Pre-Submission of Research Ethics Application

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. If I have research ethics-related questions, or need to submit a research ethics application or other protocol documents, who should I contact?

All research ethics inquiries surrounding your potential or ongoing research study, including applications, supporting documents, and/or continuing research ethics forms should be forwarded to MSVU’s Research Ethics Coordinator, Brenda Gagne, at ethics@msvu.ca.

Research ethics forms and applications can be found here, while policies, procedures, and guidelines can be found here and are updated on an on-going basis. Researchers are reminded that the MSVU REB website holds the most up-to-date versions.

2. Do I need to submit a research ethics application when dealing with human participants?

All research involving human participants (or their data) must seek REB clearance before recruiting or interacting with human participants. This includes the secondary use of de-identified participant data. Before submitting your research ethics application or exemption request, please review the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) and complete the TCPS 2: CORE-2022 (Course on Research Ethics).

For more information on which research activities require REB clearance please review question five (5) of this forum on possible exemptions and review REB.SOP.102. Please contact the Research Ethics Office at ethics@msvu.ca if you have any questions or concerns.

3. Why do I need to submit a research ethics application when dealing with human participants?

The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS instills federal policies and guidelines of three (3) federal granting councils (CIHR, NSERC, and SSHRC) for research with human participants or their data. As such, the UREB ensures that research carried out by MSVU researchers or research involving members of the MSVU community adheres to these policies and guidelines.

Following these policies and guidelines through the UREB allows the MSVU research community to apply and receive Tri-Agency funding. Furthermore, the TCPS and resulting documents created and upheld by the UREB ensures the highest protection for research participants, researchers and their constituents, and the overall institution.

Failure to fulfill the requirements of the TCPS, by the researcher or the institution, may result in recourse by the Agencies, as set out in the Tri-Agency Framework: Responsible Conduct of Research (2021).

4. If I have research ethics clearance through another institution, do I need MSVU research ethics clearance as well?

All research with human participants or their data that is conducted under the auspices of MSVU, either at or affiliated with MSVU, must be granted MSVU REB clearance before recruiting, interacting with, or collecting data from participants. For example, a collaborative study between MSVU, Dalhousie University, and the IWK Health Centre, normally must be reviewed and cleared from all three (3) participating institutions before recruiting and interacting with participants.

If a MSVU researcher requires research ethics clearance and/or has already been granted clearance from another Canadian institution, hospital, or health authority for their study, the researcher would then submit REB.FORM.010 for MSVU REB clearance. If a MSVU researcher requires research ethics clearance at a hospital or health authority for their study, the researcher should obtain clearance from that location prior to submitting the application to the MSVU REB.

5. I do not believe the study I want to conduct requires UREB clearance, what should I do?

There are select instances where UREB review and clearance may not be necessary. This could include research relying exclusively on publicly available information, the observation of people in public places, and overall, where there is no expectation of privacy. However, with the continual rise of accessible information through social media, it is important to understand the terms of service of each site being assessed, understanding users’ expectation of information they post, laws and regulations where the research is being conducted and/or the geographical location of where information is being taken, and the limitations of what is public and private domain.

Please review TCPSChapter 2: Scope and Approach for more information and additional guidance. Please contact the Research Ethics Office at ethics@msvu.ca if you have any questions, concerns, or need additional guidance on the appropriate form/application of your potential research study.

If you believe the study does not require UREB clearance, please submit REB.FORM.016 (REB Exemption Request).

6. How do I know whether my study is minimal risk or exceeds minimal risk? If my study exceeds minimal risk, do I have to do anything different for a full-board review?

Most research studies reviewed at MSVU are minimal risk; however, it is dependent on what the study is asking of participants to during data collection. For example, studies utilizing deception or stress inducing manipulations are typically regarded as exceeding minimum risk.

Although not all studies exceed minimal risk based solely on the participant population one is working in, researchers should use caution when conducting research with children, marginalized and Indigenous communities, and those who feature diminished cognitive capabilities and/or are physically incapacitated.

If a study is deemed to exceed minimal risk and a full-board review is needed, you do not have to prepare or send any additional documents. Please review REB.SOP.408 (Full Board Review) and REB.SOP.401 (Delegated Review) for additional guidance.

7. Do my participants need to sign a written consent form?

A written consent form that requires research participants signature before participation in any research-related activities is one of the most common means of documenting the consent process and signed consent is normally the default. However, there are select instances where a range of procedures to gain consent may be more appropriate. The consent process is dictated by the study, respecting diverse cultural traditions and practices, and ensuring that written consent before participation does not create barriers between the researcher and participant.

Alternatives, as derived from the TCPS, include oral consent or verbal agreement, a handshake, or the exchange of gifts, among others. Please review Article 3.12 of TCPS Chapter 3: Consent Process and Article 10.2 of TCPS Chapter 2: Qualitative Research.

If written consent is deemed to be inappropriate, alternative processes must be included in the research ethics application. The onus is on the researcher to provide sufficient details and justification to the UREB. Please review REB.SOP.701 (Free and Informed Consent) and REB.SOP.703 (Consent Updates and Ongoing Consent).

8. Do lab volunteers need to be included as team members in the research ethics application?

As each study is unique, so too are the roles of team members and volunteers. Whether a lab volunteer is listed on the research ethics application or not, depends on their access to participants and/or their data. The role they play throughout the research study may require them to be listed in the research ethics application.

All team members and volunteers, whether specifically included in the application or not, must complete CORE Tutorial training, and it is highly recommended for everyone to have completed WHMIS. CORE Tutorial certificates must be included in the research ethics application. Other training may be appropriate for team members and volunteers, depending on the specific study.

Please contact the Research Ethics Office at ethics@msvu.ca if you have any questions or concerns about how best to include team members and volunteers in the research ethics application, and for other possible training modules.

9. I would like to use secondary data that has been de-identified. Do I still need research ethics clearance for this?

UREB clearance is required when using secondary data that has been de-identified. The overall goal is to protect the original participants and their data. For guidance on when UREB clearance is required for secondary use of de-identified data, please review Article 2.4 and 2.5, Section D of Chapter 5, and Section C of Chapter 12 of the TCPS.

If a researcher is planning to use secondary data, please submit REB.FORM.005 (Secondary Use of Data) for UREB clearance.