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CBU Application for Review of Research Involving Humans: Instructions

Please note this document is for drafting purposes only. CBU REB Applications must be submitted through the CBU REB Form. Please visit https://www.cbu.ca/research/research-ethics-animal-care/research-ethics-board-forms/ for updated information and instructions. This drafting document is accurate as of November 12, 2017. Do not submit this document to the CBU REB. It is for informational and drafting purposes only.

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We recommend that the answers to this form be saved into a separate document, as you will not be able to re-edit this application once completed.

Once completed, however, you will be given the chance to Save and/or Print this completed application for your records. Please ensure that the application is complete.

Please allow 2-4 weeks for the application process; with the caveat that incomplete applications will be delayed. During the summer wait times can be longer. SSHRCwelcomes applications involvingAboriginal research, as well as those involvingresearch-creation.

1.  Type of Application

New: Project has not been submitted to the REB previously.

Resubmitting: Project was previously submitted to the REB but not approved

Renewal: Project was previously approved by the REB in the last year and the applicant is looking to extend the same project.

2.  Researcher Preparation

Confirm that you have consulted and undertake to comply with the TCPS 2 (2014)— the latest edition of Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans

3.  Administration Information

Project title: Include a title for your research project.

Student application: Indicate if the student is the principal investigator.

Funding

Describe the amount and source of any funding you have received for this project and/or describe the amount and source you plan to apply for in the future.

If you have received funding from an institutional body that requires proof that you have received ethics, please forward your approval letter to once you have received ethics clearance from the CBU REB to have your funds released.

Student Applications Only

Research Project Type

This research project is for: (select one from the dropdown menu provided)

Course: This project is part of your coursework*

Student Thesis: This project is part of a student research thesis

Other: This project is not for course work or a student research thesis

*Indicate course code if you select this option.

Supervisor

Include the name of your supervisor. If your project is for a course, please indicate your instructor’s name here.

Supervisor’s Institutional Home

Indicate the University and Department your supervisor is primarily housed in. For example, if you are a student in the CBU MBA program but your supervisor is housed at another university (e.g University of Toronto, Department of Political Science) then please include University of Toronto and not Cape Breton University.

Supervisor’s Contact Information

Include your supervisor’s work phone number and email. Please note all correspondence with CBU ethics will be cc-ed to your supervisor.

Supervisor’s Approval

Please ensure that your supervisor has read and approved your ethics application before moving forward.

Completion of TCPS 2 Core Tutorial

Confirm that you have completed the TCPS2 Core Tutorial. All applications should have the proof of completion certificate attached to this application.

4. Information of Applicant/Principal Investigator

Applicant/Principal Investigator Information

Please include your information including, name institution, phone number and email. If the research project is comprised of more than one member, please select one member to be the principal investigator. All correspondence with the REB will be with whomever is identified as the principal investigator.

Co-investigators’ names and affiliations

If the research project includes more than one researcher, include the other names and their affiliations here.

Start Date

The date you plan to start the project. Please note, research involving humans cannot begin before ethics approval has been granted.

End Date

The estimated end date for the research project. Please note, ethics approval covers one year. Researchers are required to submit a renewal form if they wish to extend their project beyond the initial one year.

Research Involving Humans

Check the box to state that “I understand that research involving humans cannot begin prior to receiving official ethics approval from the CBU REB.”

5.  Information on Research Project Plans

Summary of Research Project

Provide a summary of the proposed research, indicating clearly the role of the research participants and any procedures to which they will be

subjected. Attach copies of any questionnaires, interview guides or other instruments with your application.

Statement on Risk

Please review the statement on minimal risk from the TCPS2:

“For the purposes of this Policy, ‘minimal risk’ research is defined as research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in those aspects of their everyday life that relation to the research.

In this assessment of the acceptable threshold of minimal risk, REBs have special ethics obligations to individuals or groups whose situation or circumstances make them vulnerable in the context of a specific research project, and to those who live with relatively high levels of risk on a daily basis. Their inclusion in research should not exacerbate their vulnerability.”

Check the following options

§  I believe that this project meets the criteria for minimal risk

§  I believe that this project meets may be, or is, above the threshold for minimal risk

If your research is “Minimal Risk fill out the following

§  Identify potential risks. Please describe any provisions you will put in place to minimize risk, to ensure the safety/well-being of participants, and to handle any harm that participants may experience.

If your research is “Above Minimal Risk fill out the following

§  Identify potential risks. Please describe any provisions you will put in place to minimize risk, to ensure the safety/well-being of participants, and to handle any harm that participants may experience.

