You may find your ethics question answered here.
Yes. A pilot test is also research and must be reviewed and approved by the Research Ethics Board before the participants are approached.
No, provided that they are simply quality assurance and not research. Intention to publish the findings is not the litmus test for determining whether something is research or quality assurance.
The current Tri Council Policy Statement defines research as “an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation” and states that quality assurance studies, performance reviews, or testing within normal educational requirements do not normally require review, unless they include an element of research and the findings will be published or presented at a conference. The Tri Council Policy Statement, article 2.5, further defines quality assurance studies as studies related directly to assessing the performance of an organization or its employees or students, within the mandate of the organization or according to the terms and conditions of employment or training.
The BREB has developed a checklist to help researchers decide whether or not their project constitutes research requiring review, or whether it is quality assurance (quality improvement, program evaluation, etc.) and does not. If there is any doubt as to whether your research requires review, the BREB recommends that you consult with the Board. None of UBC’s affiliated REBs will review or acknowledge research that has already been conducted.
If you are a UBC student, put your Faculty Advisor as the Principal Investigator. If you are a student from another University doing your research at UBC or one of the affiliated teaching hospitals, your research supervisor on site should be entered on the form as the Principal Investigator.
The Principal Investigator (PI) for a study is responsible for adhering to the TCPS and other relevant guidelines, and indicates this by clicking “OK” in the Submit Activity view on the application homepage. Based on security in the RISe system, only the PI listed in Question 1.1 on the application has access to this Submit Activity on the application homepage. The PI’s signature attests to the following:
By signing below, I certify that I have read this application together with its attachments and that all information provided herein is accurate and complete.
UBC Faculty: The Principal Investigator must have a Faculty Appointment (e.g. Assistant Professor, Associate Professor, Professor, or Emeritus Professor). This includes Clinical Faculty appointments in the Faculty of Medicine.
Hospital Employees: The UBC Research Ethics Boards also review research carried out at affiliated teaching hospitals by employees who do not have Faculty appointments and who are not UBC students. In this case, the employee should be listed as the Principal Investigator and the employee’s Hospital Department Head should sign the application.
Course Instructors: Course instructors who are applying for research ethics approval for course-based assignments in subjects they are teaching (e.g., research methods courses) can be listed as a PI on their application, even if they do not hold a regular faculty appointment. Please contact Maria Valente if you are submitting a class project and require the capacity to list yourself as a PI on the application.
Time to review
Minimal risk studies go through a delegated review process and generally spend less time in review than full board studies. Further information on the concept of minimal risk is available here.
On average, the BREB reviews approximately 1,100 NEW applications each year. BREB members are full-time faculty who volunteer their time to the board.
Full Board: you should anticipate the review process taking approximately 7-8 weeks, from date of submission to date of receipt of approval. Most of the correspondence resulting from the meetings of the Behavioural Research Ethics Board will be sent out within 2 weeks of the meeting.
Minimal Risk: Applications that meet the Minimal Risk criteria are sent to one member of the Behavioural Research Ethics Board to review and the average time from submission to response is 3 weeks. Amendments/Renewals/Replies to Provisos: Turnaround is approximately 1 to 2 weeks.
Applications that are incomplete and/or that require revision because necessary information has not been provided are handled by the online system in chronological order and therefore each incoming version is placed at the end of the chronological queue. Careful completion of the application is therefore highly recommended.
The Principal Investigator (Box 1.1) and the Primary Contact (Box 1.2) listed in the ethics application will receive email notifications. You can also check the status of an ethics applicaiton at any time if you have access to the application in RISe.
Post-Approval Activities (PAA)
Yes. Create a Post Approval Activity (PAA) for an amendment in the Application Homepage on RISe. Instructions on how to do this are available here. Describe the changes in the PAA coversheet, revise the original application and attach revised versions of the letters or consent forms that have been affected by the change. Please ensure that you do not remove information regarding currently approved procedures if you have actually used those procedures in the study, even if that component of the study is now complete. The application should outline all aspects of the study, not merely the new elements you are requesting approval for. Review of minor amendments will have a turn around time of 1-2 days.
An amendment is a revision to an ongoing study. If you are changing any part of the study (e.g. co-investigators, title, agency, documentation) you must submit an amendment. Amendments to studies should be changes within the scope of the original study, not new studies that are simply related to the original study. They must be submitted for review prior to their implementation.
