Clinical Trials Registration

All clinical trials which meet either the FDA or International Committee of Medical Journal Editors (ICMJE) definition of “clinical trial” must be registered on clinicaltrials.gov’s website.  Our Guidance on ClinicalTrials.gov Registration explains the requirements associated with registration (who, what, when, and how), and the penalties for failing to meet those requirements.  Questions about registration should be sent to epeterso@jhsph.edu.

HIPAA

Investigators who wish to access, use, or disclose for research purposes Protected Health Information (PHI) from a U.S. “covered entity” must be familiar with the requirements under the Health Insurance Portability and Accountability Act (HIPAA). The guidance entitled HIPAA and Research Common Scenarios discusses several common circumstances in which HIPAA comes into play with research activities. Our Guidance on Protected Health Information and the JHSPH covers the requirements for obtaining a waiver (partial or full) of the requirement to obtain a signed privacy authorization by submitting an Application for Waiver of HIPAA Privacy Authorization, and how to proceed with obtaining an approved Authorization for Disclosure of Protected Health Information for Research.  IRB approved Authorization forms will be stamped with the IRB logo, just as we stamp our consent documents. Questions about HIPAA should be sent to epeterso@jhsph.edu.

Investigators who seek access for research purposes to limited data sets containing PHI from a Johns Hopkins covered entity (JHH, Bayview, JHCP, and all the other JHH affiliated hospitals) will need to sign a Data Use Agreement (DUA).  These Agreements are generated by the JHH Privacy Office.  To obtain a DUA, complete a Questionnaire to Obtain Business Associate Agreement (BA) and/or Data Use Agreement (DUA) from JH HIPAA Covered Entity submit it to the HIPAA Compliance specialist, Elizabeth Peterson epeterso@jhsph.edu. She will forward the information to the Privacy Office for processing