· For PIs who retain biosamples for future research, the JHSPH IRB recommends review of a powerpoint presentation by Marianna Bledsoe, MA, Clinical Research Policy Analysis and Coordination Program, OBA, OSP, OD, NIH, to assist with compliance issues.
· The IRB has revised and expanded its “Frequently Asked Questions.” Topics include General Topics, PHIRST, and Student Information. Please search the pdf. document posted by hitting CTRL and the F key, then typing your key word into the search box.
· The IRB has revised the Research Plan template in an effort to improve the information we obtain from PIs and to reduce the back and forth communications between us. In particular, the Data Security question asks the PI to select the plan that will be used to protect participants against a breach of confidentiality, and references our Data Security Guidance. The revised Final Study Report incorporates some of the questions that the IRB asks on its Progress Report so that a PI need only submit the Final Study report when closing a study. class="textcontrol"
· The IRB has revised its radiation forms and has posted new radiation risk language that must be inserted into the consent forms for studies that involve procedures that expose human subjects to the risks of radiation.
· All investigators involved in a JHSPH IRB human subjects research project must disclose all financial conflicts of interest which relate to that study. PPM 4 (http://www.jhsph.edu/schoolpolicies/ppm_faculty_4_conflicts_of_interest.shtml) governs the mechanism of disclosure. If someone has already disclosed a financial conflict, and then the conflicted person becomes involved in a human subjects research project, the conflict must be re-reviewed by the Conflict of Interest Committee so that the conflict may be “managed” in the context of that particular study. The IRB and the COI Committee worked together to provide guidance on “Conflict of Interest in Human Subjects Research.”
· The IRB Office asked Information Systems to help develop a Data Security Guidance for investigators about data security. The IRB will look to this guidance when evaluating data security and confidentiality plans described in research applications. IS has provided a site where it has posted policies and specific guidance about data classification, security of data with personal identifiers, data management roles, and transfer of identifiable data. There is also a Data Security Checklist for investigators to use when setting up a data safety plan for a research study.
· Investigators who collect, handle, store, ship, and use human derived samples (like blood, urine, and saliva), are sometimes confused about what information about these processes to include in the research plan. A new guidance, “Biospecimens: What should be included in the Research Plan?” intends to clarify what the IRB needs to know. class="textcontrol"
· The Office of Human Research Protections (OHRP) has clarified in a new guidance when an institution, or individual investigator, is “Engaged” in Human Subjects Research. The IRB has posted a simplified version of the guidance called “When is an Institution or PI ‘Engaged’ in Human Subjects Research?” that will help JHSPH researchers determine when they need to submit their projects to the IRB. This guidance also addresses the responsibilities of the PI for projects which involve downstream subcontractors who may collect research data.
· There is a new tab on the left of this web page called “Submitting New Applications”; click the tab to learn what you need to do to get started with a new application.
· How to add a student investigator to an existing IRB approved study: Submit an Amendment Application asking to change the study team and identifying the new student investigator, with the student’s CITI human subjects training certificate and the “Investigator’s Agreement” signed by the student. If a PI submits all these materials, the review should only take a couple of days.