MREB Guidance Document

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Section 17	Section 18

General Tips 

• Researchers should refer to those taking part in their studies as “participants” rather than “subjects”, unless there is a clear theoretical justification for using “subjects”. 
• The researcher should avoid uploading duplicate copies of materials.  Often this is a sign that you’ve put two items together (consent form and survey, for example).  These should be separated out and each piece put in its proper place. 
• Please carefully proofread your responses for typos/incomplete sentences. Also review your supporting documents for readability and format. Avoid run-on sentences or incomplete sentences. 
• If using templates, ensure you’ve deleted all instructions to researchers and filled in all placeholders 
• All acronyms must be written out in full the first time that they appear in the application form, recruiting materials and consent materials (unless it is obvious that everyone who receives it knows what it means) 
• Use clear names for all files. The file name should reflect who and what the document is for, for example, Interview Guide_Faculty, Survey_students, Recruitment Post_workers, Recruitment Email_CEO 
• Use precise language – avoid statements along the lines of “we will use cloud-based storage such as MacDrive” – the exact system to be used is required. 
• Ensure that all participant-facing documents are written at an appropriate reading level.  For example, you would need simpler language for English as second language participants than you would for university professor participant.  You also want to avoid using lingo that may not be known by potential participants. 

Section 1 – Screening

1.1 This first screening question determines whether you should proceed with an application to the McMaster Research Ethics Board (MREB) or if you should instead apply to the Hamilton Integrated Research Ethics Board (HiREB). 

• Please see https://research.mcmaster.ca/home/support-for-researchers/ethics/hireb-or-mreb/ for guidance on this matter. 

1.2 What kind of research ethics application do you wish to create? Click on the info button for an explanation of each application type. 

• Most applications will be “Standard MREB Application”, particularly if they are student applications 
• “Conditional Release of Funds Application” can be used to release funds for research activity that does not involve human participants.   
• “Instructor’s Course Based Application” is to be used by faculty members who are running a course in which students are expected to undertake a research project. 
• “Application for a Project with External REB Clearance” is used when the study’s main site is elsewhere, but a McMaster faculty, student or staff is involved, or when there will be active recruitment at McMaster 

Conditional Release of Funds Application  

• The Conditional Release of Funds is not ethics approval. It allows your research funds to be released to allow non-participant related activities, e.g., hiring an RA to prepare the ethics application. 
• You must complete a full MREB application before you interact with participants or obtain secondary data from the data custodian.   
• You can and should use the same project for the Conditional Release of Funds and the Standard Application – when ready for the full application, you would return to this question and change the answer to “Standard MREB Application” 

1.3 Is this a post-doc, graduate or undergraduate student project? If so, the Faculty Supervisor’s contact information will be requested and the Faculty Supervisor must sign the application prior to submission. 

• There are times when projects can be considered both faculty and student projects.  In those situations, you will have to decide who the lead is – who takes ultimate responsibility for the way the study is run, or who might be the first author. If the research is for a student’s independent research or thesis, then check “yes” to open the contact fields for Faculty Supervisor AND Student Principal Investigator.  

1.4 Please select the status of your application 

• If you received an email that said, “Review Comments from the Chair”, check the first option. 
• For your initial submission or if you received an email that said, “Comments from the Ethics Office”, check the second option.   

1.5 Upload the document summarizing your revisions below. Only upload the summary document here, as revised supporting documents (e.g. letter of information) should be uploaded in the appropriate section of the form. 

• If you’ve chosen to make changes outside of what the Chairs have asked for, please also include a description of the changes and a reason for making them. 
• Please be sure you’ve followed the instructions about your response document – failing to do things such as copy the reviewer’s comments may slow down the review process, or lead to your application being returned to you. 

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Section 2 – Contact

2.1 Faculty Supervisor (for PhD, MA, Undergrad Student PI lead projects) 

2.3 Student Principal Investigator 

2.5  Principal Investigator 

• If the project is a collaboration of two students, one student will need to be chosen as the lead student for this application.   
• Sometimes students have co-supervisors.  In those cases, one supervisor should be chosen as the lead supervisor and listed in 2.1.  You can clarify that they are co-supervisors in 2.15. Also indicate in 2.15 if both Supervisors can sign the Faculty Supervisor section of the signature page. 

2.7  Are there any Co-Investigators? 

2.8  Are there any Collaborators? 

• It can sometimes be difficult to determine the distinction between co-investigators and collaborators 
• If your research is funded by a grant, you should use the same co-I/collaborator titles as used in the grant 
• Otherwise, please consider the contributions that each researcher will make to the study.  
• Those with access to the raw data should be listed as Co-Investigators and listed on the LOI/consent so participants will be able to know who will see their information. 
• If your Co-Is/collaborators are affiliated with other institutions, you may need to obtain REB clearance from those institutions.  Please see Section 5.  If clearance is required, remember to submit a For Information Only (FIO) form to share the clearances with MREB when they become available. 

2.9  Are there any Research Assistants or Coordinators? 

2.10  Are there any Student Investigators? 

• At times, it may not be clear if a student RA should be listed a Research Assistant or a Student Investigator 
• If a student will be using the study data to satisfy any educational requirements, then they should be listed as a student investigator.   
• Please remember to submit For Information Only (FIO) forms when research assistants and student investigators join or leave the research project. 

2.15  Additional information about the research team (e.g., students or research assistants to be brought on later, this study includes co-supervisors or co-PIs who can both sign the ethics forms, etc.) 

• This question can be left blank if there are no comments to be made.

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Section 3 – General Information

3.4  How would you describe the research activity conducted in this protocol to a lay person unfamiliar with your discipline’s methodologies and jargon? (max 250 words)? 

• Very rarely, researchers will try to submit one application that should actually be two projects.  If your project has two different study objectives and different datasets, please speak to the MREB office for clarification 
• Please ensure that the lay summary is truly designed for non-specialists and the general public. If in doubt, please review our plain language guide: https://macrem.mcmaster.ca/Personalisation/DownloadTemplate/53 

3.5  What is the date you plan to begin recruiting participants?  Or, for secondary use of data, what is the date you plan to receive the dataset? 

• Please note that regardless of what start date is listed, you cannot begin your research until clearance is received 

3.6  What is the estimated last date for data collection with human participants? 

• Please ensure that the end date listed will give you enough time to collect your data. 

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Section 4 – Funding

4.1  Is this project currently being funded? 

• Ensure that all funding sources are acknowledged here. The MREB and ROADS coordinate to ensure that all grants have appropriate clearance.

4.5  Is funding or additional funding being sought? 

• If additional funding is obtained in the future, be sure to submit an FIO form to inform the MREB team 

4.7  Are you requesting ethics clearance for a research project that was not originally designed to collect data from human participants or their records (i.e., your research project originally did not involve collecting data from humans or their records but you now intend to do so)? 

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Section 5 – Location and Other REB Review

5.2  Has any other Research Ethics Board(s) or equivalent already cleared this project? 

5.2.1 Provide the name and location of the REB(s). 

• An REB application should be submitted first to the “lead site” – the site and PI who is taking on responsibility for the project. 
• If the lead site is another Canadian college or university, then you may be able to submit your application as an “Application for a project with External Clearance” 
• If the lead site is outside of Canada, including the United States, please check with the MREB office to confirm which type of application should be submitted.  
• If a McMaster co-investigator is involved with an external project, you will need to confirm with the lead site whether the McMaster co-investigator can complete and sign the ethics forms on their behalf. 
• If there is no McMaster co-investigator on an external project, the Principal Investigator will need to ask the MREB office to request a MacID to access MacREM. For the MacID we will need the full name, external email address and date of birth of the PI and anyone helping to complete the application.  

