Research

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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  

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.

Notice of proposed Rulemaking (NPRM)
The U.S. Department of Health and Human Services has issued a Notice of Proposed Rulemaking (NPRM) with the purpose of modernizing, strengthening and making more effective the federal policy for the protection of human subjects. The NPRM is 500 pages long and includes the rationale for changes (the preamble), the actual revised regulation and questions for additional comment. More information about the NPRM may be found at: http://www.hhs.gov/ohrp/humansubjects/regulations/nprmhome.html

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. 
  

An overview of required registration requirements for ClinicalTrials.gov is now available.
Investigators should familiarize themselves with the  requirements to register in order to meet  FDA regulations and ICJME  publishing requirements.  ClinicalTrials.gov: Review of Registration Requirements 

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?


Advanced Notice of Proposed Rule Making (ANPRM)

The U.S. Department of Health and Human Services announced that the federal government is contemplating various ways of enhancing the regulations overseeing research on human subjects. They have provided an Advanced Notice of Proposed Rule Making (ANPRM). This provides the government with an opportunity to receive comment on specific topics  before actually proposing regulations, Children’s Hospital has submitted comments which may be found at:  Please click here to see the comments

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

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