Office of Clinical Investigation
Newsletters
2012
September 2012 Special Communication 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 CCI Jurisdiction
What Human Subject Training Satisfies the IRB Education Requirement?
Welcome, Siena Napoleon!
February2012 Special Communication Newsletter
International Research: Avoid Non Compliance
New FDA Regulation for Informed Consents Regarding Clinical Trials.Gov
Reminder: Pharmacy Requirement for Dispensing Investigational Drug
Welcome Susie Corl
January 2012 Special Communication Newsletter
New CHeRP and Pharmacy Requirement for Dispensing Investigational Drug
2011
October 2011 Communication Newsletter
Advance Notice of Proposed Rulemaking: Request for Comment
Guidance on Use of Personal Cell Phones For Recruitment and Communication with Research Subjects
September 2011 Communication Newsletter
Staffing Updates
Our Phones Have Changed
CHERP Helpful Hints
Note re: Specific Letter Wording
June 2011 Communication Newsletter
CHeRP June IRB Update: What You Need to Know.
February 2011 Special Communication Newsletter
CHeRP IRB February 2011 Update
January 2011 Special Communication Newsletter
CHeRP IRB January 2011 Update
2010
October 2010 Special Communication Newsletter
Electronic CHeRP IRB is going Live in December!
March 2010 Special Communication Newsletter
Use of Short Forms For Non English Speaking Research Subjects During the Consenting Process.
2009
September 2009 Special Communication Newsletter
Staffing Updates
UPDATE: Pre-Review of New Protocols
UPDATE: Scientific Review
CITI Refresher Course
One Protocol, Multiple Groups: Obtaining Written Consent for Different Study Groups
Electronic IRB Submission Update
January 2009 Special Communication Newsletter
Research Involving Wards of State and Incarcerated Youth
Update on Electronic IRB Review and Submission
2008
November 2008 Special Communication Newsletter
August 2008 Special Communication Newsletter
The Committee on Clinical Investigation has revised and clarified it policies on reporting "minor" and "significant" deviations to the IRB. The changes were prompted by confusion as to what constitutes a significant and minor deviation and overlap with unanticipated reporting requirements.
October 2008 Special Communication Newsletter
Administrative Staff Changes for Office of Clinical Investigation
NEW Pre-Review Process for Protocol Submissions
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
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
