Research Ethics Board Frequently Asked Questions (FAQ) 1. What is minimal risk in a research project? 2. Do student projects require research ethics approval? 3. I want to use the students in my class as the research subjects for a project I am doing. Am I allowed to do this? 4. I want to talk to people first – can I, before starting the research? 5. I need to do a pilot test of my research tools first. Do I need approval for that? 6. I want to use Survey Monkey to do an on-line survey. Am I allowed to use this service? 7. Do I need to use a signed consent form when I do surveys? 8. Do I need to use a signed consent form for focus group participants? 9. I want to reimburse the people who participate in my project. What is allowed? What I can give them? 10. Participants might feel stressed or anxious before or during my research activity. What resources are available to them? 11. Something bad happened to one of my research participants while they were doing the experiment / test. What should I do? 12. How long am I supposed to keep my data? What about the various files and consent forms and other materials from my research project? 13. I want to do research on children. Are there any special issues I should think about? 14. How do I deal with the fact that what the child consents to and what their parent / guardian consents to, for them, is not the same? 15. I forgot to get approval before I started my research – what do I do with my data? 16. I am part of a research team involving researchers from two other universities. How do we go about getting research ethics approval? 17. I want to do research on university students at another university. Do I need to get approval from Mount Allison University’s REB, from the other university’s REB, or both? Page 1 of 13 18. I already received approval from the Mount Allison University REB, but I want to change a few things now that I have started collecting data. What are the types of changes that require approval from the REB, or can I just go ahead on my own? 19. Do I need to explain in my research report or journal articles that I received consent from participants? 20. Where can I get help completing the REB forms? 21. Does the university provide any protection for researchers and student researchers in case something goes wrong in my project? What about the REB and its members – are they protected by the university? 22. What am I supposed to do if someone in my study tells me they are going to hurt themselves or someone else? 23. If I uncover illegal activity in the course of my research, what should I do? What am I supposed to do if the police or another person of authority asks me to tell them what I have collected from a participant in my study? 24. I am a researcher at another university. I already have ethics approval from my university and I want to survey students (or faculty or staff) at Mount Allison University. Do I need to make a submission and receive an approval from your REB? 25. How do I know if my potential study participants are part of a “vulnerable population”? 26. What is the difference between confidentiality and anonymity? 27. Am I required to disclose if my research funded by a sponsor (such as a private industry or a foundation)? 28. I’m not sure if my research requires ethics review. What should I do? 29. My research project involves getting help from someone inside an organization to make people aware of the project and to help me recruit participants. What approvals do I need and what are the ethical considerations in how I should involve them? Page 2 of 13 1. What is minimal risk in a research project? Minimal risk research is defined as research in which the likelihood of possible harms to the participant is no greater than those encountered in his or her everyday life. Even if your research project involves minimal risk to the participants, it still requires research ethics approval. 2. Do student projects require research ethics approval? If the student projects involve research on human subjects, then the answer is yes. If the projects are in the context of an honours’ thesis project or an independent study project, then the supervisor and student together must prepare, sign, and submit a Form 1 application to the University’s REB. If the projects are in the context of class activities for credit, and do not involve more than minimal risk and will not be used for presentations or publications outside of the classroom, then the instructor must make application within his/her department for approval. There is a “departmental review form” available on the REB website www.mta.ca/reb. 3. I want to use the students in my class as the research subjects for a project I am doing. Am I allowed to do this? Yes, it is possible to use your students as research subjects. While this is possible, it requires careful management and full disclosure by the instructor. The major concern is that students do not feel unduly coerced into participating in the activity for fear of retribution or other measures within the context of their course activities. You will definitely need to submit a Form 1 application to the REB. The REB, in its review, will expect you to clearly address the following issues: • Full disclosure to the students about the purpose of the activity; • Guarantee of anonymity for students; • Options for students who choose not to participate; • The use of a student or other individual who can distribute and/or collect paper, electronic, or other research materials so that the instructor does not see or know who is or is not participating; • Appropriate consent forms or processes, if required; and • Appropriate debriefing materials, if required. 