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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:

• 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.

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
2020 Meeting Dates and Deadlines for Submission

CCMC Institutional Review Board B
2020 Meeting Dates and Deadlines for Submission