Institutional Review Board (IRB)

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

IMPORTANT Common Rule Changes Effective January 21, 2019

On January 21, 2019 new human subject regulations will take effect.  The regulations apply to research protocols approved as of January 21, 2019.  There will be no change for research protocols approved prior to 1/21/2019.  They will remain under the current regulations.

Some areas of change include the following:

  • Additional required elements of consent
  • Requirement for a concise and focused presentation of key information to be presented first in the consent form
  • Elimination of continuing review requirements for expedited protocols and protocols in data analysis only
  • Changes to exempt categories and some categories that do not require IRB review

 

How to Get Ready

1. Click below for a special communication newsletter that provides a more detailed overview of the upcoming IRB regulatory changes.

  2018 November Special Communications 

  •  Common Rule Changes Effective January 21, 2019

2. Come to a training sessions that will be held in the Enders Auditorium. Attendance will count as IRB continuing education credit.No sign up is required

December 6, 2018                            2-3

  December 12, 2018                         11-12

December 20, 2018                         3-4

January 7, 2019                                 3-4

January 11, 2019                               9-10

 

3. One of the most important changes for investigators is that the informed consent document must begin with a concise and focused presentation of key information that is most likely to assist a prospective participant or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension. Currently, there is no federal guidance defining “key information”. However we have implemented a template to help assist investigators and will continue to provide guidance as it becomes available from the regulatory agencies.We are also posting some sample “key information sections” that may help you think about how to prepare this portion of the consent document. Investigators will be responsible for submitting consent documents that comply with the new regulations as of January 21, 2019.Consents associated with protocols that are under review but not approved prior to January 21, 2019 will need to be modified; therefore we recommend you begin to develop consents with these changes immediately.The changes are consistent with our current federal regulations so they are permitted at this time.

 

New English Informed Consent Template (New Common Rule version dated November 2018) 

Concise Summary Example- Greater Than Minimal Risk

Concise Summary Example- Minimal Risk

Concise Summary Example-Repository 

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 Daniel Alderson or call 617-919-1918.

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

2016 June Newsletter

  • 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

2015 October Newsletter

  • Notice of proposed Rulemaking (NPRM)
  • Changes to Staff Amendment Activity in CHeRP

 

Important Changes to Staff Amendment Activity in CHeRP
An amendment is no longer required to add/remove BCH personnel from research protocols in CHeRP.  Rather than submitting a separate amendment to do so, the PI or an editor on a protocol can now select the new “Manage BCH research team” activity located at the bottom, left-hand menu within the protocol workspace to make BCH staff changes.  As with amendments, the activity will still check that appropriate human subjects training has been completed before adding new personnel.

However, an amendment is still required to modify study documentation (i.e. recruitment materials, consent forms, protocol documents, that list staff), add and/or remove non-BCH personnel, or change the study’s Principle Investigator.  

Of note, the “Manage BCH research team” activity is unavailable while an amendment remains open.  If an amendment will be/has been submitted for other modifications to the study, staff changes may be made at that time as usual.

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. Please click here for more information.

Comic Book!
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. 

 

2015 April Newsletter

  • 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

2012 September Newsletter
  • 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.  Please click here for more information.

Education Requirements

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