The guidance notes following this introduction correspond to the questions in the RISe online Application for Ethical Review and each question in the application includes a link to the relevant item discussed below.
The online application form is divided into pages or views with required fields in each view which will prevent you from proceeding to the next page unless you have completed all of the required fields. If you are unfamiliar with the application form the BREB suggests that you read the following guidance notes before you begin.
If you wish to search for a specific term in the page, please first expand all of the content. Open All
The UBC Behavioural Research Ethics Board (BREB) procedures and Guidance Notes comply with the second edition of the Tri-Council Policy Statement (TCPS) on "Ethical Conduct for Research Involving Humans" (TCPS 2). The UBC BREB operates under the authority of UBC Policy 89 on Research and Other Studies Involving Human Subjects (approved 2012).
The questions in the application form have their origins in the guiding ethical principles outlined in the Tri Council Policy Statement as respect for persons, concern for welfare and justice. All Investigators are responsible for understanding and adhering to the TCPS 2 and other relevant guidelines. These Guidance Notes are not a substitute. Please refer to the original documents for complete information.
The following Guidance Notes are intended to ensure that the applicant has the necessary information to be able to complete correctly the Application for Behavioural Research Ethical Review. The Guidance Notes are numbered sequentially and correspond to the numbered boxes on the form.
The application itself is completed online through the RISe (Researcher Information Services) system, which is available at the following link: http://rise.ubc.ca. To access RISe, you will need a campus wide login (CWL) and a Researcher Account/Number. To obtain the latter, please email firstname.lastname@example.org and provide the administrator with the following information:
- Business Email Address
- Business Telephone Number
- UBC Department of Affiliation (if none, provide the name of your Institution and Department)
- UBC Rank
- UBC Employee ID (If applicable)
- UBC Student ID (If applicable)
The RISe administrator will email you the researcher number upon receiving your request.
Behavioural Research Ethics Review at the University of British Columbia is restricted to the review of the ethical conduct of research involving humans based on a specific, delimited definition of both 'research' and 'human participants'.
According to Article 2.1 of TCPS 2, research is defined as "an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation". The TCPS defines "human participants" as "those individuals whose data, or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research question".
Based on this definition, not all individuals the researcher obtains information from in the course of a research study are defined as "human participants". According to TCPS 2 (Article 2.1),
In some cases, research may involve interaction with individuals who are not themselves the focus of the research, in order to obtain information. For example, one may collect information from authorized personnel to release information or data in the ordinary course of their employment about organizations, policies, procedures, professional practices or statistical reports. Such individuals are not considered participants for the purposes of this Policy. This is distinct from situations where individuals are considered participants because they are themselves the focus of the research. For example, individuals who are asked for their personal opinions about organizations, or who are observed in their work setting for the purposes of research, are considered participants.
According to Articles 2.2-2.6 of TCPS 2, the following studies are also exempt from REB review:
- Research that relies exclusively on publicly available information does not require REB review when:
- The information is legally accessible to the public and appropriately protected by law; or
- The information is publicly accessible and there is no reasonable expectation of privacy
- REB review is not required for research involving the observation of people in public places where:
- It does not involve any intervention staged by the researcher, or direct interaction with the individuals or groups;
- Individuals or groups targeted for observation have no reasonable expectation of privacy; and
- Any dissemination of research results does not allow identification of specific individuals.
According to a recent TCPS interpretation, a public space is one that is open to the public and intended to serve it: museums, parks, libraries and shopping malls are provided as examples of spaces that meet these requirements.
- REB review is not required for research that relies exclusively on secondary use of anonymous information, or anonymous human biological materials, so long as the process of data linkage or recording or dissemination of results does not generate identifiable information. Please go to the confidentiality of the data section for more information on what constitutes anonymous data.
- Quality assurance and quality improvement (QA/QI) studies, program evaluation activities, and performance reviews, or testing within normal educational requirements when used exclusively for assessment, management or improvement purposes do not fall within the scope of REB review.
- Creative practice activities, in and of themselves, do not require REB review. However, research that employs creative practice to obtain responses from participants that will be analyzed to answer a research question is subject to REB review.
If you believe your study is exempt from review, ensure you consult the expanded discussion of exempt research and activities in Chapter 2 of the Tri Council Policy Statement before making a final assessment. Graduate students can also consult the human research ethics requirements checklist.
If you are conducting a quality improvement/quality assessment or program evaluation study, a checklist is available to help you make a determination as to whether your project requires review. If you are in any doubt regarding whether your study requires review, you are encouraged to contact the BREB.
The Office of Research Services is able to release limited amounts of grant funding to researchers for "initial" research work that does not involve human participants. Requests are reviewed individually by the Director, Research Ethics. To submit a request, follow the instructions provided in the form. Please be aware that you will need to submit an ethics application well in advance of beginning the component of the study that involves human participants.
The Head of Department (HOD) must approve the application following its submission by the Principal Investigator. By approving the application the HOD confirms that "the Principal Investigator has the qualifications, experience, and facilities to carry out this research". Clicking the approval button is equivalent to providing a signature.
Reviewed by Department Head*
Appears in research ethics board administrator's inbox:
Minimal risk studies → Academic member reviews
Full Board studies → 2 primary reviewers → reviewed at board meeting
Approved - certificate of approval
Deferred - provisos with responses to be reviewed by full board
*Because the Department Head has to review the application before it is available for review by the REB, if you are submitting a full board application, it is important that you factor in sufficient time for the departmental review ahead of the submission deadline.the Department Head review to your submission timeline.
The Principal Investigator OR the contact person named in box 1.2 will be notified via an automated RISe e-mail when a decision has been made. The outcome of the review can be viewed by anyone listed in items 1.1, 1.2, 1.3, and 1.4.
Decisions Arising from the Review Process
The outcome of the first review of the application through either a Full Board or Minimal Risk review will be one of the following four decisions: approval, proviso, deferral, or not approved.
- Approvals – As required by the TCPS the Certificate of Approval will be issued for a term of one year. Research with human participants cannot begin until a Certificate of Approval has been issued.
- Approval – the Certificate of Approval is issued and the research may begin.
- Approval with a suggestion or request for information - the Certificate of Approval is issued with a memo providing advice or requesting minor clerical changes.
- Conditional Approval (Pending Institution approval) - If the research is carried out at another institution, UBC requires written evidence of approval from the other institution. A letter of Conditional Approval is issued if the institution requires evidence of UBC approval before it will review a request to do research in the institution.
- Provisos – Some concerns need to be addressed before approval is given. Please note that this is the most common decision arising from the review process. It does not mean that your research is unethical, but just that the reviewer would like some clarifications about aspects of the application.
- Deferred – Based on the documentation provided, the BREB is unable to make a final decision. The decision is deferred for full board review at such time as the investigators submit the supplementary information or documentation as specified by the BREB.
- Not Approved - According to TCPS Article 6.18 on Reconsideration and Appeals, "Researchers have the right to request, and Research Ethics Boards have an obligation to provide, reconsideration of decisions affecting a research project."
When the investigators and the BREB cannot reach agreement on a decision of the Board, you can request the UBC Research Ethics Appeal Board to review the BREB decision. TCPS Article 6.18 on Appeals states: "If a disagreement between the researcher and the REB cannot be resolved through reconsideration, the researcher shall have the option of appealing the REB decisions through the established appeal mechanism". Requests for appeal should be directed to the Office of the Vice President Research and Innovation. See Policy 89.
As noted above, the Certificate of Approval will be issued for a maximum period of one year. TCPS 2 Article 6.14 states "The REB shall make the final determination as to the nature and frequency of continuing research ethics review in accordance with a proportionate approach to research ethics review. At minimum, continuing research ethics review shall consist of an annual status report (for multi-year research projects), and an end-of-study report (projects lasting less than one year)."
For help with behavioural research ethics applications.
