NORTHEASTERN UNIVERSITY INSTITUTIONAL REVIEW BOARD (IRB)

It is the policy of Northeastern University that no activity involving human subjects be undertaken until those activities have been reviewed and approved by the University's Institutional Review Board (IRB). Accordingly, all university research involving human subjects must first be reviewed by the Office of Human Subject Research Protection.

REQUIRED TRAINING FOR RESEARCH INVOLVING HUMAN SUBJECTS
Under the direction of the Office of the Vice Provost for Research, Northeastern University is now requiring completion of the NIH Office of Extramural Research training for all human subject research, regardless of whether or not investigators have received funding to support their project. The online course titled "Protecting Human Research Participants" can be accessed at the following url: http://phrp.nihtraining.com/users/login.php.

Principal Investigators, student researchers and key personnel (participants who contribute substantively to the scientific development or execution of a project) must include a copy of their certificate of completion for this web-based tutorial with the protocol submission.
--------------------------------------------- Ethical Principles of the Belmont Report

MISSION OF THE INSTITUTIONAL REVIEW BOARD

  • Protect the rights and welfare of human subjects who participate in research conducted by faculty, staff, and students of Northeastern University.
  • Independently assess and evaluate the risks and benefits of proposed research, and ensure that risks to human subjects are kept to an absolute minimum and are justified by potential benefits of the research.
  • Ensure the confidentiality of information obtained from research subjects to the extent allowed by law.
  • Ensure that, where appropriate, an Informed Consent or Informed Consent and Health Information Use and Disclosure Authorization is obtained from each research subject.
  • Facilitate high quality research at Northeastern University.
  • Create a cooperative process, encouraging dialogue with researchers.
  • Comply with applicable state and federal privacy laws.

The NU IRB follows the basic ethical principals of respect for persons, beneficence, and justice as set forth in the Belmont Report. These principals are codified in 45 Code of Federal Regulations Part 46, subparts A-D - Protection of Human Subjects.


IRB'S REGULATORY AUTHORITY

As an integral part of ethical conduct of research, federal guidelines require an independent review of protocols involving human subjects before an investigator can begin the study. The IRB is governed by the federal regulations set forth in 45 CFR 46, Protection of Human Subjects. The Office for Human Research Protection (OHRP) is the federal administrative agency that monitors the IRB, its activities, and institutional compliance.


The Food and Drug Administration (FDA) also protects human research subjects as set forth in 21 CFR 50, Protection of Human Subjects, regulating clinical investigations under the Federal Food, Drug, and Cosmetic Act, as well as clinical investigations that support applications for research or marketing permits for products regulated by the Food and Drug Administration. Both OHRP and FDA have the authority to suspend research for failure to adhere to the regulations.


ASSURANCES AND IRB REGISTRATION

In order to receive federal funding for research with human participants, Northeastern University must have a Federal Wide Assurance (FWA) approved by the United States Department of Health and Human Services. In this signed agreement, Northeastern University assures the federal government that all university research will be conducted in accordance with federal regulations for research.


The University has elected to apply the protections of the federal regulations to all of our human subject research regardless of its source of support, or lack thereof.


  • Northeastern University's FWA is identified as FWA00004630 and expires on March 17, 2012.
  • Northeastern University's IRB is registered with OHRP and is identified as IRB00000356. Expires on March 17, 2012.
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Any violation of research guidelines by the University or an investigator jeopardizes this agreement and threatens the University's federal funding. These federal regulations are the minimal standards for research. State laws or University policies may impose additional requirements as deemed appropriate, but may not decrease requirements.


CATEGORIES OF REVIEW

All research activities must be reviewed by the Office of Human Subject Research Protection even when categorized as "exempt" status. In addition, please note that "expedited" does not mean "faster" review. It only refers to the federal categories of research that do not require full board review.

FINAL DETERMINATION OF EXEMPT, EXPEDITED AND FULL COMMITTEE STATUS IS MADE BY THE INSTITUTIONAL REVIEW BOARD.

  • FULL COMMITTEE REVIEW - review process for research protocols that do not fall under the "exempt" or "expedited" categories, include vulnerable populations, and/or are determined by the IRB to involve greater than minimal risk to subjects (45 CFR 46 111).

    • NOTE: For protocols that are reviewed by the full Institutional Review Board, the Principal Investigator and/or co-Investigator are required to be present at the convened IRB committee meeting to discuss their protocol and answer questions posed by the Board. (2009-2010 NU IRB Meeting Schedule)

  • EXPEDITED REVIEW - initial review process for research protocols that involve no more than minimal risk to subjects and include activities listed in one or more of nine categories published by the U.S. Department of Health and Human Services.

    Expedited review also includes review of minor changes to previously approved research during the period (of one year or less) for which approval is granted (45 CFR 46 110 (b)). Any proposed modification to previously approved research resulting in greater than minimal risk or having a negative impact on the balance between the risks and benefits of the research will be referred to the full IRB for review.

  • EXEMPT REVIEW - review process to determine if the research protocol qualifies for exemption from further institutional review by meeting one or more of the six exempt categories listed at 45 CFR 46 101 (b).


  • CONTINUING REVIEW - federal regulations (45 CFR 46.109(e)) mandate that ongoing Expedited or Full Board research studies be reviewed at intervals appropriate to the degree of risk, but not less than once per year from the previous date of approval.

IRB MEMBERSHIP

Northeastern's IRB is composed of University faculty, staff and members of the local community. As set forth in 45 CFR 46.107(a), IRB Membership, "Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects."


OFFICE OF HUMAN SUBJECT RESEARCH PROTECTION

The Office of Human Subject Research Protection provides central administration to the IRB and serves as the primary point of contact for all IRB-related issues. The Office of Research Regulatory Compliance works to educate members of the university community about their responsibilities to comply with federal, state and university research regulations relating to the protection of human subjects and to research and scholarly integrity. The Office of Research Regulatory Compliance also provides assistance to students, faculty and staff in obtaining approval for teaching and research activities under those guidelines.


It is the policy of Northeastern University that no activity involving human subjects be undertaken until those activities have been reviewed and approved by the University's Institutional Review Board (IRB). Accordingly, all university research involving human subjects must first be reviewed by the Office of Research Regulatory Compliance. For more information or assistance, please contact Nan Clark Regina, Director of the Office of Human Subject Research Protection, Northeastern University, 960 Renaissance Park, 360 Huntington Ave., Boston, MA 02115-5000; tel. (617) 373-4588 and fax (617) 373-4595.


2009-2010 MEETING DATES FOR THE FULL CONVENED IRB

  • July 8, 2009
  • August 12, 2009
  • September 9, 2009
  • October 14, 2009
  • November 18, 2009
  • December 9, 2009
  • January 13, 2010
  • February 10, 2010
  • March 10, 2010
  • April 14, 2010
  • May 12, 2010
  • June 9, 2010

NOTE: For protocols that are determined to require review by the full Institutional Review Board, the Principal Investigator and/or co-Investigator are required to be present at the convened IRB committee meeting to discuss their protocol and answer questions posed by the Board.



last update: Saturday, October 2, 2009