5.4  Will any other Research Ethics Board(s) or equivalent be asked for clearance? 

• If any member of the research team is affiliated with other institutions, clearance may be required from their institution.  Each team member should look into this possibility as soon as possible in the research process. 
• If clearance is required from other institutions and have already been obtained, the clearance letters should be uploaded as part of the application.  If clearance letters are still pending, the research team should submit a FIO form to share the letters when they are ready. 
• Study team members from other institutions cannot engage in study tasks until they receive clearance from their institutions. 
• If you are recruiting participants from other institutions, and the recruiting methods are tied to that institution (e.g. posters in the institution, using institutional emails), it is likely you will need REB approval from those institutions.  Please check with those institutions as soon as possible. 

5.7  Name the countries where the research will take place. If the project focuses on a specific region and/or cultural group within a country, then please specify. 

5.8  Is there a local REB or equivalent that will conduct an ethics review of your research project? 

• This refers to a REB that is local to the country or countries in which you are conducting your research.
• It is the researcher’s responsibility to check the local REB requirements.

5.10  Provide the title, name, and email address of a potential Ad Hoc Advisor for each country where the research will take place. 

• The Ad Hoc Advisor or “local reviewer” as they are commonly called, is meant to be someone who has research experience relevant to this study and knowledge of the participation population and local political/cultural context in order to assess the relative risk to participants. 
• A local reviewer is not always needed – they will be contacted if the MREB staff do not feel they have the expertise within themselves and the Board members to understand the political/cultural nuances of the study or a study location. 
• The advisor CANNOT be a member of the research team and cannot have a conflict of interest with the research team.  They can be an acquaintance of one or more members of the research team, but if they work closely with the team on other projects, this may be a conflict of interest 
• The local reviewer is sent a copy of the application and the supporting materials and given a timeline to return their comments.  They don’t have to provide a comprehensive review of the project, simply indicate if there are any ethical questions related to research in that location or with that population 
• We recommend providing the names/contacts of 2 or more potential local reviewers, in case your first choice is unable to provide a review 
• You may wish to consider reaching out to potential local reviewers before submitting your application.  It can shorten the review time if you have confirmed that your local reviewer is willing to complete the review. 

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Section 6 – Research Involving First Nations, Inuit and Métis Peoples of Canada

6.1 Will your research involve collecting data from First Nations, Inuit or Métis community(ies) and/or will the data pertain to Indigenous identity or knowledge? 

• You do not need to check “Yes” to this if some of your participants might just happen to be Indigenous.  You only need to check yes if you are actively seeking the voice of this community 
• Data related to research by or with Indigenous communities should be managed in accordance with principles developed and approved by these communities. Consult Engage with Indigenous Data for additional resources curated by AskResearch. 

6.2 The following statements are asked to determine whether community engagement is required. Check if applicable. 

6.2.1 Since one or more of the above statements was selected, community engagement is required (TCPS2 Art. 9.1). Select one of the following options: 

• If the researcher is hoping for an exemption to community engagement, the onus is on them to convince the MREB Chairs to allow this. 
• The researcher will have to provide a compelling justification with evidence from the literature to support it. 

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Section 7 – Conflicts of Interest

7.1  Are there any of the following relationships between the investigator(s) and participant(s)? Select all that might apply: 

7.2 Describe the multiple roles between the researcher(s) and any participants, and potential conflicts of interest. 

• Please carefully consider the potential for relationships.  The existence of relationships does not mean that the study can’t be done, but they should be acknowledged and accounted for. 
• Researchers have frequently missed the following relationships: fellow students, Instructor/TA and current or past students; colleagues.  Pay close attention to these connections. 
• Ensure you have considered and listed relationships for all members of the research team, particularly PI, student PI and co-investigators. 
• There is potential for conflict of interest when there are relationships between the research team and the participants.  While this potential is most concerning when the researchers are in a position of power over the participants (e.g., a professor who can give non-participants a bad mark), more subtle conflicts of interest must also be considered (e.g., when a researcher is recruiting family and friends, who may not want to take part, but feel obligated due to wanting the researcher to do well). 
• Relationships with the highest level of risk for a conflict of interest are when the researcher is providing a service for potential participants (either as a teacher or a service provider).  The potential participants may feel that they have to take part or lose access to the service/be penalized. Special care is needed to mitigate these concerns. 

7.3 Describe how any conflicts of interest identified above will be avoided, minimized or managed. 

• The names of everyone on the research team who will have access to the data should be on the recruitment materials.  Potential participants will be able to see who will see their answers, and recuse themselves if they are not comfortable. 
• When using email recruitment, there are things that can be done to reduce any real or perceived pressure to participate: sending out mass emails (using BCC to protect privacy) or social media ads to potential participants rather than reaching out individually, and using language to reassure potential participants that the success of the study does not rely on any individual’s participation. 
• If possible, recruitment should be done by someone with no relationship to the potential participants, or the member of the research team with the least amount of power over the group (e.g., an RA rather than the professor) 

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Section 8 – Summary of Proposed Research

8.1  Describe concisely and in plain language the study background of the proposed research project (e.g., context of the research, previous research, importance of this area of study, etc.). 

• Citations/References are not needed in this section 
•  Outline the information in layman’s terms; spell out any acronyms at first use and explain discipline specific terms.  Please be sure that it is truly plain language, please see guidance here: https://macrem.mcmaster.ca/Personalisation/DownloadTemplate/53 

8.2  Describe concisely and in plain language the specific purpose / research question for the proposed study. 

• As with the study background, ensure that it is written for a layperson without expertise in your field.  Spell out any acronyms and explain specific terms 
• Sometimes research is done on events that are not themselves the focus of the research – for example, a community workshop or a university course.  If this is the case for your research, please touch upon this event, but ensure the focus is on the study tasks alone 

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Section 9 – Participants

9.1  What is the approximate number of participants required for this study? Where applicable, also provide a rationale for your choice in sample size and/or the sample size calculation (e.g., to explain how a low sample size will still provide meaningful results, or to justify the number of participants needed in research that includes significant risks). 

• The sample size should be appropriate for the study methodology – for example, a quantitative survey should have more than 10 participants, and qualitative interview study shouldn’t have 200 participants 
• If you have different participant groups, or are drawing from different locations, please provide sample sizes for each group/location, as well as an overall total 

9.2  What are the salient participant characteristics (e.g., age, gender, location, affiliation, etc.)? Describe any specific inclusion/exclusion criteria (e.g., BMI > 30, immigrated to Canada in the past year, etc.) 

• This section should only focus on inclusion and exclusion criteria for the study.   
• In 9.2 there is no need to discuss other demographic information to be gathered, unless it impacts eligibility.  For example, if you wanted a study with a 50/50 ratio of French and English speakers, and you intend to stop recruiting one group once they’ve reached half the intended sample size. 
• The eligibility criteria should be appropriate for the study and justifiable, particularly if particular genders or cultural groups are being excluded as participants. Please see Chapter 4 of the TCPS2 about inclusion and exclusion. 

9.4  Will the study include participants who will need translation of documents or verbal communication from English to another language(s) and/or from another language(s) to English? 

