IRB Chairman Charles Bockoff, MD
Sr. IRB Administrator Laura W. Knight, MPH
781.477.3678 additional contact info below
The NSMC Institutional Review Board is a research oversight committee charged with assuring that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in approved research studies. In compliance with Federal law and NSMC policy, all research projects involving human subjects or human material must be reviewed and approved by the IRB (both in advance and by periodic review). Human-subject research is a systematic investigation, designed to develop or contribute to generalizable knowledge where an investigator obtains data on individuals either through direct intervention/interaction or through the use of identifiable private information (medical records) or specimens. Research limited to the use of non-identifiable patient information may qualify for exemption from full IRB review, however, all exemptions must be determined or granted by the NSMC IRB.
The NSMC IRB has the authority to disapprove, modify, or approve protocols based upon consideration of human subject protection. While other groups or offices may need to review and approve research, no one/office can approve a study that has been disapproved by the IRB. The IRB also requires progress reports from the investigators at least annually and oversees the conduct of the study.
The overall criteria for IRB approval are:
- The risks to subjects are minimized to the extent possible.
- The risks to subjects are reasonable in relation to anticipated benefits, if any.
- Selection of subjects is equitable.
- Unless waived, the informed consent process and documentation are adequate.
- When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
- Where appropriate, there are adequate provisions to protect the privacy of subjects and maintain confidentiality of data.
- Appropriate safeguards are included within the study to protect the rights and welfare of vulnerable subjects.
For an overview of the NSMC IRB requirements for conducting human subjects research, please refer to Research Requirements.
News and Announcements
10/16/2009 - A
NEW IRB policy is available entitled
Review of Medical Devices (Policy 031) and can be accessed under the
Policies link.
04/16/2009 - Clinical Trial Agreement Review Process: Effective
May 1, 2009, all new clinical trial agreements (contracts) for industry-sponsored, non-oncology research, involving NSMC will be reviewed and negotiated on NSMC behalf by the Partners Clinical Research Office. PCRO will also perform a Medicare coverage analysis for any non-oncology study that involves an interaction or intervention with subjects and where any tests, procedures and interventions are invoiced to third party payers. If you would like to attend an information session to learn more about the process and required documents at the time of submission of a new study, please contact Laura Knight at lwknight@partners.org.
04/16/2009 - NSMC Application form: In order to streamline the number of forms that are required and incorporate required information related to the new clinical trial review process, the NSMC IRB has revised the Application form for submissions of new studies. The revised Application form is available here and is to be used for all new submissions effective May 1, 2009. If you have any questions on the new form, please contact Laura Knight at lwknight@partners.org.
Contact Information for the IRB
IRB Chairman Charles Bockoff, MD
Sr. IRB Administrator Laura W. Knight, MPH
Mailing Address:
NSMC IRB
Union Hospital
Hartman Hall, 2nd Floor
490 Lynnfield Street
Lynn, MA 01904
781.477.3678
781.477.3526 (fax)