Amendments to studies should be changes within the scope of the original study, not new studies that are simply related to the original study. If the procedures and data collection described in the original application for ethical review have now been completed, changes that involve new research questions and also entail new procedures, measures, or study populations should be submitted in a new application for ethical review. In general, a good rule of thumb is that if you find yourself needing to update boxes on most sections of the application, then it’s probably appropriate that you submit a new application rather than an amendment. If you have any questions about when to submit an amendment or a new application, contact Maria Valente or 604-827-5112. See also item 3 below.
Amendments that involve adding procedures that are not considered minimal risk must be referred to the Full Board for review and approval. To submit such requests via the minor amendment system will create an unnecessary delay for the researcher.
Any changes in the co-investigators (as opposed to research staff) must be accompanied by appropriately updated recruitment, consent, and any other materials given to subjects.
Any changes to documents should be clearly explained in the PAA and highlighted on the attached, revised document. Where the amendment is limited to an 'administrative change' (e.g. changes in granting status, staff personnel, contact person, etc.), please include an explicit statement to the effect that the research procedures (including recruitment, consent, etc.) have not been changed in any way.
The following questions should be considered when proposing an amendment:
- Does the amendment affect the risk/benefit ratio?
- Does the amendment affect recruitment? If so, is a revised recruitment ad or letter attached?
- Does the amendment affect what the subject is asked to do or confidentiality of the data? If so, is a revised consent form attached?
- Does the consent form adequately reflect the change in time, risk, or confidentiality?
When reviewed initially did the BREB have any significant concerns about this study that should be considered when reviewing the amendment?
Briefly explain the rationale behind any changes in the study procedures.
To assist us to speed up the turnaround of amendments and renewals, researchers are requested to consider the following:
- Amendments that involve adding procedures that are not considered minimal risk must be referred to the Full Board for review and approval. To submit such requests via the minor amendment system will create an unnecessary delay for the researcher.
- Any changes in the co-investigators (as opposed to research staff) must be accompanied by appropriately updated recruitment, consent, and any other materials given to participants.
- Any changes to documents should be clearly explained in the PAA and highlighted on the attached, revised document.
- Where the amendment is limited to an 'administrative change' (e.g. changes in granting status, staff personnel, contact person, etc.), please include an explicit statement to the effect that the research procedures (including recruitment, consent, etc.) have not been changed in any way.
- Amendments to studies should be changes within the scope of the original study, not new studies that are simply related to the original study.
- Log into RISe,
- click on the Human Ethics tab to find the home page for the approved study,
- click on the name of the study to open the Home page for the approved study,
- click on New Post Approval Activity (in the upper left hand corner of the page),
- select “Request for Acknowledgement”,
- explain that you are attaching an agency approval,
- Attach a copy of the document in 9.8,
- “Save” and “Exit”,
- click on the “Submit PAA” button in the left hand column, and
- click “OK” on the Declaration page.
A PAA for Annual Renewal should be submitted prior to the expiry date on the current Certificate of Approval. The online database will send two email reminders before the Certificate expires. If the approval is not renewed, on the date of expiry, a notice will be sent to you and to your department head, advising you that the study is expired. You will be given seven days to complete the renewal, after which the approval and the study will be suspended.
FAILURE TO COMPLY WITH REQUIREMENT FOR ANNUAL RENEWAL
Failure to respond within seven days of the date of the notice of expiry will result in the suspension of the Study, and in one or more of the following actions being taken:
- The REB may hold the review/approval of current or future submissions by the Principal Investigator or the Department until the status of these studies has been addressed.
- The REB may be required to notify the funding agency/industry sponsor of the expiry of ethics approval for the study.
- The REB will terminate the ethical approval on the RISe system. Reactivation of the study thereafter will require a new application for ethical review.
After due consultation with the REB Chair and Senior Administration, the funding for the study will be frozen.
Annual renewal is not required if the researcher will have no further contact with participants for the purpose of data collection or research (e.g. for follow-up or verification). Renewal is not required to analyze data or write a paper. Before the Certificate’s Expiry data declare to the REB by completing a PAA “Completion of Behavioural Study” that the remaining research no longer requires certification because all data collection procedures described in the previously approved project have been completed. Article 6.14 of the TCPS states that “At minimum, continuing ethics review shall consist of an annual status report on the research, followed by an end-of-study report”.