About the IRB
Women & Infants’ Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects. The purpose of the IRB is to protect the rights and welfare of human research subjects and to ensure that all human subject research be conducted in accordance with federal, institutional, and ethical guidelines.
Research at Women & Infants Hospital
The IRB functions as an integral part of the research process in that IRB approval must be granted prior to commencing any research activities. Women & Infants Hospital is one of the nation’s largest and most prestigious research facilities in high-risk and normal obstetrics, gynecology, and newborn pediatrics. Additionally, Women & Infants Hospital is a major teaching affiliate of The Warren Alpert Medical School of Brown University. Our goal is to develop original research through collaboration, education, training, and support services, and to transform this knowledge into practical information that can be shared with health care providers and the community to improve the health of women and newborns. Researchers collaborate with all members of Care New England Health System (Butler, Kent and Memorial Hospitals, The Providence Center and the VNA of Care New England) as well as with hospitals and health care providers across the region and around the globe.
In order to promote research within the current ethical, legal, and regulatory framework, our staff provides professional guidance and support to the research community and helps researchers navigate the submission process. The IRB Administrative Office also serves as the administrative office for the Institutional Official and Institutional Review Board at Women & Infants.
Thinking about submitting to the IRB?
Is this subject to IRB Review?
- Does the activity involve research? (45 CFR 46.102(d)).
- Does the research activity involve human subjects? (45 CFR 46.101(b)).
- Does the human subjects’ research qualify for an exemption? (45 CFR 46.101(b)).
The Office for Human Research Protections (OHRP) provides the Human Subject Regulations Decision Charts as a guide for institutional review boards (IRBs), investigators, and others who decide if an activity must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46.
U.S. Department of Health and Human Services (HHS) Definitions
- Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
- Human subject means 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.
All members of Care New England Health System use IRBNet as their electronic portal for IRB submissions and document maintenance. There are a number of resources that provide IRBNet basics, training videos, and step-by-step training guides. These resources are even available to you before you create an IRBNet account.
Human Research Protection
Women and Infants Hospital uses Collaborative Institutional Training Initiative (CITI) for mandatory education in research ethics and the responsible conduct of research. CITI training is required for all investigators and key study personnel involved in the conduct or reporting of research.
A full library of forms, templates, and additional resources is available in the IRBNet Forms and Templates Library.
Select Care New England – Women & Infants IRB, Providence, RI – Documents for Researchers.
Research Rules and Regulations
HHS - Federal Code of Regulations Title 45, Part 46: Protection of Human Subjects
FDA - Code of Federal Regulations (CFR) Title 21, Part 50: Protection of Human Subjects
FDA - Code of Federal Regulations Title 21, Part 56: Institutional Review Boards
The Belmont Report
The Nuremberg Code
The Helsinki Declaration
Good Clinical Practice (GCP)
Health Insurance Portability and Accountability Act (HIPAA)
Contact IRB Administration
300 Richmond St, Suite 201
Providence, RI 02903
Phone: (401) 453-7677 (direct line for research subjects only)
Fax: (401) 453-7678
Alexandra Caffrey Boutros, BS
(401) 274-1122, ext. 42262
Diane Stock, CIP
Research Regulatory Coordinator
(401) 274-1122, ext. 42261
Research Systems and Compliance Specialist
(401) 274-1122, ext. 42266