IRB | Overview
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.
COVID-19 IRB Resources & References
The COVID-19 Resources & References page provides information and updated requirements for clinical research during the COVID-19 pandemic. Investigators should review the most current requirements and submit by October 1, 2020, to ensure compliance.
News and Announcements
Sophie's Science Project Animated Video:
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.
Upcoming IRB and EQuIP Educational Offerings: To meet the demand for remote educational offerings while many BCH employees are working offsite, the IRB and EQuIP Offices offer monthly educational opportunities for investigators, coordinators and other research personnel. All sessions are offered via Zoom and some require advanced registration. Note that these are intended for BCH personnel only. Qualifying attendees can earn continuing IRB education credit for some of the courses. Find more details and registration links in the Institutional Centers for Clinical and Translational Research (ICCTR) Clinical Research Education Calendar.
New Gender Neutral Informed Consent Template (July 2020) — Now with gender neutral language.
June 3, 2020 IRB Special Communication — Home Health Care Visits and Reopening of Clinical Research at BCH
April 16, 2020 IRB Special Communication — Use of Remote Interpreters when using a Short Form Consent for Research
April 7, 2020 IRB Special Communication — Cumulative Update: IRB Q & A Guidance for COVID-19 Related Issues including Remote Consent, e-Consent, and Reliance Issues.
March 31, 2020 IRB Special Communication — Changes made to CHeRP IRB SmartForms including COVID-19 items.
Partial Summary of COVID-19 Disruptions of International Clinical Trials: Comparing Guidances Issued by FDA, EMA, MHRA and PMDA, prepared by Ropes and Gray (April 3, 2020)
Please note this information is limited to the United States FDA section of the guidance provided by Ropes and Gray. The guidance is directed to Sponsors however BCH has some investigators who hold their own INDs and are considered sponsors as well as investigators. It also gives all investigators considerations for all FDA regulated trials.
COVID-19 BCH Clinical Research Advisory 3.31.20
This memo includes a standard operation procedure outlining an interim process to enable external clinical trial monitors to conduct remote source data verification during the COVID-19 site closure.
COVID-19 BCH Clinical Research Advisory 3.24.20
This memo has three important new items. All members of the clinical research community are asked to read the entire document for full details.
First, we will implement a Coronavirus Research Oversight Committee (CROC) that will be tasked with providing overall institutional guidance for this clinical research over the next 3 months. These guidelines are for protocols in which direct interaction with patients is required. Protocols that can be implemented entirely remotely, such as patient registries, do not fall under these guidelines.
Second, in addition, for this acute crisis, we will replace departmental scientific review of COVID-19 related studies with a centralized scientific review committee (SRC).
Third, during this acute crisis, to optimize infection control we will be restricting direct in-person access to families/patients for the purpose of clinical research related to COVID-19 to licensed providers only.
COVID-19 BCH Clinical Research Advisory 3.16.20
Boston Children’s Hospital will begin cancelling non-urgent and non-emergent surgeries, procedures, admissions, clinic and research visits at all of our locations. Staff and employees were directed to start immediately on this work with the plan that by Wednesday, March 18, all procedures and processes will be in place. The institution will evaluate this decision every two weeks.
BCH will continue to care for Urgent and Emergent patients during this critical time. Investigators will need to determine which encounters can be cancelled or completed via Telehealth and be responsible for communicating any changes to study subjects and families. Please provide clear directions for how to contact you as the investigator or a member of your study team should they have any questions. The use of virtual visits and/or phone check-ins when possible is encouraged—you can find more information as well as how to manage these changes on the IRB's home page below (see the IRB Q & A). Zoom is a HIPAA compliant option for communication purposes. If you are planning on recording any of the Zoom meetings, their cloud environment is not compliant. For any recording please use the instructions to record directly to the secure file share (RC-FS). If your group does not have an RC-FS account please email firstname.lastname@example.org to set one up.
The current situation with COVID-19 is being monitored closely, and the institution cannot currently commit to when our patients/study subjects can be rescheduled, for non-urgent and non-emergent study visits. While current guidelines are for the next six weeks and the institution will be reviewing recommendations constantly, it is recommended that you not reschedule any patients/study subjects for at least six weeks.