UBC BREB: See the contact page
UBC Okanagan: Lisa Shearer, Associate Manager
email@example.com | 250-807-8289
BC Cancer: Kristie Westerlaken, Manager, BCC REB
firstname.lastname@example.org | 604-877-6284
Children's & Women's: Jennie Prasad, Manager, C&W REB
email@example.com | 604-875-2441
Providence Health Care: Julie Hadden, Manager Ethical Reviews, PHC REB
firstname.lastname@example.org | 604-682-2344 ext. 63496)
Applications will not be approved if there are questions that have not been answered. Please ensure that all boxes on the form are filled out, even if the answer is "not applicable" ("N/A"), "no" or "none". Please do not answer "N/A" if the question is applicable but the answer is "no" or "none". Researchers may wish to briefly justify why they feel that the question is not applicable to their research or the answer is no/none.
The Principal Investigator (PI) for a study is responsible for adhering to TCPS 2 and other relevant guidelines, and indicates this by clicking "OK" in the Submit Activity view on the application homepage. Based on security in the RISe system, only the PI listed in Question 1.1 on the application has access to this Submit Activity on the application homepage. The PI's signature attests to the following:
By signing below, I certify that I have read this application together with its attachments and that all information provided herein is accurate and complete. If I am submitting this application in my capacity as a research supervisor, I acknowledge that responsibility for the ethical conduct of the research rests with me.
a) UBC Faculty
The Principal Investigator must have a Faculty Appointment (for example, Assistant Professor, Associate Professor, Professor, or Emeritus Professor). This includes Clinical Faculty appointments in the Faculty of Medicine.
b) Hospital Employees
The UBC Research Ethics Boards also review research carried out at affiliated teaching hospitals by employees who do not have Faculty appointments and who are not UBC students. In this case, the employee should be listed as the Principal Investigator and the employee's Hospital Department Head should sign the application.
c) Course Instructors
Course instructors who are applying for research ethics approval for course-based assignments in subjects they are teaching (e.g., research methods courses) can be listed as a PI on their application, even if they do not hold a regular faculty appointment. If you are an instructor and require the capacity to list yourself as a PI on the application please contact email@example.com (Point Grey campus) or firstname.lastname@example.org (Okanagan campus).
a) UBC Graduate Students
If the research is for a graduate degree, the graduate student's Faculty Advisor must be listed as the Principal Investigator. This is because the Faculty Advisor will be held accountable by UBC for the research. It is also the Faculty Advisor's responsibility to inform the Department Head and the BREB of any change to the application or supporting documents during a research study. The ethics application, recruiting materials, and consent documents must indicate that the research is being conducted for a Master's or Doctoral thesis. Please note that if you are a graduate student preparing the application, it is a good idea to use the third rather than the first person throughout the application, so that it is clear exactly who is doing what (e.g. the supervisor vs. the student).
UBC Students who are also employees at non-affiliated community and acute care sites
The student may be confused by two roles and two sets of rules. If this is research for a UBC degree, the student's UBC Faculty Advisor must be listed as the Principal Investigator on the ethics application. If the student plans to conduct research at his/her place of employment, the community or acute care site may require that the student designate another employee to supervise the student's research within the institution. This individual will need to be included as a co-investigator.
The consent documents must be on UBC letterhead with the UBC logo, but may also include the logo of a community or hospital site. The student must make it clear in the consent document that she/he is conducting the study in her/his role as a UBC student and avoid giving the impression that the study is part of the participant's medical care (if it involves patients) or employment (if it involves subordinates).
b) Non-UBC Students (affiliated teaching hospitals)
Students from other educational institutions wishing to do research in the affiliated teaching hospitals must do so with the supervision of a hospital employee, who will submit the application as the Principal Investigator.
Faculty and students from other educational institutions wishing to conduct research at UBC which does not involve a member of the UBC Faculty as a co-investigator may submit an application for ethical review in the non-UBC Faculty member's name. The student should list his/her faculty advisor from the home institution as the Principal Investigator. The application will need to include a covering letter indicating that it is a non-UBC affiliated study.
All personnel (including Faculty) who are associated with a research project and who will have contact with the research participants are required to complete the TCPS online tutorial 'CORE' (Course in Research Ethics') before the ethics application will be approved by the BREB. This includes (but is not limited to) undergraduate and graduate students, medical residents, research assistants, and research coordinators. The TCPS Certificate of Completion does not need to be attached to the BREB application. Copies should be retained by the Principal Investigator and be available on request. The date of completion should be recorded in the research team member's RISe profile. The tutorial is free. It takes a minimum of three hours to complete and can be found at http://tcps2core.ca/welcome.
The original TCPS tutorial and the CHRPP (Course in Human Research Participant Protection) tutorial are acceptable substitutes for CORE.
Instructors submitting Course-based projects should ensure the primary title and nickname of the project is prefaced with "Course project" so that it can be appropriately identified in RISe.
For Family Practice Residency projects, include "Family Practice Project" in the first part of the nickname.
If you plan to start data collection as soon as ethics approval has been obtained, make sure you check the first box. Only provide an estimated start date if it is at some point in the future, e.g., the period that involves research with human participants, if you are doing a multi-phase project.
The end date can be an estimate of when you expect to have completed data collection and can be extended by an application for renewal or amendment.
Research grants or contracts administered by the University or affiliated institutions will not be established until the project has been reviewed and approved by the appropriate Research Ethics Board. If you require access to a portion of your research funds in advance of involving human participants, you can submit a request for funding release.
Please note that an exact match between the grant title and Ethics Application title is no longer required; you may list multiple grants (sponsors) and titles in one application.
If you are a graduate student and have received a scholarship or bursary that is not specifically connected with your proposed research, please tick "other" in Box 2.2A. However, please note that you cannot proceed to the next section of the application form unless you list a funding source in Box 2.2.B.
The BREB needs to be satisfied that participants are informed of conflict of interest matters in the consent form. Note that "immediate family members" includes partners and children (whether living in the household or not). The BREB does not require that the investigator identify holdings in managed mutual funds to be declared in the conflict of interest statements. If you answer yes to this question you will be asked to provide more detail in View 3, otherwise you will be directed to section 4 of the application form.
UBC currently has six Research Ethics Boards (REBs) that review and approve research studies involving human participants that are conducted under the auspices of UBC. Each individual Board has varying operational procedures, and researchers are advised to familiarize themselves with the processes of the REB they submit applications to. Each REB has its own website to assist researchers with information concerning submission deadlines, meeting dates, etc.
The Behavioural Research Ethics Board (Point Grey Campus) reviews behavioural, social science and humanities research, and research which may involve the study of patients or healthcare providers, unless it is being conducted at UBC-Okanagan. Please note that behavioural studies do not involve invasive procedures such as blood draws, drug administration, and physiological interventions. They do include research involving interviews, observations, ethnographic research, the administration of questionnaires or tests, etc.
The Okanagan Behavioural Research Ethics Board reviews behavioural, social science and humanities research that is being conducted by individuals affiliated with UBC-Okanagan.
The Clinical Research Ethics Board reviews clinical research that involves clinical interventions such as surgery, the administration or testing of drugs, medical devices, medical imaging or diagnostic techniques, taking of blood or other specimens, exercise programs, the analysis of clinical (i.e. laboratory, physiological or biological) data obtained from medical records or studies of a clinical nature involving the linkage of data from existing databases or any invasive procedure involving an element of risk. The CREB reviews research being conducted at the UBC Hospital (Point Grey) site, and the Vancouver Coastal Health Authority sites.
The BC Cancer REB, Children & Women's REB and the Providence Health Care REB review research being conducted at their sites. If a UBC-affiliated researcher wishes to conduct research at ONLY one of these sites, they should submit their application to that site. If a UBC Researcher wishes to conduct research at other non-UBC affiliated sites, but not at a UBC-affiliated site, they should submit their research to the REB where they hold their primary appointment. UBC researchers who wish to conduct research at MULTIPLE UBC affiliated sites have the option of having their study reviewed by any UBC-affiliated REB. It is recommended that they utilize the REB associated with the institution where they hold their primary appointment.
At the discretion of the Chairs and Managers of the UBC REBs, a submission may be re-directed to a more appropriate REB. Please consult with REB staff if you are not sure which REB you should apply to.
4.2 A. Affiliated teaching Hospitals
VCH – Vancouver Coastal Health: Research conducted at any institution within the Vancouver Coastal Health Authority (e.g. Vancouver General Hospital) will be reviewed by the Vancouver Coastal Health Research Institute (VCHRI), in addition to the UBC Behavioural or Clinical REB.
