Answers

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 MREB Ethics Office for more information and help.

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 MREB Ethics Office is the best way to work out the particular details of your study.

I want to make a (podcast/magazine/webpage) where people can share their views on a topic.  Do I need ethics review?

If you will be analyzing the information these people given in order to answer a research question that you have, then yes you would.  If you are only providing a platform for them to share their thoughts, then you may or may not.  Please contact the MREB Ethics Office to discuss your project and get a final determination.

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.

Is it possible to have my research funds released prior to obtaining research ethics clearance??

The MREB ethics office 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 research ethics clearance. You must submit an ethics application and obtain MREB 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.

Should MREB or HiREB review my research project?

Please review the HiREB or MREB Guide.

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.

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 MREB Ethics Office for advice.

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.

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?

You would complete an 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 MREB 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 MREB 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.

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.

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 MREB 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.

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 MREB Ethics Office for advice.

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 MREB Ethics Office to set up a time.

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.

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.

I have to submit an (Amendment/FIO/Annual Report). Will it take the same amount of time to be approved as the original application?

Amendments, For Information Only (FIO) and Annual Report forms are handled via a different method, and are generally cleared much faster than initial applications.  Please see the review times and submission deadlines page for more information

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)

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.

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 ____

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 MREB 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 MREB Ethics Office with any remaining questions.

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.

If I cannot provide the incentive in-person, what are some remote incentive options?

As giving incentives in person is not an option for research conducted remotely, consider other ways to provide incentives while trying to minimize the amount of identifiable information being collected. The best options are sending electronic gift cards or e-transfer of money. Mail is another option but requires the collection and storage of full mailing address and in some studies with high social risk would not be recommended (e.g. the incentive arriving in the mail could alert someone else in the household that the participant was in the study).

If I cannot get in-person written consent, how should consent be obtained and documented?

Written consent is not recommended for conducting research remotely. Asking participants to print, sign, scan and email back signed consent forms is not only not possible for all participants but adds to participant burden. If signed consent is essential for your project then there could be alternatives such as using mail, e-signatures, or having the participant take a photo of the signed consent form (if printer, but no scanner). However, the recommended alternative is an oral consent process, which is easier for both participants and the researcher.

For oral consent, whenever possible, send a Letter of Information (signature lines removed) ahead of the interview or focus group, and follow up to obtain consent using an Oral Consent Script and document consent on an Oral Consent Log. Use of an Oral Consent Script assumes the participant has had the opportunity to read through the Letter of Information. It allows the researcher to cover the key ethics information at the time of oral consent without having to read the full Letter of Information aloud. In some study contexts or with specific participant groups, working through the full Letter of Information as part of the oral consent process may be preferable to ensure informed consent.

Online surveys or experiments, where the participant follows a link to the Letter of Information/Consent Preamble and the survey/experiment, should continue to obtain consent as before, with participants selecting a “yes” consent button to continue to the data collection or a “no” button to leave the study.

What are the recommended practices for recording online interviews and focus groups?

Moving from in-person interviews and focus groups to phone or online may seem like an easy transition, however, there are several things to consider when completing the ethics application.

• Making the Recording: The most secure way to audio record interviews/focus groups is to record to your computer or device using a recording application that directly records the audio to your hard drive. Another option is to record through the online meeting platform (e.g. Zoom) directly to your computer. For the latter option, you will need to confirm that the platform you are using can record directly to your computer as opposed to the platform’s server or to a cloud service.  As soon as the interview/focus group is finished, the audio file should be saved to a password protected storage device, e.g. computer, external hard drive, and encrypted.  This data security information should be included in the Letter of Information.  A clear consent statement needs to be included on the Oral Consent Script if audio recording.
• Video Recording: Online platforms make it easy to video record a meeting. Video recording should not be used unless it is essential for your research methodology and clearly justified. If you do need a video recording, then this needs to be stated in the Letter of Information and a clear consent statement needs to be included on the Oral Consent Script. Most interviews will not need video recording and in those cases both the Letter of Information and the Oral Consent Script should reassure participants that the interview/focus group will be audio recorded only and not video recorded.
• Attendance: Consider whether participants can choose to join the interview/focus group by audio only, given not all participants may have access to video and there may be limitations to the location from which a participant can join during this time of social distancing. Additionally, in a focus group setting, audio only increases the confidentiality of participation. If audio only is not an option, this should be clear in the Recruitment and the Consent materials.

What steps do I need to take to protect participant confidentiality and data when conducting phone and online interviews/focus groups?

The following should be considered and addressed in your ethics application if applicable.

• High-Risk Studies: If you will be collecting highly sensitive data and/or there is a significant social risk for participants if their data was disclosed or it was known they participated in your study, please contact mreb@mcmaster.ca for advice on how to proceed. Most of the available online services or a standard phone connection are appropriate for low- to moderate-risk studies, but higher risk studies may need a more secure option.

Does McMaster University have any official guidance on the use of online meeting/voice calling platforms?

Currently, Information Technology has posted a guide to best practices for privacy and security when using Zoom video conferencing. There is also a guide to creating a secure work-from-home environment, which could be useful for researchers having to switch to handling data at home that they would normally only work with on campus.

Please contact the MREB Ethics Office if you have any questions about the above or have a question not covered in this FAQ – mreb@mcmaster.ca.

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)

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.

Does “Anonymized” mean the same thing as “De-Identified”?

While these two terms may be used interchangeably in other settings, they mean different things when it comes to a REB application.  De-identified data is data that doesn’t have identifiers (names, emails, birthdates) attached directly to the data.  However, it may be possible that you still have a study key, a consent log, or another way to reconnect the person back to their data.  In that case, the data is not anonymized.  Data cannot be called anonymized until any way to reconnect the person to their data has been destroyed.