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June 2019 | IRB and Human Subjects Research Updates
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Office for the Protection
of Research Subjects
Research Coordinator Bulletin


RC Education
Summer Luncheon
Notes of June 6, 2019  


Thank you! to our presenters from the Southern California Clinical and Translational Science Institute (SC CTSI), Nicki Karimipour and Amelia Spinrad, and to Charlene Chiu from Investigational Drug Services (IDS) Pharmacy.  As requested, links to the presentations are provided below. 

Training & Educational Offerings from SC CTSI   
Nicki Karimipour 
Amelia Spinrad
Program Manager
Clinical Research Support 
Southern California Clinical and Translational Science Institute

Investigational Drug Services (IDS) Pharmacy 
Charlene Chiu
Clinical Pharmacist
Investigational Drug Services (IDS) Pharmacy

Documenting Clinical Research Informed Consent:
Problems and Solutions

Katherine Hawthorne
Program Manager
USC Office for the Protection of Research Subjects

 

Shortage of Tuberculin
Skin Test Antigens

The Center for Disease Control and Prevention (CDC) has issued a Health Advisory with recommendation for the anticipation of a 3 to 10 month nationwide shortage of a derivative (PPD) tuberculin antigen licensed by the US Food and Drug Administration (FDA) to perform tuberculin skin tests. Recommendations have been developed to prevent a decrease in TB testing capabilities due to the expected shortage. Link to: CDC Health Advisory
 

Smartphone Apps
Who else gets the data? 

A recent study explored the use of smartphone apps to collect personal healthcare data and found that third party data sharing was prevalent and often not accurately disclosed to users. To learn more see:
 Assessment of the Data Sharing and Privacy Practices
of Smartphone Apps for Depression and Smoking Cessation
.
 

Increasing Latino participation in organ donation and clinical trials 

The National Alliance for Hispanic Health and Be the Match® are aiming to imporve the number of Latinx individuals who become organ donors and who participate in clinical trials.  These efforts are explored in the following article: Groups aim to boost low Latino participation in oragan and marrow donations, clinical trials.
 

Collecting The 
Demographics 

Collection of patient demographic data not only supports the development of improved treatments and interventions, but helps in securing funding for better research infrastructure, and is required for ClinicalTrials.gov reporting.

Recent collaboration between RC Advisors, SC CTSI and OnCore staff, has served to clarify data entry procedures and the process for subsequent additions or correction to data.

Race and Ethnicity Data Collection - Cerner / Oncore
 
All study participants must be registered in Cerner – this information is then pushed into OnCore. Participants cannot be registered in OnCore unless they are first entered in Cerner.
 
Patient registration/check-in is the first opportunity for data entry, and should include the collection and entry of race/ethnicity data information.  Verification of patient information on subsequent visits also provides the opportunity to add or correct this information. Any addition to, or changes made to this information must be entered into Cerner and will then be pushed into OnCore.
 
When pre-populated information viewed in OnCore is found to be incorrect – the correction and update must take place in Cerner - from where it will be pushed into OnCore.
 

Sharing Best Practice

This section will focus on sharing best practices in research conduct.  We will look to all members of research teams including administrators and ancillary services to both share your experience, and use the opportunity to clarify processes or procedure in your department.  We will share your inquiries and offer your responses for others learn from.

Inquiry:
Where do you store your current ICF and corresponding HIPAA that provides access by researchers in remote clinics?
Please share with us how your PI or other research staff, access the most current ICF and corresponding HIPAA.  Where do you store the current approved documents?  What site does the PI or staff access to print a current ICF/HIPAA when at an off site clinic, in the hospital, or ED?

Please reply to:
research.coordinator@usc.edu  
Subject: ICF/HIPAA Access

Can we verify the
patient was fasting?  

Researchers at the National Institute of Health (NIH) may have found a way to verify that a patient has sufficiently fasted as required for best results of blood glucose testing.
The study involving children shows testing for free fatty acids prior to glucose testing may help to decrease incorrect diagnoses, and the need to re-test following high blood sugar results. To learn more see: NIH researchers indentify method to verify children fasted before medical testing.
 

For your information:


USC Research Job Opportunities

Explore the USC website Careers at USC to find new opportunities for research coordinators. Search the job category "Laboratory and Research" for available positions at all sites - Health Science Campus, University Park Campus, Verdugo Hills Hospital and Norris Cancer Hospital.
You may also sign up to receive "job alert" emails as positions become available. Click here for Jobs in Research.
 

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We apologize. Providing your information at the following link seems to solve the problem: Research Coordinator Bulletin
Thank you for your time.
Copyright © 2019  |  USC Office for the Protection of Research Subjects, All rights reserved.

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3720 S. Flower St. CUB 325
Los Angeles, CA 90089






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