C&W – Children's and Women's Health Centre of BC: Any research conducted at Children's Hospital, Sunny Hill Hospital, and Women's Hospital, collectively known as C&W, must be reviewed by the C&W REB. Please check the BCCHR web page for the Children's & Women's REB deadlines. These are not the same as the BREB deadlines.
PHC – Providence Health Care: Any research involving human participants conducted at a Providence Health Care (PHC) site must be reviewed and approved by the UBC-PHC Research Ethics Board. The UBC-PHC REB also reviews research which involves patients who are receiving care at a PHC site.
BCC – BC Cancer: Researchers at BC Cancer should submit their new applications for ethical review to the UBC-BCC REB for all clinical projects and in the case of behavioural projects to either the UBC-BCC REB or the UBC Behavioural REB. However, anyone conducting research, behavioural or otherwise, at BC Cancer, must make sure they obtain approval from any BCC Department whose resources are affected by the conduct of the study. The Principal Investigator is responsible for identifying and meeting those requirements.
4.2 B. All other locations
Please describe other locations from where research participants will be recruited and / or describe where data collection will occur (e.g. cafes, offices, homes).
According to TCPS 2, research in the humanities and the social sciences that poses, at most, minimal risk shall not normally be required by the REB to be peer-reviewed. For research that poses more than minimal risk, the BREB recognizes that there is a range of options for obtaining peer review, dependent on the nature and funding status of the study. Given this variability, the BREB requires information concerning the type of independent peer review that has been conducted and, about who conducted the review (i.e., internal or external). For graduate student research, the approval of the supervisory committee will be deemed sufficient. Please note that any review process within a for-profit agency is not considered to be independent, and so is not sufficient. Please provide details of any in-house review processes.
The process used to review new applications varies according to the level of risk that research participants could experience as a result of the particular type of research procedures used. TCPS 2 Article 2.9 states "The REB shall adopt a proportionate approach to research ethics review such that, as a preliminary step, the level of review is determined by the level of risk presented by the research: the lower the level of risk, the lower the level of scrutiny; the higher the level of risk, the higher the level of scrutiny".
The concept of 'minimal risk' provides a foundation for proportionate review. Minimal Risk is defined in TCPS 2 as follows: "research in which the probability and magnitude of possible harms implied by participation in the research are no greater than those encountered by participants in those aspects of their everyday life that relate to the research." Applications that meet minimal risk criteria are eligible for delegated review and it is expected that the majority of research submitted to the BREB will fall into the minimal risk category. However, the BREB retains the right to decide to put any application submitted for delegated review forward for full board review. In such cases, the applicant will be notified of the change in status of the application.
It is now widely accepted that the majority of research in the social sciences, behavioural sciences and humanities involves no more than minimal risk to participants. However, in determining whether your study meets the minimal risk criteria, you should consider the level of risk the study entails and the vulnerability of the research participants.
Types of risk include: physical risks, psychological or emotional risks, and social risks. Physical risks are risks of harm through bodily contact or administration of any substance – this is not a common risk in social science, behavioural and humanities research. Psychological or emotional risks are risks of harm due to feeling embarrassed, uncomfortable, anxious or upset. Psychological harms vary tremendously from study to study, from a temporary emotional reaction to a survey question to the possibility of trauma in rare cases. Social risks are risks of harm due to loss of status, privacy, reputation, legal or financial risk as a result of confidentiality breaches.
Beyond the character of the risk itself, researchers should consider the magnitude or seriousness of the harm. There is a difference between transient harms equivalent to those that people regularly experience on a daily basis (e.g., an emotional but temporary reaction to survey questions) and ones that are longer lasting (reputation loss following a breach of confidentiality). The probability of the harm occurring should also be considered; are the foreseeable harms likely, possible but unlikely, or extremely remote?
The TCPS 2 (Glossary) defines "vulnerability" as "A diminished ability to fully safeguard one's own interests in the context of a specific research project. This may be caused by limited capacity or limited access to social goods, such as rights, opportunities and power. Individuals or groups may experience vulnerability to different degrees and at different times, depending on their circumstances." Vulnerability exists along a continuum and is influenced by many factors, including (but not limited to):
- Participant capacity (mental, emotional, cognitive)
- Wellness or health status
- Power relationships
- Gender and gender identity
- Setting and recruitment
- Socio-economic status.
The TCPS 2 states that Individuals or groups whose circumstances make them vulnerable should not be inappropriately included nor automatically excluded from participation in research on the basis of their circumstances; however, it recognizes that vulnerability is contextual and relational. Article 4.7 states that, "individuals should not automatically be considered vulnerable simply because of assumptions made about the vulnerability of the group to which they belong. Their particular circumstances shall be considered in the context of the proposed research project."
Researchers are asked to perform an initial assessment of the level of risk their project entails using the following matrix which expresses BOTH participant vulnerability and research risk. After considering where the study lies on both axes, select the one box in 4.5 that corresponds to the overall level of risk the study poses.
If your study includes a low/medium level of research risk and a low vulnerability population, it would receive a "1" ranking and be eligible for minimal risk review. If your study includes a low/medium vulnerability population and a low level of research risk, it would also receive a "1" ranking and be eligible for minimal risk review. Any studies receiving a "2" or "3" ranking when the risk matrix is completed should be submitted for full board review.
Types of studies that would not qualify for minimal risk review include:
- Research that involves BOTH vulnerable populations AND highly personal, sensitive or incriminating topics or questions; e.g. studying people engaged in illegal activities (e.g. heroin use or euthanasia) and asking them about these activities; discussing experiences of bullying amongst school-aged children who have been bullied; talking to people who are currently suicidal about their experiences of depression. This does not mean that studies about these topics must always be reviewed at the full board. The overall risk level would be dependent on the population being studied and the methods of research being used.
- Research that uses deception, unless the researcher has convincingly argued that the deception is of a minor nature and the possibility of harm is remote.
- Research involving the generation of a database of populations where potential future research is unknown, and where the data could possibly be linked or traced to personally identifiable information.
Question 4.5.B gives you the opportunity to elaborate on the level of overall risk you have assigned the study. This box provides an important way of justifying your risk assessment, especially if you feel that your study might be perceived by an outsider to be sensitive or risky, but you have evidence to suggest that it is not. Ensure to describe your assessment of both participant vulnerability and research risk.
If your study falls within the minimal risk range on the matrix, it is eligible for delegated review and your responses to 4.5.C will be "yes" (study qualifies for delegated review).
There are no deadlines for applications that meet the criteria for minimal risk review. The application will be assigned for review to an academic member of the BREB as soon after the date of receipt as possible. The turnaround time depends on the volume of applications received and the availability of reviewers and is at least two weeks, unless it is determined that the application requires full board review.
UBC's Policy 89 "Research Involving Human Participants," Article 5 permits the University to enter into Ethics Review Agreements with other research institutions or organizations. Such agreements allow for alternative models for ethics review with the express purpose of facilitating collaborative research projects involving researchers, data or participants from more than one institution, and in order to avoid a duplication of efforts with respect to research ethics reviews.
UBC is a member of Research Ethics BC (REBC), whereby ethics applications are submitted in PREP (the RISe platform) and assigned to member REBs according to the jurisdictions involved in the research. See REBC for more information.
UBC has agreed to facilitate the initial review and approval of studies that have already been reviewed and approved by an authorized board of an Institution with which UBC has an Ethics Review Agreement. At present, formal agreements are in place with the University of Alberta and the University of Saskatchewan. In addition, minimal risk studies that have been reviewed and approved by another Canadian Research Ethics Board are eligible to undergo a truncated review process. A study qualifies for this process if it is minimal risk, is eligible for review by the BREB, and has been reviewed by another Canadian REB. To activate the truncated application, respond "yes" to question 4.6 and "yes" to question F.1. You will then be directed to Page 9 of the application and asked to append all relevant documentation from the other Canadian REB that has reviewed and approved the study. This includes the original application forms, informed consent documents, recruitment materials, questionnaires, surveys, certificate of approval and all correspondence between the other Canadian REB and the researcher. There may be information that is not in the other board's form that the BREB requires. In this case, the BREB will ask for the additional documentation in the course of issuing provisos.
