Written by Kasia Gore, MD; last updated May 19, 2021
This guide will help you enter the Rush IRB site and submit your research proposal. You’ll need to have completed your IRB and CITI training before you’ll be given access to this site.
Step 1: Log into the Rush IRB portal
Click onto the link for the site, http://rrp.rush.edu, and the link for logging in is in the top right corner in light blue. If you’re color blind, good luck finding it. You may also have to scroll your browser to the right to get it on the screen if you have a smaller monitor.
Enter your credentials. You will have to have completed all of your IRB and CITI training in order to log in. These should be your standard Rush single-sign out username and password. You’ll then be prompted to verify using 2-factor authorization using the Duo app on your phone. Alternatively, you may see the previous style log in as depicted below.
Step 2: Create a master project
While on the Master Project page, click the “New Master Project” button on the left side.
Step 3: Entering master project info
The Master Project will require several pieces of information. It may be best to prepare this data ahead of time to make entering online easier.
- Question 1:
- The project title is ideally a title you can see on a publication
- The short title is not required but can be the nickname of the project or anything that helps you identify the project. It is limited to 30 characters.
- Protocol number and ClinicalTrials.gov identifier likely will not apply so just type in N/A
- Question 2:
- Principal Investigator (PI) is the person who is in charge of the projected and will likely be the project’s first author. If you start typing in the person’s last name, it will provide you with potential options.
- The additional investigator portion will likely not be used, so leave it blank. This is necessary when a sponsoring agency requires multiple PIs.
- Question 3
- The Principal inventory is currently a question asks you to list the status of the principal investigator. You can figure out what you are.
- Question 4
- Co-investigator is anyone else who you think will likely be helping you author the paper
- Question 5
- Study Coordinator for the Dept of EM is Pamela Manning. You should already be in contact with her before entering the project into the website.
- Question 6
- Other study staff is probably other study staff. My brilliance is remarkable, I know. Leave it blank unless you know what to do with it.
- Question 7
- Department-Required approvals: Emergency Medicine and any other department that might be affected/included in the study.
- Question 8
- If the PI is a student, in this case list the sponsoring faculty or staff. We may get to the point where we
Select continue at the bottom of the page. If there are required items left unfilled they’ll be highlighted in red and you won’t be able to move forward. After hitting “Continue” we’ll move to the next page.
Step 4: Identify Key Personnel
Key personnel are individuals that you see contributing to the project and will need to be included in the study binder. They will need to have CITI training and will help in the completion of the project so you can delegate tasks to them. Anyone who you list as a co-investigator will likely be key personnel.
KEY PERSONNEL are defined as: The PI and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they receive salaries or compensation under the grant. Typically these individuals have doctoral or other professional degrees, although individuals at the masters or baccalaureate level may be considered key personnel if their involvement meets this definition. Consultants also may be considered key personnel if they meet this definition. “Zero percent” effort or “as needed’ is not an acceptable level of involvement for key personnel. (From the RRP “Identify Key Personnel” webpage)
Obviously, include yourself as key personnel, self-esteem permitting.
Step 5: Project Funding Information
Prime sponsor and funding organization will likely be Departmental Funding unless you have in fact received funding from a large sponsor. In which case, good job.
The answers to 1.1 and 1.2 will likely be no if you have no external funding. And since you answered no to 1.1 and 1.2, you will not need to answer question 2.
Funding organization will also be “Departmental or Internal” unless you have received money from elsewhere. Select from the list.
Unless you received public or other sponsor funds, you’ll select no here. They provide a list of organizations and agencies listed below.
Once everything is completed, select “Continue” at the bottom right and you’ll progress to the next page.
Step 6: Project Specific Information
The definitions of basic research/animal subjects and human subjects are fairly well defined in the gray column. Most studies in our department will involve human subjects and are unlikely to involve basic research or animal subjects. If you are doing a study on cadavers or completely deidentified subjects you may meet criteria for a 118 determination.
- Basic research refers to basic science projects that are “at the bench” or in the laboratory, sometimes including computer simulations.
- Animal Subjects research refers to studies of animals (e.g. mice, rats, pigs, etc.) where an IACUC approval is or will be sought.
- Human Subjects refers to research that involves clinical research that would be under the purview of an IRB. If applicable, you may seek a 118 determination (non-human subjects determination) for studies of de-identified or deceased subjects.
There are several other questions on this page.
- 5.0 Likely your project will not be reviewed by an external IRB unless it is a multi-institutional study.
- 6.0 Are you using ionizing radiation? Gamma rays? We don’t need any hulk-ification.
- 7.0 Does the study use any infectious agents, genetically engineered items or vaccines?
- 8.0 Does the study use any high risk infectious agents, toxins, Parkinsons inducing agents or nanoparticles? You’re not Tony Stark. You’re not using nanoparticles.
- 9.0 Is this project research? You should answer yes for this. The site writes “only enter “No” if there is no research study affiliated with your submission and the intention of the submission is to get a review or signature”
Step 7: Human Subjects Research Categories
The questions below will pop up if you entered that you are using humans, the descriptions are fairly well laid out and by this point you likely know what your study design will be.
Step 8: Clinical Trial Information
If your study will include an intervention that may affect “health related biomedical or behavioral outcomes” it is a clinical trial. The different protocol types are fairly easily understood and may not apply to what you are doing, in which case, chose “other.”
NIH definition of a Clinical Trial: “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes”
Step 9: You’re Done… almost
After you complete that last page, you have now reached the end. Select “Finish” and then you’ll need to complete the disclosure forms.