BCH IRB-Specific COVID-19 Guidance Questions and Answers
Given the quick and evolving COVID-19 issues, the IRB has developed a Q & A document to assist investigators in considering clinical research questions related to the impact of the COVID-19 pandemic. We encourage research investigators to proactively think about their protocols, subject populations and the potential impact COVID-19 may have on conducting their research protocols. All human subject regulations need to continue to be followed during the COVID-19 outbreak. In addition all remote visits and tools used to collect data and share or store data must continue to follow the hospital policies for being compliant with HIPAA regulations. The following question and answer document will continue to be updated as we are presented with new questions and directives from the institution. Click here to view the Q & A.
NIH sIRB Policy Effective Date Extension
The effective date for all domestic sites participating in a NIH-funded multi-site research study to use a single IRB (sIRB) has been extended to January 25, 2018 (NIH Notice). Detailed information regarding this NIH policy can be found in our July 2016 Special Communication newsletter below as well as this link to the Research Administration Department’s June 29, 2017, email announcement to the Boston Children’s Hospital research community. For additional information and to request presentations for your department, please email IRB Specialist Robleinscky Dominguez or call 617-355-5935.
2017 December Special Communication
- New NIH policy regarding Certificates of Confidentiality (CoC)
2017 July Special Communication
- Boston Children’s Hospital joins Smart IRB (Replacing Harvard Catalyst)
2016 July Special Communication
- NIH Policy on the Use of a Single IRB for Multi-site Research
- Message from the Director
- Criteria for Conditional Approval vs Deferral
- Conflict of Interest Review by the IRB
- Consent Form Bar Codes for Scanning into Medical records
- Reliance Agreements
- Congratulations Scott Meyers
- New View in CheRP
- Memo To File: From the EQuIP Office
- Notice of proposed Rulemaking (NPRM)
- Changes to Staff Amendment Activity in CHeRP
Important Change to Eligibility of Who can be a PI on an IRB Protocol
Effective June 29, 2015, the eligibility criteria for who can serve as a Principal Investigator (PI) for non-exempt, human subject research protocols submitted to the IRB will change. The new policy seeks to implement a mechanism of accountability and continuity for human subject protections and is not intended to restrict academic productivity or leadership. Trainees may no longer serve as a PI of a protocol submitted to the IRB. Individuals who do not meet the criteria to be a PI may still participate as a Co–Investigator and perform leadership roles in the conduct of the research. Please link to the attached special communication for further information about this change. More information.
We are pleased to offer all investigators access to an new comic book, “Sophie’s Science Project: What is Medical Research.” This comic book was developed with the goal of educating children about medical research. The comic can be downloaded at the link above. Paper copies may be obtained by contacting your IRB Administrator.
- AAHRPP Reaccreditation
- Memo to File: From the EQuIP Office
- Case Studies/Series Guidance
- A Fix for Consent Form Headers
- New Comic Book
- Welcome Scott Meyers
- Harvard Catalyst Research Subject Advocacy Materials
- New ClinicalTrials.Gov Oversight at BCH
- Facilitating Protocol Submissions through CHeRP
- Using the review status tab
- Using the Reportable event from
- Submitting DSMB Updates
- Adding Non-BCH Employ
- Memo to File: From the EQuIP Office
- Struggling with CHeRP?
- Clinical Research Center (CRC) Services
- New Policy on Research Involving Decisionally-Impaired Adults
- New Consent Form Template
- Memo to File: From the EQuIP Office
- Pre-Review Helpful Hints
- Update on IRB Jurisdiction
- What Human Subject Training Satisfies the IRB Education Requirement?
Short Consent Translations
The Committee on Clinical Investigation will now allow the use of short consent document translations in several commonly understood languages. This abbreviated translation or "short form" (which attests that the elements of consent have been presented orally) may be used to document informed consent in writing for individuals who do not speak English in limited situations. More information.
For information regarding the education requirement for researchers, please see: Education Requirement. Information regarding the continuing education requirement can be found at: Continuing Education Requirement.