4. I want to talk to people first – can I, before starting the research? This falls into the general category of qualitative research where the specifics of the research unfolds over time. Subject to Article 10.1, REB review is not required for the initial exploratory phase involving contact with individuals or communities intended to establish research partnerships or the design of a research study. This is typically the case in many qualitative research projects where it is necessary to “dialogue” with the community or stakeholders first to work out the details of the project. It is Page 3 of 13 important to note, however, that any “data” or information collected at this stage cannot be used for research purposes. 5. I need to do a pilot test of my research tools first. Do I need approval for that? Yes, you need approval for pilot tests. The REB will review to determine the ethical acceptability of the research before recruitment of participants is allowed. 6. I want to use Survey Monkey to do an on-line survey. Am I allowed to use this service? Conducting on-line surveys is becoming more commonplace in research. And there are many on-line survey tool options. The main concerns for the REB are related to data storage by the host company and the access to it. The REB advises that there are some security issues concerning the use of these, especially those which are housed on servers outside of Canada, such as Survey Monkey. Participants in any research project using this or a similar survey tool should be clearly informed that by clicking on the survey link that they will be entering a survey where the information they provide will be housed on servers outside of Canada and therefore subject to laws of that country (e.g. Patriot Act). There is a Canadian equivalent of Survey Monkey. They do claim that their servers are housed in Canada – http://fluidsurveys.com/. (NOTE: this does not mean that the Mount Allison University REB necessarily endorses its use). Researchers may wish to include the following text (or something similar) in consent forms, invitations to participate, or in the opening page of the on-line survey: "Please note that the on-line survey is hosted by "Survey Monkey" which is a web survey company located in the USA. All responses to the survey will be stored and accessed in the USA. This company is subject to U.S. laws, in particular, to the U.S. Patriot Act that allows authorities access to the records of internet service providers. If you choose to participate in the survey you understand that your responses to the questions will be stored and accessed in the USA. The security and privacy policy for Survey Monkey can be viewed at http://www.surveymonkey.com/ " 7. Do I need to use a signed consent form when I do surveys? Yes and no. It is likely impractical to obtain signed, written consent from people doing a survey, because you are likely involving a large number of survey participants. The one exception might be if you planned to do an intercept survey (where you stop people on the street or in a location and ask them to participate). In this case it may be possible and preferred. However, in most survey projects it will be sufficient for you to provide enough information in a cover letter or information sheet about the project and the nature of the questions / involvement, and conclude by stating that their willingness to complete and return the survey is interpreted as their consent to participate and for you to use the information they send in. For on-line surveys, a similarly worded statement involving “click here to proceed” will also be sufficient and appropriate. In any case, contact information for the research team members and for the REB must be provided. Page 4 of 13 8. Do I need to use a signed consent form for focus group participants? A signed consent form is not always necessary or possible in a focus group setting, especially if the numbers are larger, and if you have no intention of directly quoting anyone. It may be sufficient to read the purpose of the research and the nature of their participation, to the participants, and to explain the issues of confidentiality within the group, and to explain how you will use the information. You can conclude by inviting people to stay if they agree with the terms of participation, or to leave if they wish, and in doing so, without any penalty or negative consequences to them. However, it is essential that all participants be provided with some type of information sheet that summarizes what you have told them verbally, and that it has contact information for the research team members and for the REB. If you intend to quote participants directly, they must be informed of this prior to the start of the research activity, and they need to be assured that they will be quoted anonymously (no names used). If you wish to quote participants using their name(s) you must obtain signed, written consent. 