Yvonne L. Munn Center for Nursing Research

IRB Consultation Guidelines

Consultation
All MGH nurses interested in IRB consultation please contact MunnCenter@partners.org
You will be contacted by a Nurse Scientist in the Munn Center within 1 month.

The staff at the Munn Center for Nursing Research can help you answer questions regarding your IRB submission, but also, you can contact the IRB directly at: irb@partners.org Please see the links below for basic information on the IRB and trainings offered through the Division of Clinical Research Education Unit.

To access information about the MGB Human Research Committee: http://healthcare.partners.org/phsirb/
When you reach the website, see the box on right side of page “research navigator” and “employee login.” You can access this site by entering your MGB or MGH email address (e.g., name@mgh.harvard.edu), then follow the prompts. You cannot gain access unless you use your MGB-affiliated email address.

The Institutional Review Board (IRB) for Massachusetts General Hospital and the Brigham and Women’s Hospital is the Mass General Brigham Institutional Review Boards (MGB IRB) which provide ethical and scientific review and continuing oversight of human subject research in order that the rights and welfare of the participants in research are protected. All human-subject research related activities fall within MGB IRB jurisdiction as specified by both the federal regulations and local institutional policy.

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). 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 MGB IRB. There are a number of different levels of review, each dependent upon the level of risk involved in a study. Human-subjects research must be approved to be conducted by a MGB-affiliated investigator.

Quality improvement projects are reviewed by the MGB IRB in a separate process via a “Not Human Subject Research (NHSR) Application: Not Human Subject Research (NHSR)

The new REDCap application replaces the paper version of the NHSR form and the QI Checklist previously used.
If you would like to seek an official determination that a project is “not human subjects research,” (e.g., quality improvement) click on the link above to submit a request to the IRB. The IRB will quickly review your project description and provide you either a written confirmation that your project is “Not Human Subjects Research (NHSR)” or direct you to submit a full IRB application if you are conducting human subject research.

Activities that do not meet the definition of human subject research may qualify for a NHSR designation. Some examples include:

Quality improvement/assurance projects or program evaluations
Use deidentified data or specimens with no intent to re-identify subjects
Use of cadaveric materials or data.

Please note, all students (MGH employee or not) that wish to conduct a QI or research project to fulfill requirements of an academic program must register with the Centralized Clinical Placement System (CCP) before starting their QI or research project; instruction on how to do that can be found here: https://www.mghpcs.org/munncenter/Student_Research_Policy.asp

CITI: Collaborative Institutional Training Initiative is being phased-out as the required training for human research education. Every individual engaged in human research at MGB must now take HRA Clinical Research Boot Camp and HRA Good Clinical Practice, available on MGB’s HealthStream. These 2 courses are required when your current CITI certification is expiring and must be renewed every three years. If your CITI certification is current, you do not need to do anything. You will be notified by email when you are nearing expiration and need to take the new courses.

There are live webinars and pre-recorded on-demand versions of these new courses available. You may complete either version of the courses to meet the requirement.

The courses should be completed when your current CITI certification expires. More information is available on the HRA Compliance and Education Office website.

If the FAQs don’t answer your questions about the transition away from CITI training, please email: humanresearchqi@partners.org.

Other resources that may help you include:

Division of Clinical Research Education Unit www.massgeneral.org/research/education/clinical-research-education.aspx
The DCR offers multiple educational programs and related support at for scientists at all stages of the clinical research process. Researchers are asked to review this site and access classes on research development and implementation essential for the conduct of clinical investigations.

MGH Translational and Clinical Research Centers (TCRC) https://tcrc.mgh.harvard.edu/
The TCRC provides a clinical laboratory and other support for nurse scientists who conduct human subject research. Please review this website for available services and requirements for conducting clinical trials at the TCRC

updated 5/9/2023