In the wake of widespread community transmission of COVID-19 across New York, it is important for researchers to comply with Teachers College (TC) mandates and guidelines.
TC researchers should visit TC's Preparedness site for regular updates. Researchers partnering with external institutions should check those institutions' websites for up-to-date information. Researchers can also visit the Council on Governmental Relation's website which serves as a resource hub for COVID-19 related information from various institutions and agencies.
As of the date of this post, April 9, 2020, we will address concerns and constraints around conducting research and ways TC IRB seeks to support our researchers during this challenging time.
All information presented in this post is subject to change based on the evolving COVID-19 situation. Please check TC IRB’s Updates page for more information.
Modify Approved Protocols in Response to COVID-19
If your research methods are affected by COVID-19, you must notify TC IRB using the modifications submission process on Mentor IRB. Walk-through guides for COVID-19 modification submission are available on our Updates page. Additionally, if you are changing study methods or participant activities due to COVID-19 limitations, do not forget to inform your participants and update your consent forms. All relevant changes to documentation (such as consent forms, or recruitment flyers) should be submitted to the IRB along with your modification.
Secure Digital Data
Researchers are required to access, store, and manage digital data in secure ways. Efficient and safe data security methods are important for all digital data, especially sensitive data with identifiers. TC IRB recommends that all researchers adhere to the Data Security Plan. Researchers may also want to review the Data Sharing, Requests, & Encryptions section on our website.
Teachers College Information Technologies (TC IT) offers support for students, faculty, and staff. The initial point of contact should be the TC Service Desk (email@example.com or (212) 678-3300). The Service Desk can assist with the setup of all data access, collection, and storage resources.
How to Access Research Files and Essential Research Materials Remotely
In the interest of protecting both participants and researchers, the TC campus is currently closed to all non-essential personnel. Faculty who have important digital files on campus can work with TC IT to gain remote access. Physical files on campus are not currently accessible. TC IT provides the following resources for researchers:
- TC IT COVID-19 questions
- Research Related Technology Questions and reporting an incident (e.g., how to safely secure research data at home)
- Self-pace tutorials for software
- TC IT Backup Basics Presentation
- TC IT Stay Safe from Phishing Presentation
- TC IT All About Apps Presentation
We strongly recommend that TC researchers find ways to proceed with electronic files that can be remotely accessed. Researchers may email IRB@tc.edu if their inability to access physical files on campus disrupts an IRB protocol submission or review. TC IRB will work with researchers on a case-by-case basis on how to proceed.
Requirements for Remote Study Activities
Study-related activities that do not require face-to-face interaction, such as data analysis, writing up of results, grant preparation, or planning for future research, may continue off-campus if the following requirements are met:
- All identifiers must be removed from any digital data (such as computer files, recordings) or physical data (such as paper records) that have been taken off-campus;
- All data must be securely stored at the remote location, such as in a locked file cabinet, or in a secure digital location such as TC's password-protected google drive or Dropbox folders;
- AND digital data protection procedures outlined in the approved study IRB protocol must be maintained.
Any researchers wishing to move their face-to-face research to an online format should submit an COVID-19 specific IRB modification through Mentor (for a walkthrough guide, please download How to Submit COVID-19 Modification Online Activities).
If you are pausing your research for other purposes (e.g., timeline adjustments or typical research plans), or submitting a typical minor modification (e.g., research staff change) you do not need to submit a COVID-19 response modification. You can in this case submit a typical modification. To submit a typical modification (not in response to COVID-19), visit TC IRB’s Modification page.
Suggestions for Maintaining Communication and Cross-Training Staff
As New York City is currently under a shelter-at-home mandate, consider holding regular meetings with research personnel via telephone or conferencing calls (e.g., Zoom). For a guide on how to use Zoom, visit TC IT’s Knowledge Base or TC's Canvas Zoom Tutorial.
Research staff, consultants, and assistants should be updated on changes to research compliance, especially if protocols are being moved to online services or modifications have been made to research methods.
Additionally, staff should be cross-trained to perform their duties and continue research protocols, even if a vital member of the team cannot complete their duties for any reason. All staff should visit TC IT’s website for training modules and precautions when using online software. Be aware of security risks inherent in the use of these platforms (e.g., the recent phenomenon of Zoom bombing) and take precautions where possible.
Please note that while the Health Insurance Portability and Accountability Act (HIPAA) has temporarily relaxed regulations regarding patient privacy and disclosure, the HIPAA waiver only applies to hospitals covered by a public health emergency.
All TC researchers should continue to follow regular HIPAA regulations.
Additionally, HIPAA has temporarily allowed for the use of telehealth medical services via non-public-facing remote third-party services. If a researcher is planning to utilize telehealth medical services in this manner, please submit these plans in a minor modification to TC IRB.
In this trying time, we would like to thank all our researchers for their continued cooperation and support. The compliance of faculty, staff, and students in the face of evolving regulations and policy changes has helped ensure the continued protection of all our research participants. TC IRB will continue to monitor the evolving COVID-19 outbreak and communicate best practices to our investigators. We will post any further updates on TC IRB's Updates page. The TC IRB office is working diligently to maintain a responsive and supportive presence throughout the quarantine.