9. I want to reimburse the people who participate in my project. What is allowed? What I can give them? Using incentives and/or reimbursements can be tricky. Because incentives are used to encourage participation in a research project, they are an important consideration in assessing voluntariness – if you offer something, does it change people’s willingness to participate, and how does that affect the research you are doing? Where incentives are offered to participants, they should not be so large or attractive as to constitute an inducement to take risks that one would otherwise not take. The onus is on the researcher to justify to the REB the use of a particular model and the level of incentives. In considering the possibility of undue influence in research involving financial or other incentives, researchers and REBs should be sensitive to issues such as the economic circumstances of those in the pool of prospective participants, the age and capacity of participants, the customs and practices of the community and the magnitude and probability of harms. Reimbursement for participation-related expenses is intended to ensure that participants are not put at a direct or indirect financial disadvantage for the time and inconvenience of participation in research. Direct expenses are costs incurred because of research participation (e.g. paying for transportation to or parking at the research site) while indirect expenses are losses that arise from participation (e.g. taking unpaid leave from work). If you plan to include a draw for a prize of some sort, it should be reasonable relative to the effort involved for the participants, the number of participants, and the size and scope of your project. Holding a draw for a trip to Mexico to encourage 4th year Science students to participate in an on-line survey likely is not a good fit; but perhaps movie passes or a retail gift card might be. If you plan to reimburse participants who have to travel from a distance to your research location (lab, office, experiment site) then offering to cover their gas expenses or mileage expenses (using Mount Allison University rates) would be reasonable. You should especially consider this if you are asking people to make repeat visits (such as to come to your lab for monthly tests). If you are offering incentives or reimbursement, it is important to share this information with participants before the research begins, during the stage of obtaining consent. Page 5 of 13 10. Participants might feel stressed or anxious before or during my research activity. What resources are available to them? This largely depends on the specific nature of your project. As part of your research design, you may need to have professionals or counsellors on site or readily available. In other cases it may be enough to provide a debriefing letter or information sheet as people leave the room, containing information about where they can get help or assistance. If the project is more than minimal risk in nature then the REB will be looking for more details about how you will protect the interests of the participants, and will want assurances that individuals will be supported if there are problems. 11. Something bad happened to one of my research participants while they were doing the experiment / test. What should I do? Hopefully you were able to assist them and get them help. Hopefully, you stopped the research activity or experiment so that no one else might have a problem. There is a need to immediately report any issues or problems that arise, to the REB. Contact the REB Chair or the Office of Research Services (reb@mta.ca; 364-2618). The issue / problem will be assessed and recommendations will be made to you about the next steps you should take. 12. How long am I supposed to keep my data? What about the various files and consent forms and other materials from my research project? The answer is – “it depends”. It depends on many factors including the type of research and the nature of the discipline in which you are working. It also depends on whether or not you intend to publish the results of your research – usually you should keep the data and related information and forms for 5 years after the publication date. The TCPS offers some general guidance on the matter of retention. Article 5.3 suggests the following: “In considering the adequacy of proposed measures for safeguarding information during its full life cycle, REBs should not automatically impose a requirement that researchers destroy the research data. Stored information may be useful for a variety of future purposes. Appropriate data retention periods vary depending on the research discipline, research purpose and kind of data involved. In some situations, formal data sharing with participants may occur – for example, by giving individual participants copies of a recording or transcript as a gift for personal, family or other archival use.” It is best to keep copies of signed consent forms and related for at least three years after the research project has ended. These should be kept in a safe, secure location, such as a locked filing cabinet in a faculty members’ office, or in a storage box in a secure storage room. For students, it is best to consult with your supervisors to see if they will store your data, forms, and related information after you leave Mount Allison. If this is not possible, please contact the Office of Research Services (research@mta.ca) to discuss your options. Page 6 of 13 13. I want to do research on children. Are there any special issues I should think about? Children do not have the full capacity to understand the nature of their participation and to consent to it, from a legal standpoint. In these cases you must do two things. The first is that you must seek consent (written or otherwise) from parents/guardians. They will be able to consent on behalf of their children. The second is that you still must obtain some type of consent from the children. For younger children it may be sufficient to verbalize to them (alone or in a group setting) what the project is about and