• It is understood that in many cases, the study is limited to English due to a lack of resources for translation 
• However, if the study is primarily focused on one cultural group, efforts should be made to translate documents/hold interviews in the language of that group 

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Section 10 – Recruitment

10.1 How will each type of participant be recruited? 

• If you have more than one type/group of participant, it is often easiest to split this question into paragraphs for each type/group 
• Please ensure there is enough detail in this section. For example, if you intend to use posters, please explain where the posters will be hung.  If you intend to use social media, please list the platforms to be used  
• The Privacy Office has indicated that student email distribution lists should not be used for recruitment – course websites or Avenue to Learn are better alternatives. 
• If you are intending to recruit from other universities/educational institutions, it is possible that you will have to complete an REB application with them.  You should contact them as soon as possible to find out.

Direct Email

• • If using this method, please explain how you will obtain the emails you will be using.  If these people are personal contacts, please ensure that the relationships are covered in Section 7. 

Snowball recruitment 

• • When using snowball recruitment, please remember that having a participant share someone else’s personal contact information with you is a violation of that person’s privacy.  Ideally, you would ask your participant to share a snowball recruitment script with people they think might be interested.   
  • Alternatively, they could provide the names of people whose contact information is public. However, please ensure the appropriateness of the method – as an example, if you are getting the names of bank employees for a study about banking conventions, that is appropriate, but if you are getting the names of bank employees for a study about relationships, that is less appropriate. 

10.2  Who will recruit each type of participant? 

• Whenever possible, ensure that the person doing the recruiting has as little power over participants as possible.  This could mean that a PI who wishes to study their students may ask an RA to recruit on their behalf rather than doing it themself.  This reduces the perceived pressure to participate.  Even if you believe your participant group would not feel this pressure, it is still a requirement to mitigate the potential if possible. 
• If someone is recruiting on your behalf, it is vital to stress the importance of using the scripts created.  This external person should not have power over the people they are trying to recruit (e.g. a boss recruiting their staff) unless it is impossible to avoid.  In those cases, the recruitment tasks should be limited, such as sending out an email script. 

10.3  Will you require permission to conduct any of the above recruitment strategies? (e.g., permission from an employer to recruit employees on site). 

10.3.1  State who will need to provide recruitment permission and how you will go about obtaining permission (or describe how permission has been obtained already). 

10.4  Do you have any letters or documents confirming permission to recruit participants? 

• Permission would be required in situations where the researcher wouldn’t otherwise have access to the potential participants (e.g. a presentation to a class or a notice in the class’s Avenue to Learn page) 
• Permission is generally required when doing in-person recruitment at religious institutions and community groups  

10.6  Identify the documents that will be used during recruitment (select all that apply): 

• Recruitment material should make it clear that this is a research study 
• Eligibility criteria should be clearly listed in all recruitment material  
• Recruitment material should contain the pertinent information required for participants to determine if they want to know more about the study: A quick outline of what the study’s about, what their tasks will be, approximately how long the tasks will take. 
• You will want to include the names of the research team in recruitment material, particularly if it is a sensitive topic 
• Ensure consistency, particularly in the estimates of time needed for study tasks.  The times given in the recruitment material should also match those given in the Letter of Information/consent. 
• Your recruitment material should include a statement that the study has received clearance from the McMaster Research Ethics Board.   
• If your study involves sensitive topics (e.g. asking about sexual assault), please inform potential participants about this, as it may be very important in deciding whether they wish to take part 
• Sometimes researchers can make their recruitment material very lengthy, sounding more like a Letter of Information than a Recruitment script.  This is not ethically wrong but may not be as effective.  Recruitment material should be kept short and interesting if possible. Some recruitment material such as emails or social media posts can have the Letter of Information as an attachment if the researcher desires. Posters and short social media ads may wish to include a link/QR code to a webpage with more information. 
• Ensure that the recruitment material clearly outlines the next steps for people if they decide they are interested in the study.  This may include contacting a member of the research team to get more information or set up an appointment, or it may be a link to an online survey. 
• Please ensure that you use language that does not pressure the person to participate.  Avoid language such as “we need your help” or “your assistance is vital”.   
• You can find Templates and Samples for Recruitment documents on our Templates and Guides page 

Direct email 

• • If you will be following up on the initial contact, please indicate the time frame (e.g. “after one week”). One follow-up is the norm; a researcher who wishes to send more than this will need to provide justification.  This also applies to emails sent on behalf of the Researcher. 

Email sent on behalf of Researcher 

• • Often, researchers make the mistake of retaining the language, “If we haven’t heard from you after one week, a follow-up will be sent” – please remember that the email sender will not know who has responded, so any follow-up must be to the entire group.   
  • You will want to add in a statement that clarifies that the person sending the email/their organization will not know who took part in the study 

Poster 

• • Please see the policy for posters at McMaster here.  
  • A specific process is required for posters in the Student Centre. Please see here for more information 
  • When placing posters at other locations, ensure you follow the instructions of the person in charge of the location. 
  • Please be courteous and remove posters once recruitment has ended, unless there is a policy for the location holder to remove it on your behalf  

Social Media Script 

• • You will want to consider if you want to warn people viewing the social media ad that liking or commenting on the post may reveal their participation/interest in the study. 
  • Social media ads can reach a wide geographical region.  If the study is limited to participants from a certain area, please make sure that is clear in the ad 

Snowball Recruitment Script 

• • A script should consist of two parts: what you will say to the participant to request their help, and what you want the person to share with their contacts.   

SONA 

• • Some departments host a SONA recruitment database.  If you intend to use your department’s SONA, be sure to familiarize yourself with the rules and regulations before developing your ads.
  • If you are using the PNB SONA, don’t forget to develop and upload a SONA debriefing form, which provides more information about your study.

10.7  Will potential participants answer screening questions to determine eligibility to participate in the study? 

10.8  Describe how the screening process will take place. 

10.9  a) Describe what will happen to a person’s screening information if they participate in the study, and also what happens to the information if they are ineligible to participate.  b) Describe how screening responses will be kept secure or securely discarded. 

• Most screening information can be discarded as it won’t include information used for analysis. If you are keeping screening responses, they should be stored following the same practices as the rest of your data. You can contact McMaster Research Data Management Services if you have questions related to data storage or security.

10.10  Upload the document(s) with the screening questions. 

• Screening is typically done before the person consents to take part in the study, in order to ensure that the person is eligible to take part. Only check “yes” to this question if you want participants to do this task Before they sign the consent form – screening done after the consent does not need to be addressed here. 
• A screening questionnaire/document should include an introduction that acts as a mini-consent for the collection of this particular information.  This introduction should explain why the information is needed, and explain what will happen to the data provided 
• Please consider if a screening process is required at all.  If the eligibility criteria are simple (such as being an undergraduate student), you can assume that anyone who responds to the recruitment material meet these criteria 
• If a formal screening process is needed, ensure that you are only asking the questions necessary to determine the person’s eligibility.  All other questions must wait until study consent has been obtained 

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Section 11 – Research Methods

11.1 Describe sequentially, and in detail all data collection procedures in which the research participants will be involved (e.g., paper and pencil tasks, interviews, focus groups, lab experiments, participant observation, surveys, physical assessments etc. —this is not an exhaustive list). Include information about who will conduct the research (include tasks done by assistants, translators, transcriptionists etc.), how long it will take, where data collection will take place, and the ways in which data will be collected (e.g., computer responses, handwritten notes, audio/video/photo recordings etc.). 

