The administrative office of the Human Subjects Research Review Committee is in the Office of Research and Sponsored Programs. The Institutional Official overseeing the activities of the Human Subjects Research Review Committee is Stephen A. Gilje, Associate Vice President for Research. The Chair of the HSRRC is appointed usually for a three-year term.
HSRRC Members
A. The Human Subjects Research Review Committee is charged with certain responsibilities and authority in accordance with institutional policy and Federal regulations. These are listed below.
1. Determine whether a given activity should be considered human subjects research.
2. Review and approve, require modifications in (to secure approval), or disapprove research activities which involve human subjects.
3. The HSRRC shall approve research based on the Committee's determinations that the following requirements are satisfied:
(a) Risks to subjects are minimized:
(1) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and
(2) whenever appropriate by using procedures already being performed on the subjects for diagnostic or treatment purposes.
(b) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of knowledge that may reasonably be expected to result. In evaluating risks and benefits, the committee shall consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The Committee shall not consider long-range effects of applying knowledge gained in the research as among those research risks that fall within the purview of its responsibility.
(c) Selection of subjects is equitable. In making this assessment the Committee shall take into account the purposes of the research, the setting in which the research will be conducted, and the population from which subjects will be recruited.
(d) Require that information given to subjects as part of informed consent is in accordance with institutional policy and may require that information, in addition to that specifically required by Federal regulations be given to the subject when in the Committee's judgment, the information would meaningfully add to the protection of the rights and welfare of subjects.
(e) Require documentation of informed consent or waive documentation in accordance with institutional policies in compliance with federal regulations as a minimum.
(f) Where appropriate, the research plan makes adequate provision for monitoring the data collected to insure the safety of subject.
(g) Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
4. Conduct continuing review of research at intervals appropriate to the degree of risk but not less than once per year, and shall have authority to observe or have a third party observe the consent process and research.
5. Determine which projects need verification from sources other than the research investigators that no material changes have occurred since the previous HSRRC review.
6. Report to appropriate institutional officials and, when appropriate, the OPRR, any serious or continuing noncompliance by investigators with the requirements and determinations of the Committee.
7. Suspend or terminate approval of research that is not being conducted in accordance with the Committee's requirements or that had been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement about the Committee's action and shall be reported promptly to the investigator, institutional officials and appropriate federal officials, if required.
B. The HSRRC is appointed with variable term appointments by the Associate Vice President with the approval of the President.
C. In compliance with DHHS regulations, the Committee is comprised of people from diverse backgrounds and with professional competence necessary to review specific research activities. A variety of professions are represented including at least one member whose primary expertise is in a nonscientific area and at least one member who is not otherwise affiliated with the institution personally or through an immediate family member.
These Guidelines are based on and implement the Federal Assurance of Protection of Human Subjects (FWA# 00000174) approved for Binghamton University by the Office of Human Research Protection (OHRP) at the Department of Health and Human Services (DHHS) on May 14, 2007 and expires May 14, 2010.
Human Subjects Research Review Office
Raymond Romanczzyk, Chair
Anne M. Casella, Administrator
Diane L. Bulizak, Secretary
ITC Alpha Building
Room 2205
PO Box 6000
Binghamton NY 13902-6000
Fax: (607) 777-5025
Telephone (607) 777-3818
http://humansubjects.binghamton.edu
hsrrc@binghamton.edu
Questions, Complaints or Concerns
Investigators and research staff are invited to contact the HSRR Office to obtain answers to questions, express concerns, and convey suggestions regarding the human research protection program.
If you would like to report a compliance issue anonymously, please call the anonymous/confidential hotline number at (607) 777-5049. This service is offered by the Office of Compliance and Risk Managment, Lisa Havtur, Administrative Compliance Coordinator. For more information contact Lisa at (607) 777-3734 or lhavtur@binghamton.edu.
BINGHAMTON UNIVERSITY |
About
the HSRRC
Educational Requirement & Resources Links: Belmont Report |
PLEASE VIEW IN INTERNET EXPLORER Mission Statement Binghamton University is guided by the ethical principles regarding all research involving humans as subjects set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the "Belmont Report,") Binghamton University has established the Human Subjects Research Review Committee (HSRRC) as the institutional review board (IRB) responsible for the institution's obligations to review research involving human research. All research projects involving human subjects conducted by University faculty, staff and students or done under the sponsorship or auspices of the institution must be reviewed and approved by the HSRRC. This includes research involving subjects from outside the university and research which is not funded. |
| Dates | September 4 |
October 2 |
November 6 |
December 4 |
Protocols Due |
August 25 |
September 22 |
October 27 |
November 24 |