what they will be asked to do, and to ask them if they would like to go ahead. For older children this approach is also appropriate, but it may be possible to use a plain language, simplified version of the consent form given to their parents/guardians. You should also be aware that if you are conducting the research in a school or classroom setting, it will important to put in place a process or sufficient information to avoid any notion in the minds of students about possible coercion that may arise by involving teachers or school administrators in the recruitment of students to participate; you may need to have a separate ethics review and approval at the school or school board / district level (or a letter from them saying that they do not need such review and approval); you may need to submit to a criminal record check (if required by the school); and so on. 14. How do I deal with the fact that what the child consents to and what their parent / guardian consents to, for them, is not the same? When doing research involving children, you will likely need consent from parents / guardians. In some cases the child may agree to participate while the parent / guardian does not agree to have their child participate; in other cases their parent / guardian allows participation but the child does not wish to participate. In these cases you should not include the child in question since there is not full agreement on participation. Sometimes both may agree to participation but not agree on how the child may be involved or be quoted, for example. In these cases, you should only involve the child or quote the child, taking the most conservative approach. For example, this may mean that you must not use their name or even a pseudonym, as per the instructions on the consent form that has been signed. 15. I forgot to get approval before I started my research – what do I do with my data? Ideally, you should have applied for research ethics approval first. Depending on the nature of the research and the data you have collected, it may not be possible for the REB to grant you approval to use the data, and you will have to start all over again. However, if the data is anonymous and the involvement was minimal risk to the participants, it may be possible to seek approval. The REB may ask that you seek consent from the participants. You may ask for a waiver of consent, subject to Article 3.7 of the TCPS: “The REB may approve a consent procedure that does not include or that alters some or all of the elements of consent or may waive the requirement to seek informed consent, provided that the REB finds and documents that all of the following apply: a. the research involves no more than minimal risk to the participants; Page 7 of 13 b. the alteration or waiver is unlikely to adversely affect the welfare of the participants; c. it is impossible to carry out the research and to answer the research question properly, given the research design, without the alteration or waiver; d. whenever possible and appropriate, the participants will be debriefed and provided with additional pertinent information after participation or at a later time during the study; and e. the altered or waived consent does not involve a therapeutic intervention, or other clinical or diagnostic interventions.” 16. I am part of a research team involving researchers from two other universities. How do we go about getting research ethics approval? The Mount Allison University REB has the authority to review all research protocols if the research is conducted by Mount Allison University researchers when they are part of a larger research team involving those from other institutions. The REB accepts submissions by the team using forms and attachments from the REBs of other recognized institutions. Mount Allison University researchers may submit their protocols to the REB before, concurrently with, or after submission to or approval from other REBs. Approval from another institution’s REB does not automatically mean that the REB will provide approval. If and when other institutions’ REBs provide approval, the REB requires copies of approval letters or certificates for record-keeping purposes. 17. I want to do research on university students at another university. Do I need to get approval from Mount Allison University’s REB, from the other university’s REB, or both? You will definitely need to get need approval from the Mount Allison University REB. Whether you need approval from the other university’s REB depends on how you intend to involve the other university. If your recruitment will be done through publicly available means with no assistance / endorsement from the other university (such as, for example, putting up recruitment posters on campus or posting information on a Facebook page or going to the campus and doing some type of intercept recruitment such as an information booth), then you do not need their REB review and approval. However, if the other university will be involved in any way, such as, circulating email recruitment notices or information, promoting the project in specific classes, etc., then you will need REB approval from that university. If the latter is the case, you can get approval from both institutions simultaneously or you could obtain approval from one and then the other. Copies of protocol submissions and approvals from each institution would need to be filed with the other, for record keeping. 