Mission and Responsibilities

The IRB at MCNY is dedicated to ensuring the ethical and responsible conduct of research involving human participants. Its primary role is to safeguard the rights, dignity, and well-being of individuals participating in research studies. The IRB operates in compliance with and adheres to established ethical principles guiding human research.

Ensuring the protection of research participants is a shared responsibility among the institution, researchers, the IRB committees, and the IRB Office. Together, these entities work to uphold ethical standards and regulatory requirements for all research conducted under MCNY鈥檚 oversight.

The MCNY IRB Office oversees the review and approval process for human subject research, ensuring compliance with federal regulations and institutional policies.

Definition of Human Subjects

According to 45 CFR 46.102(f), human subjects are living individuals from whom researchers collect data in one or both of the following ways:

1

Through intervention or interaction

  • Intervention: This includes physical procedures (e.g., collecting blood samples) or controlled modifications to a participant鈥檚 environment (e.g., adjusting room temperature) conducted for research purposes.
  • Interaction: Any direct communication between researchers and participants, such as interviews or surveys, falls under this category.

2

Through identifiable private information

  • Private information: Data related to behaviors or personal records that individuals expect to remain confidential, such as medical history, financial records, or personal experiences.
  • Identifiable information: Any data that could reveal an individual鈥檚 identity, such as names, addresses, or unique identifiers.

IRB Submission Categories

Researchers submitting studies for IRB review should be aware of the different submission types and their requirements:

  • Initial Studies: New research proposals involving human subjects that require IRB approval before data collection begins.

  • Modifications: Any changes to an approved study, including protocol adjustments, consent form updates, or changes in study personnel, must be reviewed and approved by the IRB before implementation.

  • Continuing Review & Closure: Studies that require ongoing IRB oversight must undergo periodic review. Researchers must also formally close studies once data collection and analysis are complete.

  • Reportable New Information (RNI): Researchers must promptly report any unexpected risks, adverse events, or deviations from the approved protocol that may impact participants’ safety or the integrity of the study.

Types of Reviews

The level of IRB review required depends on the nature of the research and the potential risk to participants:

  • Exempt Review: Applies to research involving minimal risk and meeting specific exemption criteria under federal regulations.

  • Expedited Review: Research involving minimal risk that fits within federally designated expedited categories may be reviewed by a single IRB member rather than the full board.

  • Full Board Review: Studies involving greater than minimal risk, vulnerable populations, or complex ethical considerations require review by the full IRB committee.

IRB Submission Process

To apply for IRB review, researchers must complete the following steps:

  • Training Requirement: All applicants must submit a (valid within the past five years).

  • Application Submission: Researchers must submit their IRB application through the (MCNY credentials required).

  • Institutional Affiliation: Any research intended for publication must clearly list 名媛直播 (MCNY) as the institutional affiliation.

Research Ethics & Historical Foundations

Nuremberg Code (1948)

The Nuremberg Code was established following the Nuremberg Trials, which prosecuted war crimes committed during World War II. It was the first international document to define ethical standards for human subjects research, emphasizing voluntary participation and informed consent. The Code arose in response to unethical medical experiments conducted in Nazi Germany and remains a cornerstone of research ethics today.

Declaration of Helsinki (1964, Revised 2013)

Developed by the World Medical Association (WMA), the Declaration of Helsinki provides ethical guidance for physicians and researchers conducting studies involving human subjects. It extends the principles of the Nuremberg Code, particularly regarding informed consent, risk minimization, and the protection of vulnerable populations. The declaration is regularly updated, with the most recent revision in October 2013, and serves as the foundation for Good Clinical Practice (GCP) guidelines worldwide.

National Research Act (1974)

In response to the unethical Tuskegee Syphilis Study, Congress passed the National Research Act in 1974. This legislation established Institutional Review Boards (IRBs) to oversee research involving human subjects and created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The commission was tasked with defining ethical principles to ensure human subjects are protected in research.

The Belmont Report (1978)

Published by the National Commission for the Protection of Human Subjects, The Belmont Report outlines three fundamental ethical principles guiding human research:

  1. Respect for Persons 鈥� Recognizing the autonomy of individuals and ensuring informed consent.
  2. Beneficence 鈥� Maximizing benefits while minimizing potential harm to participants.
  3. Justice 鈥� Ensuring fair distribution of research risks and benefits.

The Belmont Report serves as the foundation of U.S. research ethics regulations and remains a key reference for IRBs, including at MCNY.

Contact Information

For any questions or assistance, please contact:

Dr. Sophie Lee

Chair, IRB Office, 名媛直播