Answers

Should MREB or HiREB review my research project?

Please review the HiREB or MREB Guide.

How long does the ethics review process take for the McMaster Research Ethics Board (MREB)? Does the MREB have a submission deadline?

The vast majority of projects submitted to MREB (>95%) are considered minimal risk and qualify for delegated review, meaning they can be submitted at any time.  The submission deadline is only relevant for ethics applications that are greater than minimal risk and require full board review at a monthly MREB meeting.  Please see the review times and submission deadlines page.

Where do I get the application form and who do I submit it to?

MREB has transitioned from Word-based forms to MacREM. The McMaster Research Ethics Manager (MacREM) is the web-based system to submit, review and track research ethics applications. It is the online system for the McMaster Research Ethics Board (MREB). You can log into MacREM with your MacID.

Are there any sample applications or templates I can see or use?

The McMaster Research Ethics Board website does not have examples of applications, but the Templates page in MacREM does have many samples and templates of supporting documents (e.g. Recruitment Scripts, Letter of Information) that you may use and alter for your study.

Where can I get help completing my application form?

The ethics staff are available by email or telephone to answer questions. MREB staff are also available by appointment if you need one-one consultation. It is advisable that students work with their supervisor before submitting the application.There are several recommended online tutorials that are very useful in learning about Canada’s ethics guidelines. Gaining familiarity with the Tri-Council Policy Statement (TCPS) can be very useful when you do your research because, ethics isn’t a form, it’s a process.

Is there anyone who can come and speak to my class about research ethics?

Yes. A Research Ethics Advisor, and/or the Chair of MREB, would be happy to accept an invitation to make a presentation or speak to your class about research ethics. Please contact the Ethics Office to set up a time.

I have obtained funding and need ethics clearance for the funds to release. A phase of my research involving human participants will not begin for another year. Can money for start-up release in advance?

MREB has a Conditional Release of Funds form that you can submit to explain that you are not ready to begin data collection from human participants, but need your funds released for planning and administrative purposes (e.g., paying staff, developing the project).  The conditional release of funds is good for one year, with option to extend if necessary.The conditional release of funds is not an ethics clearance.You must submit an ethics clearance before the recruitment of research participants or receiving secondary use data from the data custodian.

To create a Conditional Release of Funds form, you would log into MacREM https://macrem.mcmaster.ca/ using your MacID and ‘Create a New Project’. For question 1.2 you would select Conditional Release of Funds Application and complete the short form. The form asks for basic administrative details about the project and for the reason the funds need to release before MREB clearance.The Research Ethics Officer will check the form and issue the conditional release of funds approval

Once you are ready to seek MREB clearance for the project, you can go back into your cleared Conditional Release of Funds application and change the answer to question 1.2 to Standard MREB Application.  This will open up the full application form for you to fill in and it will keep the same MREB number that is on file with ROADS with your funding.

If you need more help with this process, please contact the MREB Ethics Office.

I am a co-investigator at McMaster who has colleagues at other universities. Where do we get ethics clearance first?

The best process is for the principal investigator (PI) to first obtain ethics clearance at his or her home institution as the first step. If you are not the PI, then once the PI has clearance at their home institution you can submit the application form “Application for a Project with External REB Clearance” in MacREM. As part of completing this form we will ask you to include the PI’s cleared application package (i.e., application form and supporting documents) and the external REB’s clearance letter or clearance certificate. Most of these applications have a shorter review process when reviewed by the MREB Chair or Vice-Chair.  If the home institution is outside of Canada, please send the externally approved application form to the MREB Ethics Office to confirm that the External Application is the correct form to use.

How can I make a change to my research that MREB already cleared?

You will need to submit an Amendment Form, or in some cases a For Information Only Form, through the MacREM system. You can go to the original project application in MacREM and then use the action “create sub-form.”

