Connecticut Children’s Medical Center’s main campus is located at 282 Washington Street in Hartford, Connecticut.

Institutional Review Board

The Institutional Review Board (IRB) is a committee appointed by Connecticut Children’s Physician-in-Chief, Juan Salazar, MD, our institutional official for the program.

The IRB prospectively reviews the initiation, modification and continuation of research involving human subjects and approves research in accordance with the requirements of the applicable federal, state and local regulations, the Federal Wide Assurance and institutional policies.

The Institutional Review Boards (IRB) for Connecticut Children’s Medical Center are composed in accordance with and operates in compliance with FDA and HHS regulations.  The Connecticut Children’s IRB A is registered with the U.S. Department of Health and Human Services (DHHS) as IRB00000703.  The Connecticut Children’s IRB B is registered with DHHS as IRB00009717.

Connecticut Children’s utilizes an electronic web-based system (IRBManager) for submission, review, approval and ongoing oversight of all research activities. All human research related submissions and correspondence are sent through this system.   

To determine if an activity qualifies as human subjects’ research, please use the definitions of “human subject” outlined in the HRPP Standard Operating Procedures as a guide and submit a human subject research determination form through IRBManager. 

All human subjects research conducted under the auspices of Connecticut Children’s must meet the criteria for one of the following levels of review:

  • Exempt
  • Expedited review
  • Full board review

Detailed policies and procedures for IRB review are included in the HRPP Standard Operating Procedures.  Additional guidance can be found through the Connecticut Children’s Research Institute intranet.

If you have questions or need clarification regarding the IRB review process, please call the IRB Office at 860.837.5515 or email IRBstaff@connecticutchildrens.org.

We are surrounded by amazing breakthroughs in medicine every day. There are vaccines that can prevent diseases; there are new surgical techniques that allow operations to be performed through the smallest of incisions, as well as medicines that allow children with chronic illnesses to live healthier lives. While medicine has come a long way, there is still much more that needs to be done. One important way to advance medicine is through clinical research.

Clinical research can help us to understand how medications and therapies affect children. Many new drugs and medical devices go on the market without being tested among children. Despite the lack of research data for children, these therapies become widely used. The US government has offered incentives to manufacturers to conduct clinical trials with children for drugs and devices that have already been approved for adults. These clinical trials can determine whether drugs and treatments are both safe and effective for children.

For children with chronic illnesses, new therapies that are not yet on the market may offer more choices to manage their conditions. For example, new ways of delivering insulin to diabetic children, such as pumps and inhalant devices, were first tested in clinical trials to determine if they worked as well as injected insulin.

Connecticut Children’s Medical Center has a Clinical Trials Unit that helps physicians, nurses and families participate in clinical research studies. The staff of the Clinical Trials Unit has more than 40 years combined experience conducting clinical research and understands the special needs of children and families.

Our physicians and Clinical Trials Unit staff work hand in hand with the assistance of study volunteers – incredible children and their families who are willing to participate in clinical studies that help determine if research ideas hold promise for better treatment, prevention and cures.

Volunteers can be of any age or gender. Studies need both healthy volunteers and children with a specific illness or inherited disorder. Volunteers have diverse cultural, ethnic and racial backgrounds.

To choose to participate in research is an important family decision. Whatever the reason to participate in a research study, each and every research volunteer and his or her family is instrumental in shaping the future of medicine.

Patients who are interested in volunteering to participate in research can learn more by viewing informational videos, brochure, list of questions to ask researchers, and additional resources related to research participation that have been created by the Office for Human Research Protections (OHRP), a federal government agency:

For more information, please see Frequently asked Questions for Families. »

In addition, those considering volunteering for research can review the Belmont Report, which outlines the ethical considerations in research involving human subjects. The report was compiled by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979, and served as the framework for the federal regulations created to protect human subjects.

 

SPECIAL NOTE TO RESEARCH PARTICIPANTS:

If you have any questions or concerns about your role and rights as a research participants, would like to obtain information or offer input, or would like to register a complaint about a specific study, please contact Stacy Chandna, HRPP Director via email or at 860.837.5517.

*Anonymous inquiries are welcomed.

Francis DiMario, MD, CIP
Director, Human Research Protection Program
Chair, Connecticut Children’s Institutional Review Board

Stacy Chandna, MS, CIP
Director, Human Research Protection Program
Vice Chair, Connecticut Children’s Institutional Review Board
860.837.5517

Carrie Zevetchin, MS, CIP
Sr. IRB Manager, Human Research Protection Program
860.837.5514

Jennifer Delgado, MPH, CIP
IRB Operations Manager, Human Research Protection Program
860.837.5516

Aislyn Griffin, BA
IRB Coordinator, Human Research Protection Program
860.837.5515

General IRB Inquiries Email

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