News & Announcements Archive

Guidance on Payments to Research Subjects – Elimination of Use of VCN Form

We are writing to inform the research community of a change in our practices for reporting and accounting for payments made to research subjects (“participants”) enrolled in certain studies at Johns Hopkins University – those that anticipate using a VCN form. Payments for participation in human subject research constitute taxable income to the participant for […]

eHIRB Update Delay

Please be aware that the Homewood IRB’s electronic protocol system, eHIRB, is undergoing required revisions in order to be compliant with the Revised Common Rule, 45 CFR Part 46. The process will be complete on or near February 1, 2019. This may cause a delay in approval of new IRB applications only. Previously approved applications […]

Changes in the NIH Management of Genomic Summary Results Access Policy

The NIH recently announced changes in the NIH Management of Genomic Summary Results Access Policy (available at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-023.html) , which will permit unrestricted download of genomic summary results data by third parties from the NIH Database of Genotypes and Phenotypes (“dbGaP”). Please note these changes apply to the sharing of summary results only and do […]

Action Required For New Applications Related To The Revised Common Rule

New applications that are in a status of Tabled or Approved with Administrative Changes ​​​If your new application was reviewed by the IRB and is in either a Tabled or Approved with Administrative Changes state, we encourage you to submit your response as quickly as possible so it can be processed under the existing rule. […]

Exempt study materials no longer stamped

As of August 6, 2018, consent documents and recruitment materials associated with Exempt studies will no longer be stamped as “IRB Approved”. The documents associated with studies that the IRB determines to be exempt will be listed in the IRB Exempt Determination Notice. Only those consent documents or recruitment materials that are a part of […]

Revised JHU Policy on Conflict of Interest In Research

As Johns Hopkins prepares for the January 25, 2018 effective date of the NIH requirement that all domestic, multi-site, non-exempt research studies utilize a single IRB (“sIRB”), adjustments have been made to the JHU Policy on Individual Financial Interests and Financial Conflicts of Interest in Research. The updated policy can be found at http://web.jhu.edu/conflict_of_interest/JHU_Policies. The […]

Understanding the Changes to the Federal Policy on Protection of Human Subjects (the Common Rule) – A Review of the Changes & Tips to Ensure Compliance

A revised version of the federal rule governing Human Subjects Research (i.e. the Common Rule) is currently scheduled to go into effect on January 19, 2018. All studies approved on or after the effective date must comply with the new rule. For new studies submitted after the effective date and for studies where the initial […]

Revised Common Rule

A revised version of the federal rule governing Human Subjects Research (i.e. the Common Rule) is currently scheduled to go into effect on January 19, 2018. All studies approved on or after the effective date must comply with the new rule. For new studies submitted after the effective date and for studies where the initial […]