The Human Research Protection Program (HRPP) is a comprehensive system to ensure the protection of human subjects participating in research. The objective of the HRPP is to assist Connecticut Children’s in fostering an ethical culture in our research programs and ensuring that we continuously meet ethical principles and regulatory requirements for the protection of human subjects in research.
The HRPP is made up of various individuals and committees including an the Institutional Official, the HRPP Medical Director, the HRPP Director, the Institutional Review Board (IRB) and staff, the Scientific Review Committee, the Clinical Research Feasibility Committee, Research Leadership, investigators, research staff and research pharmacy staff.
Connecticut Children’s is fully accredited by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP),which demonstrates our strong commitment to the highest ethical standards in research.
Institutional Review Board (IRB)
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:
- 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 [at] 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:
- 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.
fdimari [at] connecticutchildrens.org (Francis DiMario, MD, CIP)
Director, Human Research Protection Program
Chair, Connecticut Children’s Institutional Review Board
SChandna [at] connecticutchildrens.org (Stacy Chandna, MS, CIP)
Director, Human Research Protection Program
Vice Chair, Connecticut Children’s Institutional Review Board
czevetchin [at] connecticutchildrens.org (Carrie Zevetchin, MS, CIP)
Sr. IRB Manager, Human Research Protection Program
jdelgado03 [at] connecticutchildrens.org (Jennifer Delgado, MPH, CIP)
IRB Operations Manager, Human Research Protection Program
agriffin01 [at] connecticutchildrens.org (Aislyn Griffin, BA)
IRB Coordinator, Human Research Protection Program
irbstaff [at] connecticutchildrens.org (General IRB Inquiries Email)
Research Compliance Program
Connecticut Children’s Research Compliance Program serves all members of the research community including but not limited to the Institutional Review Board (IRB), Office of Grants and Sponsored Research Programs, Clinical Trials Unit, research department, investigators and research staff.
The goals of the program include the following:
- Facilitate a culture of research compliance through continuous quality improvement activities including post-IRB approval study reviews, education and consultation;
- Assess research compliance with Connecticut Children’s policies and procedures, applicable federal, state and local regulations; and coordinate organizational-wide initiatives to reduce research compliance risks;
- Support the goals of the Human Research Protection Program (HRPP) to ensure the rights and safety of study subjects;
- Improve investigator performance by identifying risk areas and assisting investigators and research staff in the implementation of tools and strategies to prevent research compliance issues.
Study Specific Audits: Post-approval study review designed to support research compliance through assessment and education. Studies are randomly selected for routine reviews.
Programmatic Audits: Designed to evaluate processes in place across research at the organization by looking at a larger sample of studies but with a specific focus area, including:
- Alternative Forms of Consent
- Clinical Trial Billing Reviews
- Conflict of Interest
- Investigational Pharmacy Reviews
- Material Transfer Agreements
- Non-English Speaking Participants
- New Investigator or Research Staff Orientation: Provides an overview of the research program, research policies and available resources.
- One-on-one or Small Group Consultation/Education: Upon request, provides additional training, education, or assistance regarding best practice on various research topics.
- Study Initiation Visits: Conducts study initiation meetings with investigators and associated research staff to ensure the following: correct understanding of the protocol, clarify study procedures, study start-up materials, review roles and responsibilities of each staff member, identify regulations and policies pertinent to the study, as well as provide material and tools to facilitate adherence for each new study (e.g. source document templates).
- Research Education Series: A collaboration between Corporate Compliance and the Human Research Protection Program (HRPP) to bring practical education and disseminate process updates. The series generally runs on a monthly basis covering topics relevant to the research community.