• Please consider if you intend to collect your data in an anonymous, deidentified or identifiable way. This will determine how you structure your data collection process and consent. 
• If you are collecting data in a fully anonymous way, then no one, not even the researcher, will know the names of people who took part. Typically, this can only be done via an anonymous survey 
• If you are collecting data in an anonymized way, you as the researcher will know who took part (at least some of them), but not be able to connect participants to their particular data. Often, this involves one survey for the study data, which then has a link to a second survey to collect personal information in order to share incentives, study results, and/or choose participants for follow-up interviews 
• Quite often, data is collected in identifiable ways. Almost all interview/focus group/in-lab studies will be identifiable. It is typically a good practice to de–identify the data once it is collected. If you need to be able to link participants to their data, you can pseudonymize data instead of de-identifying it. For some guidance and resources, see the McMaster Research Data Management Services webpage on Data Anonymization, or reach out to them directly with questions.  
• Will your sample be divided into groups? If so, explain why it is necessary and how you will do this. If the study tasks involve groups, this may impact other aspects of the study – for example, if one person withdraws their data, the data from other group members may have to be removed as well. Please clarify this in the application. 
• If you intend to use the data collected during this study to compare to another group, please explain how you will obtain this other group’s data (e.g., published articles, raw data shared by researcher, etc.) 
• In cases where your data collection relies on other, non-study tasks (assessing a new teaching module, assessing the results of a workshop), be sure to clarify which portions are background and which are the essential study tasks. 
• All data collected should have a demonstrated relevance to the research question. In cases where the researcher would like to gather additional data for use in potential future studies, they would need to follow the procedures for creating a research database in Section 12. 
• Please indicate where the data collection will take place (e.g., in the {XX} lab, in a library meeting room, online). Please note that public places such as coffee shops are not ideal for data collection, as the chances of being overheard are high 
• In rare cases, researchers will want to ask participants to prepare for the study visit – for example, not smoke or drink alcohol the night before. These are generally okay, but if the preparation involves changes to typical medication use, please reach out to the MREB as soon as possible for guidance. 

Interviews/Focus Groups 

• • Please note that we have guides/templates for interviews and focus groups.  Please find them on our templates page
  • Please note that interviews and focus groups cannot be called anonymous. Anonymous is only used when not even the researcher knows who the participant is, which is impossible to do in an interview/focus group 
  • Will you be doing your interviews/focus groups in person, remotely, or a combination of the two? All of these choices are allowed, but aspects of the interview/focus groups will change depending on what type (e.g., you will record a Zoom interview in a different way than an in-person interview) and you will need to account for all these aspects in your application and materials. Please consult Using Video Conferencing for Collecting data from Human Participants for additional remote interview platform guidance from AskResearch. 
  • While most people now have access to technology to allow for online interviews/focus groups, this may not be the case for everyone. Please consider if this may be an issue for your sample and provide your plan if people cannot do an online interview/focus group. 
  • Clearly and consistently indicate how long the interview/focus groups will take. Generally, using a range (between XX and YY minutes) is a good option as some people will speak more than others. Ensure the time seems reasonable for the amount and complexity of questions – it may help to run a mock interview if you do not have a lot of experience with the topic. 

Interview-specific 

• • In some studies, researchers find benefit in sharing with participants a transcript of their own interview, to assure accuracy and allow follow-up thoughts. Please consider if this may be beneficial for your study. Online transcription services may increase privacy risks. Please consult Using Transcription with Data from Human Participants for additional transcription platform guidance from AskReseach. 

Focus Group-specific 

• • Focus groups are more prone to breaches of privacy than interviews are. Extra steps may need to be taken, including reminding participants to protect the confidentiality of what was said, and asking participants to sign an oath of confidentiality. Ensure you’ve addressed these issues in Section 15. 

Surveys/Questionnaires 

• • Most surveys/questionnaires are online these days.  This helps with branching logic in particular (i.e., if you answered “no” to this question, skip to Q8). Please note if your questionnaire will be online or in hard copy. 
  • If doing an online questionnaire, please indicate which platform (e.g., LimeSurvey, Qualtrics, etc) you will be using.  We recommend against using public survey tools such as SurveyMonkey due to privacy concerns. Please consult Tools for Online Surveys Involve Human Participants for additional guidance on survey software selection from AskResearch. 

Lab Tasks 

• • Please describe sequentially how the task(s) will be done.  Use both the official name of tasks (e.g., will complete the WAIS) and a layperson description (a validated psychological test to measure IQ). 
  • Certain lab tasks may contain risks or unique challenges for certain populations. Please see Section 15 for discussion about these risks and challenges. 
  • If doing lab tasks, a copy of the instructions as the participants will see them should be uploaded in the application. 
  • Please consider if your tasks require specific instructions (e.g., wear comfortable clothing to do an exercise task; remove head coverings in order to apply electrodes) and ensure participants are made aware of them before arriving. 

Observation 

• • If using observation, please indicate what will be observed and analyzed.  
  • Please note that even if observation is in a public place (such as a church) the people you are observing may have the right to an expectation of privacy. As such, your observational tasks may require participant awareness. This would involve speaking to the leaders of the groups and getting their permission, sharing documents with and making announcements to the group, and allowing a consent process – which may be an opt-out process, where the participant can ask that no records be made about them. 
  • Occasionally, researchers will indicate that they wish to video-record interviews/focus groups in order to observe non-verbal behaviors or interactions. If you wish to do this, please outline how you intend to quantify these observations into data that can be analyzed. 

Data Collection/Recording methods 

• • Please be sure to list all methods of recording the data you will be using. For example, if you are holding interviews, please explain if the interviews will be recorded, if notes were taken, and/or both. 
  • Best practice is to record the interview/focus group if possible. It is difficult to perform thematic analyses on notes. Note-taking also interferes with the engagement with the participant 
  • If you are recording the interviews/focus groups, clearly state how they will be recorded. MS Teams and Zoom are recommended platforms due to institutional support and alignment with security standards.  Please consult Using Video Conferencing for Collecting data from Human Participants for additional remote interview platform guidance from AskResearch. If you are using an alternative platform to record, please carefully review the documentation on the platform to confirm the security of your recordings. Some apps grant themselves access to your content.
  • If you are generating recordings, please explain how they will be transcribed (manually, using software) and by whom. This information should be shared with the participants, and if using an external transcription company.Please consult Using Transcription with Data from Human Participants for additional transcription platform guidance from AskResearch. 
  • If data will be recorded in a digital notebook, carefully review the platform documentation to confirm appropriate data security. Please consult Selecting an Electronic Lab Notebook for additional guidance from AskResearch. 

11.2  Describe your data analysis methods, (e.g., statistical analysis, textual analysis, NVIVO, analysis resulting in creative outputs, etc.)? 

• Provide a few details about the anticipated analyses. With quantitative data, will the analyses be descriptive or inferential, or will you use both? What theory will underlie your qualitative analyses? 
• Will you be performing the analyses by hand, or will software be used to assist? If you are using software, which one? McMaster researchers can access a variety of research software free of charge or at reduced rates. Consult Access Software for Research for additional resources curated by AskResearch. Additionally, specialized resources and support are available for data analysis and visualization. Consult Analyze and Visualize Data for additional information curated by Askesearch. 

11.6  Are you doing community-based research?  

• Community based research (CBR) is a type of research where the researcher embeds themselves with a particular community and said community has an active role in the design and implementation of the research. For additional resources, consult the Community Research Data Toolkit. 

11.14 Select and upload copies of all questionnaires, interview guides (i.e., lists of questions), tests, or data collection instruments, etc. 

