Regulatory Support , Advocacy and Bioethics Core (RSAB)

Services Provided

The RSAB offers the following services:

1. Concierge services that include a coordinated and simplified approach to regulatory compliance tasks:

These and other services are offered individually or as a package. For a detailed service list, click the button below.

2. Research Participant Advocacy

  • Consult on subject safety issues
  • Complete a risk assessment
  • Evaluate data safety monitoring plans, data monitoring committees, and safety reports
  • Evaluate adverse events (AEs)
  • Evaluate unanticipated problems involving risks to subjects

3. Education and training programs on regulatory topics

  • Core members are available to speak to departments and research programs about the regulatory core services and regulatory requirements.

For Questions or Services

Consultation is available by appointment. Kindly complete the service request form that can be accessed by clicking on the 'RSAB Service Request' button on the left side of this page.

If you have general questions, you can contact Lauren Walsh (laurenw@uic.edu).

Billing Information:

Initial consultation with an RSAB Coordinator to discuss potential services is free of charge. Fees for RSAB services may be subsidized based on project funding source. Please contact Andrea Carnegie at acarnegi@uic.edu for details.



Protocol Development

We will help turn your grant into a protocol or modify your existing protocol for regulatory submissions.

Service plan: A la carte

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IRB Submissions

On behalf of the investigator, we will complete any type of IRB application including Western IRB Applications, specialty committees such as the Cancer Center Protocol Review Committee, VA submissions, and Radiation Safety and Biosafety committees; write the consent form, HIPAA authorization form, Appendices, DSMP & other IRB related documents; work with the investigator to respond to IRB modification requests in order to obtain full IRB approval.

Service Plan: Platinum, Gold, Silver, A la carte

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Data & Safety Monitoring Plan (DSMP)

Our staff will help you draft the DSMPs for your grant or protocol should your study require them.

Service Plan: A la carte

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Data & Safety Monitoring Board (DSMB)/Data Monitoring Committee (DMC) Management & Oversight

We will conduct a risk assessment. We will help you decide if your study needs a DSMB. We will help set up the structure of the DSMP and evaluate data safety monitoring plans, data monitoring committees, and safety reports.

Service Plan: A la carte

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IND/IDE Submission

We will help you decide if your study needs an IND or an IDE and if one is needed we can help you prepare and submit the information required for the application(s).

Service Plan: Platinum, Gold, A la carte

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IND/IDE Report Submission Assistance

We will help investigators collect the information necessary to submit an Annual Report, an Amendment to the IND/IDE, a Report of New Investigators, or Protocol Amendment to FDA.

Service Plan: A la carte

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Adverse Experience Reporting to the IRB and External Agencies

We will help you evaluate adverse events (AEs) and serious adverse events (SAEs) in preparation for you making timely & complete reports of AEs/SAEs to the FDA, the IRB & other oversight agencies.

Service Plan: A la carte

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Good Clinical Practice (GCP) and Study Start-up Education

We provide education sessions on the practical application of Good Clinical Practice activities for you & your research staff. We can also provide one-on-one consultations to help study staff initiate/ transition studies with GCP in mind.

Service Plan: Free

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Consultation

We can provide guidance on IRB requirements and best practices. We also provide guidance on: genetic research, repositories, data banks, and vulnerable populations.

Service Plan: Free

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Initial Clinical trial registration

We can help you with ClinTrials.gov registration to ensure you are in compliance with this requirement for publication.

Service Plan: A la carte

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Certificates of Confidentiality

We can complete the COC application, collect the required documents and submit to NIH

Service Plan: A la carte

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Conflict of Interest

We will assist you with preparation of a Statement of Explanation and Management (SEAM) if necessary.

Service Plan: A la carte

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Research Ethics Consultation

Investigator may request a Research Ethics Consultation (REC) at any stage of a study. Also, the IRB may request REC consultation.

Service Plan: Free

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