A designated IRB's primary responsibility is to ensure that the rights and welfare of human subjects in research are protected. In doing so, the IRB must ensure that the human subject research is conducted ethically, and in compliance with Federal regulations, the requirements of applicable New York State and local law, and institutional policies and procedures. The ethical conduct of research is a shared responsibility. It requires cooperation, collaboration, and trust among the institution, investigators and their research staff, the subjects who enroll in research, and the Institutional Review Board (IRB).

An IRB is an appropriately constituted group that has been formally designated to review and monitor research involving human subjects. In accordance with the Common Rule and FDA regulations, the IRB has responsibility for approving, modifying, and/or disapproving human subject research. The IRB also has the authority to suspend or terminate research in order to protect research subjects and for noncompliance with applicable rules and regulations.

	IRB Links and Documentation Downloads

IRB Forms Page Institutional Review Board Policies and Procedures for Research Involving Human Subjects IRB Policies We are currently in the process of revising our policy. Rosemary Kraemer, PhD, Director, Human Subjects Protection (646) 962-8196 rtkraeme@med.cornell.edu Statement of Compliance Information about the WCMC IRBs IRB Policy on Consenting Non-English Speaking Subjects English Short Form & Translated Versions

Human Subject Regulations Decision Charts

The Office for Human Research Protections (OHRP) provides graphic aids as a guide for institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46. The charts address decisions on the following:

• whether an activity is research that must be reviewed by an IRB
• whether the review may be performed by expedited procedures, and
• whether informed consent or its documentation may be waived.

To view the Human Subject Regulations Decision Charts click here.


New OHRP Frequently Asked Questions and Answers on Quality Improvement Activities

OHRP has posted a new set of Frequently Asked Questions and Answers (FAQs) on quality improvement activities.  These FAQs provide guidance on OHRP's current thinking on this topic and should be viewed as recommendations unless specific regulatory requirements are cited.  The quality improvement activities FAQs can be accessed at http://www.hhs.gov/ohrp/qualityfaq.html#q2


Contact

Rosemary Kraemer, PhD Director, Human Subjects Protections E-mail: rtkraeme@med.cornell.edu Telephone: (646) 962-8196