At universities, it is increasingly common for data to be collected for dual purposes. For example, data may be routinely collected for assessment and evaluation purposes, but there may simultaneously be an intent to use this data for larger as-yet-unspecified research purposes. Alternatively, you may have previously collected data in a particular research context, and now would like to make this data available to other researchers for unspecified research purposes.
As the TCPS 2 notes, there are clear benefits to establishing a data repository, including the "avoidance of duplication in primary collection and the associated reduction of burdens on participants." Yet, answering the standard questions on the research ethics application can be difficult in these contexts, which requires applicants to have a specific research project in mind for such secondary uses of data.
Question 4.7 is designed for these situations – when your interest is in using data collected in one context for other unspecified research purposes, or in making it available for such purposes. Responding "yes" to question 4.7.A will take you to the research database branch off Page B. If your application deals exclusively with the use of this type of data, ensure you respond "yes" to question 4.7.B. This will truncate the application form so that once you have completed page B you will be directed to page 9, where you will need to attach all relevant documentation.
The questions on Page B pertain primarily to issues around privacy concerns and questions about the need to seek consent, especially if the data contains identifiable information – i.e. information that could be expected to identify an individual, alone or in combination with other available information (e.g. name, SIN, student ID number, date of birth, address, etc.). Obtaining consent for the new use of the data is an ideal that becomes achievable if your application is for data being collected prospectively. For example, if you are planning to start using routinely collected assessment and evaluation data for research purposes (e.g. the scholarship of teaching and learning), students should have the right to opt out of having their data used for research purposes, even though they may have no choice in the provision of the original data.
However, the TCPS 2 permits secondary use of identifiable information without consent in certain circumstances (see Article 5.5). Therefore, if you are not planning to obtain informed consent (B.7) you must provide a justification which includes the following:
- Explain why inclusion in the database involves no more than minimal risk to the participants;
- Confirm that the lack of participants' consent is unlikely to adversely affect their welfare;
- Demonstrate that the purpose or aim of the database would be impossible or impracticable to carry out, if the prior consent of the participant is required;
- Explain why the value of conducting this research using this database exceeds the public interest in protecting the privacy of individuals;
- Demonstrate compliance with any known preferences previously expressed by individuals about any use of the information; and
- Confirm that any other necessary permission for secondary use of information for research purposes are in place.
The TCPS recognizes that there are a number of contexts at universities where the intent of research activities is not primarily to extend knowledge but to train students, i.e. to give students hands-on research experience in their field of study for the purposes of skill development. The TCPS 2 acknowledges that this research is distinct and can be treated differently than independent, stand-alone research projects conducted outside of a course context. If you are incorporating a pedagogical research activity into an undergraduate or graduate course, responding "yes" to question 4.8 will lead you to the Course-based research project branch-off (Page D) and will then truncate to section 9. The Course-based research project branch-off asks generic questions about the research activity you will be conducting in your course and can be used even if students have the latitude to design individual projects within the broad parameters you establish. However, you must be willing to place boundaries on the types of recruitment strategies and consent processes the students use and you must also ensure that the projects are minimal risk.
The Course-based research project branch off can be used in the following contexts:
- Undergraduate and graduate research methods courses;
- Undergraduate research practicums;
- Courses offering fieldwork exercises to give students experience in aspects of the course (e.g., research communication courses, courses on a particular type of method/theory where instructors want to give students practical experience in it, etc.).
The following types of student research projects are not eligible for review as Course-based research project applications and the regular RISe application should be used:
- Projects conducted for undergraduate or graduate dissertations (honours, master's, PhD)
- Student-designed class projects involving more than minimal risk
- Graduate research practicums or other courses where the function of the project is arguably goes beyond pedagogical purposes (e.g. Family Practice resident projects, etc.)
- Student activities conducted as part of a researcher's own research program.
Please ensure that your Course-based Research Project application is clearly identified as such by prefacing the study title and nickname with "Course project."
Please also note that the TCPS 2 allows the review of these projects to be delegated to non-REB members (Article 6.12). Departments may set up a Departmental Ethics Officer to review these projects.
If your department has a DEO in place, please list them in Box 4.8.B to ensure that they are assigned as the application reviewer.
NOTE ON TERMINOLOGY: Although the TCPS 2 guidelines specify a preference for the term "participant," researchers may use the term of their choice (e.g. "participant" or "subject") as long as they are consistent throughout their application rather than switching back and forth. It is also important to be clear in your terminology. For example, if your study involves collaborators and participants, and these are distinct groups, do not use the term "participants" interchangeably to refer to both.
Succinctly state the research question or hypothesis, if a hypothesis is appropriate to the study. Describe the purpose in lay language or include definitions of jargon or technical terms. Also, all acronyms must be written out in full the first time that they appear in the application form, recruiting materials, and consent form. Please ensure that your full study proposal is appended to section 9 of the application.
Do not "paste" in descriptions from research applications, or cite papers or books in lieu of explaining procedures. All information directly relevant to the proposal should be succinctly summarized in Box 5.1.B using language accessible to non-specialists. Please remember that the Tri-Council requires Canadian Research Ethics Boards to include members from the community; your ethics application should be accessible to them as well as to academic members.
The selection of participants must consider TCPS 2 Article 4.1. It states that: "Taking into account the scope and objectives of their research, researchers should be inclusive in selecting participants." At the same time, the TCPS cautions against recruiting research participants solely because they are easy to access or manipulate, and highlights researchers' special obligations toward individuals or groups whose circumstances may lead to or increase their vulnerability in the context of a specific research project or study.
The BREB cautions against analyses that may contribute to the stereotyping of groups on the basis of ethnocultural background, sexual orientation, etc. Therefore, when the study sample includes specific groups or a range of groups and asks participants to categorize themselves according to "race," ethnicity, colour, etc., the researcher must describe the nature of the analysis to be undertaken in order to assure the board that these data will not be analyzed in such a way that unfair stereotypes may be drawn and that reports will not allow others to use the data to create unfair stereotypes.
In cases where First Nations, Inuit and Metis people in Canada are the focus of analysis, the BREB takes direction from Chapter 9 of TCPS 2 and, if the study is health-oriented, from the CIHR guidelines for research with Aboriginal populations.
Article 4.1 of TCPS states that "researchers shall not exclude individuals from the opportunity to participate in research on the basis of attributes such as culture, language, religion, race, disability, sexual orientation, ethnicity, linguistic proficiency, gender or age, unless there is a valid reason for the exclusion". If exclusions are proposed that are not germane to the research question, a justification for excluding participants on the basis of such attributes must be provided.
- Describe how you will gain access to names, addresses, telephone numbers, or e-mail addresses of potential participants.
- Attach copies of any recruitment materials such as letters, advertisements, flyers, radio or television scripts, or Internet messages to Box 9.4 or Box 9.6 of the application. Potential participants should not be asked to write their name and/or contact information on an advertisement posted in a public place. The Board believes UBC researchers should treat this information as confidential.
- Indicate where participants will be recruited (e.g., hospital, clinic, school).
- Ethnographic fieldwork may require very different means of contacting people. Please describe how you plan to initiate relationships with the people you will be studying.
Research that is "limited" to a telephone interview (i.e., where no other method of gathering data on the individual participant will be used), will usually require initial contact by letter or e-mail and the letter or e-mail must include all the components of a consent form. The researcher should explain (in Box 6.6) what methods will be used to document consent to the interview.
If the researcher plans to follow-up the consent document with a telephone call, the consent document should include a contact name and number for the participant to call to stop further contact.
Note on Skype or cell phone interviews: In general, these technologies are a less secure means of communication than landlines (e.g. although Skype-to-Skype calls are encrypted, Skype-to-landline calls are not; analog mobile phones are not encrypted; different mobile phone companies have different policies around encryption, etc.). Therefore, if your study involves a highly sensitive topic where there may be legal ramifications for participants if they are identified as participating in the study, more secure forms of communication should be used.
