From the Desk of the Vice Dean - Letters and memorandums from the Vice Dean for Clinical Investigation

December 2022:

• OHSR Address Change

February 2021:

• Submitting Formative/Pre-Clinical/Pilot Research Activities to the JHU IRBs
• What Must Investigators Submit to the JHU IRBs?

January 2021:

• Key Changes and FAQs for eIRB Version 9 conversion

August 2020:

• Organization Policy on Reporting 

July 2020:

• Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English

April 2020:

• Requesting Interpreter for Research Consent

March 2020:

• Transfer of Human Biospecimens to Outside Entities

January 2020:

• Guidelines for Managing Investigational Product Returns from Research Participants

December 2019:

• Registration of Clinical Trials on ClinicalTrials.gov

October 2019:

• 103.25 Organization Policy on Registration of Clinical Trials

September 2019:

• Insurance and Research Participant Financial Responsibility Information Sheet: Signature No Longer Required 

August 2019:

• Requesting the Use of Patient Safety HERO and SCA Data for Purposes of Research

July 2019:

• Research Requiring Point-of-Care Testing at Johns Hopkins
• Certificates of Confidentiality
• Publicly Available Data

June 2019:

• Research using the Precision Medicine Analytics Platform [PMAP]

May 2019:

• 107.1 Organization Policy on IRB Composition and OHSR Staff Qualifications
• Insurance and Research Participant Financial Responsibility Information Sheet

April 2019:

• 103.24a Organization Policy on Principal Investigator Responsibilities
• Principal Investigators Responsibilities

February 2019:

• Payments to Research Subjects – Elimination of Use of VCN Form
• Johns Hopkins Institutional Approval Process for Research Involving Institutional Data Sets

January 2019:

• Public Health Surveillance Activities

December 2018:

• Notice of New JHM IRB Combined Informed Consent/HIPAA Authorization Template
• Maryland Advanced Research Computing Center (MARCC) guidance 
• Research Involving Apps and Software​
• APPs in the Research Setting - A Checklist for Researchers
• Organizational Policy on Prompt Reporting of Reportable Events

October 2018:

• Research Requiring the Services of the Johns Hopkins Blood Bank or Bone/Tissue Bank

May 2018:

• Recruitment Document Formatting Requirements

February 2018:

• 107.1 Organization Policy on IRB Composition and OHSR Staff Qualifications

October 2017:

• Change in Federalwide Assurance (FWA) Numbers
• NIH announces new changes regarding Certificates of Confidentiality for NIH-funded research

May 2017

• Policy 111.14 Organization Policy on Governing Physician Role in the Research Consent Process
• Physician Consent guidance