Research at Johns Hopkins Medicine

HUMAN SUBJECTS RESEARCH

NOVEMBER 2008

There are no Human Subjects Research articles in the November 2008 issue.

Archived articles:

OCTOBER 2008

There are no Human Subjects Research articles in the October 2008 issue.

SEPTEMBER 2008

Data and Safety Monitoring Boards: Skills Building Workshop 9/29/08

Course developed for those designing and sponsoring clinical trials as well as those interested in serving on data and safety monitoring boards.

AUGUST 2008

There are no Human Subjects Research articles in the August 2008 issue.

JULY 2008

JHM Human Subjects Research Program Reaccredited

Accreditation results in new and revised policies now available on the IRB website.

JUNE 2008

There are no Human Subjects Research articles in the June 2008 issue.

MAY 2008

Register Your Clinical Trials
What should be registered, who should register it and and other vital information on clinical trial registration explained online.

APRIL 2008

There are no Human Subjects Research articles in the April 2008 issue.

MARCH 2008

There are no Human Subjects Research articles in the March 2008 issue.

FEBRUARY 2008

There are no Human Subjects Research articles in the February 2008 issue.

JANUARY 2008

eIRB Tips and Tricks

Downloadable document provides reference for eIRB submission and approval process.

Reminder: New Consent Form Template
All new and revised consent forms must use new template immediately.

DECEMBER 2007

IRB and Office of Human Subjects Research (OHSR) Holiday Schedule

Meeting cancellations and office closures listed.

Reminder: New Consent Form Template
All new and revised consent forms must use new template by January 1, 2008.

NOVEMBER 2007

There are no Human Subjects Research articles in the November 2007 issue.

OCTOBER 2007

HIPAA Course
"HIPAA and Research" course replaces "Privacy Issues Relating to Research" course.

SEPTEMBER 2007

Updates to IRB Website

Go online to see recent updates and changes to policies and guidances.

AUGUST 2007

New Additions to IRB Website (http://irb.jhmi.edu)

In response to faculty requests, new material is available on the IRB website clarifying how to report events to the IRBs.

JULY 2007

There are no Human Subjects Research articles in the July 2007 issue.

JUNE 2007

New Version of eIRB Application Released

Go online to see new features including streamlined applicaiton, easier format, shorter application options and additional help.

MAY 2007

There are no Human Subjects Research articles in the May 2007 issue.

APRIL 2007

Improvements to eIRB New Research Applications

New application, available in late April, will improve on existing features. View a live demonstration of new features online.

MARCH 2007

New HIPAA Section on IRB Website

Section devoted to information regarding HIPAA and research.

FEBRUARY 2007

WIRB No Longer Reviewing New Applications
All new applications for human subjects research must be submitted to the JHM IRBs.

JANUARY 2007

There are no Human Subjects Research articles in the January 2007 issue.

DECEMBER 2006

There are no Human Subjects Research articles in the December 2006 issue.

NOVEMBER 2006

Johns Hopkins HealthCare Data Sharing Committee Guidance

Go online to learn more about data sharing and the committee's work.

Guidance on Certificates of Confidentiality
Go online to learn all about Certificates of Confidentiality.

Organization Policy on Electronic Submission of Information to the JHM IRBs

View the policy online.

Offices Closed November 3

The offices will re-open on Monday, November 5.

OCTOBER 2006

There are no Human Subjects Research articles in the October 2006 issue.

SEPTEMBER 2006

Course on Research Ethics (C.O.R.E.) - Last chance for PIs

Deadline extended until October 1, for human subject research PIs.

Protocol Deviations Guidelines
New information now posted online.

AUGUST 2006

There are no Human Subjects Research articles in the August 2006 issue.

JULY 2006

Course on Research Ethics (C.O.R.E.) - Last chance for PIs

Two new sessions of the C.O.R.E. offered for PIs who missed June 30 training deadline. PIs MUST complete C.O.R.E. by October 1, to avoid interruption of studies.

IRB Review of Research: Project Closed to Accrual, in Data Analysis Only, or Terminated

Check out new guidelines regarding the IRB review proces online.

JUNE 2006

IRB Monitoring Upate

Compliance Monitoring Specialists present one hour educational session on recordkeeping issues and FDA inspections of research protocols in June.

MAY 2006

Changes in Johns Hopkins Medicine Protocol Review by WIRB
JHM IRB system rebuilt to review protocols quickly. Effective July 1, SOM faculty can submit new applications to JHM IRBs for review, regardless of the source of support.