Provide a statement of the researcher's relationship, if any, to the participants (e.g., treating physician, teacher, supervisor, etc.). Whenever the person doing the recruiting is in a position of authority over potential research participants, special care needs to be taken. For example, whenever the relationship between the researcher and research participant is such that coercion could be perceived to be a factor (e.g., when the researcher is also a caregiver or teacher), non-coercive means for inviting participation should be used. Examples of non-coercive methods include recruitment by a third person, posting notices to invite volunteers from the entire group concerned (e.g., the whole student body, rather than a specific class, or all employees of the institution), and procedures whereby the teacher/researcher is precluded from knowing which students have declined to participate in the research. See also 6.5.1, below.
In some studies, the researcher requires access to personal data (names, addresses, names of relatives, etc.) in order to recruit potential participants or to obtain information from a third party's records (e.g., where a primary caregiver holds the personal patient information). In such cases, permission to use the data must be obtained from the prospective participant by the third party before access to the information is granted. The third party must ask prospective participants for explicit permission to release their names to the researcher. The researcher may facilitate this by asking the third party to distribute an introductory letter describing the study, with details on how to contact the researcher if invitees are interested in participating. Details of how third party recruitment will be accomplished must be described and copies of the letters attached to page 9 of the ethics application.
BC Privacy Legislation
The BC Freedom of Information and Protection of Privacy Act (FIPPA) applies to public sector institutions. These include some health care (e.g. hospitals), public (e.g. government Ministries, WCB), and educational (e.g. School boards, universities) bodies. Section 35 of the Act states "A public body may disclose personal information or may cause personal information in its custody or under its control to be disclosed for a research purpose, including statistical research, only if … (a.1) the information is disclosed on condition that it not be used for the purpose of contacting a person to participate in research." This stipulation does not apply in respective of research in relation to health issues if the commissioner approves:
- The research purpose,
- The use of disclosed information for the purpose of contacting a person to participate in the research, and
- The manner in which the contact is to be made, including the information to be made available to the persons contacted.
The Personal Information Protection Act applies to private sector organizations. Section 21 states "An organization may disclose, without the consent of the individual, personal information for a research purpose, including statistical research, only if….(a.1) the disclosure is on condition that it will not be used to contact persons to ask them to participate in the research."
Note that the BREB does not assess the legality of research procedures, and that the Board's approval for a project does not imply that the procedure is in conformity with legislation. When in doubt, investigators should consult a qualified legal expert.
Snowball sampling involves the use of individuals who are known to the researcher facilitating the recruitment of potential participants who are known to them. The process must conform to the third party recruitment policy described above (5.4.4). Contacts may not give researchers the names and contact information or any other detail about potential participants without first obtaining permission from those individuals. Exceptions to this rule will need to be justified in the ethics application, and are reviewed (before the research begins) on a case-by-case basis by the BREB.
- The description that will be posted to the online system will need to be attached to Page 9. The posting must describe the study purpose, any restrictions on participation, how long the experiment will take, the number of credits, the names of the researchers, and what a participant will be required to do as part of the experiment.
- If the experiment involves deception, the Deception Form must also be completed and attached to the ethics application. If the consent form does not include, or alters, some or all of the elements of informed consent that researchers must provide in the Debriefing form, in addition to candid disclosure, a full explanation as to why the experiment required less than full disclosure.
Researchers planning to use online survey companies should acquaint themselves with the relevant laws. In particular, section 30.1 of the BC Freedom of Information and Protection of Privacy Act (FIPPA) which states:
A public body must ensure that personal information in its custody or under its control is stored only in Canada and accessed only in Canada, unless one of the following applies:
- if the individual the information is about has identified the information and has consented, in the prescribed manner, to it being stored in or accessed from, as applicable, another jurisdiction;
- if it is stored in or accessed from another jurisdiction for the purpose of disclosure allowed under this Act;
- if it was disclosed under section 33.1 (1) (i.1).
Please check out the Online Survey Guidance Notes for more details. If you have any questions regarding FIPPA legislation and online surveys please consult the Access & Privacy Manager at the Office of the University Counsel, at email@example.com.
Ideally, Canadian companies with servers located in Canada should be used for survey purposes instead of using online survey companies located outside of Canada. However, the BREB will consider online surveys using companies located outside Canada (e.g. United States, Australia) which involve giving the survey internet address to the potential research participant to access from any computer (i.e. the company's server may collect the IP address of the participant's computer) and which do not collect demographic data that could be used to identify the research participant.
The consent document or letter of introduction must indicate the location of the survey company's server and include a description of any associated limits to confidentiality. An example of a typical statement is,
If existing records (e.g. health records, clinical lists or other records/databases) will be used to IDENTIFY potential participants, please describe how permission to access this information, and to collect and use this information will be obtained. For example, "permission was obtained from the participant prior to creation of the record," or "consent will be sought prior to collection for research," or "a database custodian will provide de-identified data."
Describe in a step-by-step manner the research procedures, including who will be involved, where the activity will occur, how data will be collected and any follow up activities involving participants. If non-research activities will be used for data collection, please describe how the activity will differ from the norm: e.g., a unit of instruction may be part of the regular curriculum, but the collection and analysis of the students' test scores will form part of a research project. Describe the period during which the procedures will be carried out, how long each procedure will last, and the frequency of the procedures. If applicable, please include a brief description of the sampling method (e.g., random sampling), group assignment (e.g., randomization), and type of research design (e.g., ethnography).
The methods described below are included here because they represent possible alterations to standard processes of obtaining free and informed consent. They are not intended to represent an exhaustive list of research methods. Therefore, if you are not using any of these methods please tick "no". Please do not tick the "expert interview" box unless you are actually doing expert interviews (see 5.7.5).
Action research involves researchers investigating their own practice where dual relationships exist between the researcher and participant. When the relationship involves individuals of lesser power or status than the researcher, such as the researcher's students, employees, inmates or clients, there is a potential for coercion. Please refer to the Action Research guidelines for more information.
Autobiography is when a researcher retrospectively and selectively writes about his or her past experiences. Auto-ethnography, on the other hand, is an approach to research and writing that seeks to systematically explore the researcher's subjective experience and connects it to wider cultural, political, and social meanings and understandings. Although some forms of auto-ethnography involve retrospective reflection, others may involve a process in which the researcher places him/herself in a particular research context in order to prospectively analyze his/her experiences. Both of these methods involve possible problems associated with obtaining the initial and continuing consent of individuals mentioned in the narrative. If there are no other people interviewed or named (or whose identities can be otherwise ascertained) in the narrative, and it draws purely on retrospective reflection, ethical review is not required. However, if you are interviewing other people or engaging in prospective data collection at a particular fieldsite (i.e. your study leans heavily on ethnographic as well as auto-biographical approaches), research ethics approval is required.
Research involving deception occurs when participants do not know the true purpose of the research in advance. A simple test for possible deception is to ask yourself: "Is there any information in the procedures section of the ethics application that I would not be willing to tell the participant in the study prior to their participation?" If the answer to this is yes, then deception is involved. Only research that meets the requirements of TCPS 2 Article 3.7 will be exempted from full disclosure at the time of consent. If you are conducting a study involving deception you must complete the Deception Form. This information, and the rationale behind its exclusion from the initial consent process, must be provided to the participants in a debriefing procedure. As the application section of Article 3.7 of the TCPS 2 notes,
Where partial disclosure or deception has been used, debriefing is an important mechanism in maintaining the participant's trust in the research community. The debriefing… should be proportionate to the sensitivity of the issue. Often, debriefing can be a simple and straightforward candid disclosure. In sensitive cases, researchers should also provide a full explanation of why participants were temporarily led to believe that the research, or some aspect of it, had a different purpose, or why participants received less than full disclosure. The researchers should give details about the importance of the research, the necessity of having to use partial disclosure or deception, and express their concern about the welfare of the participants. They should seek to remove any misconceptions that may have arisen and to re-establish any trust that might have been lost, by explaining why these research procedures were necessary to obtain scientifically valid findings.
Please note that participants must be able to indicate their consent or their refusal at the end of the debriefing process.
Researchers who plan to work with First Nations, Inuit or Métis participants must read TCPS 2 Chapter 9. Researchers applying to the UBC BREB must be clear about the approach they are taking and the contacts they have already made with the communities or people.
