The Institutional Review Board (IRB) at New York College of Health Professions operates under the leadership of the director of IRB for institutional effectiveness. Its principal duty is to oversea the college’s program for the protection of human subjects involved in research. The IRB meticulously reviews research proposals from the NYCHP research community, ensuring adherence to the fundamental ethical principles essential for any research involving human participants.

New York College of Health Professions encourages the conduct of research in the various subjects of integrative health and alternative medicine and in partnership with other educational institutions, agencies, and organizations. Our research community conducts groundbreaking studies in areas such as alternative, integrative, biomedical, social-behavioral, and community-engaged research. While fully upholding the faculty’s right to academic freedom in research, the college steadfastly commits to the core ethical principles that guide the appropriate conduct of human subject research.

This website has been designed as a comprehensive resource for our research community. It provides detailed information on the IRB process and outlines the expectations for all investigators.

 

Steps in the IRB Process:

The following section provides a detailed breakdown of the IRB process and outlines the necessary steps that you, as an investigator, need to undertake. We strongly urge you to peruse this information meticulously. Should you have any questions about the IRB process, please feel free to reach out to your research director for additional guidance.

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.

 

1. Review the “Information for Investigators” page.

Prior to initiating the IRB procedure, please explore the “Information for Investigators” webpage. This resource provides vital knowledge necessary for the preparation and submission of your IRB protocol, and it outlines your obligations as an investigator.

NOTE TO STUDENT INVESTIGATORS:

Please ensure you go through the “Student Investigators Guide” and confirm that you have met the following prerequisites:

• For research relating to a thesis or dissertation, students must first obtain formal approval for their thesis/dissertation proposal before embarking on the IRB process.
• For research not associated with a thesis or dissertation, students must gain approval for their research proposal from their academic or faculty advisor prior to commencing the IRB process.

 

2. Complete the required CITI Human Subjects Protection training.

It is required for all those engaged in research involving human subjects – including principal and co-investigators as well as all research team members (such as research assistants) – to successfully complete the CITI (Collaborative Institutional Training Initiative) Course in the Protection of Human Subjects specific to your college or academic division. Information related to this course can be found on the “CITI Training” webpage.

 

3. Complete the Researcher Qualification Form.

Every participant involved in human subjects research, including both principal and co-investigators, as well as all research team members such as research assistants, are obligated to complete and submit the Researcher Qualification Form.

 

4. Complete and submit the New Protocol Submission Form.

To have your research study reviewed by the IRB, you are required to complete and submit the New Protocol Submission Form.

 

5. Submit for Amendment, Continuing Review, Study Closure, or Status Update.

Guidance for filing a Modification/Amendment (applicable to all submissions), a Continuing Review (exclusive to Expedited and Full submissions), a Study Closure (limited to Expedited and Full submissions), or an Exempt Research Status update (pertinent only to Exempted submissions) can be sourced from the “IRB” webpage.

 

Understanding the IRB Process:

 

1. Welcome to the Institutional Review Board (IRB)
   • Objective: Introduce students to the basic steps and requirements of the IRB process.
   • Tasks and Steps:
     • Review the “Information for Investigators” Page: Acquaint yourself with the broad overview of the IRB and its pivotal functions.
     • CITI Human Subjects Protection Training: Grasp the importance and intricacies of protecting human research subjects.
     • Research Qualification Form: Understand and fulfill the primary qualifications essential for initiating research.
     • New Protocol Submission Form: Get insights into preparing and submitting fresh research protocols.
     • Further Submissions: Familiarize yourself with procedures relating to amendments, ongoing reviews, study closures, and regular updates.

 

2. Information for Investigators

• Objective: Delve into the intricate specifics of the IRB and the effective ways to navigate through it.
• Key Points:
  • Definition of the IRB: Discover the objective and significant role of the IRB within the research realm.
  • NYCHP IRB Approval Criteria: Comprehend the situations warranting NYCHP IRB’s approval for your research endeavors.
  • Steps for the Investigator: Traverse through the systematic process from the viewpoint of an investigator.
  • Investigator Responsibilities: Recognize the imperative duties and ethical obligations associated with research investigators.
  • Guidance with NYCHP IRB Sheets: Benefit from documents and templates tailored for NYCHP’s IRB requirements.
  • Resourceful Websites: Explore a myriad of platforms for extended guidance and enriched comprehension.

 

3. CITI Training

• Objective: Empower students with comprehensive knowledge and norms centered around safeguarding human subjects during research, courtesy of CITI’s platform.
• Topics Covered:
  • Human Subjects Protection Training/Education: Familiarize yourself with the core objectives.
  • Training Requirements: Get acquainted with the prerequisites for adhering to human subjects protection norms.
  • Additional CITI Courses: Delve into other pertinent CITI courses and discern their relevance and necessity.
  • Training Frequency: Understand the recommended intervals for recurrent CITI training sessions.
  • CEUs Fee Reimbursement: Decipher the processes and protocols for availing reimbursements linked with CITI program’s CEUs charges.

 

4. IRB Forms and Templates

• Objective: Make students adept with the array of forms, templates, and guiding materials pertinent to IRB submissions and research methodologies.
• Materials:
  • Consent Guidance and Templates: Perfect the nuanced approach of securing informed consent from your research participants.
  • Participant Recruitment: Absorb the protocols and best practices pivotal for recruiting study participants.
  • Miscellaneous Forms and Letters: Avail of auxiliary documents tailored for diverse research circumstances.
  • HIPAA Forms: Grasp and meet the standards set by the Health Insurance Portability and Accountability Act.
  • UP/AE/SAE Reporting: Understand the detailed reporting protocols for Unanticipated Problems, Adverse Events, and Serious Adverse Events.

 

5. IRB Policies and Procedures

• IRB SOP Manual: This crucial document is the cornerstone for researchers and those involved in human research oversight. It provides a comprehensive guide that ensures the safety, rights, and well-being of research participants are prioritized. Below are specific highlights from the manual.
• Topics Covered:
  • Purpose of the IRB: The initial sections generally discuss the overarching purpose of the IRB, which includes the safeguarding of human research participants and ensuring that research is conducted in an ethical and compliant manner.
  • Review Process: This section elaborates on the review mechanisms in place, whether full board reviews, expedited reviews, or exemptions. It focuses on how the IRB reviews research proposals, the criteria for approval, and what researchers can expect during this phase.
  • Informed Consent: The manual provides guidelines on drafting and obtaining informed consent, including considerations for vulnerable populations and situations where consent can be waived.
  • Reporting and Documentation: This segment educates on the need for appropriate documentation, what needs to be retained, and for how long.
  • Closing Studies: Understand the criteria and procedures for concluding a study, ensuring that all obligations have been met and participants are duly informed.
  • Audits and Assessments: Learn about the periodic audits the IRB may conduct to ensure ongoing compliance and the continuous improvement of research practices.

 

6. Information for Research Participants
   • Objective: The New York College of Health Professions is unwavering in its mission to orchestrate research that prioritizes participant safety, rights, and welfare. To honor this and in line with Federal regulations, NY College has instituted the Institutional Review Board (IRB) to rigorously evaluate all research entailing human participants.
   • Materials:
     • • Rights of Research Participants: This segment elucidates the rights and privileges of participants, ensuring their well-being and informed involvement in research.

 

7. Contact Us

Engaging with our IRB staff has never been easier. We’re dedicated to ensuring that you receive timely and accurate information. Whether you’re inquiring about protocols, need assistance with documentation, or have any other concerns, we’re here to help.