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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. Please see the links below for information on IRB forms and trainings offered through the Division of Clinical Research Education Unit.

The Partners 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 email address “name@mgh.harvard.edu” then follow the prompts. You cannot gain access unless you use the @mgh.harvard.edu email address.

The Institutional Review Board (IRB) for Massachusetts General Hospital and the Brigham and Women’s Hospital is the Partners Human Research Committee (PHRC) provides 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 PHRC 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 PHRC. 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 Partners-affiliated investigator.

To access the Protocol Summary Template please click here

CITI: Collaborative Institutional Training Initiative  http://www.citiprogram.org 
The CITI program was developed by experts in the “IRB community” and consists of two “Basic” courses in the Protection of Human Research Subjects for Biomedical as well as for Social/Behavioral Research. CITI also offers case based “Refresher Courses” for continuing education. Members of the MGH research community are required to take the Basic Biomedical course. The Basic Biomedical course contains 16 modules. Each module includes reading material that can be read on screen or printed and a brief on-line quiz. The format is “open book”- you may refer back to the text at any time while taking the quiz.

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 Clinical Research Center www.massgeneral.org/crc/ 
The CRC 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 on the CRC.

 

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