NYCDOE IRB COVID-19 FAQ (03.22.2020)
- My study was under review by the NYCDOE IRB but was not approved before the closure of schools and the shift to remote work. Is the NYCDOE IRB continuing its work during this time?
Yes, but we are presently prioritizing amendments and research that aims to address the COVID-19 pandemic and its impact on NYCDOE families and staff.
- Why must some human subject research studies or specific activities be paused?
The COVID-19 pandemic has altered the risk/benefit ratio for in-person contact associated with research activities. Ethical principles of research as well as federal regulations for the protection of human participants in research require an acceptable risk/benefit ratio.
- Can the study team conduct home visits to collect data?
- Which studies or study procedures must be paused?
Studies or study procedures involving face-to-face interaction with participants that have no direct therapeutic benefit must be paused or modified.
Procedures such as telephone contact or remote communication or remote data collection may continue.
- What previously approved human subject research activities may continue?
On-going research that does not entail in-person interaction or intervention may continue.
Researchers are asked to voluntarily suspend their research if they can do so safely and if the suspension will not jeopardize the scientific integrity of the research. Note that NYCDOE schools are presently closed.
- My study involves observations on classroom activities, but now classroom activities have been moved to a virtual platform. May I continue observations of, for example, a Google classroom?
These requests will be considered on a protocol-by-protocol basis and must be submitted to the IRB for consideration via protocol amendment.
- Does modifying from in-person to remote (e.g. phone, Teams, Zoom, etc.) data collection require prospective review and approval from the IRB?
Yes, review and approval from the IRB for all changes to previously approved data collection procedures is required. The exception to this is a change implemented to reduce or remove immediate risk to research participants. These changes must be reported to the IRB using the Unanticipated Event xform within 10 business days of the implemented change.
- For an approved and ongoing study, can the study team collect data and follow-up with previously enrolled subjects by telephone or through other electronic communication platforms?
Yes, but only after this change to data collection has been reviewed and approved by the NYCDOE IRB through the submission of a protocol amendment.
- My research (e.g. timeline for data collection) has been directly impacted by closure of NYCDOE schools. Do I need approval from the IRB to reflect the impact/change this has had on my previously approved data collection and enrollment targets?
Researchers must submit amendments to reflect the necessary changes they will be required to make to their studies. These amendments may be submitted at the researcher’s discretion.
- Does a change to the consent process to enroll new study subjects (e.g. from in-person to electronic) require prospective review and approval by the NYCDOE IRB?
Yes. Among other considerations, consent determinations correlate with previous risk determinations. Further, changes to the previously approved consent process may require changes to previously approved consent forms.
- If I revise my study to migrate data collection to an electronic platform, will I need to reconsent my study subjects?
These determinations will be made on a protocol-by-protocol basis. Generally, an information letter will suffice.
- What do I need to know about conducting research with students/children online?
Conducting remote or online research with children is subject to additional laws, regulations, policies, ethical principles. and administrative safeguards. This includes, but is not limited to, COPPA, numerous NYS and city laws, as well as applicable NYCDOE regulations. For guidance, please email firstname.lastname@example.org (additional formal guidance is forthcoming).
- How do I open a new research study related to COVID-19?
Email email@example.com with the subject line “COVID-19 research study”. All requests will be reviewed on a case by case basis but will be prioritized if demonstrated to be of importance to the NYCDOE or to the wellbeing of NYCDOE families and/or staff.
- Can new study subjects be enrolled in protocols that are already ongoing?
To minimize the burden on NYCDOE families and staff, it is recommended that new study subject enrollment be halted for the time being, but requests to enroll new subjects in ongoing research will be considered by the NYCDOE IRB on a case by case basis. Please email firstname.lastname@example.org for guidance.
- Do I need to notify the IRB if I pause my research?
No, unless the research is federally-funded.
- What about federally-funded studies with mandatory progress report and other deliverable deadlines?
For suspended or paused studies with federal funding (e.g. IES, USDE, NIH, NSF, HHS, etc.) for which the NYCDOE IRB is serving as the IRB of record, the following information must be emailed to Marianna Azar at email@example.com immediately:
- Name of PI
- Protocol number
- Name of Sponsor
- Grant award number
- Contact information for your grant officer or point person
- I have a progress report due in the near term and my study has been impacted by the COVID-19 pandemic and/or closure of NYCDOE schools. Should I include information relating to this pause/impact in my progress report?
Yes. You should also work with your grant officer to determine the agency-specific requirements that may have been put in place to address the pandemic and its impact on ongoing research.
- My study is going to expire in the coming weeks or months. Should I submit a renewal request even if I cannot continue the research during this time?