Should I use an Amendment or For Information Only subform?
There is an explanation on the top of the form (Screening section) about what kinds of changes can be submitted on the For Information Only form as opposed to an Amendment form.
If you are ONLY making administrative or other minor changes that do not substantively alter the currently approved protocol and documents, then you may be able to submit a For Information Only subform to document the change, instead of an Amendment. The For Information Only form is only reviewed by the Ethics Secretariat staff to confirm the change does not require an Amendment form and ethics review. If you are unsure which form to use, please contact the MREB Ethics Office.
Some examples of changes that may only require a For Information Only form include:
• Change to study title
• Change to investigator information
• Update of funding status
• Reporting clearance from other REBs
• Change to level of project
• Updating an open-ended interview guide (in certain cases, see TCPS, Art. 10.5)
• Minor or administrative changes to the Letter of Information or other study documents (e.g. new contact information, changing wording for clarity or to address typos/grammar, removing a survey question)

I’m going to do some unfunded human participant research during my sabbatical year in another country. I’m only asking a few questions. Do I need ethics clearance?

Yes, University policy and the TCPS requires that funded or unfunded research carried out with human beings, their tissue or their records in Canada or elsewhere must have ethics clearance before your research can begin. Contact the Ethics Office for more information and help.

I am teaching a course that will have student projects involving research with humans. Can I submit one application for the entire class?

Yes. There is a separate MacREM application form for instructors who teach undergraduate and graduate courses where students engage in minimal risk research projects with human participants. Please see our Guidelines for Course-based Research.  When you create your application in MacREM, select “Course-Based Application” for Question 1.2.

Feel free to talk with the ethics staff about your course projects. Remember that because different instructors set different projects for their students, course-based clearance is granted to the instructor of each course.

Do I need to read the Tri-Council Policy Statement (TCPS)?

It is valuable to become familiar with the TCPS, Canada’s national research ethics policy, and the one that Canadian universities, colleges and hospitals have adopted as their guidelines for research with humans. The Panel on Research Ethics offers a collection of its responses to requests for interpretation of the TCPS2 and has released a new free online  Course on Research Ethics (CORE) tutorial. Please contact the ethics office if you have any questions.

Do I need to take the Panel on Research Ethics “Course on Research Ethics” (CORE) online tutorial?

At the present time, the McMaster Research Ethics Board (non-medical board) does not require researchers to take the CORE online tutorial. Though, many course instructors do make it mandatory for their students.

Do I need to give participants an information letter and consent form?

The Tri-Council Policy Statement (TCPS) outlines many ways to get informed consent. A signed written consent form may not be the ideal method for obtaining consent in all situations. Oral consent is an appropriate and sometimes more respectful and secure way to get consent in some situations. All studies need to document consent, and most studies do ask participants to read and keep a letter of information.

I hear that MREB has Student Research Ethics Committees (SRECs) that review undergraduate research. What form do I use and to which SREC do I submit my application?

SRECs review minimal risk undergraduate research and Course Instructor applications. Log into MacREM to create and submit a Standard application. The Research Ethics Office will determine whether the study is appropriate for review by a SREC.  If your department, school, or program does not have their own SREC, The McMaster Research Ethics Board, or another SREC, will review your study.

If I am applying for a grant, when should I submit my ethics application?

If you are applying to a one of the Tri-Council funding agencies (CIHR, NSERC, SSHRC), or to another funding agency you can submit your ethics application once the award has been granted.

I will only be doing naturalistic observation or interviewing close friends or family. Do I need ethics review?

If you plan to do naturalistic observation in a public place that does not allow for the identification of the participants, isn’t staged by the researcher and is non-intrusive, ethics review is not normally required. If you are interviewing friends and family, even self study, as part of your research you need ethics clearance. Consulting with the Ethics Office is the best way to work out the particular details of your study.

I’m part of a small group of students who are going to do some research with human participants. Do we use the standard application form or can our instructor submit a course application on our behalf?

It depends on the project. The instructor can submit a course application for similar minimal risk student projects that he/she has set as part of a course assignment to learn about research ethics etc. If you are proposing a separate project and one that poses greater than minimal risk then you and your fellow students need to submit the standard application form. Get in touch with the Ethics Office for advice.

I would like to do a research project in the local district schools but I don’t know the procedure for doing so.

Before you can do research in local district schools, you will need ethics clearance from the MREB first. Once obtained, you must apply to the school board’s Research Review Committee (RRC) where you plan to conduct your research. School boards will not permit access to their schools or students without these clearances. Because you need to go through an extra review process make sure you leave enough time to get both clearances. Contact the Ethics Office for advice.

