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MSU Denver

How to make an IRB submission...

Collaborative Institutional Training Initiative - CITI Certification

CITI courses are intended to provide researchers (faculty, staff, and students) with an overview of human subjects research and protections.  The CITI training is the minimum requirement for researchers who are submitting materials for IRB review.  Basic course trainings are valid for 3 years from completion.


Are you new to the CITI program?

 

Registering for CITI Training:

1.  Go to the CITI website (www.citiprogram.org) and register as a new user.

2.  To complete CITI training, you must be affiliated with a participating institution.  Please select “Metropolitan State University of Denver” from the participating institutions dropdown list.

3.  You will need to create a user name and password.  Keep track of this information as it will allow you to log in and out of the program and complete the training modules at your own pace.

4.  The program will ask you if you will be requesting CME/CEU credits for the course(s) you are about to complete.  Choose “No” for this question, so the training is free.

5.  Fill out all the required fields, including your institutional email address (@msudenver.edu).

6.  When you select your curriculum, in Question 1 for Human Subjects Research learner groups (see below), most researchers at MSU Denver are conducting social and behavioral research and should select that learner group.  The course that you will complete is the “Social & Behavioral Research – Basic/Refresher”, unless you are conducting biomedical research.

If you have any questions on the type of research you may be conducting and what CITI training modules would best apply to your studies, please contact the HSPP.

7.  For ALL other questions under the curriculum choices (Questions 2- 6), select “Not at this time” or simply leave the choices unchecked when “Not at this time” is not an option.

Please Note: Researchers are welcome to add and complete other courses and training in the CITI program, but only the basic course in Human Subjects Research is required for IRB submissions.  Once you register for the CITI program, you can always change learner groups or additional modules later.  This is helpful for researchers who may need to complete additional training in CITI for other MSU Denver offices or programs. It is recommended that ALL researchers complete a Responsible Conduct of Research course which includes a training module on Conflicts of Interest.

8.  The program will ask you if you want to register with another institution (besides Metropolitan State University of Denver), please select “No.”

9.  The Basic Course should appear under your course list in the Main Menu.  Follow the link to access the individual modules.  The Main Menu will show you the status of the training and allow you to access a completion report when the training is complete.  You may log out of the training at any time and the program will keep track of the modules you have already completed. The optional modules are optional and do not count towards your completion report.

10.  Once you have completed all the required modules in the training (including quizzes), you will be granted a completion report.   The CITI basic course training is valid for 3 years.  

As a courtesy, the CITI program will alert you to expiring training via email and provide access to a refresher course as you near the expiration date.

It is your responsibility to ensure that the required training is complete and current when submitting to the IRB and conducting human subjects research.


Accessibility:  According to the CITI Program website, the course modules are compatible to screen readers.  In addition to English, many of the courses are available in the following languages: Chinese, French, Korean, Japanese, Portuguese, Russian, Spanish, and Thai.


 

Who needs to complete the required training?

The Principal Investigator and ALL research personnel involved with human subjects in your study. This includes any researcher who:

  • obtains information about living individuals by intervening or interacting with them for research purposes;
  • obtains identifiable private information about living individuals for research purposes;
  • obtains the voluntary informed consent of individuals to be subjects in research; and/or
  • is studying, interpreting, or analyzing identifiable private information or data for research purposes.

For research teams that involve external investigators (from other institutions or community members), the PI may provide alternate, comparable training for HSPP consideration.


 

CITI Human Subjects Research Learner Groups for MSU Denver include:

Social & Behavioral Research Investigators:  This Human Subjects Research basic course is required for all members of a research team when submitting a social-behavioral research protocol to the MSU Denver Institutional Review Board.  MOST researchers at MSU Denver fall into this learner group.

Biomedical Research Investigators: This Human Subjects Research basic course is required for all members of a research team when submitting a biomedical research protocol (e.g., clinical trial, drugs, devices) to the MSU Denver Institutional Review Board.

Research with Biomedical Data or Laboratory Specimens ONLY: This Human Subjects Research basic course is required for all members of a research team when submitting a protocol involving data repository or laboratory specimen research to the MSU Denver Institutional Review Board.

IRB Members:  These training modules are required for all members of the Institutional Review Board.

 

CITI Training Affiliation

Please Take Note: As you register for the CITI program, make sure your affiliation is with “Metropolitan State University of Denver” and not simply “Metropolitan State University.”

If you are not associated with the correct institution, you cannot access MSU Denver’s required training modules.

Investigator Manual, Forms & Templates

HRP-103: Investigator Manual

This manual outlines the submission process throughout the life cycle of a study and should be referred to when you have questions.


APPLICATION FORMS:

HRP-211 FORM: Initial Review   This form is REQUIRED for a new study submission for IRB review.

HRP-212 FORM: Continuing Review   This form is REQUIRED for all continuing review and final review (closure) submissions.

HRP-213 FORM: Modification   This form is REQUIRED for all modifications/amendments to IRB-approved studies.

HRP-214 FORM: Reportable New Information   This form is REQUIRED for any new information submission to the IRB, such as a report of an unanticipated problem or adverse event.  Refer to page two of the form for specific examples.

A note on HSPP application forms that require a “signature”:  There is no requirement to provide a hand-signed, scanned copy on any IRB submission materials.  Your typed name is sufficient for all application materials in the submission process, and the form is associated with your (the Principal Investigator’s) unique profile and access in IRBNet.

A note on multiple requests for the same study:  For approved research, a modification request, continuing review, and new information report require separate IRB review processes and different forms.  Modifications and Continuing Review applications must be submitted as separate packages in IRBNet for processing and review.


TEMPLATES:

Templates are tools that may be used to develop materials for your study.  There is no requirement to use these exact formats for your submission.  However, all researchers are encouraged to review the templates for content and language that may be relevant to your research and may be considered during IRB review.

