The Visiting Nurse Service of New York (VNSNY) established an independent Institutional Review Board (IRB) in September 1999. The purpose of the IRB is to protect the safety and welfare of all human subjects–patients, families, caregivers and staff–participating in any research study conducted at VNSNY.

An IRB, also known as an independent ethics committee (IEC), or ethical review board (ERB), is a committee of professional and lay persons that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim of protecting the rights and welfare of the research subjects. In the United States, the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS), specifically the Office of Human Research Protections (OHRP), have put in place regulations that empower IRBs to approve, require modifications in, or disapprove research. An IRB performs critical oversight functions for research conducted on human subjects to ensure that the research studies meet the highest scientific, ethical, and regulatory standards

The VNSNY IRB consists of 18 board members and three non-voting staff members. Of the 18 board members, 11 are VNSNY employees from various disciplines, three are external members from various disciplines from different organizations and four are community members. The IRB Chair was appointed by VNSNY president and CEO, Carol Raphael. The VNSNY IRB is registered with the Office of Human Research Protections (OHRP).

IRB Process

All research projects and surveys that involve VNSNY patients, caregivers or staff, directly or through clinical chart, electronic data, personnel record review or any form of Protected Health Information must be submitted for review and approval by the VNSNY IRB prior to data collection.

Review is a three-tier process, requiring review at all applicable levels including:

1. Administrative Review: To obtain approval by the head of the VNSNY administrative unit in which the research will be conducted.

2. Scientific Review: To determine that the research protocol meets at least minimal scientific criteria.

3. Human Subjects Protection Review: To ensure that the rights of subjects are protected and to ensure compliance with regulations set forth by the Federal Government and in keeping with agency policies and procedures.

For some types of research, an investigator may apply to the IRB for exempt status. Potentially exempt studies are those that involve:

• Research conducted in established or commonly accepted settings, involving normal educational practices;
• Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior;
• Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior;
• Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.