18. I already received approval from the Mount Allison University REB, but I want to change a few things now that I have started collecting data. What are the types of changes that require approval from the REB, or can I just go ahead on my own? You will need to get approval, using our Form 2. A Form 2 is a request to modify a project that has already received REB approval. Modifications may include a change of location, a change in population, a change in the timing of the research, change of questions to be used, etc. A Form 2 is only used when there has not been a substantive change in the nature of the research project. When in doubt about if you need to complete a Form 2, please contact reb@mta.ca. Page 8 of 13 19. Do I need to explain in my research report or journal articles that I received consent from participants? This will vary from discipline to discipline and journal to journal. When it doubt, you should briefly explain in your methodology that you obtained consent, and the manner in which you did so. 20. Where can I get help completing the REB forms? The Office of Research Services provides support for research ethics on campus. Please email reb@mta.ca with your questions or needs, or call 364-2618. Alternatively, the Chair or other members of the REB can provide advice and guidance. A full list of members is found on the Research Ethics Board web page. 21. Does the university provide any protection for researchers and student researchers in case something goes wrong in my project? What about the REB and its members – are they protected by the university? Mount Allison University’s insurance coverage – CURIE (Canadian Universities Reciprocal Insurance Exchange) would cover any incident that might arise out of research as long as the research is part of the employment obligation of the faculty member. If the University was sued the University would be covered. If a faculty member was sued for something done while working for the University (carrying out their experiments) they would be covered. If the University is paying the student to do research (employed by a faculty supervisor) or they are carrying out their own research (supervised by a faculty supervisor) they too are covered. The REB committee members would also be covered, provided it has acted as a reasonable and prudent REB should act in all circumstances. So long as all of the proper checks and balances and good practices were in place while undertaking the project, and the terms and conditions agreed to as approved by the REB were followed, then we (everyone involved) have shown due diligence and care and would not likely be found to be negligent. Given the potential risk present in a specific project, it is necessary that anyone (students, research assistants) administering any tests or procedures receive the proper training and supervision. The principal investigator of the study is responsible for protecting the student by giving adequate training and supervision. 22. What am I supposed to do if someone in my study tells me they are going to hurt themselves or someone else? You are required to report to appropriate authorities any situations where someone tells you that might kill or severely injure themselves or someone else. If your research study involves experiments or questions related to the possibility that someone might report they are going to harm themselves or others, or the participants involved are from a population where the likelihood or possibility of this being told or indicated to you, then you should, before the study begins, include a statement such as the following in your consent form or indicate this verbally to the participants “Should I (or we) become Page 9 of 13 aware that you are a danger to yourself, others or children in the household we are legally obligated to will report this to the appropriate authorities.” You must definitely report cases of child abuse or elder abuse. 23. If I uncover illegal activity in the course of my research, what should I do? What am I supposed to do if the police or another person of authority asks me to tell them what I have collected from a participant in my study? In general, researchers have no obligation to provide specific information about any individual to an authority figure, unless they have been served with a valid warrant, subpoena or other valid legal process. And, even if served with some such legal process, a researcher may seek to resist, on legal grounds, the validity of the court order. If you are conducting a study about illegal activity, such as illegal drug use, the REB would only approve such research as long as participants are informed prior to their participation that the researchers will not report the illegal activity, except in the case of self-harm or harm to others, and as long as all other appropriate measures are taken to ensure the safety, privacy and rights of participants. 