MSU Denver

How to make an IRB submission...

Cayuse - IRB Submissions

IRBNet is no longer available for IRB submissions, Cayuse will be our new submission platform and will be available starting Monday, March 7th.

  • Please Note: You will be able to log-in to Cayuse, using your MSU Denver credentials.  If you are unable to log-in, please click ‘Create Cayuse Profile’ below.
  • MSU Denver’s IRB requires that the Principal Investigator on any human research study be a member of the faculty or staff.  A student may make the submission, but the advisor must be listed as the Principal Investigator.
  • Cayuse support & training can be found in the application process.  At every step, you will have access to help buttons and different resources.
  • All forms will be completed online, there is no longer a need to submit Word documents of your protocol, consent or review forms.
  •  After reviewing these resources and accessing Cayuse, if you have any questions or need any assistance please contact the HSPP.

Begin your Cayuse experience here.  During your first log-in, you will be prompted to take a tour of the system, we strongly encourage you to do so, as this will provide your initial Cayuse training.  Afterwards, you may utilize the help buttons located on every page.  At the top of the page you will see “Products”, click here and select “Human Ethics”, this will lead you to begin your submission process.

*If you were previously an IRBNet user,  you will already have access to Cayuse using your MSU Denver credentials.  If not, please click the link below to request access to Cayuse.

 

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.


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.