Skip to main content

Training and Quality Assurance

The Saint Louis University IRB maintains an education program and a quality assurance program to provide researchers with services to aid in the navigation of the IRB process, improve study conduct and quality of study records, and provide ongoing and current information from the field of research.

Below you can find additional information on:

Human Subjects Research (HSR) Training

Training on the involvement of human subjects in research is mandatory at Saint Louis University.

All faculty, staff, students and collaborating researchers who conduct human subjects research must complete a Collaborative Institutional Review Board Training Initiative (CITI) Human Subjects Training course or provide documentation of comparable training.

Investigators who have completed a human subjects research training course other than CITI may provide a copy of their training certificate (with listed course modules) to the IRB Office with their IRB application or to irb@hwfj-art.com. The IRB will determine whether the training course satisfies the mandatory education requirement. 

CITI Training: Mandatory for HSR Studies

For CITI Training, please register at http://www.citiprogram.org.

Complete one of the following courses as it relates to you/your research:

  • Biomedical Research: Individuals who conduct any biomedical research should select this course during the registration process.
  • Social/Behavioral Research: Individuals who conduct only social/behavioral research should select this course during the registration process. 
  • External Collaborator: This course is for non-博彩网址大全 collaborators, such as community partners (not 博彩网址大全 faculty, staff or students), who are assisting on a 博彩网址大全 research project. Those who routinely partner on 博彩网址大全 research should select the Biomedical or Social/Behavioral Research basic courses instead of this course.

CITI Registration Instructions:

When registering, carefully follow the instructions to provide 博彩网址大全Net ID information to ensure your training links to the eIRB system. You should also save the training completion report (with listed course modules) for your records. Documentation of an approved educational program must be on file with the IRB Office before research on human subjects may begin.

GCP Training: Mandatory for NIH-Funded Clinical Trials

Good Clinical Practice (GCP) training focuses on quality standards for designing, conducting, recording and reporting research to help assure the safety and integrity of studies. The IRB recommends all researchers train on the principles of GCP and industry sponsors may require it, but the course is only mandated for investigators conducting NIH-funded clinical trials.

The NIH Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials (NOT-OD-16-148, effective date January 1, 2017), mandates GCP training every three years for all investigators and study staff of NIH-funded “clinical trials.” A clinical trial is defined by NIH as “a research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” For NIH interpretation, see the clinical trial definition.

博彩网址大全 researchers are able to satisfy these requirements through their 博彩网址大全 CITI account (see registration instructions above) with the follow courses: 

  •  GCP for Clinical Trials - Investigational Drugs and Medical Devices (U.S. FDA focus)
    Biomedical GCP, Basic and Refresher courses available
    Researchers conducting biomedical research must take this course. A basic GCP training must be on file before a refresher training will be accepted to satisfy the requirement.
  • GCP - Social and Behavioral Research Best Practices for Clinical Research
    Behavioral (BSS) GCP, Basic (Refresher coming soon!) course available
    Researchers conducting behavioral research should take this course.
    This course does not satisfy the requirement for biomedical researchers,
    however, biomedical researchers are also encouraged to take it.

Comparable courses may also be accepted, such as:

Documentation of comparable training must be submitted to the IRB for review/acceptance and to enter into our database so training will automatically appear in eIRB applications.

Please note, GCP course completion does not count toward the mandatory IRB/Human Subjects Protections education requirement noted above.

Research with team members found out of compliance with training requirements may be asked to halt activities until compliance is restored.


IRB Courses/Continuing Education

The IRB maintains an education program that features routinely offered introductory sessions, periodically offered special topic sessions and customizable courses that can be brought into the classroom or research unit upon request. Past topics have included the history of ethics in human subjects research, primary investigator and research team responsibilities, IRB submission requirements, and common submission pitfalls and solutions.

Until further notice, all 博彩网址大全 IRB education sessions will be held online via Zoom.

Please complete the 博彩网址大全 IRB Education Request Form to request and schedule an IRB education session. For additional inquiries about educational sessions, educational collaborations, or information about educational materials, please contact the IRB Office at 314-977-7744 or irb@hwfj-art.com.

The IRB can also offer informational sessions to community groups. See additional information on the For Research Participants page of the IRB website for more information.