24. I am a researcher at another university. I already have ethics approval from my university and I want to survey students (or faculty or staff) at Mount Allison University. Do I need to make a submission and receive an approval from your REB? If you are contacting research participants from Mount Allison University directly, on your own, using publicly available information (such as contact information on departmental websites, through listserves, or social media), you do not need review and approval from our REB. However, if you are needing or plan to request help from someone at Mount Allison University (such as an administrator to send an email to all students on your behalf, a faculty member to recruit students on your behalf for your study, or a department head or Dean to forward information to faculty members inviting them to participate in your study), you will need approval from our REB. If this is the case, you can submit your original REB application and approval letter / certificate from your own university, along with a cover letter explaining this approval. In addition, in the cover letter, you should explain if there are any variations on how you will do recruitment at Mount Allison University if it is not already clearly explained in the original approved application. Finally, you should also provide us with a copy of the recruitment text / information, and consent information, tailored to Mount Allison University, that you will use for the study. When in doubt, please contact us at reb@mta.ca. 25. How do I know if my potential study participants are part of a “vulnerable population”? This issue is discussed in Chapter 1 of the TCPS 2.0 under the core principle of “Justice” http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter1-chapitre1/. “Vulnerability is often caused by limited capacity, or limited access to social goods, such as rights, opportunities and power. Individuals or groups in vulnerable circumstances have historically included children, the elderly, women, prisoners, those with mental health issues and those with diminished capacity for self-determination. Ethnocultural minorities and those who are institutionalized are other examples of groups who have, at times, been treated unfairly and inequitably in research, or have been Page 10 of 13 excluded from research opportunities. People or groups whose circumstances cause them to be vulnerable or marginalized may need to be afforded special attention in order to be treated justly in research.” The REB needs to know if any or all of your participants might be considered “vulnerable”, so that it can give an appropriate review of your application and understand if and how you will ensure your research methods (including recruitment processes, experiments, tasks, and so on) take into account the needs of the individuals. Just because your participants may be “vulnerable” does not mean the project cannot proceed – it simply means that you must carefully consider and explain how you will involve them in the study. The onus is on the researcher(s) to discuss this in the application, and, in cases where it is possible that members of the REB and the researcher(s) might have potentially different opinions about whether or not the participants are “vulnerable”, you should take care to explain why you feel that the participants are not part of a vulnerable population. Section C of the Form 1 application form asks you to indicate whether or not the participants might be considered vulnerable and how you will address their needs. 26. What is the difference between confidentiality and anonymity? Confidential data: This occurs when there is a documented linkage between a participant’s identity and his/her response(s). The researcher provides assurance in the protocol and in the informed consent form that the participant’s identity will not be revealed in any report of the study. Confidential also means that the researcher can (or could) identify individuals who participated in a study, perhaps through a code. (https://orra.rutgers.edu/anonymous-vs-private-vs-confidential-data) The ethical duty of confidentiality refers to the obligation of an individual or organization to safeguard entrusted information. The ethical duty of confidentiality includes obligations to protect information from unauthorized access, use, disclosure, modification, loss or theft. This means that you will not share or disclose the information to people outside of your research team, and that you will put in place measures to ensure that data and information is not stolen or used by others who do not have permission to have it or use. To achieve this, you need to keep your paper copies stored in a locked place, and you need to use coding or encryption to protect digital data. When you report the results of your research, you are not breaking confidentiality – you are using the information in ways you told the participants you would be using it. In some cases, you may have to break confidentiality, for example, if participants tell you they are going to hurt themselves or someone else, or if, under force of law, you are required to tell authorities what you have been told or what has been shared with you. Anonymous data: No personal identifiable information is collected, and data are recorded in such a way that no identifier whatsoever exists to link a participant's identity to his or her responses. No one can link an individual person to the responses of that person, including the investigator. (https://orra.rutgers.edu/anonymous-vs-private-vs-confidential-data) Anonymity means that someone’s identify is not revealed. Usually, in most research projects, you will know who the participant is because you have interviewed them or conducted an experiment with them. You cannot claim to offer anonymity for them, even if you intend to anonymize the data by removing identifiers, because you will still know who they are. In other research projects, you may not know who they are – they remain anonymous. For example, participants complete a survey and return it with no identifying information. If you do not collect any identifying information, and there is no way for Page 11 of 13 you to trace who they are, then you have completely anonymous data. If you do collect identifying information, it is possible to create an “anonymized” data set by removing all of that