policy.
All requests to use a commercial IRB must be sent to IRB@mssm.edu using HRP-229A. The PPHS office must approve any request to submit an application to the commercial IRB. While the official IRB review will then be conducted by the external IRB, all other institutional requirements must be met. These are including but not limited to Investigational Drug Service review, Radiation Safety Committee review, submission to the Grants and Contracts Office, Conflict of Interest disclosure and management, and fulfillment of education requirements. Requests will be evaluated to ensure these institutional requirements have been met before a study team will be granted permission to move forward with their application.
There is a one-time administrative set up fee of $575 for industry sponsored research permitted to use a commercial IRB for the official IRB review of the study.
For additional information, please review the Use of Commercial IRBs under Guidance and Policies.
After reviewing the 229A form and Commercial IRB guidance and policies, if you have questions about the policy and if your study might qualify, please contact Liz Carroll at firstname.lastname@example.org or 212-824-8225.
Back in July, the GCO released Sinai Central Investigator Form (IF) Instructions, which are a comprehensive set of policies and procedures that apply to the Icahn School of Medicine at Mount Sinai and all the member hospitals. “Designing and implementing the best conflict of interest management policy is complicated,” says Jessica Moise, Grants and Contracts Officer and Senior Associate Dean for Sponsored Programs. “Filling out the disclosure forms shouldn’t be.” The IF instructions include technical instructions on completing the form, common problems and solutions, status tables, a contact section, and other helpful information.
This Fall, effective with competitive grant applications submitted on or after January 25, 2016, the National Institutes of Health (NIH) plans to release updated SF424 application instructions and funding opportunity announcements that will include additional requirements in the Research Strategy section. The Research Strategy section must address three more points of consideration as follows:
- Scientific Premise
- Rigorous Experimental Design
- Consideration of Sex and Other Relevant Biological Variables
Although the NIH requires more information in this section, the page limit does not increase.
Principal Investigators will also need to include a new attachment entitled “Authentication of Key Resources” into their application. In this attachment, researchers disclose what they have done to authenticate key biological and/or chemical resources.
The NIH has posted more information in two policy notices, NOT-OD-15-102 and NOT-OD-15-103, and the research community can also refer to NIH’s FAQs , which contain helpful definitions and other practical information on this topic.
Have you ever been stumped at the dizzying array of budget corrections from your GCO Grants Specialist and thought “If I only knew the ins and outs of budgeting beforehand, it would have been so much easier?” Even if you haven’t thought that, maybe you are thinking that now? And if you aren’t thinking that now, what exactly are you thinking about? Lest the author of this paragraph digresses any further, please do consider taking GCO’s budgeting class entitled, “GCO 201: Sponsored Projects Budgeting”. This class is designed for PIs, research coordinators, administrators, and anyone involved in the budget preparation process. Although this class is an introduction to the topic of budgeting, there is no such thing as an introductory, or simple, budget. By the end of the class, you will be conversant in basic budgeting terms and equipped with calculation tools to help you figure out your budget. Additional information on the class, including prerequisites, is posted here. Please register on PEAK > Classroom Based Trainings > Research. Class size is limited to 12 seats. GCO will consider adding more sessions if classes develop wait lists. Please contact Allison Gottlieb at Allison.Gottlieb@mssm.edu with any questions.
“National Research Administrator Day is observed annually on September 25. This is a day to recognize the contributions made by administrators every day,” says the author of the National Research Administrator webpage posted here. “Come celebrate with us,” we at the GCO say. “What did you have in mind?” you say. “Well, according to this website, you can take us out to lunch, but it is a major NIH deadline so we’ll be brown-bagging it. Feel free to send us an e-mail or give us (or your departmental grants administrator, the IRB, IACUC, Sponsored Projects Accounting, FACTS, Research IT, the Office of Research Services, or even Research Compliance) a call to say… THANKS!