• Please upload copies of all the instruments you intend to use. If you wish, these can be grouped into one file which shows the order in which the participant will complete them. 
• If your study has more than one participant population (e.g., service providers vs service users), consider if each group will need their own set of interview guides/data collection materials. This can make collecting the data much easier. 
• Ensure that all your instruments contain clear instructions to participants, particularly if the participant is completing the form without the researcher around to answer questions 

Interview/Focus Group guides 

• • We recommend including an introduction at the beginning of any interview/focus group guide, particularly if there may be any psychological or social risk 
  • This introduction can remind participants that they can skip any question they do not want to answer or end the session at any time for any reason. It should also outline any limitations – for example, a researcher cannot guarantee that other participants will not reveal what was said in a session 
  • If you want the participants to Avoid saying certain things (such as specific names or policies) please be sure to state this at the beginning of your script 
  • If your study intends to conduct any follow-up interviews/focus groups, the scripts for those sessions should also be uploaded. If this is not possible because the content of the follow-up will depend on what was said in the initial data collection, please clarify this in 11.1 and be sure to submit a For Information Only (FIO) form once the follow-up interview/focus group guide is ready. 

Demographic forms   

• • Consider which demographic information is pertinent for your type of research study. You may wish to  
  • Collect data at the minimum (least identifiable) level needed to answer your research question. For example, rather than asking for a date of birth to calculate age, ask them for their age. If you want to know someone’s rough geographic area, asking for the first 3 digits of their postal code is preferable to asking for all 6. If you simply want to confirm if they live in the GTA, ask them that instead of asking for any part of their postal code. 
  • If you are doing interviews, it may be easiest to verbally ask the demographic questions as part of the interview 
  • Asking demographic questions should be avoided in situations where data collection is performed in a group. In those cases, having a questionnaire online or a paper copy which can be handed in face down may be best 
  • Careful consideration needs to be used when asking about ethnicity and sex/gender. For a deeper discussion, please see our guidance document on Demographic Questions 

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Section 12 – Secondary Use of Data

12.1  In this current research project are you planning to use secondary data that was originally collected for another purpose? 

• This “other purpose” may be information gathered as part of a course, information gathered by a business as part of their business dealings, or research data gathered by another research team or even the researchers themselves in order to answer a different research question. 
• If your study consists ONLY of secondary data, AND that secondary data is publicly available, your study may not require REB review.  Please see Article 2.2 of the TCPS2 and speak to a MREB staff member if you think your study falls into that category 

12.5  List the variables you will receive in the box below or upload a document(s) listing the variables. In some cases it may be easier to upload the surveys/test instruments from which the data originates – with some indication (e.g. highlighting) of which questions you will receive data from. 

• The ideal method here is to upload a copy of the questionnaire(s) as the participants saw them.  This will provide not only the questions but the response options.  
• A statement such as “I will receive demographic variables” is not sufficient, as the risks to participants differ based on the demographic questions or grouping of questions asked.  Please list out the questions included in the demographic questionnaire 

12.8  Do you have any written data access agreements in place with the owner of this data to allow you to use this data for your research? 

• The need for these agreements will differ based on the organization providing the data 
• If the data is coming from faculty/staff/students at another academic institution, they should check with their local REB to determine if an agreement is needed. 
• Support for Data Sharing/Access/Transfer Agreements can be obtained through the McMaster Industry Liaison Office (MILO) by contacting the Research Contracts Advisor associated with your research area.  

12.32 Does your research involve the creation and/or modification of a research database (databank) containing human participant information? A research database is a collection of data maintained for use in future research. The human participant information stored in the research database can be identifiable or anonymous. 

• A research database is a formal collection of data maintained and administered by you for use in future research by you and other researchers. This is different from simple data storage of your research data for your own future use. Big Data or databank projects most likely would need to select Yes but most researchers collecting data can select No. Contact the ethics office if not sure. 
• Support for Data Sharing/Access/Transfer Agreements can be obtained through the McMaster Industry Liaison Office (MILO) by contacting the Research Contracts Advisor associated with your research area.  
• Questions around best practices for research data management support, including considerations relevant to data access frameworks can be directed to McMaster Research Data Management Services. A Data Management Plan (DMP) can be helpful for planning out management of data access.  
• For support building relational databases, contact the Sherman Centre for Digital Scholarship, RHPCS, or your Faculty IT unit. 

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Section 13 – Incentives, Reimbursements and Compensation

13.1   Will participants receive an incentive for participation? 

• Be aware that incentives are not the same thing as benefits.  Incentives are the “payment” or “thank you” (either financial or in-kind) given to participants in recognition of their time and contribution to the project.  The benefits are the positive outcomes that may occur for participants as a result of taking part in the project. 
• Incentives should not be large enough to apply undue pressure on people to participate.  What constitutes large enough differs from case to case and takes into account the risk of the project and the financial situation of prospective participants. 
• Incentives can be designed as a lump sum payment, or as a payment per section completed (for example, a payment for each interview in a multi-interview study 
• Incentives can be financial (cash, gift cards, entry into a draw for cash/gift cards) or in-kind (e.g., course credits, access to study software after the study is over, getting to keep the Fitbit they used for the study) 

13.5   Will participants be reimbursed for expenses related to participating in the research (e.g., transportation, parking, childcare, taking unpaid leave from work)? 

• While it is not an ethical obligation to reimburse all participants equally, you may wish to consider what is fair to all participants 

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Section 14 – Risks and Benefits

14.1/2  Physical risks (including any bodily contact or administration of any substance)? 

• If you are asking participants to engage in physical activity as a study task (walking, climbing stairs, playing basketball), potential for harm while doing these activities must be considered. 
• Consider the risks in terms of the abilities/agility of your participants – for example, a VO2 max test may have fewer risks to elite athletes than average adults. 
• If your study involves attaching things such as sensors to the body, consider the possibility of a reaction to the adhesive, etc. 

• Mitigation for physical risks may be limited by the nature of the project, but researchers should make sure that the risks are made clear to participants before the beginning of the study. 

14.3/4  Psychological risks (including feeling demeaned, embarrassed, worried or upset)? 

• Psychological risks are the risks of becoming distressed (sad, angry, embarrassed, anxious) when answering questions or completing study tasks 
• View the possibilities from different perspectives – for example, a study about opinions on a course may carry no risk for most of the students, but it may cause distress to those who did not pass it. You will still want to address that risk. 
• Even if a task doesn’t rate performance, a participant may experience distress from performing poorly. 
• If you have reason to believe that a participant can face significant distress in the study, you should have a plan if the participant becomes very upset or discloses thoughts of self-harm. 

14.5/6 Social risks (including possible loss of status, privacy and / or reputation as well as economic risks)? 

• Social risks are risks that a participant might face if their study data (or even the fact that they took part in a study) became known outside of the research team 
• In some cases, such as anonymous surveys, or interviews of policy makers who wish to be identified, social risks are negligible. In other cases, such as interviews where people admit to illegal activities, the social risks are significant. Most studies fall in the middle. 

14.7/8  Do you have a list of community counselling or other support services to give participants if they were to become distressed during participation in your research? 

• This is a requirement if the study regards sensitive topics (crime, addiction, abuse, forced emigration) and is an option that should be considered if the study has more than minor psychological riskss. 
• Ensure the list is appropriate for your participant base in terms of locale, language and culture 
• If possible, include multiple contacts for each resource (e.g,. phone, website, etc.) to make contact as easy as possible for your participants 
•  A sample Resource Sheet can be found on the MREB website 

14.9  Is there any deception or partial disclosure involved in this research? 

• Some examples of deception/partial disclosure used in the past include creating false newspaper articles, manipulating the difficulty of tasks, or saying that the purpose of the study is different than it actually is. 
• Deception/partial disclosure should only be used if the nature of the study is such that full disclosure would skew the results of the study. 
• If deception/partial disclosure is used, participants should be debriefed (told about the deception and the reason for it) as soon as possible after the session and re-consent/re-assent sought 

14.12 Describe how participants will be debriefed about the study (e.g. provided with a more complete description of the purpose of the research). 