information and saving the information in a separate file. You might include a code that links this data back to a separate data set with the identifying information. This will provide some measure of anonymity, but as long as you or someone else can go back to the original data, you are not providing complete anonymity. It may not be feasible, desirable, or possible to provide anonymity in your study. This is okay in a research project, so long as the participants are aware of this. For example, interviews with people in public office are usually not anonymous because even if you do not reveal names, by virtue of the topic and location and the public nature of the person, people will be able to figure out who it is. 27. Am I required to disclose if my research funded by a sponsor (such as a private industry or a foundation)? Article 3.2 of the TCPS outlines the range of information that should be provided to potential participants in order for them to make an informed decision about whether or not to participate. You are not required to disclose if and by whom, your research is funded. The only directive related to this is to provide “information concerning the possibility of commercialization of the research findings, and the presence of any real, potential, or perceived conflicts of interest on the part of the researchers, their institutions, or the research sponsors.” Having said that, if your research is sponsored or funded by a company, organization, foundation, or other body, it might be an important consideration for a participant to know this before making their decision to participate or not. Furthermore, participants should be made aware of what will be provided to the funder (for example, any or all of a summary report, an anonymized data set, a full data set with potential identifiers, etc.). 28. I’m not sure if my research requires ethics review. What should I do? When in doubt about whether REB review is required, it is always best to contact the REB Chair or the Ethics Coordinator at reb@mta.ca, to obtain best advice. While the TCPS provides direction on what requires review (see Article 2.1) and what does not require review (see Article 2.2 to 2.6) there can still be questions about interpreting and clarifying with respect to a specific proposed project. Furthermore, given the unique aspects of qualitative research with emergent design (see Article 6.10 and Article 10.5), it is important to contact the REB before starting a project to determine when, in the research project, REB review would be required. 29. My research project involves getting help from someone inside an organization to make people aware of the project and to help me recruit participants. What approvals do I need and what are the ethical considerations in how I should involve them? The University of Waterloo provides some excellent instructions and examples of how to handle these situations https://uwaterloo.ca/research/office-research-ethics/research-human-participants/presubmission-and-training/human-research-guidelines-and-policies/guidelines-conducting-researchwithin-structures-and). These individuals are commonly referred to as gatekeepers or points of contact. When you want to conduct research within an organization or recruit persons from within an organization, you should consider the following: Page 12 of 13 • • • • You may need formal ethics approval from that organization (for example, health organizations, school board, etc.). A gatekeeper or point of contact can facilitate this. You may need an official letter of endorsement or approval to do the project. A gatekeeper or point of contact can facilitate this. You may want someone in the organization to promote awareness of the project, perhaps by emailing potential participants or by posting information somehow. This should be done carefully to avoid the perception of undue coercion, or, in cases where a report from the study might be given to the organization or the gatekeeper, that participants’ identities are protected. There could be issues if someone was encouraged to participate by chose not to do so. Any communication from the gatekeeper to potential participants should make it clear that if people choose to participate, on what basis can they participate (during working hours or outside of working hours, if it is part of their usual activities or extra commitment, etc). You may want someone to provide you with contact information (such as email addresses) of potential participants. This should be carefully considered – for example, the sharing of employee email addresses could be a violation of the organization’s policies, or could be a violation of provincial regulations associated with protection of personal information. It is important to consider these and related issues when you will potentially involve a representative (gatekeeper) of an organization, business, institution, etc., because it will dictate, in part, how you shape recruitment materials, consent forms, reports, and so on. Extra care will be required in describing the role(s) of the gatekeeper and how you will minimize potential negative impacts or risks to potential participants. Useful Links • • • • Panel on Research Ethics Website o http://www.pre.ethics.gc.ca/eng/index/ TCPS 2.0 o http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/ On-line Tutorial o http://www.pre.ethics.gc.ca/eng/education/tutorial-didacticiel/ Interpretations of the TCPS 2.0 o http://www.pre.ethics.gc.ca/eng/policy-politique/interpretations/Default This file last updated August 17, 2015. Page 13 of 13