§  If your research involves more than minimal risk, describe the measures to you propose for facilitating continuing review of this research, during the entire course of the project.

6.  Benefits and Purpose

Identify the Benefits + Purpose

What is the benefit of this research? What new knowledge is anticipated as an outcome of this study?

7.  Statement on Research in Aboriginal Contexts, in Health Fields, in School

Read the following on Chapter 9 of the Tri-Council Policy Statement which deals with research in Aboriginal Contexts. All researchers working with aboriginal communities or participants in Canada or internationally need to be familiar with this chapter.

In addition, researchers working in Nova Scotia with the Mi’kmaq community should be familiar with MEW procedures.

Researchers are reminded to show evidence of a research agreement or community consultation prior to submitting their project to the CBU REB.

§  A reminder that researchers doing work in the health field may also need approval from the Nova Scotia Health Authority

§  A reminder that researchers doing work in the school board may also need permission/approval from the CBVRSB or equivalent

It is the PI’s responsibility to understand what jurisdiction their research may fall under and seek appropriate ethical clearance.

8.  Information on Research Participants

General Information

§  How many research participants to you anticipate?

§  Who are the research participants in your project? How will they be recruited, and from what population? Be as specific as possible. Please attach any recruitment materials (emails, posters, etc.) that you plan to use.

Competency of Research Participants

The TCPS2 does not state an age of consent for research; it is up to the researcher to consider age of majority where they're doing research, the nature of the research, the capacity of their participants, and the question of assent/dissent when designing the consent process for their projects.

Select all that apply:

§  Children

§  Youth (16 – 18 – mature minor)

§  Participants (children/youth/adults) who may lack decision-making capacity

§  Adults (19 or older)

Please describe how you plan to handle parental/guardian consent, and/or assent/dissent of children, youth, or adults who may lack decision-making capacity.

Deception

§  Does this research involve deception or partial deception?

§  Provide an explanation of how/if you plan to debrief participants (Article 3.7A and B). Describe as well the expected benefit resulting from this deception, justifying waiving of the normal requirements for full disclosure.

Inducements

Inducements could include anything from providing bus fare to participants, to offering pizza at a focus group, or beyond.

§  Will any inducements be offered to encourage participation?

§  Please describe the inducements and how they will be handled.

Informed Consent

Please see the CBU Informed Consent template, available on our website.

§  Will informed consent be sought from all participants?

§  Will you be seeking oral or written consent?

§  How will the aims of this research be explained to potential participants? Attach a copy of any documents used for this purpose.

Duty to Disclose

Researchers are reminded that both the Tri-Council and the government of Nova Scotia (or whatever province or territory you’re working in) have specific rules relating to the duty to disclose suspected or alleged abuse or neglect of a child or adult in need of protection. CBU's Informed Consent Template contains language on the Duty or Disclose.

§  By checking this box I confirm that I am familiar with both the Tri-Council and the local rules and procedures on the duty to disclose: “I confirm that I am familiar with both the Tri-Council and the local rules and procedures on the duty to disclose.”

§  If you anticipate that children or vulnerable adults may disclose abuse or neglect in the course of participating in your research project, please describe your plans for handling this.

9.  Privacy

Privacy during data collection, dissemination, and storage

§  Will complete anonymity of participants and data be maintained?

§  Will complete confidentiality of participants be maintained?

§  Describe how issues of privacy (e.g. identifiability, anonymity, and/or confidentiality) will be handled at all stages of the research.

§  Where possible, describe plan/process of destroying the data.

Follow-Up: Feedback, Final Reports, and Extensions

All research requires a brief report upon completion of the research. Suitable report forms are found on our website.

Brief Annual Reports are required for extended studies. Suitable report forms are available on our website.

Attachments: Research Documents

Please attach, by email, any research documents, including, where possible: Informed Consent, Questionnaires/Research Instruments, recruitment tools, etc.

* Please click "Print Form --> Save as PDF" prior to submitting your application. Keep a copy for your records.

* Students must have their supervisors read and approve the application prior to submission to the REB. NB: Supervisors will be cc'd on all communications with the researcher.

By hitting 'Submit', your application will be sent directly to , where it will be processed by staff in the Office of Research and Graduate Studies.

A copy of your submission will be sent to the email you have provided.

Reviewers are given two weeks to review applications.

You should anticipate between 2-4 weeks for the REB process in the case of most applications.

You should receive a confirmation that your application has been processed 72 hours after you have submitted. If you do not receive a reply, please contact .

Good luck with your research!