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| Jessica A. |
Happy Friday! Just letting you know that we are cancelling Monday's workgroup call. Please post any discussion topics or questions here on basecamp in the meantime.
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| Jessica A. |
Good morning! We are postponing our workgroup call until next Monday, May 18th at 2pm. Let us know if you have any topics you would like to discuss.
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| Robin K. |
I might have missed it as well with everything going on here.
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| Shelby L. |
As a reminder, please complete the IRB assessment by Thursday, April 2nd. The assessment links were sent to the POC listed for your jurisdiction or the State Epidemiologist if a POC was not provided. CSTE understands that this is a busy time with the COVID-19 response and highly encourages jurisdictions to forward the assessment to a designee if needed. Please let me know if you did not receive the assessment or have any questions. Thank you in advance for taking the time to complete it and thank you again to those who provided feedback to strengthen the instrument.
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| Joni K. |
Hi Shelby - I might have missed it, but don't think I received the assessment. Thanks, Joni
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| Jessica A. |
We are planning to send out the link to the assessment today. The links will be sent to the POC listed for your jurisdiction; if no one has been listed it will be sent to the State Epidemiologist. Let me know if you have any questions. Thank you in advance for taking a few minutes to complete it, and a big thank you to those who provided feedback to strengthen the instrument prior to launch.
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| Craig C. |
--We have not yet encountered a situation where our health department is listed as a research site as for a multisite study subject to the revised common rule Single IRB requirements. OHRP allows exceptions to single IRB requirement to be made "where review by the proposed IRB is prohibited by a federal, tribal, or state law, regulation, or policy, or if there is a compelling justification for the exception. " Our DPH administrative rules state "The Director may require that proposals submitted to the Department that have been approved by another IRB be subject to review and approval of the Department's IRB", but given the OHRP guidance, I am thinking our rules may need revision to more closely align with the OHRP verbiage re "prohibition". |
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| Craig C. |
--Of note, OHRP just released information about two exceptions to the single IRB review requirement in the revised Common Rule. You can find information about the single IRB exceptions under the Common Rule's Cooperative Research Provision (45 CFR 46.114) here: https://www.hhs.gov/ohrp/regulations-and-policy/single-irb-requirement/114b-exception1/index.html
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| Jessica A. |
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| Joni K. |
...if the investigators...
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| Joni K. |
(1) Has your IRB established criteria for Single IRB to determine which IRB will be the Single IRB (e.g., risk assessment, entity receiving grant funding, etc.)? (2) If you are not the Single IRB, is your IRB still responsible for tracking human subjects protection training and evaluating in the investigators are competent to conduct the research (i.e., review of investigators' CVs and resumes)?
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