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“Creating a Data Management & Security Plan for Human Subject Research”

Presented by:
Melanie Locher, B.S., CIP IRB Director
Elizabeth W. Carter, M.S., Data Governance Specialist, �պ�����HN Data Management Office

The �պ����� RPO, in collaboration with the �պ�����HN completely overhauled the DMSP with the goal of collecting all of the information required by applicable laws, regulations, and institutional policies & procedures that dictate the management, privacy and security of the data collected/derived, used and shared for the purpose of research. Review the new form sections, review the medical and behavioral guidance documents and discuss best practices to safely store, analyze and share research data.

Thursday March 9, 2023
12:00-1:30PM
Location:

Tuesday March 21, 2023
12:00-1:30PM
Location: HSRF conference room 400

We encourage all researchers to attend one of the training sessions. All medical and behavioral researchers conducting an expedited, full board or exempt 2(iii), exempt 4(iii) or exempt 3(i)(C) protocols will be required to complete the revised DMSP at time of new protocol or modification submission that affect data. It is important for researchers to understand its use and importance.

No registration is needed.

Did you miss the February IRB Education? 

“Using and Disclosing Protected Health Information for Research”
Lynn Combs, JD Manager, Compliance and Privacy �պ�����HN

Access HIPAA slides and taped

NEW! Research Protections Event Offerings

The RPO offers access to a variety of event training centered on education in all realms of research.  Find sessions for humans subjects, animals, biosafety and controlled substances here. 

IRB Updated Policies

• 1.3 Operations of the IRB
• 2.0 Institutional Ancillary Reviews
• 9.1 Children
• 9.10 Telemedicine and Research Visits
• 14.3 Grant Proposals Lacking Definite Plans for Involvement of Human Subjects
• 24.0 Subjects Vulnerable to Coercion or Undue Influence
• 24.2 Research Involving Prisoners
• 27 Noncompliance Policy and Procedures

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Starting March 1, 2023 an IRB “approved date” watermark stamp will be issued in the form header on all newly approved and revised Data Management & Security Plan forms.  This is similar to the approved date on protocol and consent forms.  When uploading be sure to choose the correct category of “Data Management and Security Plan.”

IRB Click user guides links are now listed in the Help Center for researcher ease of access.

�պ����� Medical Center News

Fundamentals in the Conduct of Clinical Research Training Program
March Fundamentals in the Conduct of Clinical Research Training Program Dates:

Wednesday, March 08, 2023, 9:30am-12:00pm
Wednesday, March 15, 2023, 9:30am-12:00pm
Wednesday, March 22, 2023, 9:30am-12:00pm
Wednesday, March 29, 2023, 9:30am-12:00pm

More information about the fundamentals program can be found on the OCTR Commons/SharePoint site .

Research Professionals Network Educational Opportunity

Join us for the our upcoming Workshops

Thursday, March 30, 2023, 3:00-4:30pm:

Thursday, April 20, 2023, 3:00-4:30pm:

LCOM and �պ����� Medical Center COVID Policy

With the recent changes in �պ����� HN entry point screening processes and COVID-19 testing procedures we have updated our LCOM �պ����� HN Clinical Research Guidelines.

The updated guidance can be found on our Commons/SharePoint site.