HRP-503a TEMPLATE PROTOCOL: Social-Behavioral   This template can help you build a research protocol that includes information considered by the IRB during the review process.  Your research protocol is the key document in your submission package that should be supported by all supplemental materials.

UNIVERSAL CONSENT TEMPLATE   This template should be utilized by most research studies performed at MSU.  This can be used for anonymous surveys, as well as when collecting identifiable data.  This template can be adapted to best fit your research and subject population.

HRP-502c TEMPLATE CONSENT DOCUMENT: Release Form for Images and Recordings   For some studies, a separate release form may be appropriate to gain specific permissions for data collection through photography, video-recording, and/or audio-recording.  This template may be edited to fit your research.  In other studies, the researchers may integrate language and permissions for this type of data collection into their consent form.

HRP-502d TEMPLATE CONSENT DOCUMENT: Assent Templates   This template provides guidance on drafting verbal scripts and/or written assent forms for gaining permission from child participants.

HRP-502e TEMPLATE CONSENT DOCUMENT: Parental Consent   For studies that involve child participants, this template can be used to develop a consent document for parents.

HRP-502f TEMPLATE CONSENT DOCUMENT: Adult Unable to Consent   For studies that involve adult participants who are unable to consent, this template may be used to develop a consent document for legally authorized representatives (LAR).

HRP-507 TEMPLATE CONSENT DOCUMENT: Short Form   A short form is required when gaining consent from subjects who cannot read an English consent form.

***If you do not see a consent template that you think will best suit your needs, please contact HSPP for further assistance.


HRP-504 TEMPLATE LETTER: School Permission to Conduct Research   This templates provides example language for permission to conduct research in a school setting.

IRB forms and templates are also available in the IRBNet Library.

Please Note:  The IRB website and IRBNet library contains forms and templates most commonly used by MSU Denver investigators, primarily for social-behavioral research.  The HSPP staff can provide you with forms and templates for biomedical research (clinical trials, research with drugs or devices, etc.) if needed.

IRBNet Training & Resources

To access IRBNet, go to www.irbnet.org.

  • Please Note:  All submissions to the IRB are to be made by the Principal Investigator.  MSU Denver’s IRB requires that the Principal Investigator on any human research study be a member of the faculty or staff.
  • IRBNet training “energizers” provide step-by-step screenshots to guide you through accessing and using the system.  Brief IRBNet training videos can also guide researchers through new project submissions and post-submission management of projects.
  • IRB Forms and Templates are found in the IRBNet Library and on our website.
  •  After reviewing these resources and accessing IRBNet, if you have any questions or need any assistance please contact the HSPP.

Please follow these steps to create an account with IRBNet and begin making submissions to the IRB:

#1 How to Register with IRBNet and Create a Profile:

Review IRBNet: How to Register as a New User (screenshots), to:

  • Create and activate your account in IRBNet
  • Manage your affiliations from your User Profile
  • Add and submit necessary Training & Credential records
  • Maintain your Training & Credential records on an on-going basis

A note on Training & Credentials for IRB submissions:  The IRB requires the Principal Investigator to provide a current curriculum vitae (CV) or résumé with submissions.  This can be simply uploaded to your profile and submitted to the IRB.  Your CITI completion report can also be uploaded to your profile and submitted.  Researchers can also review this information, IRBNet: How to Upload CV & CITI Training, for specific questions on managing training and credentials in IRBNet.


#2 How to Create a New Study and Submit an Initial Review:

Review IRBNet: How to Submit a New Project for Review (screenshots), to:

  • Login to IRBNet
  • Manage projects
  • Build your first electronic project package.
  • Share projects with your research team and communicate with co-investigators (At MSU Denver, registered IRBNet users are only members of the faculty or staff)
  • Sign your submission package
  • Submit your project for IRB review
  • Revise incomplete submissions
  • Access review decisions and IRB documentation

 

When you build submission packages in IRBNet, create and upload your study materials as distinct documents within your submission package (e.g., research protocol, consent form, questionnaire, etc.).  Clearly title each document and keep track of version numbers (or version dates).


#3 How to Manage Submitted Projects:

(submit revisions, modifications, or continuing reviews for existing projects)

Review IRBNet: How to Manage Projects After Submission (screenshots), to:

  • Learn about advanced project management
  • Manage project reminders
  • Review project messages and alerts
  • Create a subsequent package (respond to modifications required, continuing review submission, amendments to approved projects)
  • Add and revise documents
  • Complete and submit subsequent packages

 


TIP#1:  Once a study is created in IRBNet, follow the guidance for managing submitted projects to add subsequent packages for further activities (continuing reviews, modifications, etc.).  The idea is to keep the same six-digit assigned IRBNet number for the study.  The submission package is noted each time following the six-digit number.  For example, your new study can be assigned the number 654321-1.  A subsequent revision would receive the number 654321-2.  Then a continuing review would receive the next package number 654321-3.  And so on…

TIP#2:  Each activity that requires an IRB form (initial review, continuing review, modification, reportable new information) also requires a separate submission package in IRBNet.  If you are submitting for continuing review and proposing a modification at the same, these activities should be submitted in IRBNet as two separate submission packages for the same project.

TIP#3:  To better manage study documents in IRBNet, create and upload your study materials as distinct documents within your submission package.  Clearly title each document and keep track of version numbers (or version dates). This way, you can more easily make requested or needed revisions to documents and manage your approved materials.  An example:

    • Initial Review Form_v.1
    • Research Protocol_v.1
    • Recruitment Script_v.1
    • Consent Form_v.1
    • Questionnaire_v.1
    • Demographic Form_v.1
    • CITI Training for Researchers