Institutional Review Board

The NSMC Institutional Review Board (IRB) 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). 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.
Electronic submissions now required

NSMC Investigators may now submit research proposals to the NSMC IRB using Insight. Insight is used for new protocol submissions. It is also a platform for submitting amendments, continuing reviews and adverse events for IRB review. Insight is already operational at MGH, BWH, NWH, and Spaulding; all Partners hospitals will eventually adopt this system. As of January 1, 2013 paper submissions will no longer be accepted. 

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:

  1. The risks to subjects are minimized to the extent possible.
  2. The risks to subjects are reasonable in relation to anticipated benefits, if any.
  3. Selection of subjects is equitable.
  4. Unless waived, the informed consent process and documentation are adequate.
  5. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
  6. Where appropriate, there are adequate provisions to protect the privacy of subjects and maintain confidentiality of data.
  7. Appropriate safeguards are included within the study to protect the rights and welfare of vulnerable subjects.

Please read our research requirements for conducting human subject research.