Expedited Review – Retrospective studies: A New Path Stephanie Gentilin, MA, CCRAKatherine Bright Director SCTR SUCCESS Center, eIRB Team MemberIRB, Grants.

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Presentation transcript:

Expedited Review – Retrospective studies: A New Path Stephanie Gentilin, MA, CCRAKatherine Bright Director SCTR SUCCESS Center, eIRB Team MemberIRB, Grants Administrator

System upgrades Address identified system issues or problems Edit language to clarify intent of question or provide help information Incorporate enhancements When possible −Streamline processes and reduce regulatory burden Why Change the System?

A new abbreviated application path was implemented for projects created after 8/25/2013 that involve ONLY retrospective studies for Expedited Review Category #5. −This is not applicable if you indicate multiple expedited review categories. Designed to solicit and capture relevant data Effective August 25, 2013

Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. 45 CFR & 21 CFR Expedited Research: An Overview

Expedited Review Categories  Clinical studies of drugs and medical devices if certain conditions are met  Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture  Prospective collection of biological specimens for research purposes by noninvasive means  Collection of data though noninvasive procedures routinely employed in clinical practice  Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis)  Collection of data from voice, digital, or image recording made for research purposes  Research on individual or group characteristics or behavior

New Smartform to verify that the project involves only retrospective review If you check this box… You now get this Smartform…

Requests details of the records reviewed, date range and inclusion/exclusion criteria New Records Review Smartform Date validation field: cannot be after today’s date

The Waiver of Informed Consent of Subjects or Alteration of Consent Elements option is a defaulted selection. New Filtered Application Checklist

Commonly Misunderstood question

The Smartform to request a HIPAA waiver is required later in the application. The HIPAA Waiver of Authorization option is a defaulted selection in question #2 on the Access to PHI for Research page

Continuing Renewal– A New Path for Retrospective Chart Review Studies

A new continuing review pathway has been created only for studies approved as Expedited Review Category #5 Retrospective Studies Includes some of the most significant changes to Smartform Designed to capture only relevant data, as well as skip pages such as the Subject Enrollments/Demographics/Withdrawals and Research Findings Smartforms The following new pages have been included in the path: Effective September 18, 2013

Original Jump To Smartform Pages New Jump To Smartform Path eliminated

Original “Changes Required” Smartform page 1

New “Changes Required” page – Retro Chart Review “Changes Required” Page 2 unchanged with the exception of the title and still includes Complaints Interim findings Relevant multi-center trial reports

Changes to “Number of Subjects” Smartform Original Smartform New Retro Smartform

A ‘Yes’ response to below question includes the next Smartform that’s been modified for this path:

And Finally….

A New Protocol Template– A template designed specifically for retrospective studies

Expedited Retrospective Review Protocol: Key Points What type of data will be collected? −Chart data, scans, specimens, etc. From where will it come? −Internal medical records or external source How many subjects? −Give maximum What information will be recorded? −Be specific: MRN, discharge dates, lab values, test results, etc.

Key Points (cont.) Where will the data be stored? −MUSC network storage! How will confidentiality be protected? −Coding of data (data points kept separately from identifiers - name, MRN, etc. - and linked using a code), all stored on MUSC network Will data be maintained in accordance with IRB and OCIO data storage policy? −Maintain research data for 6 years

QUESTIONS?