June 2008

• Guidance - Training Requirements for Human Subjects Research
• Guidance - Registration of Clinical Trials
• Policy 115.2 Organization Policy on Protocol Record Retention Requirements for Investigators
• Policy 103.25 Organization Policy on Registration of Clinical Trials
• Policy 103.6(a) Organization Policy on Reporting
• Policy 103.6(b) Organization Policy on Reports of Unanticipated Problems Involving Risks to Participants or Others
• Policy No 103.7 Organization Policy on Investigator Non-Compliance
• Policy 107.2 Organization Policy on Consultants
• Policy 109.6(b) Organization Policy on Continuing Review of Approved Research
• Policy 111.5 Organization Policy on Scientific Review
• Policy 113.1 Organization Policy on Suspension or Termination of IRB Approved Research
• Policy No. D403 Organization Policy on Research Involving Children
• Policy No. FDA 312/812 Organization Policy on Clinical Investigations with FDA “Test Articles”
• Policy No. ORA.1 Organization Policy On Sponsor Responsibilities
• Policy No. PER 1 Organization Policy on Planned Emergency Research and Requirements for Waiver of Consent in Planned Emergency Research

May 2008

• Informed Consent of Subjects Who Do Not Speak English

• Conflict of Interest Statement in Human Subjects Consent Forms

March 2008

• Compliance Monitoring Program

November 2007

• Policy No. 103.24(a) Organization Policy on Investigator Responsibilities
• Policy No. 103.25 Organization Policy on Registration of Clinical Trials

September 2007

• Policy No. 102.2(a) Organization Policy on Quality Improvement/Quality Assurance Activity
• Policy No. 102.2 Organization Policy on the Definition of Research As It Applies to Clinical Practice and Public Health Activities
• Combined Informed Consent/Authorization Template
• HIPAA and Research course
• Research Using FDA Test Articles
• Investigational Medical Devices

August 2007

• Policy No. 103.7 Organization Policy on Investigator Non-Compliance
• Policy No. C304 Organization Policy on Review of Research Involving Prisoners
• Policy  ORA.1 Organization Policy on Sponsor Responsibilities
• Policy 107.1 Organization Policy on IRB Composition and OHSR Staff Qualifications
• I.  Informed Consent Guidance
• II. Informed Consent Guidance - How to Prepare a Readable Consent Form
• III. Informed Consent Guidance - FDA Regulated Studies
• Policy No. 103.18 Organization Policy on Development and Communication of Human Research Protection Program Policies, Procedures and Guidance
• Policy No. 103.10(a) Organization Policy on Ancillary Reviews for Human Subject Research Studies
• Policy No. FDA 50.2 Organization Policy on Clinical Investigations with FDA “Test Articles”
• Department & Ancillary Reviews
• Administration of Gadolinium for Research MRI Procedures
• Changes to, or Waiver of, the DHHS or FDA Requirements for Informed Consent
• Application of GCP to the Conduct of Clinical Research
• New Application Process - flowchart

July 2007

• Policy No. 111.7 Organization Policy on Sample Size
• Policy No.103.16 Organization Policy on Support for the Human Research Protection Program
• Policy No. 103.11 Organization Policy on Committee on Outside of Interests (COI) and the JHM IRB
  
• Submission of Sponsor IND Safety Reports
• IND Safety Reports Flowchart
• Form - R.F.5 IND Safety Report Transmission Report
  
• Reporting Protocol Deviations
• Deviations Flowchart
• Form - R.F.4 Protocol Deviation Summary Sheet
  
• How and When a Principal Investigator Should Report Death of a JHM Research Participant
• Organization Policy on Reporting Death of a JHM Research Participant (Policy No. 103.6(b)(i))
• Form - R.F.2 Report of Death of a JHM research Participant
  
• Organization Policy on Reports of Unanticipated Problems Involving Risks to Participants or Others (Policy No. 103.6(b))
• Unanticipated Events Flowchart
• Form - R.F.1 Unanticipated Problem/Event Report Form
  
• Magnetic Resonance Imaging Standard Language for Consent Documents
• Inclusion of Howard County General Hospital as a study site
• Common Informed Consent Problems and Solutions - Spring 2007 Monitor Information Session

May 2007

• Policy No. 116.5 Organization Policy on Use of Research Data in Cases of Questionable Consent Documentation

April 2007

• Continuing Review

March 2007

• Baltimore City Health Department Reciprocity Agreement
• Registration of Clinical Trials
• Policy No. 103.19 Organization Policy on Pharmacy and Therapeutics Committee and JHM IRB

February 2007

• Policy No. 102.4 Organization Policy on Research Involving Human Embryonic Stem Cells, Germ Cells, and Stem Cell-Derived Test Articles

January 2007

• HIPAA & Research

November 2006

• HIPAA Requirements for Case Reports
• Case Report Publication Guidance: IRB Review and HIPAA Compliance

October 2006

• eIRB Classes
• Kennedy Krieger Institute Research