What is the National Center for Advancing Translational Sciences (NCATS)?
NCATS is the funding agency of Tufts Clinical and Translational Science Institute (Tufts CTSI). It is one of 27 institutes and centers at the National Institutes of Health (NIH). Its Clinical and Translational Science Awards (CTSA) Program supports a national network of medical research institutions, including Tufts CTSI, to help catalyze innovation in training, research tools and processes so that new treatments and cures for disease can be delivered to patients faster.
Does my study need to be IRB approved prior to proposal submission?
No. IRB approvals are not required at the time of proposal submission, but applicable awarded projects will be required to obtain IRB approval before seeking NIH/NCATS approval. Please note: projects involving human subjects may not begin until all institutional and regulatory approvals are received.
Why is NCATS prior approval required?
Consistent with the US Department of Human and Health Services (HHS) regulations (§46.120) and NIH policies on human subjects protections and vertebrate animals, Tufts CTSI must seek prior approval from its funding agency, NIH/NCATS, to support all Pilot Studies Program projects that involve human and/or animal subjects. This requirement applies to all Tufts CTSI-supported project that receive any direct funding and/or voluntary committed cost share through the Tufts CTSI NCATS CTSA award.
My research study does not involve human subjects. Does the NCATS prior approval requirement apply to me?
No, research studies that do not involve human subjects, as determined by the IRB, do not require NCATS prior approval.
How long does it take to get NCATS prior approval?
To reduce administrative burden, NCATS classifies human subjects research studies into the following categories:
- Category 1 (require both submission of NCATS-required documentation and receipt of NCATS’ formal prior approval, with the review process taking generally 30 days):
- Human subjects studies that involve greater than minimal risk;
- Human subjects studies that meet the NIH-definition of a clinical trial;
- Human subject studies that involve a foreign component, as defined by NIH;
- Category 2 (require submission of NCATS-required documentation, but do not require NCATS’ formal prior approval)
- Human subjects studies that involve minimal risk or studies that are otherwise exempt, as determined by the IRB.
What would delay approval of my NCATS prior approval request?
The most common reasons for delays identified by NCATS include inconsistencies in submitted documents (e.g., titles of study differ on protocol and consent/assent documents; target enrollment number varies in protocol, consent, inclusion plan, and/or enrollment table/inclusion data records), failure to include the required documents/information or provide proper justifications (e.g., not providing sufficient detail to allow evaluation of the procedures; not following instructions outlined in Forms F guidance developed and maintained by NIH; not including a budget and/or budget description/explanation clarifying of what is being supported by NCATS), providing outdated documents or documents with tracked changes and typographic errors, and submitting a parent protocol for a sub-study or ancillary study instead of a specific study protocol for research to be supported by NCATS.
How do I know if I my research project involves human subjects and/or requires Institutional Regulatory Board (IRB) approval?
Such determination can only be made by the IRB offices federally-mandated to protect the rights and welfare of human subjects. Therefore, it is the responsibility of the awardee to provide an overview of their proposed research and any relevant documentation to their respective IRB office to determine if the proposed research falls under their purview. If so, awardees will be required to request a formal review and approval of their research activities following the policies and procedures outlined by their respective ethical administrative bodies.
How long on average does it take to receive IRB approval?
The length of the IRB review and approval varies by different IRB offices, ranging usually from three to six weeks. It depends on the number of factors, such as the volume of IRB submissions at the time of the review request, complexity and nature of the proposed research, investigators’ ability to respond to the IRB’s requests for clarifications and modifications in a timely manner, review type (exempt, expedited, or full review), and frequency of the IRB full-board review meetings, when applicable. Many IRB offices provide their target and actual turnaround times as a general guide. Please contact your respective IRB for more information.
The IRB has approved my study in an expedited manner. What human subjects NCATS study category does my research fall into?
The FDA Code of Federal Regulations (21 §56.110) authorizes IRB offices to review and approve certain kinds of research through an expedited review procedure without the full IRB committee convening. The kinds of research that can be reviewed in an expedited manner are strictly limited those that involve no more than minimal risk or that require minor changes in previously approved research during the period covered by the original IRB approval. As such, the expedited review procedure alone cannot be used to determine the NCATS study category. For instance, research that meets the NIH definition of a clinical trial may be reviewed in an expedited manner.
Whom can I contact with additional questions?