IRB News Archives - 2016
“Johns Hopkins Medicine has convened a Data Trust Council that is setting policies for the access and use of clinical data from JHH and its affiliates. The Research Data Subcouncil has posted FAQs for all researchers to help them navigate the new procedures for accessing clinical data: see http://intranet.insidehopkinsmedicine.org/data_trust/research-data-requests.html. Contact the JHSPH IRB office if you have questions.”
Due to the upcoming holidays, IRB-X and IRB-FC will miss a few meeting days. IRB-X will not meet on November 24 and December 29. IRB-FC will not meet on December 28. Please keep this schedule in mind as you prepare your submissions.
On September 16, 2016, NIH issued a requirement that “all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP)….” (See: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html). The NIH definition of a clinical trial is, “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” The JHSPH IRB offers access to GCP training through the JHSPH’s CITI training account, which you may access here: https://www.citiprogram.org/. When you log into the CITI site (selecting Johns Hopkins Bloomberg School of Public Health as your institution), select “Add a Course”, then under “Question 2”, select the first Learner Group which offers GCP training.
The IRB office has revised its Research Plan for New Data Collection to include new questions on data confidentiality and security. The questions are more detailed and we hope that it will inform investigators of the high standards of security required for research data. The template also has more space and designated areas for responses; this is an effort to make the finished document easier for reviewers and staff to read. We welcome your comments - please send them to email@example.com. Thank you!
Investigators working with JHH affiliates with studies that involve clinical services must be familiar with the PRA (“Prospective Reimbursement Analysis”) and CRMS (“Clinical Research Management System”) processes that help control the billing procedures for those study services. The SOM Vice Dean for Clinical Investigations has agreed to allow JHSPH investigators to submit these projects through the SOM’s eIRB2 system, which automates the PRA and CRMS processes. Contact the JHSPH IRB Office if you have any questions.
NIH has created a new “human subjects” webpage that links investigators to training and to the Certificates of Confidentiality kiosks. It also helps investigators prepare their “human subjects” sections of their research proposals. Check it out! See: https://humansubjects.nih.gov/. “
The JHU School of Public Health IRB is posting the PHIRST (Public Health Institutional Review System Tracking) User Guide developed specifically for investigators and study team members using the PHIRST system, our portal for all new human subjects research applications. This manual includes the following topics to get you started:
- The PHIRST registration process
- An overview of the submission and review process
- Basic methods and terms you need to know to create and submit electronic IRB applications