Every family that entrusts their child to a research study places extraordinary faith in us, faith that we will protect their child and pursue meaningful discovery. For many, participation also opens doors to advances in care where today's options fall short. Upholding that trust demands rigorous ethical standards and robust safety oversight. Manne Research Institute’s Office of Research Integrity and Compliance, which includes Research Compliance, Regulatory and Quality Assurance, and the Human Research Protection Program, promotes responsible conduct of research by our study teams. The Human Research Protection Program is a collaborative effort among those involved in conducting, reviewing, approving, and facilitating human subjects research, including the institutional review board (IRB). IRBs, the committees of scientists, nonscientists, and community members who follow federal regulations to evaluate and monitor human subjects research, ensure that risks are minimized and that participants give voluntary, informed consent. They provide ethical review of research procedures, such as study designs and informed consent processes, and ensure compliance with federal, state, and institutional policies. IRBs operate at institutions that conduct research involving human subjects, making sure that researchers follow strict guidelines, especially when working with children.
Federal guidelines specify extra protections for research involving children and require IRBs to enforce these safeguards during the review process. This includes assessing certain research activities involving children that might be exempt if conducted with adults; evaluating the potential benefits and risks of pediatric research to justify the inclusion of children; and making certain study teams obtain parental permission and, when appropriate, child assent. The informed consent process is central to IRB review and research participation. Our principal investigators and study teams work closely with parents or guardians to ensure they understand the study’s nature, benefits, risks, and their child’s rights. They also meet with interested children to assess whether they can assent to participation, ensuring children understand what they are voluntarily agreeing to and what involvement entails, explains Tricia Eifler, MBA, CIP, Director of the Human Research Protection Program at Manne Research Institute. As part of our overall informed consent process, we require verbal assent from children up to 12 years of age and written assent from children aged 12–17. IRBs consider the children’s ages, maturity, and psychological state when reviewing proposed assent procedures. To promote the fair and equitable selection of participants, Tricia and Jennifer Rubin, MD, an attending physician of neurology at Lurie Children’s, collaborate on efforts to improve the translation of study documents into other languages. Currently, we provide IRB-approved informed consent short forms in more than 20 languages, and the IRB reviews each study to ensure compliance with ethical standards of justice and that participants are selected fairly and study materials are in a language they can understand.
Alongside Tricia’s guidance, a skilled team supports the work of our Human Research Protection Program and IRB. As assistant director of the Office of Research Integrity and Compliance, Gretchen Anding, MA, CIP, manages the daily operations of the Human Research Protection Program, including overseeing the weekly IRB meetings, onboarding and training new staff, and providing ongoing education and support for the research compliance coordinators: Allison Harris, Lorraine Rich, Laura Smith, Bisma Manzoor, and Liliana San Miguel. These coordinators serve as subject-matter experts for the IRB review process for human subjects research, offering regulatory guidance to the research community and IRB members and conducting comprehensive pre-reviews of submissions to the IRB. Our IRB comprises pediatricians from Lurie Children’s, nurses, researchers, and key community members like parents or grandparents of previously cared-for children. They contribute diverse perspectives to the panel, provide valuable insights into the questions posed to potential research participants, and help identify any ambiguities in the consent process forms. Lurie Children’s representatives leading the panel include Jennifer Rubin, MD, IRB chair; Mark Fishbein, MD, IRB chair; Denise Rizzo, PharmD, IRB vice chair; and Sara Huston, MS, IRB vice chair.
Our research compliance team and IRB are essential in maintaining research integrity, assessing the scientific significance of pediatric studies, and safeguarding the health, welfare, and privacy of our participants. Importantly, their collaboration advances our mission to improve children’s lives through scientific discoveries and helps preserve public trust in human subjects research and our research institute.
