DIVISION OF RESEARCH INTEGRITY
Northeastern University's 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 Division of Research Integrity. |
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- CONTACT INFORMATION
- POLICIES & PROCEDURES - updated
- FORMS & INSTRUCTIONS - updated
- INFORMED CONSENT - updated
- NIH EDUCATIONAL REQUIREMENTS
- TRAINING & EDUCATIONAL RESOURCES
Mission of the IRB
- 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 April 21, 2009.
- Northeastern University's IRB is registered with OHRP and is identified as IRB00000356. Expires on July 5, 2010.
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.
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."
Division of Research Integrity
The Division of Research Integrity (DRI) provides central administration to the IRB and serves as the primary point of contact for all IRB-related issues. The DRI 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 DRI 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 DRI. For more information or assistance, please contact Nan Clark Regina, Director of the Division of Research Integrity, Northeastern University, 413 Lake Hall, 360 Huntington Ave., Boston, MA 02115-5000; tel. (617) 373-4588 and fax (617) 373-4595.
last update: Wednesday, April 9, 2008