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. Investigator Resources Tools Announcements Expedited Review Categories Exempt Categories Conflict of Interest 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 860.837.5515. Participant ResourcesWe 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: Becoming a Research Volunteer: It’s Your Decision Visit HHS.org to learn more about Research Participation 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. Additional Resources Department of Health and Human Services Human Subject Protection Regulations Food and Drug Administration Human Subjects Protection Regulations Food and Drug Administration IRB Regulations 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. Electronic Submission SystemIRBManager 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 860.837.5515. 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 the Science Review Committee. Board Meeting DatesCCMC Institutional Review Board A 2021 Meeting Dates and Deadlines for Submission Meetings are held via Zoom at 4 pm unless otherwise indicated Meeting Date (2nd Monday of month) Submission Deadline (3 weeks prior) January 11, 2021 December 21, 2020 February 8, 2021 January 18, 2021 March 8, 2021 February 15, 2021 April 12, 2021 March 22, 2021 May 10, 2021 April 19, 2021 June 14, 2021 May 24, 2021 July 12, 2021 June 21, 2021 August 9, 2021 July 19, 2021 September 13, 2021 August 22, 2021 October 12, 2021 (Tuesday) September 20, 2021 November 8, 2021 October 18, 2021 December 13, 2021 November 22, 2021 CCMC Institutional Review Board B 2021 Meeting Dates and Deadlines for Submission All meetings are held via Zoom at 4 pm unless otherwise indicated Meeting Date (4th Monday of month) Submission Deadline (3 weeks prior) January 25, 2021 January 4, 2021 February 22, 2021 February 1, 2021 March 22, 2021 March 1, 2021 April 26, 2021 April 5, 2021 May 24, 2021 May 3, 2021 June 28, 2021 June 7, 2021 July 26, 2021 July 5, 2021 August 23, 2021 August 2, 2021 September 27, 2021 September 6, 2021 October 25, 2021 October 4, 2021 November 22, 2021 November 1, 2021 December 20, 2021 (tentative) November 29, 2021 Contact Us 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