OHSR Guidance on Research Databases
Guidance clarifies which projects require submission of an eIRB application and which do not.

Course on Research Ethics (C.O.R.E) Reminder
The next Course on Research Ethics (C.O.R.E) will be offered on May 31. PIs must complete the new C.O.R.E. training or its equivalent by June 30.

APRIL 2006

Registration of Clinical Trials Policy
All JHUSOM clinical trials shall be registered with a trial registry electronically searchable and accessible to the public at no charge.

Guidance for Faculty Conducting Research Involving the Baltimore City Health Department
JHM IRB now serves as the IRB of record for human subjects research conducted involving BCHD sites, facilities, or personnel.

MARCH 2006

There are no Human Subjects Research articles in the March 2006 issue.

FEBRUARY 2006

There are no Human Subjects Research articles in the February 2006 issue.

JANUARY 2006

Clinical and Translational Science Awards Efforts
Award is part of NIH Roadmap Strategy to transform how clinical research is conducted in academic medical centers. Dr. Daniel Ford leads Hopkins' response.

DECEMBER 2005

There are no Human Subjects Research articles in the December 2005 issue.

NOVEMBER 2005

IRB Monitoring Information Session

Compliance monitors present one-hour overview of research project issues on Nov. 10.

OCTOBER 2005

All New Research Protocol Submissions Must Now Be Submitted Electronically

Effective September 1, 2005, eIRB must be used for new protocol submissions.

Clinical Trials Registration
The ICMJE will only publish clinical trial reports of registered studies. Registration can be completed online.

Course on Research Ethics (C.O.R.E) Offered October 17, 2005
Faculty who participate in clinical research must complete C.O.R.E. or its equivalent by June 30.

SEPTEMBER 2005

New Vice Dean for Clinical Investigation

Daniel E. Ford, M.D., M.P.H. named new Vice Dean for Clinical Investigation.

Policy Changes Following Accreditation
Changes affecting policies, guidance documents and forms outlined online.

Course on Research Ethics (C.O.R.E) Offered October 17, 2005

Faculty who participate in clinical research must complete C.O.R.E. or its equivalent by June 30.

AUGUST 2005

eIRB Now Available for New Protocol Submissions

All JHU SOM researchers may now use eIRB for new protocol submissions and must use it beginning September 1.

Clinical Trial Registration and Publication
The International Committee on Medical Journal Editors (ICMJE) implements policy that requires registration of new clinical trials as a condition of publication. Details available online.

Participation of Foster Children in Research Studies
Recent media attention raises red flags; Hopkins responds.

International Compilation of Human Subject Research Protections
NIH develops website to help facilitate collaborative proposals with institutions outside the U.S.

JULY 2005

AAHRPP Accreditation
Human subjects research protection program receives full accreditation.

Paul Lietman Steps Down as IRB 3 Chair
Term ends June 30, 2005.

JUNE 2005

There are no Human Subjects Research articles in the June 2005 issue.

MAY 2005

There are no Human Subjects Research articles in the May 2005 issue.

APRIL 2005

There are no Human Subjects Research articles in the April 2005 issue.

MARCH 2005

AAHRPP accreditation site visit reminder.

IRB Review Agreements

Overview of new and existing reciprocity agreements between JHM IRB and outside entities.

FEBRUARY 2005

IRB Accreditation

Following years rebuilding the human subjects review system, JH applies for and is granted a site visit from the Association for the Accreditation of Human Research Protections Programs.

JANUARY 2005

Revised Training Requirements for Human Subjects Research

JHM IRB no longer requires non-JHM investigators to complete training certification at Hopkins.

DECEMBER 2004

Scientists and Subjects: An Online Research Seminar on the Ethics of Research with Human Subjects (Funded by NIH)

Unique seminar on responsible conduct of human subjects research runs from January 10 through March 20, 2005.

NOVEMBER 2004

Roadmap Initiative to Provide Training for Future Leaders of Clinical Research

Hopkins one of seven institutions selected to receive NIH roadmap award.

Updated Signature Authority Memo

Obtain new memo online.

OCTOBER 2004

There are no Human Subjects Research articles in the October 2004 issue.

SEPTEMBER 2004

New IRB Email Address
New address established for any IRB-related questions, comments, or suggestions.

AUGUST 2004

There are no Human Subjects Research articles in the August 2004 issue.

