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.

Human Subject Research Determination

The responsibility for initial determination as to whether an activity constitutes human subjects research rests with the investigator. This determination should be made based on the definitions of “human subject” and “research” in the HRPP Standard Operating Procedures.

Final determination rests with Connecticut Children’s HRPP. A confirmation that an activity does not constitute human subjects research should be requested by submitting a Human Subject Research Determination form through IRBManager. All requests must include sufficient documentation of the activity to support the determination.

If you have questions or need additional information regarding the human subjects research determination process, please contact the HRPP Director at 860.837.5517.

IRB Review

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.

If you have questions or need clarification regarding the IRB review process, please call the IRB Office at 860.837.5516.

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.

IRBManager is the electronic submission system used at Connecticut Children’s for research involving human subjects. Please contact the IRB/HRPP Office if you need assistance, have questions or to request a consultation regarding IRBManager by calling 860.837.5516. All prospective investigators should note that all IRB submissions must be made through IRBManager. Paper submissions will not be accepted.

IRBManager is a web-based tool and can be accessed from any Internet browser. Please note: IRBManager is NOT accessible through the Hartford Hospital portal or the Connecticut Children’s shared drive.

You will need a username and password to access this system for the first time.  Your password should be kept confidential and not shared with anyone.  Please contact the IRB office to obtain a username and password for IRBManager.  IRB office personnel are available to meet with investigators and research staff  to offer training and assistance in the use of the electronic submission system.

Before beginning an application, please send your study protocol and any data collection tools for scientific review unless your application is for a multi-centered trial and/or an industry sponsored trial. Materials can be emailed to Brenda Labbe, Science Review Committee.

CCMC Institutional Review Board A
2018 Meeting Dates and Deadlines for Submission

Meeting Date
(2nd Monday of month)

Submission Deadline
(3 weeks prior)

Meeting Location
(Meetings start at 4 pm)

January 8, 2018 December 18, 2017 Conference Room E & F
February 12, 2018 January 22, 2018 Conference Room E & F
March 12, 2018 February 19, 2018 Conference Room E & F
April 11, 2018 (Wed.) March 19, 2018 Conference Room 5C
May 7, 2018 April 16, 2018 Conference Room E & F
June 11, 2018 May 21, 2018  Conference Room E & F
July 9, 2018 June 18, 2018 Conference Room D
August 13, 2018 July 23, 2018 Conference Room E & F
September 10, 2018 August 20, 2018 Conference Room E & F
October 8, 2018 September 17, 2018 Conference Room E & F
November 12, 208 October 22, 2018 Conference Room D
 December 10, 2018 November 19, 2018 Conference Room E & F

CCMC Institutional Review Board B
2018 Meeting Dates and Deadlines for Submission

Meeting Date
(4th Monday of month)

Submission Deadline
(3 weeks prior)

Meeting Location
(Meetings start at 4 pm)

January 22, 2018 December 29, 2017 Conference Room D
February 26, 2018 February 5, 2018 Conference Room D
March 19, 2018 February 26, 2018 Conference Room E & F
 April 23, 2018 April 2, 2018 Conference Room E & F
 May 21, 2018 April 30, 2018 Conference Room D
 June 25, 2018 June 4, 2018 Conference Room E & F
July 23, 2018 July 2, 2018 Conference Room D
August 27, 2018 August 6, 2018 Conference Room D
September 24, 2018 August 31, 2018 (Friday) Conference Room D
October 22, 2018 October 1, 2018 Conference Room E & F
November 26, 2018 November 5, 2018 Conference Room D
December TBD TBD TBD

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
IRB Manager, Human Research Protection Program
860.837.5514

Jennifer Delgado, MPH, CIP
IRB Systems Analyst, Human Research Protection Program
860.837.5516

Taylor Dubreuil, BA
IRB Coordinator, Human Research Protection Program
860.837.5515

 

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