- To all investigators whose studies may be affected by the government shutdown: Please let us know if you need help with research stoppages, review deadline problems, or other IRB related complications to your work.
- The JHSPH IRB is launching a new web-based module series called “QUALITY IMPROVEMENT THROUGH SELF-ASSESSMENT.” This series is designed to help human subjects research investigators meet their commitment to comply with legal, regulatory, and institutional requirements by monitoring their own research studies. It’s public, and we are not collecting identifiers from the users. We’d appreciate feedback from you; please direct questions/comments/suggestions to our Quality Improvement Specialist at firstname.lastname@example.org.
- The JHSPH IRB has revised the Investigational Drug Data Sheet (IDDS) required for research applications that involve Investigational New Drug Applications. The instruction section is simpler and the form incorporates a more detailed protocol section to collect site specific information. Please feel free to contact the IRB office if you have any questions.
- We have updated our CITI FAQs to help you understand the new compliance training requirements.
- The JHSPH IRB has updated its requirements for human subjects research ethics training for JHSPH faculty, staff, and students engaged in human subjects research. Certification of completion of CITI training must be renewed every 5 years. Certain specialized research requirements have been added for investigators conducting clinical trials, working on Native American reservations, using Protected Health Information (PHI), and/or funded by the Department of the Navy. Training requirements for non-JHSPH collaborators have not changed. The IRB has updated its website to more fully explain its requirements and CITI course offerings under the CITI training link.
- The HIPAA page on our website has been updated to include information about how to obtain a limited data set containing PHI from the Johns Hopkins Health System. Investigators must complete a Questionnaire to Obtain Business Associate Agreement (BA) and/or Data Use Agreement (DUA) from JH HIPAA Covered Entity. The revised HIPAA Privacy Authorization and Waivers Guidance explains the requirements.
- All PHIRST users will note a change to the New Application process starting January 24, 2013. After a Principal Investigator (PI) completes the application and clicks “Finish” at the end, there is a new step to complete before submission. The PI must perform a new activity called “Request Study Team Participation.” This activity will send an email to all study team members (every co-investigator, student investigator, and study contact) listed in the application requesting them to agree or decline their proposed roles in the study. When a person agrees, they will affirm adherence to principles of research ethics and the obligation to disclose any conflicts of interest with the study. Once all study team members have agreed to participate, the PI will be able to access the “Submit” activity and will be able to submit the New Application. If you have questions or problems with this process, please contact email@example.com.
- The IRB has revised its Student Investigator Policy 103.02 to make clear that JHSPH faculty may not serve as Principal Investigator for undergraduate students. It also has clarified the Conflict of Interest Policy for IRB Members, Policy No. 111.11. Click here for updated policies.
- The IRB has revised the research plan to incorporate new questions about HIPAA (Question 3.e.), data custody (Questions 5.d. and 16.b.), and incidental findings for future research using biospecimens (Question 18.f.). The instructional template update will follow. Click here for forms.