• The TCPS2 states that debriefing must occur in any studies with deception/partial disclosure, unless it is impossible, impracticable or inappropriate 
• The onus is on the researcher to convince the MREB that debriefing is impossible, impracticable or inappropriate. They may need to provide supporting evidence from existing research. 
• On rare occasions, a researcher can delay the debriefing process, if they can prove to the Board that debriefing right after the session will interfere with the results of the study.  In those cases, researchers must keep careful records of participants and debrief as soon as feasible. 
• The debriefing should be as complete and clear as possible, in order to “undo” any harm that may have been caused by the study 

14.16 Describe how participants will be given the opportunity to refuse consent and request the withdrawal of their data after being debriefed on the deception or partial disclosure. See the info button to the right for more details on the re-consent process. 

• As with debriefing, participants should be given this chance to refuse reconsent unless there is a compelling reason that can be supported with existing evidence 
• Reconsent can be written or verbal (and recorded in a consent log or other manner) 
• Please see our Debrief and Reconsent template for additional guidance 
• If in Psychology and using the PNB SONA, you must create both a SONA debrief and a debrief and reconsent.  They have different purposes and content 

14.18  Discuss potential benefits that justify involvement of participants in this study: a) any potential benefits to the scientific community, society in general and/or educational benefits (e.g. training students) b) any direct benefits to the participants (e.g., participants receive training as part of the research methods). Note that many studies do not have direct benefits to participants. 

• Be sure to answer both a and b – this is quite often forgotten 
• Often, there is no direct benefits to participants.  This is acceptable, so long as the risks are low, and a benefit to society/the scientific community can be shown 
• Don’t overstate the benefits.  Often, the benefit is simply an increased understanding of topics related to the research question, and that is a valid benefit. 

14.19  What is your experience with this kind of research? Include information on the experience of all individual(s) who will have contact with the research participants or their data. If this is student research, include the experience of your supervisor. Mention your familiarity with: (a) the proposed methods (b) the study population(s) and/or (c) the research topic. 

• The reviewers will be looking to determine if the experience level of the team as a whole is adequate for the risk level of the study. 
• Students often don’t have much research experience, so it is important to outline the experience of their supervisor and other study team members 
• Students should consider obtaining the TCPS2 core certificate, which will give them additional training in ethics to balance their inexperience 
• If there is not enough experience within the members of the team, you may wish adding a collaborator with the necessary expertise. 

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Section 15 – Confidentiality, Anonymity and Data Security

• Pay attention to the distinction between administrative data (15.1-15.4) and study data (15.5-15.11).  Administrative data is contact information – the information you need to schedule meetings, give incentives, distribute findings, etc.  Study data is the material (survey responses, interview transcripts, etc.) that you need to answer your research question.  
• You can contact McMaster Research Data Management Services if you have questions related to data storage or security. 

15.1 Are you collecting personal information for administrative purposes during the recruitment, screening or consent phases of the study and/or to provide participants with incentives, reimbursements or study results? 

• It is an expectation from TCPS2 that researchers make the findings of a study available to participants.  If you are not collecting contact information from participants, you will want to make sure there is another way to share results – such as posting them on a website, and sharing the address in the consent 

15.2 What identifiable personal/contact information will be collected? (Check all that apply.) 

• If you are collecting signed consent forms/verbal consent forms, you will be collecting at least names 
• If you are setting up appointments or asking participants to contact you for more information, you will be collecting personal information without directly seeking it. 
• Please consider how you may be providing incentives/a summary of the results.  If you are allowing “via mail” as an option, please select “mailing address”.  If not, please be sure that your supporting documents make it clear that participants should not share mailing addresses 

15.2.2 Describe the administrative purpose(s) for which this information is required (e.g. setting appointments, consent forms, consent log, distributing incentives, follow-up with participants for further research, sharing research results, etc.) 

15.3.1  Please describe: a) Who will have access to the personal information collected for administrative purposes (including people outside of the research team). b) If your answer to (a) includes people outside of the research team, then describe the information they have access to, why they need access, and what measures are in place so that participant confidentiality is maintained. 

• Rather than saying “the research team” – please explain who on the research team will have access.  This information should be available to only those who need it, and if possible, those with relationships to the participants should not have access to the identifying information. 

15.3.2  How will the personal information be collected securely and how will it be kept secure during storage? If multiple members of the research team are collecting and storing the personal information, provide details on all collection and storage procedures, and how the personal information will be shared with other team members. 

• Personal information should be encrypted and password protected.  ?McMaster Research Data Management Services hosts an online module Getting Started with Encryption which you can consult.  
• Hard copy data should not be stored in a personal home, but rather, should be held in an institutional office 
• USB keys are not very secure, and should not be used for medium risk data, even with encryption  
• Consult Tools for Online Surveys Involve Human Participants, Using Video Conferencing for Collecting data from Human Participants, and Using Transcription with Data from Human Participants for additional guidance on research tool selection and secure storage from AskResearch. 

15.3.3  How will the personal information be transported securely from the field to the storage location, between McMaster and a home office, or other scenarios requiring the movement of the personal information? This could be hard copy documents (e.g., consent forms) or electronic (e.g., a laptop containing files with contact information). 

• You should not use a service such as Dropbox or Google Drive to store/transport identifiable information.  Instead, use a McMaster approved service such as MacDrive or McMaster’s instance of OneDrive 
• If conducting research that requires travel, please consider digitizing all personal information and study data and moving it to a secure cloud service such as MacDrive before travelling, in order to protect the material from being seen by airport/border personnel. 

15.4  Provide details on the retention of personal information for administrative purposes (e.g., consent forms, contact information).  Please include: a) Length of time you plan on retaining the administrative documents containing personal/contact information. If some documents will be kept longer than others, please specify. b) The reason why you need to retain the documents for the length of time stated in (a). c) Details on how the documents will be destroyed at the end of the retention period.  d) If the procedures for longer term storage of personal information are different than what is described in 15.3, please provide the details. 

• The amount of time you retain identifying information will depend on your methodology – you will need to keep this information for the same period you are allowing participants to withdraw from the study, and you may need to keep this information until the end of the study so you can provide a summary of the findings. 
• Information should be securely deleted using a tool such as Shred-It, Eraser, or Linux Shred 
• Deletion from MacDrive is considered secure deletion 

15.5  Are you collecting any research data that directly identifies participants (e.g., audio or video recording) or that could indirectly identify participants (e.g., a combination of demographic variables – date of birth, postal code, occupation, ethnicity, etc.)? 

15.8 Will there be a separate file with a unique code or pseudonym linking the participant name/contact information to the data (e.g., linking data between multiple sessions within a study, linking data in the current study to a future study)? 

• Please ensure that any code you develop is not potentially identifying – for example, don’t use the person’s initials as the study code. 

15.10  Select all (potentially) identifiable data that will be collected for this study and explain why each type of identifiable data is necessary to conduct the research. (Select all that apply) 

15.10.10  Describe how identifiable the quotations will be when disseminating the research results. Will they be attributed to named participants or will you attempt to anonymize the quotations? If anonymizing, is there still the possibility of certain people being able to identify a participant based on the content of the quotations? If the participant identifies a third party in their quotation, will the reference to that third party be anonymized? 