Yes. Studies that are allowed to expire will not be renewed and will necessitate the submission of a new initial submission detailing all research to be carried out moving forward.
- At this time, the NYC DOE External Data Request Committee will continue processing requests, but we are currently working with severely limited capacity to fulfill approved requests, so it will take substantially longer to complete requests at this time. We will continue to update this page with additional guidance when available. Please contact RPSGResearch@schools.nyc.gov with any questions, thank you for your patience.
The DOE provides two options for research on New York City schools
- Institutional Review Board (IRB): If you are looking to conduct research inside schools, or plan on contacting anyone associated with the DOE (administrators, teachers, parents, students), you must submit a proposal to the DOE IRB.
- Data Requests: If you are planning a research study or evaluation that will use data on individuals (student- or staff-level data), you must submit a proposal to the DOE Data Request Committee. If you are only looking for school-level data, see what's available with our Citywide Information and Data overview.
For more information on the Institutional Review Board and Data Requests, see below.
Institutional Review Board
The NYC DOE IRB may approve researchers to conduct studies within schools or undertake research activities that involve contacting anyone associated with the NYC DOE while ensuring that research does not compromise the privacy of our students, parents, and staff or disrupt the work of students, teachers, and administrators. In order to receive approval, researchers must submit a proposal to the DOE IRB.
External or outside researchers must submit a proposal along with documentation of approval from their IRB of record. The NYC DOE IRB serves as the IRB of record for NYC DOE affiliates only. The NYC DOE IRB may require external researchers to change research proposals approved by their IRB of record. These required changes, including, but not limited to, any/all changes to consent procedures or documents, must also be reviewed and approved by the external researcher’s IRB of record.
How do I submit a research proposal?
Proposals to conduct research or evaluations in schools or that involve contacting anyone associated with the NYC DOE are reviewed by the DOE IRB. All research proposals must be submitted through the DOE’s electronic submission platform, IRBManager. For more information on how to log in to the system and create an account, see our overview How to Use IRBManager.
What is the NYC DOE IRB review process?
Submissions are reviewed on a rolling basis. Studies that require review by the Full Board are placed on the agenda for the next available meeting date once they are determined to include all required elements for review.
Where can I get more information about the IRB process?
The NYC DOE IRB is registered with the United States (US) Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP). The DOE IRB registration number is: IRB00011754
Federal Wide Assurance:
The DOE has filed a Federal Wide Assurance (FWA) with the US DHHS OHRP, which documents the DOE’s commitment to comply with federal regulations for the protection of human subjects in research. The DOE FWA number is as follows: FWA00005811
General questions about the IRB process should be emailed to IRB@schools.nyc.gov.
Regulatory or compliance questions should be directed to:
Director and Chair of the New York City Department of Education Institutional Review Board
What if I do not need to conduct research in schools or contact anyone associated with schools?
If your research does not involve human subjects, and instead exclusively relies on the use of DOE administrative data, you do not need to submit a proposal to the IRB. Instead, you must complete the data request process below.
The DOE may approve researchers to use individual-level (students or staff) administrative data from New York City schools as part of research studies or evaluations. In order to receive individual-level data, researchers must submit a data request to the DOE Data Request Committee. School or other DOE staff cannot provide data to external researchers. Additionally, research directly involving data collection in schools must first be approved by the IRB.
Researchers are strongly encouraged to first explore the school-level data that is publicly available. Information and Data Overview contains links to data on School Quality Reports, test results, graduation results, and demographics.
The Data Request Committee is a part of the DOE's Research and Policy Support Group (RPSG).
If you are a DOE Central Administrator in need of data from a DOE source system, please visit the Office of Data Management's Data Request Form page.
To request individual student records or transcripts, please visit this page.
How do I submit a data request?
Proposals to conduct research or evaluations in schools are reviewed by the Data Request Committee. All data requests must be submitted through the DOE’s electronic submission platform, IRBManager. For more information on how to log in to the system and create an account, see our overview How to Use IRBManager.
Datasets for the 2018-19 school year and earlier years are currently available for request.
How does the Data Request Committee review my request?
Data requests are reviewed regularly for approval and prioritization. The Data Request Committee meets once a week, typically. Approval of requests are based on the completeness of the data request, expected educational value or benefit provided to the NYC education community as a result of the study, the availability and regulations governing access to data, and the amount of staff time and other DOE resources required to grant the request. Processing times will vary depending on the content of the request, the number of requests the Data Request Committee is currently processing, and the availability of Committee members.
Data Request approval requires the completion of a Non-Disclosure Agreement (NDA). NDAs are emailed to researchers during the review process.
Where can I get more information about the data request process?
Please read the FAQs for External Data Requests before submitting a data request. The FAQs include a list of datasets available to researchers.