The people being studied have a right to know that they are being studied, what the research is about, what is required of them, and that they have a right not to be researched. Participant observation studies that do not meet the above standard are still possible as long as the relevant group approves the project. For example, spending a year in a remote indigenous community may require the approval of the community council or appropriate authority rather than the approval of each individual. The BREB also acknowledges that in some cases it may not be possible to obtain the appropriate approvals prior to arriving at the research site and establishing relationships with members of the community. Fieldworkers need to be specific in their application by outlining their approach to obtaining approval either prior to, or once in, the field.
The BREB recognizes that some anthropological fieldwork is necessarily exploratory in nature. Research methods may need to be altered in the field and information gathered may fundamentally alter the focus of the research. Much anthropological research is based upon long-term relationships developed between researcher and the community being studied, and will therefore evolve over time. Also, the demands of the collaborative research model are such that researchers planning to undertake this type of research cannot have a defined agenda before establishing relationships with the people with whom they intend to work.
The researcher should describe the type of consent process he/she intends to use and explain why it is the most appropriate method. For example, an oral consent process is clearly necessary in non-literate cultures, with illiterate participants, or where participants perceive a request to sign a formal document as a risk, a lack of trust, or an insult. In the application for ethical review the researcher must, where possible, demonstrate knowledge of the community and its expectations regarding consent and the behaviour of the researcher. If this is not possible, the researcher should outline how he/she plans to determine the appropriate form of consent once in the field.
Expert interviews are defined here as those that involve an interview with an expert in a similar position to the researcher (e.g., an academic, politician, owner or executive of a company, head of an NGO, or president of an association or union) and which are designed to obtain factual accounts of an event, a procedure, a process, history, and so forth, where there is minimal or no risk to the interviewee. If the person being interviewed is someone authorized to release information or data about their organization and its policies, the research does not require review and the person does not need to complete a consent form, although professional interview procedures should be observed (see Studies exempt from review). If the expert is being asked to proffer a personal opinion, then an ethics application must be submitted, and consent (written or oral), to the extent appropriate to the situation is required. For example, if the interviewees agree to be interviewed, consent may be assumed, but they should be explicitly asked if they are agreeable to be interviewed about the subject before the interview begins (see Article 10.2 of TCPS 2).
Describe a consent process that ensures that the interviewee is fully informed. This may involve written or oral consent. Where oral consent is appropriate, the researcher should make a contemporaneous journal entry of the event and circumstances or audio recording of the event.
Naturalistic observation is used to study behaviour in a natural environment. Because knowledge of the research can be expected to influence behaviour, naturalistic observation generally implies that the subjects do not know that they are being observed, and hence cannot have given their free and informed consent. As noted in the 'Studies exempt from review' section, naturalistic observation studies in public places where there is no expectation of privacy are exempt from REB review. However, due to the need for respect for privacy, naturalistic observation in other settings can raise concerns of the privacy and dignity of those being observed.
If your study does not meet the exemption requirements, describe the nature of the activities, the environment, and the method of recording the activities to be observed. If individuals will be identified you must justify the need for this. For further advice on studies involving naturalistic observation in real or virtual settings please consult TCPS 2 Article 10.3.
TCPS 2 Article 5.5 defines secondary use of data as, "the use in research of information originally collected for a purpose other than the current research purpose. Common examples are social science or health survey datasets that are collected for specific research or statistical purposes, but then re-used to answer other research questions. Another common example is the use of data collected for non-research purposes to answer a research question. Secondary use of data (including data linkage) for research purposes requires review and approval by the Research Ethics Board unless the data was collected anonymously or is in the public domain (see 'Studies exempt from review' section of guidance notes).
According to TCPS 2 Article 5.5, researchers who seek a waiver of consent for secondary use of identifiable information in research must satisfy the BREB that:
identifiable information is essential to the research;
- the waiver is unlikely to adversely affect the welfare of individuals to whom the information relates;
- the researchers will take appropriate measures to protect the privacy of individuals and to safeguard the identifiable information;
- the researchers will comply with any known preferences previously expressed by individuals about uses of their information;
- it is impossible or impracticable to seek consent from individuals to whom the information relates; and
- The researchers have obtained any other necessary (e.g. legal) permission for secondary use of information for research purposes
If there is a possibility that the published data could be linked to individuals, the researcher should propose a strategy for obtaining consent or otherwise informing the participants.
Data linkage is when you are linking two or more separate datasets. If the datasets you plan to link contain identifiable information, please be aware that the BC Personal Information Protection Act states that "An organization may disclose, without the consent of the individual, personal information for a research purpose, including statistical research, only if linkage of the personal information to other information is not harmful to the individuals identified by the personal information and the benefits to be derived from the linkage are clearly in the public interest". Therefore, you must ensure that you address this additional criterion, along with the standard criteria for obtaining a waiver of consent for secondary use of identifiable information (TCPS Article 5.5).
Please be aware that even when the individual data sets contain anonymous information, the data linkage may present risks of identification and threats to individual privacy. Therefore, regardless of whether the datasets contain identifiable or anonymous data, researchers should exercise caution in the creation and use of data of this kind. The TCPS 2 advises that:
Only a restricted number of individuals should perform the function of merging databases. Researchers should either destroy the merged file immediately after use, or use enhanced security measures to store it. Whether the data are to be used statistically or otherwise, all members of the research team must maintain security of the information (see article 5.8).
If any individuals present in an experimental setting that is being video-recorded decline to participate, researchers must take extra care to protect their rights. On the one hand, it is unfair to require non-participants sit outside camera range if this also excludes them from participating in any activity that is not part of the research project or marginalizes them in some other way. On the other hand, participants' rights not to take part in the research must be respected.
Electronically distorting the facial features of non-participants does not honour the participant's wish not to participate. It is not a matter of non-identification but a matter of non-participation.
The consent form must explain the purpose and specific use of the sample, how it will be obtained, and what will happen to any residual sample. Generally, unused samples should be destroyed at the conclusion of the testing. If the sample is to be stored, you will need to justify for the Board why the sample will be stored and any future uses. Otherwise, include assurances in the application and the consent form that the samples will be destroyed as soon as testing is completed (or within x days of testing).
Saliva samples used as a diagnostic procedure in a clinical study: The application for ethical review must be submitted to the UBC Clinical REB.
This question is essentially asking how much of a participant's time the study will take up. Ensure that you also include this information in the consent form and that the amount of time stated is consistent in the application, recruitment letters or posters, and consent form. Approximations are acceptable but consistency is required. For naturalistic observation studies, the response would be "N/A".
Describe the potential risks or inconveniences to the participant associated with each procedure, test, interview, or other aspect of the study. Please also address the broader impacts of your study on individual participants and the groups to which they belong. Such impacts may include: social stigmatization, threats to reputation, the creation of unfair stereotypes, and/or psychological harms such as anxiety, regret, or guilt feelings. Describe strategies to be used to minimize or manage the study impacts for participants and other affected individuals. If you think there are no risks associated with your study, please indicate this (e.g., writing "no known risks") rather than responding "N/A".
- Researchers should avoid assuming a secondary role as caregiver or counselor to the research participant.
- If there is a risk that the participant may experience increased emotional stress as a result of the interview, questionnaire, or other research procedure beyond what might be encountered in the course of daily life, the researcher should have a prepared list of appropriate, available, and affordable resources and counseling services to be handed to every participant prior to the interview or questionnaire. Participants who may require support and counseling do not necessarily indicate this directly to the researcher and they should have this information (on hand) so that they can self-refer. Include in 6.2 a statement / assurance that a (current or updated) list is available.
Specify the potential benefits to the participants. If there are no benefits, state this explicitly. If any specific benefits cannot be assured, but may be hoped for by the participant, state explicitly that the subject may or may not benefit from participation in the study. It's important to be realistic about what your study can potentially accomplish and not to overpromise on what it can deliver.
Some types of research impact communities as well as individual participants. This is especially true of ethnographic research, community-based research, research on particular ethnic or social groups, etc. If applicable, please provide a discussion of the potential impacts of your research on the community.
Voluntary consent must be free of undue influence in the form of inappropriate inducements. The amount or kind of payment should not be such that the participant will base his/her decision to participate on the potential material rewards.
The application section of TCPS 2 Article 3.1 states, "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".