15.11.1  How will the research data be collected securely, to ensure participant privacy and confidentiality during the data collection phase of the study? If an online survey platform, video-conferencing platform, or similar will be used to collect the data, then provide information on how that service protects the data (this could include a link to the service’s privacy policy). 

• Please ensure that virus protection and antimalware is up to date on any computer handling research data. 
• If you are collecting recordings (video/audio) please explain how it will be collected (e.g. built-in Zoom recorder, hand-held audio recorder, recording app on a smartphone). Please note that some apps may grant themselves access to your content – these apps should be avoided 
• When gathering recordings, best practice is to destroy the recordings after they are transcribed and the transcriptions checked.  Please indicate if you will be doing that, and if not, please provide justification for keeping the recordings longer. 
• Consult Tools for Online Surveys Involve Human Participants, Using Video Conferencing for Collecting data from Human Participants, Using Transcription with Data from Human Participants, and Selecting an Electronic Lab Notebook for additional guidance on research tool selection and secure data collection from AskResearch. 

15.11.2  How will research data be stored (e.g. digital files, hard copies, audio recordings, etc.)? Specify the physical and/or online storage location(s) and how data will be secured to minimize the risk of a data breach. If multiple members of the research team are storing the research data, provide details on all storage procedures and how the research data will be shared between team members. 

• Please consider all forms of data.  Researchers can sometimes forget to explain how hard copy consents or handwritten notes will be stored 
• Please consult the Data Storage Finder for additional guidance on data storage. You can contact McMaster Research Data Management Services if you have questions related to data storage or security. 

15.11.3  How will the research data be transported securely from the field to the storage location, between McMaster and a home office, or other scenarios requiring the movement of the research data (e.g. sending to a translator, downloading data from an online platform)? This could include both hard copy documents and electronic files. 

• Sometimes researchers will supplement primarily digital data with things such as hand-written notes, but forget to explain how that hard copy data is transported and stored securely.  Ensure that you have consider all forms of your data. 
• When travelling internationally, please consider moving all research data from physical devices to a secure cloud storage service such as MacDrive before taking flights or crossing borders where devices may be examined.  This is particularly important with sensitive data. 

15.11.4 Please describe: a) Who will have access to the research data (including people outside of the research team, e.g. translator, transcription service).  b) If your answer to (a) includes people outside of the research team, then describe the information they have access to, why they need access, and what measures are in place so that the data is kept secure. 

• If you are a student, please consider if you want to allow your supervisor to have access to the research data in order to provide support and guidance 

15.11.5  Will you be asking anyone who has access to research data, access to other study documents (e.g. contact lists), and/or knowledge of who participated in the study, to sign an oath of confidentiality? 

15.12  Will any research data and/or study related documents be transferred to another institution or organization (e.g. to a research partner organization, to a separate research team at another university requesting use of the data, following OCAP principles, etc.)? 

15.13  Describe: a) the institution/organization where the data will be transferred,  b) who will have access to the data there, and  c) the procedures that will be used to ensure a secure transfer of data. 

15.14  Will the transferred study data or related documents contain directly identifying or potentially identifying information? 

15.15 Describe:  a) the identifiable information that will be transferred and  b) why the other institution/organization needs this identifiable information. 

• All transfers of data must be protected.  Files should be encrypted during transfer. McMaster Research Data Management Services hosts an online module Getting Started with Encryption which you can consult. 

15.16  Does the transfer of the data require a data transfer/sharing agreement between McMaster and the other institution/organization? 

• Support for Data Sharing/Access/Transfer Agreements can be obtained through the McMaster Industry Liaison Office (MILO) by contacting the Research Contracts Advisor associated with your research area.  

15.16.1 Explain why a data transfer/sharing agreement is not necessary. 

15.18  How will the data from study participants be reported in the dissemination of research results (e.g., aggregated data, identifiable descriptors, de-identified descriptors, etc.)? 

• In projects involving expert informants, it is allowable to refer to participants by name, so long as their explicit consent has been obtained.   
• In most other situations, dissemination is most likely best done without the use of names.   

15.19  Provide details on the retention of research data. Please include: a) Length of time you plan on retaining data. If some parts of the data will be kept longer than others, please specify.  b) The reason why you need to retain the research data for the length of time stated in (a). c) If applicable, details on how the research data will be destroyed at the end of the retention period. 

• When audio/video recording data, best practice is to transcribe the material as soon as possible after collection, then delete the raw recordings.  If this will not be done in your study, please provide justification for retaining the recordings longer 
• McMaster does not have a data retention policy requirement for research data. Please see the McMaster Research Data Management Services Data Retention webpage for guidance on data retention.    
• When choosing a retention period, make sure you are providing enough time for project completion, following any applicable funder policies, and will be able to address potential research integrity concerns after publication. 
• If you are a student, choose a retention period that aligns with your program expectations and keep data at least until after your thesis is defended. 
• Please avoid statements such as “will be kept for a minimum of XX years” which is overly vague 
• If you intend to keep the data indefinitely, this information needs to be in the LOI/consent 

15.20  Will you be retaining identifiable and/or coded research data long-term (i.e. beyond the initial data analysis phase)? Coded data refers to a de-identified data set that can be re-identified with a document linking participant ID numbers to names. 

• Best practice is to de-identify research data and delete identifiable information and linking documents as soon as possible, when it is no longer needed for the research.  

15.22 Explain: (a) why the data needs to be retained long-term in an identifiable or coded state (as opposed to anonymizing the data), and (b) specify if the data will be anonymized at a certain point during long-term data retention. 

• Ensure you provide a clear justification for keeping identifiable/coded data long-term. Occasionally researchers will mention following up with participants – if follow-ups are expected, this should be addressed in Section 11. 

15.23  Will longer term storage procedures used for keeping research data secure differ from the storage procedures used during data collection and initial analysis described above in 15.11.2? 

• Long term storage may be done in a different place than where data is stored during the active phase of the research. Please consult the Data Storage Finder for additional guidance on data storage. 

15.25 Do you have plans to have identifiable data professionally archived? (e.g. interview recordings kept in a library archive) 

15.27  Will someone other than the Principal Investigator be retaining the study data long-term? In the case of student research, will someone other than the Student Investigator and/or Faculty Supervisor be retaining the data long-term? 

15.28 Specify: a) who will store the data and  b) where it will be stored and how they will keep it secure. 

15.29  Do you plan to post research data to a database accessible by other researchers and/or the general public, or to make data available to other researchers upon request?  (e.g. some journals require sharing of data for verification purposes as a condition of publication) 

• If you are sharing participant data, this information needs to be in the LOI/consent.
• Please see the McMaster Research Data Management Services “Publish Data” website for additional information on data publishing. 

15.30  Provide the details of sharing the data (e.g. the specific database), the rationale for making your data available, and describe the nature of the data that will be made available (e.g., identifiable or not, any variables being removed). 

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Section 16 – Informed Consent 

16.1 Describe the process the investigator(s) will use to obtain informed consent from participants with the capacity to provide consent 

• Clearly state how you intend to record the consent.  Ensure this method is feasible – it may be very difficult for a participant to provide written consent if they are participating remotely 
• Typically, studies with in-person data collection should collect written consent where possible.  Remote studies are often best served with oral/verbal consent.  Electronic surveys may involve a participant checking a box in the survey to indicate consent 
• In studies where participants may choose to either participate in-person or remotely, researchers can combine in-person and verbal consent methods to best serve their participants 
• If your study has more than one session, please outline how continuing consent will be determined.  It may be helpful to have a script for this. 
• Please consult Tools for Electronically Documenting Consent for consent collection platform guidance. 

