Children's Hospital Research Children's Hospital Labs Office of Clinical Investigation Home Info about the CCI Info for Researchers Info for CCI Members Guidelines & Policies Educational Resources EQUIP CCI Newsletters Informed Consent Library Newsletters 2008 August 2008 Special Communication Newsletter Administrative Staff Changes for Office of Clinical Investigation May 2008 Special Communication Newsletter REVISED REPORTING POLICY: Reducing Adverse Event/Unanticipated Problem Reporting & Increasing Reliance on Data and Safety Monitoring Communications with the IRB March 2008 Special Communication Newsletter Elimination of Three Year Rewrite Reviews & Changes to Continuing Review Process I. Why is the three year rewrite requirement being eliminated? II. Now that the three year rewrite is eliminated, how will this impact the continuing review process? III. When is this policy change effective? IV. If I have received a three year rewrite notice and have already prepared the three year rewrite what should I do? V. If I received a three year rewrite request and have not prepared it what should I do? VI. If I have three year rewrite that was reviewed by the IRB and I received a conditional approval or deferral what should I do? VII. The GCRC and Radiation Safety Committee require review three year rewrites, how will this impact them? VIII. My department requires scientific review of three year rewrites, has this changed? IX. Is there a new continuing review form? X. Who do I contact for questions and further information? 2007 December 2007 Special Communication Newsletter I. Clinical Trials Registration IMPORTANT REGULATORY UPDATE October 2007 I. What Human Subject Research Activities Fall under the Jurisdiction of the Children's Hospital Committee on Clinical Investigation? II. Documenting Scientific Review: Is it Complete? III. AAHRPP Site Visit Scheduled for January 23-25 IV. Organize your study documents! Study regulatory binder templates now available Special Communication Newsletter Administrative Staff Changes for Office of Clinical Investigation 2006 I. Web Based Informed Consent Library Now Available II. New Guidelines for Using the Internet to Conduct Research Activities III. Important Policies for Including Wards of the State in Clinical Research Protocols IV. Continued Use, Storage and Distribution of Biological Samples Collected During Research V. Changes in CCI staff May 2006 I. Staffing Changes II. New Procedure for Continuing review of Medical Record and Discarded Specimen Requests III. Visit Our New Website IV. Clarification in Serious Adverse Event Reporting Policy V. Updated Forms VI. New Continuing Education Training Requirements VII. Reminders/Did You Know that& October 2006 2005 November 2005 Special Announcement: Revised Protocol Submissions October 2005 I. Accreditation Update II. Protocol Numbers Will No Longer Change III. Policy, Procedure and Form Changes IV. Unanticipated Problems Involving Risks June 2005 I. New Classifications for Use of Human Biological Specimens and Existing Data for Research Purposes II. What is the Difference Between Privacy and Confidentiality? III. Scientific Review: Updated Requirements for Protocol Submissions IV. Do You Need Help Writing an Informed Consent? V. Welcome and Farewell: Staff Changes April 2005 Special Announcement: New Continuing Education Requirement for Human Subject Protection February 2005 I. Improved HIPAA Authorization for Research Consents II. New Look for Informed Consent Documents III. New HIPAA Language for Research Informed Consents January 2005 I. Funding for Translation of Research Informed Consent Documents II. How to Request Translation of an Informed Consent?    2004 April 2004 I. Informed Consent Assistant Now Available II. New Procedure for Continuing review of Medical Record and Discarded Specimen Requests III. Accreditation: Where are We? IV. Update on Scientific Review Requirements V. Electronic Continuing Review Notification to be Implemented June 2004 I. Administrative Staff Changes for Committee on Clinical Investigation September 2004 I. New Children's Hospital Research Website to Post Clinical Research October 2004 I. Children's Hospital has Developed a:"A Parent's Guide to Medical Research," A Web-Based, Interactive Educational Program for Parents. December 2004 I. Update on Accreditation II. Improving the Informed Consent Process III. Post Recruitment Notices on the Children's Hospital Website IV. Do You Know Your Department's/Division's Scientific Review Process? V. New and Revised Websites VI. Important New Policies/Procedures and Forms 2003 December 2003 I. Revised Guidelines for Determining Which Quality Improvement and Educational Activities Require IRB Review November 2003 I. New Web-Based Tools for Investigators II. Informed Consent Research Underway III. Important CITI Training Notice IV. Quality Improvement Initiative to begin in January 2004 Special Newsletter I. Revised Protocol Application Now Available September 2003 I. Grant to Understand and Strengthen the Informed Consent/Assent Process II. Quality Improvement Program for Human Subject Protections Established III. Commitment Made to Apply for Human Subject Program Accreditation IV. Revised and Improved Guidelines for Human Subject Training May 2003 I. New Conflict Interest Guidance II. CCI Staff Update and Department Assignments March 2003 I. HIPAA Research Consent Templates Now Available II. Complete CCI Forms On-Line III. Pregnancy Testing Guidelines for Research IV. HIPAA Research Training Update V. Contacts for HIPAA Questions February 2003 I. HIPAA Training II. How Can Investigators Prepare for HIPAA III. Existing Approved Protocols: How To Use HIPAA Authorization Addendums IV. New Protocols: Combing Informed Consent and HIPAA Authorization V. HIPAA And Medical Record/database reviews & Discarded Specimen Requests VI. Contacts for HIPAA Questions 2002 November 2002 New Policy on Dispensing Investigational Drugs, Effective December 1, 2002 New HIPAA Requirements for Clinical Investigation Informed Consent Policy Changes: 1) Addition of Age and Date of Birth 2) Witness Signature Copyright 2004-2007 Children's Hospital Boston