Preparing to Complete an Ethics Application at VCH Part I

(With special tips for those whose research project is funded by the VCH Research Challenge)

Getting Started. Steps to follow for First Time Users Applying Online:

1.  Determine who will be the Principal Investigator (PI) for your project. In order to submit an ethics application you will need to have a Principal Investigator and you will need to know the Researcher Number for the PI (details below). The PI for your research project can be either a UBC Faculty member (your mentor, perhaps) or a VCH employee (team leader or any team member, but preferably someone who is a supervisor level or higher). In some cases, the VCH employee will have to receive permission from the VCH Research Institute to be listed as PI on a study. If you wish to be the PI on your Research Challenge project, and have never been PI on a VCH research project before, you will need to fill out the attached form (called the VCHA Manager Declaration form) and forward copies of it to Pia Ganz and Stephania Manusha ( and ).

Contact Amber Hay if you’re not sure which team member on your Research Challenge team will be listed as PI. The PI for a study is responsible for adhering to the Tri Council Policy Statement (TCPS) and other relevant guidelines, and indicates this by clicking “OK” in the “Submit Application” view on the application homepage.Based on security in the RISe system, only the PI listed in Question 1.1 of the application has access to this “Submit Application Activity” on the application homepage.

2.  Apply for a Campus-Wide Login (CWL). If you will be logging in to create or make changes to the application, you need to apply for a Campus-Wide Login (CWL) Account. If you will be listed as a study team member on the application, but do not need to view or make changes to the ethics application, you need a researcher number, but not a CWL. The PI needs both a CWL and Researcher Number.

1.  Go to http://www.it.ubc.ca/cwl/homelink.shtml

2.  Follow the instructions for setting up a Standard CWL Account. UBC employees should sign up as either Faculty, Staff, or Student. Non UBC employees are advised to select the Basic Account option.

Complete your identification information and choose your own CWL username and password.

Once your account has been created, you will be prompted to check your email for a confirmation message whereupon you are expected to validate your email address.

3.  Apply for Researcher Number. Each member of the research team listed in the application will need a Researcher Number.

If you do not know whether a Researcher account exists for you, please email and provide the administrator with the following information. The RISe administrator will email you the researcher number upon receiving your request

 First/Middle/Surname

 Email Address

 Business Telephone Number

 UBC Department of Affiliation (if none, provide the name of your Institution and Department)

 UBC Rank

 UBC Employee ID (If applicable)

4.  Login to RISe:

·  Once you have your CWL username and password, visit the RISe website (https://rise.ubc.ca) where you will be prompted to enter your CWL upon initial RISe Login to the Research Compliance Protocols and Grants Administration module. Depending on the nature of your account, during the initial login you may or may not be prompted to enter the researcher number provided to you. On subsequent logins you will only be asked for your CWL username and password.

·  Upon initial login, you will be prompted to review and update your account information. Make sure your profile is correct and up-to-date and hit “Apply” to continue.

·  For detailed instructions on how to complete specific tasks, select the "User Tutorials" tab from your “My Home” page and consult the appropriate set of guidelines.

·  Please note: always update your profile by logging into the "Research Compliance Protocols and Grants Administration Module"

  1. Additional Notes and Assistance:

·  The following 30 minute workshops are a great start for new researchers and can be found on the RISe website http://www.research.ubc.ca/ore/creb-advice-online-presentations

·  Basic Introduction to the Clinical Research Ethics Process

·  Common Challenges in Clinical Research Ethics Submissions

·  The UBC Clinical Research Ethics General Guidance Notes (GN) and Application (RISe) Guidance notes can be found at http://research.ubc.ca/ore/ubc-clinical-research-ethics-general-guidance-notes

·  Part A deals with General guidance and Part B the RISe Application. It is recommended that Researchers have the application close at hand while completing the application.

·  Please see the BC Common Clinical Informed Consent Form template

·  The following is a link to the RISe application FYI http://research.ubc.ca/sites/research.ubc.ca/files/Draft%20Clinical%20Application%20for%20website.pdf

If you have questions, please contact:

Pia Ganz,

Telephone: (604) 875-4149

Fax: (604) 875-4167

http://www.research.ubc.ca/ethics/clinical-research-ethics-board