This website is designed to assist the clinical research community in safeguarding the rights and welfare of human subjects who participate in research. Boston Children's Hospital has established a human research protection program to assure full compliance with all federal regulations, state laws, and hospital policies governing the use of human subjects in research.

News and announcements

*Updated* informed consent template now available (July 2026)

We are pleased to announce that Boston Children’s Hospital IRB has revised the BCH informed consent template. The IRB provides an informed consent template to assist PIs and research teams in developing research consent documents. We have worked with various individuals and departments across BCH to perform a comprehensive update. The new template is intended to be participant centered and includes simple lay language. It also sets expectations for the language inserted or created by investigators. The template provides universal formatting and identifies language that is either required by the IRB or is provided as a sample for researchers to use if they so choose. The new ICF template is available here. Use of the new ICF template will be required for NEW protocols submitted to the BCH IRB on or after October 1, 2026. There is no requirement for currently approved protocols to revise their consent forms. Detailed information on implementation of the new ICF templates may be found in the FAQ, also available here.

Upcoming IRB new research coordinator training

Please join us for one of our upcoming IRB New Research Coordinator Training sessions. Please click on the date below that you are interested in attending to register:

Sophie's Science Project animated video and comic book

The Harvard Catalyst Regulatory Foundations, Ethics, and Law Program has created an animated video from our first comic book Sophie’s Science Project. The video, created by Thomas Naughton, Senior Software Quality Assurance Engineer of the Harvard Catalyst Informatics team, can be found here

The comic book, Sophie’s Science Project: What is Medical Research? was developed by Boston Children’s Hospital, Cincinnati Children’s Hospital Medical Center, and the Children’s Hospital of Philadelphia with the goal of educating children about medical research. Our second comic book, BioBank: Questions and Answers, developed by Boston Children’s Hospital and Harvard Catalyst, was recently released to explain in simple terms how biobanks work, how and why samples and information are collected, and how these are used and shared. Both comics can be downloaded here, and paper copies of each may be obtained by contacting the IRB Office.