Human Subjects Research

It is the policy of Oklahoma State University that all research involving human subjects conducted by Faculty, Staff or students of OSU what be submitted to the OSU Institutional Review Board for review before it is initiated. This is true, regardless of the location where the research is conducted.

 

To determine if your project requres IRB review, find definitions here: Applying to the IRB

All personnel (i.e., principal investigators/instructors (PIs), research faculty/staff, graduate students, laboratory technicians, students, etc.) involved in human subject research must complete prescribed mandatory training prior to protocol approval.

 

OSU-CHS offers an online training course provided through the Collaborative Institutional Training Initiative (CITI), which is hosted by the University of Miami.

ACCESS THE TRAINING

 

Training instructions

Applications are to be submitted via the online system, IRB Manager

 

For application requriements and guidebooks, be sure to review all requirements by visiting Applying to the IRB

Meeting dates are generally the third Wednesday of each month.

 

Please be sure that you have allowed ample time for review, keeping in mind that the IRB committee members all have other full-time positions.

Review deadlines can be viewed by visiting Applying to the IRB

The IRB is a large component of the human research protection program, and while they work together, they are separate. The HRPP assists the University in meeting its legal, regulatory, and ethical obligations and routinely collaborates with other offices across the University, as well as community partners, on various programs and initiatives related to research that foster compliance, quality, efficiency, and the protection of human participants.  The HRPP provides compliance oversight, independently and in conjunction with the IRB, for research activities involving the use of human subjects. The HRPP serves as an advisor and informational resource for institutional policy and regulatory requirements; provides educational opportunities, training, and investigator consultations; and serves as the IRB's facilitator. The HRPP conducts required reporting to federal regulatory agencies, external organizations, and institutional administration.  In addition, the HRPP provides educational support to principal investigators and their research staff, provides administrative and regulatory support to the Institutional Review Board (IRB), and works closely with external IRBs when research is ceded to them for IRB review.

• Return to your home page by clicking on the “Home” icon.
• At the bottom center of the page, select the study number of the protocol needing a continuing review, amendment or reportable event.
• From within the study’s protocol page, select “Start xForm” from the left menu.

If you know you have taken your training but it is not showing up in IRBManager, you need to verify what email account your CITI account is set up with. If it is not an OSU CHS account then you need to enter the CITI email used in the CITI Alternate Emails section in your IRBManager profile, confirm that your account is affiliated with the OSU Center for Health Sciences or add your OSU CHS email to CITI.

 

If your email accounts are listed correctly your training will show as complete after the CITI and IRBManager systems update overnight.

I entered incorrect information on my xForm, submitted the xForm and is it now in the PI review and Signature state.  How do I make corrections to the form wile it is in this stage?

Contact the PI and ask that she or he go into the xForm, check “Requires changes before IRB review” and submit it. The xForm will be returned to you and you will be able to make corrections.

The system will not be able to add personnel to the study team if they have never logged into IRBManager/previously registered an account. Have them go to https://osu-chs.my.irbmanager.com/ to register for an account.

IRBManager customizes the questions that you need to answer based on your previous responses.  It cannot generate the appropriate questions for your research if you skip a section.

Sometimes an answer to a question isn’t one of the options. You can provide an explanation or additional information for the question. While in the xForm, each question title is in a light blue bar. The right side of this blue bar has a link to “Add Note.” Additional information and notes can be typed here.

I am trying to help a colleague and get the continuing review form ready for them because they are very busy right now. When I searched for their study in IRBManager, I can’t find it. Why is this?

 

Only IRB-approved research personnel can access a study. If you are not approved by the IRB to be on the study, you will not be able to prepare any study-specific forms for the PI.

The individual who starts an xForm (submitting user) is the only person who will have access to that form in Application Data Entry unless others are added as collaborators. The IRB Office recommends manually adding the PI and Supervising Investigator as collaborators on the study with edit, manage, submit access at the beginning of the Application Data Entry stage to allow them to contribute to the application’s completion.

1. Click on the “Collaborators” link at the top of an application to add individuals as collaborators on the xForm.
2. Enter the email address of the individual to be added as a collaborator.
3. Select the collaborator access -

View only:  Can only view the application

Edit:  This will allow the person to edit the application

Edit and manage:  Allows the person to edit the form and invite new collaborators

Edit, manage and submit:  Allows editing the form, inviting new collaborators and submitting the application

 

4. Type in the “Note for Collaborator” field the text if you would like included in the automated email notification that will be sent to the collaborator.
5. Once added, the collaborator should see the xForm on their dashboard under “xForms awaiting your attention”.

Note: Collaborators that are added at any stage are not retained once out of that stage. However, when an xForm is returned to the submitter from a later stage - such as when the IRB office returns the form for more information – the system is set up to include the PI and Supervising Investigator as collaborators automatically. If you wish for the collaborators to have continued access, you will need to re-add them when the form is returned to you.

Select My Courses -> View Courses

Pick course to “Review Course” (It will either be under the Social, Behavior or Biomedical Research, whichever is applicable to the research type)

 

 It opens required, elective and optional modules.  -> Find the additional required course -> Select “start” on an optional module