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About the INSTITUTIONAL REVIEW BOARD (IRB)

 

IRB Administration

The administrative office of the Insitutional Review Board is located in the Division of Research and Sponsored Programs. The Institutional Official overseeing the activities of the IRB is Nancy Lewis, Assistant Vice President for Research Compliance. 

 
IRB Members
  • Peter Gerhardstein, PhD, IRB Chair
  • Linda Reynolds, IRB Associate Director
  • Eric P. Hoffman, PhD, School of Pharmacy and Pharmaceutical Sciences
  • Suk Young Kang, PhD, Department of Social Work, College of Community and Public Affairs
  • Kenneth Kurtz, PhD, Psychology
  • Pong-Yu (Peter) Huang, PhD, Watson School of Engineering and Applied Science
  • Melissa Sutherland, PhD, FNP-BC, Decker College of Nursing and Health Sciences
  • Pamela Sandoval, PhD, Graduate School of Education
  • Timothy Cortesi, Assistant Director of Technology Support Services, ITS
  • Allen D. Alt, MD, Retired Community Physician
  • Rev. Robert J. Sullivan, Religious Advocate (alternate member) 
  • Titilayo Okoror, PhD, Department of Africana Studies, Harpur College (alternate member) 

IRB Coordinator Michele Lukovich is the support staff for the IRB and can be reached at hsrrc@binghamton.edu or (607) 777-3818.

 
IRB RESPONSIBILITIES

Binghamton University has established the Human Subjects Research Review Committee (HSRRC) as the Institutional Review Board (IRB) responsible for the review of research involving human subjects under the terms and conditions set forth by the Office of Human Research Protections (OHRP) of the Federal Government Department of Health and Human Service (HHS) and the Food and Drug Administration (FDA). 

 

All research studies involving human subjects conducted by University faculty, staff, and students in connection with their institutional responsibilities, or done under the sponsorship or auspices of the institution, must be reviewed and approved by the IRB prior to commencement of the research. The IRB serves to confirm that all University researchers comply with OHRP regulations, as well as state and local laws, and University policies.

 

 

The primary purpose of the IRB is to protect the rights and welfare of human subjects involved in research activities being conducted under its authority. In so doing, the IRB shall ensure adherence to the criteria for IRB approval as listed in 45 CFR 46.111 and 21 CFR 56.111 i.e., that:

  • The risks to human research subjects are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose the research participants to risk.
  • The risks to human research subjects are reasonable in relation to the anticipated benefits (if any) to the individual, and the importance of the knowledge that may be expected to result.
  • The selection of human subjects for research participation is equitable.
  • Human research subjects are adequately informed of the risks and benefits of research participation and the procedures that will be involved in the research; and that informed consent is obtained from each prospective human research subject, or his/her legally authorized representative, in accordance with, and to the extent required by federal regulations and IRB policies.
  • Informed consent of human research subjects is obtained in advance of research participation and appropriately documented in accordance with, and to the extent required by federal regulations and IRB policies.
  • The research plan, when appropriate, makes adequate provisions for monitoring the data collected to ensure the safety of human research subjects.
  • There are adequate provisions to protect the privacy of human research subjects and to maintain the confidentiality of research data.
  • Appropriate additional safeguards have been included in the study to protect the rights and welfare of human research subjects who are likely to be vulnerable to coercion or undue influence (e.g., children, prisoners, pregnant women, decisionally impaired persons, or economically or educationally disadvantaged persons).

 

The IRB and IRB office staff serve to assist investigators in the design of ethical and regulatory compliant human subject research studies.

 

The IRB is appointed with variable term appointments by the Assistant Vice President for Research Compliance with the approval of the president. In compliance with HHS regulations, the IRB is comprised of people from diverse backgrounds and with the professional competence necessary to review specific research activities conducted by the members of the campus community. A variety of professions are represented, including at least one member whose primary expertise is in a nonscientific area and at least one community member who is not otherwise affiliated with the institution personally or through an immediate family member. 

 

Federal Wide Assurance (FWA)

Binghamton University holds a Federalwide Assurance with the Office for Human Research Protections (OHRP) in the U. S. Department of Health and Human Services (DHHS). FWAs are required for every institution that is “engaged” in Federally-supported human subject research. An FWA is an agreement with HHS to review and approve research involving human subjects in accordance with the ethical principles outlined in the Belmont Report and the DHHS regulations at 45 CFR Part 46.

  • Binghamton University FWA# 00000174

 

An institution that receives a direct HHS award to support research is automatically considered to be “engaged”, even if all of the activities involving human subjects are carried out by a subcontractor or collaborator. In this case, the awardee institution is ultimately responsible for protecting human subjects under the award. 

 

CONtact information
Peter Gerhardstein, Chair
Michele Lukovich, IRB Coordinator
Linda Reynolds, IRB Associate Director

ITC Building, Room 2204
PO Box 6000
Binghamton NY 13902-6000
Telephone (607) 777-3818
hsrrc@binghamton.edu
 
 
Anyone who would like to obtain information about a research study, or who has questions, concerns, complaints or wishes to discuss problems should contact the IRB Office.
 
RESEARCH PARTICIPANTS

The researcher team conducting the study you are participating in should provide you with answers to specific questions about the study. You may contact the researcher with questions at any time before, during or after the study. If you would like to obtain information about a research study, or if you have questions, concerns, complaints or wish to discuss problems or your rights as a research subject with someone unaffiliated with the study, plese contact the IRB Office at 607-777-3818. Anonymity, if desired, will be protected to the extent possible. As an alternative method of contact, an email may be sent to hsrrc@binghamton.edu or a letter sent to the attention of the IRB Associate Director at the address noted above.

Last Updated: 7/7/20