16.2 Do any individuals lack the capacity, in the context of your study, to make an informed choice to participate in the research (e.g. children, people with cognitive impairments)? 

• If this is the case, please provide a robust plan for establishing sufficient capacity.  This should also consider ongoing consent for populations that may lose capacity during the course of the data collection session. 
• While children may lack the capacity to consent, they have the right to be told about the study in an age-appropriate way, and to decline to participate if they so choose.  This means that an age-appropriate assent process must be followed for children old enough to understand what the researchers are saying.  We have a template for an assent form: https://macrem.mcmaster.ca/Personalisation/DownloadTemplate/2  

16.4 Are you seeking an exception to the requirement that researchers seek consent from participants prior to the collection of data? 

16.5 Explain and provide details for a proposed alternative consent process. If consent will not be obtained at any point, provide a justification (See TCPS2, Articles 3.7A and 3.7B and applications). 

• Alterations to the general informed consent process must meet the requirements from Article 3.7 of the TCPS2, and in most cases, will require a process of debriefing and reconsent 
• If conducting a study with children that includes deception/partial disclosure, you will want to complete a debriefing/reconsent with the parents if at all possible.  You mostly likely will want to complete a debriefing/re-assent with the child as well, unless there is a reason it would not be in the best interest of the child.  It is up to the researcher to convince the MREB that debriefing is not in the best interest of the child.  We have a template for the child debriefing/re-assent form here: https://macrem.mcmaster.ca/Personalisation/DownloadTemplate/1122  

16.6 Select the document(s) that will be used in the consent process.

• Ensure all documents that participants will see are on McMaster letterhead, or contain the McMaster logo at the top 
• Ensure all consent documents are written in plain language, and avoids jargon  
• We have a guide in writing in plain language: https://macrem.mcmaster.ca/Personalisation/DownloadTemplate/10  
• TCPS2 outlines what information is required in a consent document (Article 3.2)  We have developed a template based off of these requirements: https://macrem.mcmaster.ca/Personalisation/DownloadTemplate/11  
• To ensure clarity, ensure that that your information is separated into pertinent sections, e.g. Purpose, Methods, Incentives, Benefits, Risks, Withdrawal.  
• Ensure your LOI/consent has the name and contact information of a person who can be contacted for any questions or concerns 
• If the study is a student project, the name of the student and the supervisor need to be on the consent form, and it should be clear it is a student project under the supervision of the faculty member. 
• If the project is a student project, it should be made clear in the LOI.  The student’s and supervisor’s names should be listed in the LOI 
• If you intend to use transcription services you should mention this in your LOI so that your participants are aware of who else may see their data and how it is being used. 
• If the identified/de-identified study data will be shared with another researcher/organization, this should be clearly stated in the LOI 
• If you intend to use the study data for other projects, this should be indicated on the LOI.  Ideally, you would ask them if they are willing to let you use the data in future research. 
• Please include all information pertaining to data security in the LOI: how data will be stored; on what device recordings will be made; that these recordings will be destroyed once transcribed. 

Oral/Verbal Consent 

• • If you are doing verbal consent, you will need to have a way to record that consent.  Most often, this is through an oral consent log.  You can find a template for that here: https://macrem.mcmaster.ca/Personalisation/DownloadTemplate/5.  Another potential option is to audio record the oral consent process. 
  • If you are doing an oral consent, you will need to explain to MREB how you will secure the participant’s oral consent.  Most often, this is via the use of the oral consent script – we have a template for that here: https://macrem.mcmaster.ca/Personalisation/DownloadTemplate/17 – alternately, you can indicate in 16.1 that you intend to read the entirety of the LOI/consent to participants 
  • You may have to adjust the consent section of the LOI if you are doing oral consent or are giving participants the option of oral/written consent.  If you are only oral consent, remove the lines for signatures, etc.  If you are providing participants the option, you may have to provide instructions for each option 
  • Your verbal consent log should have columns to collect all required information; consent to participate, consent to record, where to send results, etc. 

16.7  Will participants be able to learn about the study results (e.g., mailed/emailed brief summary of results in plain language; posting on website or other appropriate means for this population)? 

• Article 4.8 of the TCPS2 clearly states that “Results of the research should be made available to [participants] in a culturally appropriate and meaningful format, such as reports in plain language in addition to technical reports” 
• The LOI should clearly state when and how the participant can get access to the study results. 
• Sharing results can be challenging when study participation is anonymous.  Best practice would be to post the results to a public website, and provide a link to that website in the LOI. If the researcher doesn’t have their own website, they can use their LinkedIn account, or MacSphere: https://macsphere.mcmaster.ca/ 
• Another common practice is to ask participants to email the researcher for results, but this can compromise the anonymity of the participant’s involvement in the project. 

16.10  Will participants have the right to withdraw from the study during their data collection (e.g. during an interview, during a lab session)? 

16.11  Will participants have the right to withdraw their data from the study after their data has been submitted/collected? 

16.12  Explain why a participant cannot withdraw their data after it has been submitted/collected (e.g. data collection was anonymous). 

• There may be challenges to withdrawal related to focus groups/workshops.  The data from that person is likely to be intertwined with the other participants and difficult/impossible to pull out.  It is okay to disallow withdrawal in these cases, but participants must be clearly informed of this limitation in the LOI 
• There are limitations to withdrawing data when the study involves focus groups.  Researchers typically state that “given the interactive nature of a focus group, it is not possible to have an individual’s data withdrawn from the group (although they can still cease their participation at any time).” 
• In most cases, participants should receive the full/pro-rated incentive when they withdraw from the study.  When this is not the case, it should be clearly listed in the LOI, and researchers should avoid statements along the lines of “there will be no consequences if you withdraw”. 
• Ensure the LOI explains not only That the participant can withdraw, but How the participant can withdraw – who do they contact, and how? This method should be as easy as possible for participants, and should be appropriate for their situation – e.g. people without access to computers shouldn’t be asked to withdraw via email. 
• There should be a firm withdrawal deadline listed in the LOI – wording such as “around December” could cause issues if they come to you at the end of December and you intended the beginning of December to be the deadline 
• You most likely will not want to make the deadline the date that you submit your thesis or the date you publish – this may cause unnecessary extra work if someone withdraws right before submission.  You may wish to make the date around the time you expect to begin analysis. 
• If a participant withdraws, the default should be to ask them if they want to withdraw the data collected up to that point 

16.13  Is there a potential of material incidental findings resulting from your research? See the info button for further details (most studies reviewed by MREB will not have incidental findings). 

16.15  Is there a reasonable possibility the researcher will obtain information from participants that will require the researcher to break confidentiality and report details to a third party? This could be a legal or ethical requirement (e.g. suspected child abuse, imminent self-harm or harm to others). See the info button for further details. 

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Section 17 – Application with External REB Clearance

• If you are completing an external application because you are moving to McMaster, you will need to ensure that your participant-facing documents are updated with your new affiliation 
• Consult Bring Research from Previous Institutions for additional guidance and resources for researchers moving to McMaster, curated by AskResearch. 

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Section 18 – Additional Information

• Ensure that any items you upload in this section don’t actually belong elsewhere 
• There is no need to upload a copy of your protocol/references, though you can if you wish

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