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Kevin Gibbs, IT Operations Manager at CSTEAmanda Masters, Director of Workforce Development at CSTEAl DemariaJennifer Lemmings, CSTEErica Runningdeer, ILJessica Arrazola, Director of Educational Strategy at CSTEJeff Engel, Senior Advisor for COVID-19 at CSTERita Altamore, EpidemiologistLesliann HelmusRachel StricofAmanda Payne, Senior Consultant at J Michael ConsultingKatie BrownAnne KjemtrupJen FiddnerJulius Tonzel, Epidemiologist at LA DOH, OPH, IDEPI +112 others
Posted by Jessica Arrazola ·

Human Subjects Research Training Requirements

•What training does your agency use for internal researchers? 
•For external researchers with training available via their own institution, which is tracked by  the institution, what training information do you require researchers to submit? 
  • Certification with initial submission
  • Certification—initial and ongoing
  • Certification with initial submission  and PI verification that all staff certifications are up to date with subsequent  progress reports
  • Other

Comments & Events

Craig Conover, Medical advisor, Chicago DPH, IRB Chair IL DPH Craig Conover, Medical advisor, Chicago DPH, IRB Chair IL DPH
At the state health dept.  in IL, after the demise of the NIH training module, we recently began using the Association of Clinical Research Professionals (ACRP) online/free training for  internal staff.  Although  the training is  targeted to clinical researchers, it has  pretty good coverage of research ethics and privacy/confidentiality issues.  There is a required quiz at the end, and it generates a certificate for documentation purposes. 
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Sharmini Rogers Sharmini Rogers
Missouri state health Department has purchased the training modules from CITI program for all the IRB members to take the training and the IRB chair and administrator. We have not pushed it out to the internal staff yet. It is $4,400 a year for as many users and the state can generate reports and certificates of all those trained.

Dr. Sharmini V. Rogers, MBBS, MPH, Administrator
Section for Healthy Families and Youth
Division of Community and Public Health
Missouri Department of Health and Senior Services
930 Wildwood Drive
Jefferson City MO 65109
E-mail: Sharmini.Rogers@health.mo.gov
Tel: 573-751-6253
Public Health: Better Health. Better Missouri.
This email is from the Missouri Department of Health and Senior Services. It contains confidential or privileged information that may be protected from disclosure by law. Unauthorized disclosure, review, copying, distribution, or use of this message or its contents by anyone other than the intended recipient is prohibited. If you are not the intended recipient, please immediately destroy this message and notify the sender at the following email address: Sharmini.Rogers@health.mo.gov<mailto:sharmini.rogers@health.mo.gov> or by calling ( 573 ) 751-6253.
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Lou Gonsalves Lou Gonsalves
Connecticut Department of Public Health has purchased CITI Program Human Subjects Research training for our staff and our Human Investigations Committee (our IRB).
For external researchers seeking HIC approval, we require them to provide certification of CITI, PHRP or approved institutional HSR training. We ask them to complete a training log with new applications, available here: https://portal.ct.gov/-/media/Departments-and-Agencies/DPH/HIC/HICHumanSubjectsResearchTrainingLog_Oct2019.docx?la=en 
I am considering asking them to also complete it when they submit Continuing Review requests (certainly for the larger studies at least).
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Sharmini Rogers Sharmini Rogers
Hi Lou, Missouri has done the same thing but I am wondering what topics do you make your internal researchers take. There are very specific ones for the IRB members and chair.

Dr. Sharmini V. Rogers, MBBS, MPH, Administrator
Section for Healthy Families and Youth
Division of Community and Public Health
Missouri Department of Health and Senior Services
930 Wildwood Drive
Jefferson City MO 65109
E-mail: Sharmini.Rogers@health.mo.gov
Tel: 573-751-6253
Public Health: Better Health. Better Missouri.
This email is from the Missouri Department of Health and Senior Services. It contains confidential or privileged information that may be protected from disclosure by law. Unauthorized disclosure, review, copying, distribution, or use of this message or its contents by anyone other than the intended recipient is prohibited. If you are not the intended recipient, please immediately destroy this message and notify the sender at the following email address: Sharmini.Rogers@health.mo.gov<mailto:sharmini.rogers@health.mo.gov> or by calling ( 573 ) 751-6253.
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Lou Gonsalves Lou Gonsalves
We find that the 'Biomedical Data or Specimens Only Research' course (6 required modules) or the 'Biomedical Research' course (14 required modules) fit our needs for our internal research staff.
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Sharmini Rogers Sharmini Rogers
Thank you very much.

Dr. Sharmini V. Rogers, MBBS, MPH, Administrator
Section for Healthy Families and Youth
Division of Community and Public Health
Missouri Department of Health and Senior Services
930 Wildwood Drive
Jefferson City MO 65109
E-mail: Sharmini.Rogers@health.mo.gov
Tel: 573-751-6253
Public Health: Better Health. Better Missouri.
This email is from the Missouri Department of Health and Senior Services. It contains confidential or privileged information that may be protected from disclosure by law. Unauthorized disclosure, review, copying, distribution, or use of this message or its contents by anyone other than the intended recipient is prohibited. If you are not the intended recipient, please immediately destroy this message and notify the sender at the following email address: Sharmini.Rogers@health.mo.gov<mailto:sharmini.rogers@health.mo.gov> or by calling ( 573 ) 751-6253.
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Craig Conover, Medical advisor, Chicago DPH, IRB Chair IL DPH Craig Conover, Medical advisor, Chicago DPH, IRB Chair IL DPH
For external researchers, we are planning to transition to 1) requiring documentation of human subjects research training certification to be submitted with the initial IRB application, and 2) subsequently requiring that the PI verify that all all study staff have up to date training certification when yearly progress reports (or status update reports) are submitted to our IRB. PIs will also be informed that we may choose to do an audit and request documentation of staff training, at which point the certifications will need to be promptly submitted. 
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Robin Krause Robin Krause
We use CITI and luckily the external researchers and institutions we collaborate with use CITI as well. We require them to submit their certificate with initial submission and will have them link it to their profile in our IRB software program and then we are able to verify all training with each continuing review and amendment.
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Alysia Kwon, Vice Chair and Administrator Alysia Kwon, Vice Chair and Administrator
LA County has a CITI subscription for internal and external researchers as well as our bi-monthly in-person trainings.  We require submission of certificates with initial submission (unless it is on file with us already).  We currently do not require verification at time of annual progress report.
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