As a researcher, I would like to know how best to obtain consent to record an interview?

There are different ways to lay this out and you do not need to use the exact wording, but you should make sure you explicitly offer the choice to have the interview recorded. With the increase in use of online videoconferencing platforms, it is also important to explain whether you will record audio only, or record audio and video. This insures that the interviewee has a moment to think about their choice and that you have documentation of their consent to recording. On the consent form, before or after the place for the signature of the participant, you can ask two questions:

I agree to participate in the research study by participating in a research interview. Further,
A) I agree to audio recording of the interview ____
B) I agree to audio and video recording of the interview ____
C) I prefer that the interview not be recorded ____

What do I do to make sure my study continues to remain cleared by the MREB? How about if my study is complete and I want to close it?

All studies that received an ethics certificate need to complete an annual report. 4-6 weeks before the anniversary of your clearance we’ll send you a friendly email reminder along with a link to an easy to use electronically-based annual project status/study completion form that takes a few minutes to complete. This makes it easy for you update us on your study’s status; if you are still collecting data, or if your study has completed. Completing the annual report ensures compliance with university policies and funder’s requirements and if your research is funded, there won’t be any interruption in the flow of funds.

What are the most common research ethics acronyms used at McMaster?

• McMaster Research Ethics Board (MREB)
• Tri-Council Policy Statement 2nd edition 2010 (TCPS2)
• Student Research Ethics Committee (SREC)
• Panel on Research Ethics (PRE)
• Institutional Review Board (IRB) (United States)
• Letter of Information (LOI)
• Consent Form (CF)
• Hamilton Integrated Research Ethics Board (HiREB)

The REB at my former institution cleared my research project. What do I do about ethics clearance now that I’m at McMaster?

You must submit an ethics application via MacREM. In this case you would submit the “Application for a Project with External REB Clearance” in MacREM. As part of completing this form we will ask you to include the cleared application package (i.e., application form and supporting documents) and your former REB’s clearance letter or clearance certificate. Most of these applications have a shorter review process when reviewed directly by the MREB Chair or Vice-Chair.

If your research is funded and you are moving funds to McMaster, contact the Research Office for Administrative Development and Support (ROADS) staff to tell them you are working on obtaining clearance at McMaster.

When you receive your McMaster ethics clearance certificate, send a copy to ROADS. Contact MREB with any remaining questions.

When I started my research project (funded or unfunded) I didn’t intend to collect data from humans, (or use their biological material, or access their records), but now I want to? What should I do?

Please contact the Ethics Office especially if you haven’t done human participant research before, to get some helpful advice

You must submit an ethics application via MacREM and obtain clearance BEFORE you collect any human participant data.

If your research is funded, contact Research Office for Administrative Development and Support (ROADS) staff and inform them that you are changing your research & will be requiring human ethics clearance. Once you receive McMaster human ethics clearance. Email the Assistant Director of McMaster Research Finance with your protocol number (e.g. 2012-000) after you have received clearance from MREB.

Please contact the Ethics Office with any remaining questions.

I’m a co-investigator on a study that will have a human participant component (humans, their biological material or their records) and the Principal Investigator (PI) is at another institution. I understand that ethics clearance will be obtained at the PI’s institution. What do I do about ethics clearance?

Application for a Project with External REB Clearance” in MacREM. As part of completing this form we will ask you to include the cleared application package (i.e., application form and supporting documents) and the external REB’s clearance letter or clearance certificate. Most of these application have a shorter review process because the MREB Chair or Vice-Chair directly reviews them. The PI for the project needs to sign the application form in MacREM. They can contact the ethics office to get a temporary MacID to access MacREM.

If your research is funded, contact Research Office for Administrative Development and Support (ROADS) staff to inform them that you applied for and you are awaiting human ethics clearance at McMaster.

When you receive your clearance from MREB, send a copy to Research Office for Administrative Development and Support (ROADS) if there will be a transfer of funds from the PIs institution to McMaster to cover your part of research.

Please contact MREB with any remaining questions.