The BREB will weigh the amount of compensation offered against the amount of time and inconvenience to the participant on a case-by-case basis. It is considered unacceptable to have payment depend on completion of the project. However, in many cases it would be considered acceptable to pro-rate the amount of compensation given to participants who withdraw before completion or to divide the research into stages, with an honorarium attached to each stage.
The UBC Finance Department Research Subject Payments guidelines can be found at the following link: https://finance.research.ubc.ca/policies-guidelines/guidelines#ressubpay.
As an incentive to participate in studies, researchers frequently offer participants a chance at a prize in a draw. If such a draw does not include those who withdraw from the study, technically it becomes a lottery and is illegal in British Columbia without a license. Consequently, researchers must ensure that participation in the draw is not contingent on participation in the research, and any participants who withdraw must also have the opportunity to have their names included in such draws.
Special care should be taken when offering compensation or prizes in a draw that the method of collecting payment or the prize or entering a draw does not compromise the confidentiality of the participant.
Unlike clinical research, it is acceptable in behavioural and social science research to include reference to remuneration on recruitment posters because a) the value of the remuneration is usually smaller than that offered in clinical trials and the risks are not as great and b) if there is no benefit to the participant, the researcher may need to offer an incentive.
Article 3.12 of TCPS 2 states that "Evidence of consent shall be contained either in a signed consent form or in documentation by the researcher of another appropriate means of consent". Indicate who will ask for consent (e.g., the Principal Investigator, Co-investigator(s), and/or research assistant(s). The BREB recognizes that written consent is not necessarily appropriate for research with particular populations. Article 10.2 of TCPS 2 also states that "Under a variety of circumstances, signed written consent is not appropriate in qualitative research". If you are obtaining oral consent, please attach a copy of the script you will use to describe the study and obtain consent to section 9.2 of the application.
In some situations, it is possible for exceptions to be made to the general rules regarding informed consent. Contexts where this might occur are research involving deception, naturalistic observation studies, studies in virtual space, studies involving secondary use of data, etc. Please be aware that if you are asking for a waiver or alteration of the requirement for informed consent, 5 requirements must be met:
- The research involves no more than minimal risk to participants;
- The lack of consent is unlikely to adversely affect the welfare of the participant;
- It is impossible or impracticable to carry out the research and to answer the research question properly without the waiver or alteration;
- Whenever possible and appropriate, the participants will be debriefed and provided with additional pertinent information after participation;
- The waived or altered consent does not involve a therapeutic intervention.
Researchers seeking a waiver of informed consent must address each criterion in section 6.6.A.
Passive Consent occurs when a parent is asked to return a consent form if they do not want their child to participate in a study, whereas active consent occurs when a parent is asked to sign a consent form indicating they are willing to allow their child to participate in the study. Regardless of the form of consent used for parents, the child must always be given the opportunity to assent or consent (depending on capacity, see GN 6.8) to participate. The BREB will consider the use of passive consent with approval from the school district for youth in grades 9-12 because the youth would generally be mature enough to consent for themselves outside of the school setting. Passive consent in younger children is not permissible, unless a strong case is made justifying its use. All studies proposing passive consent in younger children will require full board review. Please note that school boards have their own requirements regarding consent. If the BREB approves passive consent in a study, but the school board does not agree with the decision, the researchers will be asked to change their consent forms to active consent. Please ensure lay language is used in all consent forms as not all parents are able to understand the complexities of some consent forms.
Article 3.2 of the TCPS 2 includes the following: "For consent to be informed, prospective participants shall be given adequate time and opportunity to assimilate the information provided, pose any questions they may have, and discuss and consider whether they will participate. The time required for this initial phase of the consent process will depend on such factors as the magnitude and probability of harms, the complexity of the information conveyed and the setting where the information is given". Thus, there is no standard amount of time required for consent, which should be entirely dependent on the nature of the study. Please indicate the amount of time between when the participant is provided with information about the study and how long they have to decide, providing a rationale for your response.
Although the age of majority in British Columbia is 19, neither applicable law nor the TCPS 2 relies on the age of majority to determine whether people have the capacity to consent to participate in research. According to the Interagency Advisory Panel on Research Ethics (PRE), seeking consent from minors should not be based on their age but on whether they have the capacity to understand the significance of the research and the implications of the risks and benefits to themselves (click here for further details). Researchers conducting studies with minors should therefore consider: the nature of the research, the research setting, the level of risk the research poses to participants, and provincial legislation.
Within BC, there is nothing that abrogates the application of the common law in relation to a minor's legal capacity to consent. The common law presumes that all persons, including minors, are legally and mentally capable of providing their own consent. There are two doctrines directly applicable to the consent of minors: the 'emancipated minor' doctrine and the 'mature minor' doctrine. The emancipated minor doctrine provides that persons under the age of majority who are 'emancipated' in the sense of living on their own, earning their own income, etc., are generally capable of consent, because they are 'emancipated from parental control and guidance'. For example, the BREB considers university students under the age of majority, minors who are themselves parents, etc., to be emancipated minors.
The mature minor doctrine recognizes that if a minor has reached a level of intellectual and emotional maturity such that he or she is capable of understanding and appreciating the nature and consequences of a particular decision, together with its alternatives, he/she can be considered capable of providing his/her own legal consent. The BREB therefore will consider requests for obtaining consent from minors on a case-by-case basis, based on the nature of the research, the research setting and the level of risk the research poses to participants. However, please be aware that in some settings you may be required to obtain parental consent, regardless of whether you deem the minors to be capable of providing their own consent. For example, written parental consent (as well as authorization from appropriate school authorities) is normally required for research in the schools whenever students under 19 are involved (see, for example, the Vancouver School Board research guidelines).
Please note that if parental consent is required due to agency or institutional requirements, you must also present an opportunity to the minor (either orally or in writing) to refuse to participate or withdraw at any time. A copy of what is written or said to the parents/guardians and to the minor must be included for review by the BREB.
ASSENT: "Assent" means to concur with the decision of another, whereas "consent" means to provide permission. If parental consent is necessary for research with children due to their lack of capacity to consent, assent is required from the child. Children old enough to understand the concepts described in a consent form should be provided with an assent form to sign. Regardless of capacity due to age or ability, and in spite of authorized third party or parental consent, the investigator is not permitted to compel a participant to take part if it is clearly against his/her will.
The Principal Investigator must judge the potential participant's capacity to consent on his or her own behalf, in all participants, in all research projects, regardless of age. For research involving individuals who lack the capacity, either permanently or temporarily, to decide for themselves whether to participate, they should be given information and involved in decision making to the extent possible. See the related discussions in TCPS 2 (Article 3.9, Articles 4.4, 4.5, 4.6). The BREB may request that a written assent document accompany the consent process, depending on the nature of the project and the age or ability of the participant population.
TCPS 2 Article 4.6 states, "Where a researcher seeks to involve individuals in research who do not have capacity to consent for themselves, the researcher shall satisfy the REB that:
- The research question can be addressed only with participants within the identified group; and
- The research does not expose the participants to more than minimal risk without the prospect of direct benefits for them; or
- Where the research entails only minimal risk, it should at least have the prospect of providing benefits to participants or to a group that is the focus of the research and to which the participants belong.
TCPS 2 Article 3.10 states, "Where an authorized third party has consented on behalf of an individual who lacks legal capacity, but that person has some ability to understand the significance of the research, the researcher shall ascertain the wishes of that person with respect to participation. Prospective participants' dissent will preclude their participation."
TCPS 2 Article 3.8 states, "Subject to all applicable legal and regulatory requirements, research involving medical emergencies shall be conducted only if it addresses the emergency needs of the individuals involved, and then only in accordance with criteria established in advance of such research by the REB." See Article 3.8 for the criteria that apply. Note that you must justify to the REB recourse to the provisions of this exception.
TCPS 2 Article 3.3 states that "consent will be maintained throughout the research project. Researchers have an ongoing duty to provide participants with all information relevant to their ongoing consent to participate in the research". Renewal of consent might be particularly appropriate in the context of ethnographic research, community-based research or those studies where participants are interviewed or surveyed on multiple occasions (e.g. longitudinal research).
