مكتب البحوث والشؤون التنظيمية

Investigator Manual Version 1.0 (4/19/24)

Other Guidance

• Recruiting & Advertising for Research Participants
• OIG Speaker Fees Fraud Alert Guidance

IRB Manager, our web-based submission system, allows users to enter protocols and protocol related information such as: new submissions, progress reports, adverse events, attachments, comments and more. Investigators have access to see the protocols they’re investigating as well as attachments, events and documents generated for their study.

https://cchhs.my.irbmanager.com/Login.aspx
User Manual
Quick Sheet

Please email CCHHSIRB@cookcountyhhs.org at the Office of Research & Regulatory Affairs to obtain a login and password. If you need assistance or would like to schedule a training session, please send an email to the address above.

Templates

• HRP-503 Template Protocol (Biomedical) 
• HRP -503a Template SBS Protocol (Social-Behavioral)
• HRP-508 Template Site Supplement to Sponsor Protocol
• HRP-502 Template Consent Document V1 (8/7/23)
• HRP-506 Template Consent Document (Emergency Use or Compassionate Device Use) V1 8/7/23
• Cook County Health HIPAA Authorization for Research
• Cook County Health HIPAA Authorization for Research – Spanish 

Short Forms

• English Short Form Consent
• Arabic Short Form Consent
  • Arabic Certificate of Translation
• Creole Short Form Consent
  • Creole Certificate of Translation
• Mandarin Short Form Consent
  • Mandarin Certificate of Translation

• Polish Short Form Consent 
  • Polish Certificate of Translation
• Russian Short Form Consent
  • Russian Certificate of Translation
• Spanish Short Form Consent
  • Spanish Certificate of Translation
• Urdu Short Form Consent
  • Urdu Certificate of Translation

الاستمارات 

• صيدلية 
  
• معمل 
• Reliance Agreement Request 

All persons who are to be substantively involved in human participant research at Cook County Health must be properly trained.

Research & Regulatory Affairs is excited to introduce the CITI Program for Research Ethics and Compliance Training to Cook County Health. In order to ensure the protection of our research participants, our Human Subjects Research (HSR) / IRB training will now expire every 3 years. With over 800 active users in IRBManager, online certification is necessary to keep up with best practices and law changes, standardize the educational platform across institutions for multisite studies, and ensure our researchers meet single IRB and sponsor requirements.

Researchers looking to become certified for the first time will now complete the HSR CITI modules prior to their in-person training. You must have a Cook County Health ID to attend the in-person session. Researchers who have already completed the in-person training will only have to complete the CITI modules. Researchers who have not taken the in-person training in the last 3 years are required to complete the HSR course by the end of 2019. Those that have completed the in-person training within the last 3 years will be required to renew at their 3-year expiration date.

• Cook County Health Guidelines for Investigators – Under Revision
• CITI Program Instructions
• CITI Program: https://www.citiprogram.org/login

The Office of Research & Regulatory Affairs conducts audits on research projects involving human participants.

Two types of audits are conducted: random post-approval monitoring audits and for-cause audits, which are a tool to provide insight to research related conduct at Cook County Health and achieve compliance with applicable federal regulations and laws as well as Cook County Health policies and procedures. Audits are also a vehicle for quality improvement, awareness of operations and continuing education.

The purpose of the audit is to review and inspect the ethical conduct of human participant research, adherence to the study protocol, and adherence to what is presented to the IRB as well as to participants in the informed consent process. Audits typically involve the review and inspection of informed consent forms, HIPAA authorization forms, IRB records, training documentation and data management/documentation with an emphasis on confidentiality and privacy procedures. Please click on the link below to access a checklist to help you prepare for your audit.

Cook County Health Audit Checklist

The Office of Research & Regulatory Affairs charges a processing/administrative fee for the Cook County Health IRB review of all industry sponsored human participant research.

CCH IRB charges a review fee for industry sponsored research. IRB review fees are not charged for non-profit sponsored studies supported by the National Institutes of Health (NIH), other government agencies, or investigator-initiated studies. Any industry sponsored budget and clinical trial agreement submitted after November 1, 2023 will be subject to these updated fees. There will be no charge for amendments/modifications, protocol deviations, unanticipated events involving risk, or final reports. Please click on the link below to access the current fee structure. These fees are subject to review and change.

Cook County Health Fee Structure Memo