JULY 2004

IRBs and Blood/Tissue Specimens
Scientists are reminded of IRB and HIPAA requirements to study blood and tissue specimens.

Triage of Research Protocols to WIRB

New changes in the triage of human subject protocols to WIRB, effective July 1, are announced.

JUNE 2004

New Electronic IRB System (eIRB)
OHSR unveils a new Web-based system for IRB application submissions.

Johns Hopkins Medicine and MedStar IRBs Sign Reciprocity Agreement
New agreement will facilitate collaborative research efforts between JHU SOM and MedStar facilities.

MAY 2004

There are no Human Subjects Research articles in the May 2004 issue.

APRIL 2004

Fellows Must Take Course on Research Ethics (C.O.R.E.)
Register now for one-day course held April 16.

MARCH 2004

Human Subjects Research vs. Quality Improvement/Quality Assurance
Temporary clarification provided in IRB website while new policy is under review.

FEBRUARY 2004

IRB-X News
Nursing administrator Robin Newhouse, Ph.D., RN, joins IRB-X.

JANUARY 2004

Adverse Event Reporting
JHM IRBs develop updated Event Reporting policy.

DECEMBER 2003

Use Federalwide Assurance Numbers
Multiple Project Assurance Numbers replaced begining January 1, 2004.

NOVEMBER 2003

Human Subjects Research Training Requirements
New information and training deadlines announced.

Changes to IRB Consent Form Template
A new “Combined Informed Consent/Authorization” form is now available.

OCTOBER 2003

Take the IRB Website Survey
Provide your feedback on the department's new site.

Bayview IRB Moving
Staff will join Human Subjects Research offices in Reed Hall.

SEPTEMBER 2003

There are no Human Subjects Research articles in the September 2003 issue.

AUGUST 2003

New IRB Review Procedures
IRB 4 disbands August 1.

Office of Human Subjects Research (OHSR) is Moving
Reed Hall to become new home in September.

JULY 2003

Reorganization of the OHSR Office
Compliance functions and operations of the office will separate.

New JHU WIRB Liaison
LaSharon Holt replaces Wanda Bell-Farrell.

JUNE 2003

New Director of Research Coordinator Education
Dr. Hayden "Bud" Braine begins July 1, 2003.

MAY 2003

New Requirement to Conduct Human Subjects Research
A letter from the Vice Dean for Clinical Investigation.

New IRB Website
Check out their newly revised and redesigned site.

New Policy for Postdoctoral Fellows Participating in Human Subjects Research
Now available online.

APRIL 2003

Mandatory HIPAA Training for All Employees: Training Web Site Now Available
All JHM employees must complete training by April 14.

Adverse Events in the X-SCID Gene Transfer Trial
RAC findings lead to NIH policy.

The Effects of HIPAA
AAMC to quantify the effects of HIPAA on research.

Responsible Conduct of Research Seminar Series
Schedule of Spring series.

MARCH 2003

HIPAA and Consent Forms
New consent form template available online.

Human Subject Protection Course
ACRP sponsors March 14 course on facing realities in research.

FEBRUARY 2003

HIPAA Information
Detailed information on new federal privacy regulations.

Course on Research Ethics
Next C.O.R.E. to be held on March 11, 2003.

JANUARY 2003

There are no Human Subjects Research articles in the January 2003 issue.

DECEMBER 2002

Research Fellows in Human Subjects Research
Current policy clarified on research fellows involvement.

Nursing Staff and Human Subjects Research
Nursing Approval Process has been developed to enhance collaboration with investigators.

NOVEMBER 2002

JHM IRB Launches New Web site
Updated information now at your fingertips.

OCTOBER 2002

OHRP Lifts Restrictions
JHSOM completes "all required actions" stipulated by OHRP.

JHM IRB Update Sessions
Meetings planned to help faculty and staff navigate new processes.

SEPTEMBER 2002

Michael J. Klag, M.D., M.P.H., Vice Dean for Clinical Investigation, recently summarized developments in the process of human subjects research review and describes some upcoming enhancements that will help to facilitate the IRB review process. > Read the full text of this letter.

Letter highlights:

OHRP Site Visit
Things looking up with OHRP

No More Dual IRB Review
Collaboration simplifies IRB grant submission process

Name Change
Say "Goodbye" to JCCI

Web-based Access to IRB Data
New site will cut down on paperwork

"How-To" Information Systems
IRB review processes made simple


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