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.

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.
Here are our research requirements for conducting human subject research.

New Policies:

Policy 032 - Reporting Unapproved Deviations in Research (March 2012)
This new policy outlines the difference between major and minor deviations and how to report each.

Updated Policies:

Policy 020 - Unanticipated Problem and Adverse Event Reporting (March 2012)
This policy has been updated to revise the reporting requirements and timeframe for unanticipated problems. Specifically, all internal events that are serious and unexpected are to be reported promptly, regardless of relationship to the research. In addition, a specific listing of unanticipated problems and adverse events has been provided to clarify what needs to be reported. The reporting timeframe was changed from 10 working/14 calendar to 5 working/7 calendar days.

Policy 022 - Continuing Review of Approved Research (March 2012)
This policy and associated application form and checklist have been updated to allow for reporting of minor deviations at the time of contiuing review and to clarify the criteria for determining continuing review intervals.


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 .