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Human Research Protections Policy

The mission of the Institutional Review Board is to promote compliance with institutional research policy, federal research regulations, good clinical practice, and ethical standards as they relate to clinical research. As such, we adhere to the WCM Human Research Protection Program Policy (HRPP) that describes the plan of Weill Cornell Medicine to comply with ethical and legal requirements for the conduct and oversight of Human Research.

I. Purpose

This Policy describes the plan of the Weill Cornell Medicine  to comply with ethical and legal requirements for the conduct and oversight of Human Research.

II. Scope

The HRPP applies to all Human Research that engages Weill Cornell Medicine, and all Human Research submitted to the Weill Cornell Medicine Institutional Review Board (“WCM IRB”) for review.

III. Definitions

Human Research is any activity that is either:

  • Research” as defined by DHHS and involves “Human Subjects” as defined by DHHS; or
  • Research” as defined by FDA and involves “Human Subjects” as defined by FDA

*The FDA provides a side-by-side comparison table of DHHS and FDA Human Subjects Protection Regulations

Definitions of "Research"

DHHS: Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

FDA: FDA has defined "clinical investigation" to be synonymous with "research". "Clinical investigation" means any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA...or the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit.

Definitions of "Human Subjects"

DHHS: Human subject means a living individual about whom an investigator (whether professional or student) conducting research (1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

      • Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
      • Interaction includes communication or interpersonal contact between investigator and subject.
      • Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
      • Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
      • An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

FDA: An individual who is or becomes a subject in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. A human subject includes an individual on whose specimen (identified or unidentified) a medical device is used.

Definition of "Engaged in Human Research"

WCM is engaged in Human Research when its employees or agents are interacting or intervening with Human Subjects for the purpose of conducting research. 

Definition of "Institutional Official (IO)"

The IO is the organizational official responsible for ensuring that the HRPP has the resources and support necessary to comply with all federal regulations and guidelines that govern Human Research. The IO is the individual who is legally authorized to act for the institution and, on behalf of the institution, obligates the institution to the terms of its Federal-Wide Assurance.

Definition of "Institutional Review Board (IRB)"

A specifically constituted review body established or designated by an entity to protect the rights and welfare of human subjects recruited to participate in biomedical or behavioral/social science research.

Definition of "Investigator"

The person responsible for the conduct of Human Research at one or more research sites. If the Human Research is conducted by a team of individuals at a research site, the investigator is the responsible leader of the team and may be called the principal investigator.

IV. Policy

To ensure the highest standards of human subject protections, Weill Cornell Medicine has developed and supported a Human Research Protection Program (“HRPP”). We pride ourselves on our commitment to excellence in all research activities and recognize the institutional responsibility for the ethical conduct of research. Such standards are vital for the success of the research enterprise, participant safety and public trust.

The HRPP shall ensure compliance with all WCM policies as well as all federal, state, and local laws and regulations.

The HRPP includes mechanisms to:

  • Establish a formal process to monitor, evaluate, and continually improve the protection of human research participants.
  • Provide guidance to investigators and research staff for the ethical conduct of research.
  • Dedicate resources sufficient to do so.
  • Exercise oversight of research protection.
  • When appropriate, intervene in research and respond directly to concerns of research participants.

The HRPP will adopt operating procedures to implement this Policy.

Ethical Principles

The HRPP is be guided by the principles set forth in the Ethical Principles and Guidelines for the Protection of Human Subjects of Research (often referred to as the Belmont Report). These principles include respect for persons, beneficence, and justice.

The WCM-IRB applies these ethic principles to all Human Research regardless of support or geographic location. Policies and procedures applied to research conducted domestically are applied to international research.

The following categories of individuals are expected to abide by these ethical requirements:

  • Investigators
  • Research Staff
  • IRB members, IRB chairs, and IRB vice-chairs
  • Human Research Compliance staff members
  • Institutional Officials
  • Employees and agents
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