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eIRB Update May 2011
May 7, 2011
As part of quarterly scheduled updates, the following changes have been made in eIRB:
- Section 6 – Protocol Information, Q. 3.0 – The current instructions for uploading a tracked-changed version of the protocol have been modified.
- Old: Only if requested by the IRB or for Changes in Research (must also upload clean version above).
- New: Upload a track-changes protocol only if changes are requested by the IRB or for Changes in Research.
- Section 12 – Participant Information, Q. 6.0 – The current instruction for uploading documentation for studies involving foster children in Maryland refers to a “DSS application”. The naming convention used for this form is “DSS submission form”. The instructions have been modified to correct this error.
- Section 24 - Human Bio Samples, Q. 1.0 – added “cells” (e.g., blood, cells, tissue, urine)
- Section 24 - Human Bio Samples, Q. 3.0 – added “Human pluripotent stem cells subject to oversight by the JHU Institutional Stem Cell Research Oversight (ISCRO) Committee" as a check box option.
- Section 28 - Radiation Calculator – The current instructions for uploading a RCU-5 form state that a RCU-5 form should be completed and uploaded for research procedures only. However, the RCU-5 form is required for both research and standard of care procedures.
- Standard Language Modifications on approval letters:
- Pregnant women: Addition of the pregnant women regulatory citation. The language will now read: “45 CFR 46.204. This study has been approved for the involvement of pregnant women and fetuses prior to delivery.”
- Johns Hopkins Sites: the following language will appear in the approval letters for studies requiring review from a Johns Hopkins research site: Your application included (Hopkins study location) as a research site. You may not conduct this research at that site until you receive notification of site approval. If you have already received site approval, you may begin conducting research immediately.
- “Sibley Memorial Hospital” has been added as a Hopkins study location throughout the eIRB application.
- References to the Course on Research Ethics (CORE) have been replaced by Research Ethics Workshops About Responsibilities and Duties of Scientists (REWards) throughout the eIRB application.