Post-Clearance of Research Ethics Application and Conducting Research

Statement

The information included in the FAQs listed below is for researcher information and guidance purposes only. Each research study poses unique properties and/or situations that may require additional or different guidance than what is presented. The information throughout this forum is meant to provide general situational advice and does not constitute research ethics compliance in absolute form. If you have any questions or need further guidance, please contact ethics@msvu.ca.

The development of these questions was aided by MSVU’s Research Ethics Board (REB) and information from publicly available documents at Canadian Universities, such as Carleton University, Queen’s University, and Dalhousie University.

1. How long do I have research ethics clearance for?

UREB clearance is granted for one (1)-year from the initial clearance date. Researchers who are continuing their study beyond this year must submit REB.FORM.003 (Annual Report/Request for Renewal) prior to the expiry date. This report must be filled out every year that the study is continuing*.

*Researchers may, with submission of the Annual Report/Request for Renewal, renew their research ethics clearance for up to four (4) additional years (original clearance +4 annual renewals). After five (5) years, the researchers must re-apply to the UREB for review/clearance. This review will be expedited wherever possible.

When the study is complete, researchers must submit REB.FORM.004 (Final Report).

2. Who on my research team should have access to the research ethics application once it has been given UREB clearance?

The research ethics application outlines the major objectives, procedures, and goals of the study. It should be paramount that all managers, coordinators, team members, and volunteers review the cleared research ethics application before collecting data with participants.

This will further help undergraduate and graduate students, as well as new researchers, to learn how to best complete a research ethics application while ensuring the highest ethical standards are being demonstrated throughout the entirety of the research process.

3. What if I experience an unanticipated or adverse event, or a privacy breach, during the research process?

Unanticipated issues and problems include those that may increase the level of risk to participants or affect participants welfare, and not anticipated by the Researcher in the research ethics proposal. Unanticipated problems further include those that are unexpected, related or possibly related to participation in the research, and places research participants or others at a greater risk of harm whether physical, psychological, economic, or social. This could include adverse events. If an unanticipated event arises during the research process, please submit REB.FORM.008 (Unanticipated Research Event).

An adverse event is any untoward medical occurrence or serious non-medical occurrence in a research participant, who has been administered investigational product, including an occurrence which does not have a causal relationship with the product. A local adverse event includes experiences by research participants enrolled by the researcher at the centre under the authority of MSVU’s REB. A non-local (external) adverse event includes experiences by research participants enrolled by researchers at other centers or organizations, external to MSVU REB’s authority. If an adverse event occurs, please submit REB.FORM.007 (Adverse Event Report).

Please contact the Research Ethics Office at ethics@msvu.ca if you have any questions or concerns, and if you are unsure of which form to submit.

A privacy breach is the unauthorized collection, use, or disclosure of personal information or personal health information. If a privacy breach has occurred, researchers are required to immediately submit REB.FORM.015 (Privacy Breach) and REB.FORM.008 (Unanticipated Research Event).

 

For additional clarification of terms, please review REB.INFO.001 (REB Glossary of Terms).

4. Am I able to change or make amendments to the Principal Investigator after I have been granted research ethics clearance, during the research process?

Researchers can make amendments to MSVU faculty or staff Principal Investigator (PI). Please submit REB.FORM.021. This form can be used regardless of the current stage of research.

This form can only be used for MSVU faculty or staff PI changes.

5. What happens when my study, or my student's study, is completed?

All research that has received UREB clearance must submit REB.FORM.004 (Final Report) once the study has concluded. The UREB is unable to close the research ethics file for the study without this report.

6. How long should I keep my data once the study is complete? Should my participants be aware of this?

Regulations and best practices for data retention vary and may depend on funding agency, nature of the research, publication requirements or the deposit/sharing or future use of research data  i

All researchers should clearly define data retention, destruction, sharing, and deposit requirements in the consent form. It is good practice to inform participants in the consent form whether data may be transferred from MSVU-affiliated database to another professional or personal database.

For additional guidance, please review REB.INFO.503 (Sensitive Data).