Contact Information:

Lisa A. Bonneau, MSED
Institutional Review Board Administrator
Human Protections Administrator
Southern New Hampshire Medical Center IRB
8 Prospect Street, PO Box 2014
Nashua, NH 03061-2014
Office: 603-577-2963
Fax: 603-577-2772
Lisa.Bonneau@snhmc.org

The primary responsibility of the IRB is to protect the rights and welfare of human research subjects involved in medical and health related research studies.

List of Members:

The IRB consists of nine members with diverse backgrounds who provide a balanced review of the studies. Current members include physicians, nurses, pharmacists, non-scientists, clergy, legal council, and community members. (IRB Roster)

Christian Rodriguez, M.D. - Chairperson
Maurice Collard, R. Pharm.
Sue Fetzer, RN, Ph.D
David Gilmour, M.D.
Sue Holmes , RN , CBCN
Laurie Perreault, Esq.
Erica Bodwell, Esq.
Rev. Soushan Saliban, D. Min
Robert Theriault, D.O.

Is it Quality Assurance/Quality Improvement Or Research that Needs to be Reviewed by an IRB?

Federal regulations define a human subject as a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information. Research is a systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalizable knowledge.  For purposes of this document, "generalizable knowledge" is information (findings) that can be applied to populations or situations beyond those being immediately studied. If the project is conducted with the goal of contributing to generalizable knowledge, the IRB must review it.  If there are no intentions to develop or contribute to generalizable knowledge, IRB review is not required.
 
Quality Assurance (QA) activities are done to assure known quality.  These activities are mechanisms to assure that organizations function optimally. Quality Improvement (QI) activities are done to improve quality of programs, improve services, or improve the provision of medical care, customer service, etc.  QA/QI projects are usually done for internal purposes only.  However, some QA/QI projects may fall under the federal definition of research, and therefore may require IRB review.
 
To determine whether QA/QI activities involving human participants or individually-identifiable data must be submitted to the IRB, consider the definition of research.  Note that QA/QI activities, regardless of whether they meet the definition of research, should not pose any risk to individuals, infringe on individual privacy, or breach individual confidentiality.

IRB review of QA/QI activities may be required when:
 
You anticipate in advance of conducting the project, or while conducting the project, that you will analyze, interpret, and disseminate the findings of your investigation beyond the scope of your department or division

                           OR
 
The knowledge gained from your project will be applied beyond quality assurance or improvement to new, shared procedures or processes.

If at least one of the above statements applies to you, next consider whether proposed activities are a “systematic investigation”.  For example, does your study systematically:
Gather information beyond what is routine for patient care, e.g., extra medical tests, surveys, or data collection?
Assess the effectiveness of processes or procedures?
Compare two or more treatments, interventions, or processes?
Manipulate a current process to determine which is best?
 
For clarification, contact the IRB Administrator. (In many cases, these projects may meet the criteria for an Exempt Review.)

Scope of the IRB:

• Evaluate studies for ethical treatment of patients
• Assess studies for appropriateness of SNHMC/FMP as study site
• Validate consent forms to: Assure that aspects of study are accurately represented; Assure that language is easily understood by prospective study participants