Frequently Asked Questions (FAQs)
These questions and answers have been developed in response to frequent inquiries from investigators and coordinators. We welcome suggestions for additions to this list. Please contact the Office of the IRB at 516-719-3100 or nbluhm@nshs.edu.

Policy and Procedures
The Institutional Review Board (IRB) is a committee whose purpose is to ensure that the rights and welfare of human subjects are protected in all medical, behavioral and social sciences research. In accordance with federal and state regulations governing research, an IRB must review and approve research involving human subjects prior to its initiation.

Conflict of Interest Policy
The purpose of this policy is to ensure that the design, conduct, or reporting of research, will not be biased by any conflicting commitment or financial interest of those investigators who are responsible for the research.

Federal Wide Assurance
The FWA is the documentation of the commitment to the Federal Department of Health and Human Services (DHHS), Office of Human Research Protections (OHRP) indicating that our Health System and the Office of the IRB function in compliance with the federal regulations governing research with human subjects. It is also indicative of the commitment of the Health System to conduct research within the ethical standards recited in the Belmont Report. The FWA includes a listing of the entities within the Health System that utilize our IRBs and also the other IRBs whose decisions we can accept. Finally, it lists the officials within our System that are responsible for the activities of our IRBs.

IRB Meeting and Deadline Schedule
The Office of the Institutional Review Board oversees two separate IRB committees, each of which meets monthly. Listed below is the schedule of meeting dates for both IRBs.

How to Submit a Protocol to the IRB
Unless otherwise indicated in these instructions, the following forms are required for all protocols being submitted for IRB review.

IRB Forms
Listed on this page are the IRB forms presently available online. The forms are in MS Word format.

Chart Reviews
Research based on reviews of patient records is subject to IRB review.  The method for and the type of data to be collected will dictate the category of IRB review that is appropriate.

Consent Form Guidelines
Informed consent is a process that involves a comprehensive discussion between the investigator and subject in order to ensure the subject’s understanding of a proposed research study.  This process is documented and reinforced by a written consent form.

Informed Consent Translations
The Office of the IRB provides a generic short informed consent form to be used for the occasional circumstance in which a potential subject does not read or understand English.

Marketing Department Guidance: Procedure for Clinical Trial Ad Development and Placement
Implementation of all clinical trial media advertising within the North Shore-LIJ Health System must be facilitated by the System's Marketing Department. Below are procedures that have been developed to make this process as efficient as possible.

HIPAA Research Information
HIPAA stands for the Health Insurance Portability and Accountability Act. It is Federal legislation meant to enable a person to go from one health insurance plan to another with continuity of care and not be denied coverage for a “pre-existing condition” (portability); it details government oversight to protect fraud and finally adds protections for confidentiality of protected health information (PHI) that is collected (accountability).

Contacts

Consulting Session Schedule

Useful Links
Links to useful sites at NIH and DHHS