The following information outlines the steps involved in the Institutional Review Board (IRB) process and specifies your responsibilities as an investigator. Please scrutinize this information meticulously. Should you have any queries regarding the IRB process, we encourage you to reach out to your Research Director for additional guidance.
If you are a student investigator, we strongly recommend that you peruse the Student Investigators Guide prior to initiating the IRB process.
ATTENTION: Please note that no research participants should be contacted, nor should any research activities commence—including data acquisition and analysis—until you have received formal approval from the IRB. This approval will be accompanied by an approval memo and pertinent documents. These restrictions also apply to preliminary or pilot study activities.
The Institutional Review Board (IRB) is an administrative body that is responsible for ensuring the protection of the rights and welfare of human research subjects who are involved in research activities conducted under the umbrella of the institution it is affiliated with.
The IRB oversees all research or clinical investigations involving human subjects, irrespective of whether they are funded or unfunded, that are conducted by faculty, staff, and/or students of the affiliated institution.
Key responsibilities of the IRB include:
To ascertain whether your study requires IRB approval from New York College of Health Professions (NYCHP), it must meet either of the following criteria:
The study aligns with the Department of Health and Human Services (DHHS) definitions of “research” and “human subjects”.
It fits within the Food and Drug Administration (FDA) definitions of “clinical investigation” and “human subjects”.
Please follow this checklist to determine if your study necessitates NYCHP IRB approval:
Does my study need NYCHP IRB approval? (Checklist)
If, after going through the checklist, you think your study might not require IRB approval, please complete the “Human Subjects Research Determination Form” available on IRB Website. For more information regarding the completion of this form, visit our “IRB Website” page.
Steps for the Investigator:
The following are the necessary steps investigators must follow for the Institutional Review Board (IRB) process. Read these steps carefully, and if you have any questions, please consult your Research Director for additional guidance.
Familiarize yourself with all the information for investigators provided on this webpage.
If you are a student investigator, review the “Student Investigators Guide” and ensure that:
a. For research related to a thesis/dissertation, official approval of the thesis/dissertation proposal must be received before beginning the IRB process.
b. For research not related to a thesis/dissertation, approval of the research proposal from your academic/faculty advisor is required before starting the IRB process.
Review the NYCHP IRB Guidance Sheets and other useful links available on this page.
Complete the required “CITI Human Subjects Protection Training”.
Complete the “Researcher Qualification Form”.*
Complete and submit the “New Protocol Submission Form”.*
For submissions that are exempted: File Amendments and an annual “Exempt Research Status”.
For expedited & full submissions: File Amendments, Continuing Review, and Closing Report.
As an investigator, your responsibilities include the following:
If you’re a student investigator, you must obtain official approval for your thesis/dissertation or research proposal before initiating the IRB process.
Completion of the CITI Human Subjects Protection Training is mandatory. It is your responsibility to ensure that this training remains up-to-date for all study team members throughout the study’s duration until it has been officially closed. Recertification is needed every three years.
Prior to contacting any participants or starting any research activities, you must complete the “New Protocol Submission Form” and obtain official IRB approval. Upon approval, an approval memo and additional documents will be provided to you.
It is your responsibility to conduct the study as approved in your “New Protocol Submission Form“. Any changes to the study must be reported and approved through an “Amendment Form” before implementation. This applies to all types of submissions; exempted, expedited, and full review.
For exempted submissions, you must file the “Exempt Research Status Form” annually.
For expedited and full review submissions, if your study continues to collect or analyze data, you must file the “Continuing Review Form” annually.
Upon completion of all research-related activities, including data analysis, you must submit a “Closing Report Form” for expedited and full review submissions.
Any unexpected or adverse events must be reported immediately to the IRB Office.
This guidance sheet offers an overview of how researchers collect initial information, evaluate research design or methods, and formulate survey instruments for their research submission.