IRB Submitter 101
  • Format: Offered regularly online
  • Length: 60 minutes
  • Course description: This introductory course covers the basic history and mission of the IRB, how to determine which projects need review, choosing the appropriate forms to submit, basic information on the submission and approval process, and tips for successful submissions.
  • Is this course for me? Submitter 101 is for anyone newly involved in research (or those looking for a refresher), who are interested in learning the basics of human subjects research and submitting to the IRB.
eIRB 101
  • Format: Offered regularly online
  • Length: 60 minutes
  • Course description: Learn how to use the electronic IRB (eIRB) submission system, including how to create and manage protocols and their subsequent submissions; obtain appropriate signatures and approvals; and other systems tips and tricks.
  • Is this course for me? eIRB 101 is for anyone who is interested in learning the basics of using the IRB’s electronic submission system.
Post-Approval 101
  • Format: Offered regularly online
  • Length: 60 minutes
  • Course description: Learn the important compliance requirements following IRB approval, including study conduct, proposing changes, completing renewals, and reporting requirements (what to report, when and how). 
  • Is this course for me? Post-Approval 101 is for anyone interested in learning the research requirements after receiving IRB approval and is recommended after taking Submitter 101.
Informed Consent 101
  • Format: Offered regularly online
  • Length: 60 minutes
  • Course description: Learn researcher responsibilities surrounding the informed consent process and its proper documentation; how to apply for waivers and other non-traditional consent types; as well as common consent process and documentation mistakes to avoid.
  • Is this course for me? Informed Consent 101 is for anyone interested in learning the different types of informed consent, how to be compliant with research consent requirements, and how to avoid the most common consent mistakes.
Central IRB 101
  • Format: Offered regularly online
  • Length: 60 minutes
  • Course description: This course covers the basics of the Central IRB Reliance Program, including the 博彩网址大全 process for using central IRBs, as well as the specifics of working with our current established partners including eligibility requirements, the submission process, and investigator’s post-approval requirements.
  • Is this course for me? Central IRB 101 is for anyone interested in learning about the Central IRB Reliance Program. This course is not recommended for students. Use of a central IRB is restricted to researchers or research units conducting eligible industry-sponsored, clinical trials.
IRB Classroom 101
  • Format: Offered in-person or online, by request
  • Length: 30 to 60 minutes (or as requested)
  • Course description: Classroom 101 course content is completely customizable. Possible topics can range from an introduction to the IRB (mission and foundations), how to navigate the IRB process and prepare a submission, and tips and tricks for IRB success. An interactive “Be the IRB” case study game is also available.
  • Is this course for me? This tailored session is designed to meet a wide range of needs (for submitters or non-submitters) for instructors or departments looking to have IRB topics presented to their group.
IRB: Who We Are
  • Format: Offered in-person, by request
  • Length: 15 minutes (or as requested)
  • Course description: This course is meant to be a high level summary of the IRB’s mission, purpose and primary function at 博彩网址大全. It briefly covers what projects require IRB review, how to submit to the IRB, and other practical basics so attendees are familiar with the IRB and know where to go for more information/assistance.
  • Is this course for me? This general session works well for new graduate student, resident and new faculty orientations or others needing a short, high-level introduction to the 博彩网址大全 IRB.
IRB Bootcamp
  • Format: Offered in-person, by request
  • Length: 45 minutes (or as requested)
  • Course description: This course covers department-specific information on how to navigate the IRB process, including tips on choosing the appropriate forms to submit, information on the submission and approval process, and tips for successful submissions and conduct of research. The IRB Bootcamp session is designed to be delivered quickly and succinctly; and is tailored to the most common types of research done in the unit and highlights common pitfalls and ways to avoid them.
  • Is this course for me? This tailored session is designed for instructors or departments looking to have IRB topics presented to their group in a targeted, practical session to meet their unique needs.
IRB Brown Bag Series
  • Format: Offered in-person or online, as noted
  • Length: 60 to 90 minutes, as noted
  • Course description: This continuing education series is designed to provide the 博彩网址大全 research community with in-depth understanding and discussion concerning the latest policies, procedures, and requirements pertaining to human subjects research. Participants are encouraged to bring a lunch or a snack to enjoy during the session.

    The Brown Bag Conversations series offers sessions that focus less on traditional lecture and more on facilitated discussion that may promote advancement of human subjects research protections at 博彩网址大全.
  • Is this course for me? Brown Bag sessions are for anyone who conducts research or submits materials to the IRB. This includes 博彩网址大全 investigators, study coordinators, and any student, staff or faculty member looking for continuing IRB education.


Quality Assurance Review (QAR) Program

The IRB maintains a QAR Program aimed at promoting high ethical and quality standards in human subjects research by providing monitoring and educational opportunities for researchers who conduct research involving human volunteers. See the QAR Program and FAQs for more information.

Please complete the 博彩网址大全 Quality Assurance Review (QAR) Request Form to request and schedule a compliance review. For additional inquiries about the QAR Program, please contact the IRB Office at 314-977-7744 or irb@hwfj-art.com.

For-Cause Visits

 

QAR Visits

The QAR Team conducts routine investigator visits to assess whether research operations are being conducted in compliance with IRB-approved protocols, regulations and institutional policies. Review types vary in size and focus, and include things like consent process observation, consent documentation reviews, and study organization/documentation reviews. Investigators are selected randomly and once reviewed, are not eligible for routine re-selection for another two years.

Voluntary Visits

Principal investigators, research directors or study teams may also voluntarily request the QAR Team to visit and perform a specific type of review.  If you would like to request a review, please contact irb@hwfj-art.com or 314-977-7744.

Investigator Self-Assessment Program

Principal investigators, research directors or study teams interested in monitoring their own research programs for compliance and quality assurance can use the QAR Investigator Self-Assessment Checklist. The tool can be used in whole, in part, or in combination with unit or sponsor specific elements to ensure that all requirements are being met in the conduct of the research.