Describe any provisions planned for participants, or those consenting on a participant's behalf, to have special assistance, if needed, during the consent process (e.g., consent forms in Braille, or in languages other than English). Attach copies of contact letters or consent forms that have been translated into other languages to page 9 of the application.
Written evidence of approval (to use the premises or to access students, clients, patrons or patients) is required for projects carried out at other institutions. If agency approval cannot be obtained without prior approval of the UBC BREB, a letter of conditional approval will be issued for submission to the institution if all other aspects of the application are satisfactory. Whenever possible, applications should be submitted concurrently to the UBC BREB and the other institution. Please indicate whether a request for approval has been submitted to the institution or whether conditional approval by the UBC BREB must accompany a request to the institution for approval.
TCPS 2 Article 8.3(b) states, "Research conducted under the auspices of a Canadian research institution and conducted outside its jurisdiction, whether elsewhere in Canada, or outside Canada, shall undergo prior ethics review by both: (i) the REB at the Canadian institution under the auspices of which the research is being conducted; and (ii) the REB or other responsible review body or bodies, if any, at the host research site. In many international settings there are no institutional ethics approval processes – or ones that exist are only available to researchers working in institutional contexts. This information should be provided in section F.
If this research study involves Indigenous communities or organizations, or identifies Indigenous persons as a participant category, ensure that you are familiar with TCPS 2 Chapter 9 and the CIHR Guidelines for Health Research Involving Aboriginal People if you are conducting a health-related study. Also attach a copy of the research agreement with the community (if available) in Question 9.8. Please describe the community consent process. If no community consent is being sought, please justify.
Researchers must be very careful to explain any data sharing agreements entered into with partnering organizations. These agreements must be clearly explained in the consent materials and include descriptions of – who will and who potentially may – have access to data gathered over the course of the study.
If your study falls within the expanded definition of a clinical/intervention trial provided by the ICMJE (International Committee of Medical Journal Editors), then your study must be registered with an authorized registry BEFORE it is started (but not necessarily before ethical approval is granted).
The ICMJE defines clinical trials as: "any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes". Health-related interventions include any intervention used to modify a biomedical or health-related outcome including behavioral treatments, dietary interventions, and process-of-care changes. Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. Purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) do not require registration.
This item must be completed. It is acceptable to provide an estimate or a range for the number of participants if the exact number is not known in advance. However, the number provided should be consistent throughout the application. If you are conducting a naturalistic observation study where no participants are actively recruited and data collection will end after an interval of time rather than once a certain number of people have been recruited, you can respond "not applicable", indicating the reason why.
Who will actually conduct the study and what are their qualifications to conduct this kind of research? For example, if the study includes focus groups, describe the researcher's relevant training and/or experience in facilitating group discussions in a research context.
All members of the research team - including Faculty - who will have contact with research participants are required to complete the TCPS online tutorial before the application will be approved.
TCPS 2 CORE tutorial: http://www.pre.ethics.gc.ca/eng/education/tutorial-didacticiel/
In general, researchers have an ethical duty of confidentiality – an obligation to safeguard information entrusted to them by protecting these data from unauthorized access, use, disclosure, modification, loss or theft. Applicants should therefore demonstrate how the confidentiality of the data and participant privacy will be maintained during data collection and analysis, including hard copies of participant data (e.g., interview transcripts, completed questionnaires, fieldnotes, etc.) and electronic files. Standard measures include: password protecting electronic files and storing hard copies of study materials in a locked filing cabinet. Confidential information must not be collected or exchanged via e-mail unless the information has been encrypted (e.g., documents are password-protected). Web-based questionnaires must use encryption software. Please also beware of using online storage services such as "Dropbox" to store or share your study data, especially if you are researching a sensitive topic. For example, Dropbox's user policy states that:
We may disclose to parties outside Dropbox files stored in your Dropbox and information about you that we collect when we have a good faith belief that disclosure is reasonably necessary to (a) comply with a law, regulation or compulsory legal request; (b) protect the safety of any person from death or serious bodily injury... If we provide your Dropbox files to a law enforcement agency as set forth above, we will remove Dropbox's encryption from the files before providing them to law enforcement...
The TCPS 2 identifies 5 different categories of data collected from research participants, each with different implications for the privacy of participants (see TCPS 2, Chapter 5, P. 56):
- Directly identifying information – the information identifies a specific individual through direct identifiers (e.g., name, social insurance number, personal health number).
- Indirectly identifying information – the information can reasonably be expected to identify an individual through a combination of indirect identifiers (e.g., date of birth, place of residence or unique personal characteristic).
- Coded information – direct identifiers are removed from the information and replaced with a code. Depending on access to the code, it may be possible to re-identify specific participants (e.g., the principal investigator retains a list that links the participants' code names with their actual name so data can be re-linked if necessary).
- Anonymized information – the information is irrevocably stripped of direct identifiers, a code is not kept to allow future re-linkage, and risk of re-identification of individuals from remaining indirect identifiers is low or very low.
- Anonymous information – the information never had identifiers associated with it (e.g., anonymous surveys) and risk of identification of individuals is low or very low.
IMPORTANT NOTE: Unless your data fits the definition of 'anonymity' provided in the TCPS, it is usually more appropriate to promise confidentiality than anonymity.
Ethical concerns about privacy decrease as it becomes more difficult to associate information with a particular individual and concerns also vary with the sensitivity of the information collected and the extent to which it might harm an individual or group. The easiest way to protect participants is through the collection and use of anonymous or anonymized data, although this is not always possible or desirable (TCPS 2 Chapter 5, p. 57).
Photography, Video / Audio Recording
If there are any plans to use photography (including digital photographs), video or audio recording in the research, those who will have access to the recordings and the methods used to protect the participant's identity must be described in the consent form. The eventual fate of the records must also be disclosed (i.e. where and for how long they will be stored and whether they will be destroyed, any plans for secondary uses of the recordings). If there are plans to use these materials for any other purpose than the research project (e.g. for teaching purposes) and the participant could be identified, separate consent is required.
If the research includes both audio/visual recording and other methods (e.g., paper-and-pencil questionnaires, interviews), the consent form must specify to which method(s) the respondent is consenting; e.g., some participants may consent to give an interview, but not to having it recorded.
The research team should be aware that the patient as a research participant may think that they have given vital information during an interview to their health care providers, when in fact the information is not passed on by the researcher. The researcher's actions on this issue must be communicated clearly in the consent form.
Give the names (if known) of those who will have access to the raw data, which may include information that would identify the participants. This category includes translators and transcriptionists. Please explain how those who will have access to the study will be made aware of their duties around maintaining confidentiality, etc. The research participants must also be told in the consent form who will have access to his/her data and what use will be made of it, either now or in the future. Temporary student assistants and clerks may be referred to by their role instead of name.
Interview participants may prefer to have their comments attributed in publications rather than to remain unnamed. The BREB recognizes and accepts this possibility, provided that there is no unacceptable risk to the participant. (NOTE: In some cases, the participant may be aware of the risks and decide to take them anyway – e.g., whistleblowers.) However, if disclosure of one participant's identity may jeopardize the welfare of other participants who wish their identities to remain confidential, it may not be appropriate to attribute comments to those wishing to be identified in publications or dissemination of research results (see TCPS 2 Articles 5.1 and 10.4). If you are planning to disclose the identity of participants, this should be specified in the consent process.
The investigators should note in the consent process that only limited confidentiality can be offered in focus groups, as they cannot control what other participants do with the information discussed. For example, include a sentence on the consent form that says something like, "We encourage all participants to refrain from disclosing the contents of the discussion outside of the focus group; however, we cannot control what other participants do with the information discussed."
Some research may involve an increased possibility of reports of child abuse or other reportable offences. There are distinctions to be made between offences which must be reported and circumstances where the researcher may decide – but is not legally required – to report criminal or harmful behaviour.
The Child, Family and Community Service Act of B.C. requires that anyone who has reason to believe that a child may be abused, neglected, or is for any other reason in need of protection, must report it to the Director or a designated social worker (Ministry of Children and Family Development).
The Adult Guardianship Act includes provision for the protection of incapacitated adults, where there is information that an incapacitated adult is abused or neglected and is unable to seek support or assistance. The BREB may request that a sentence be included in the consent form informing participants that reports or allegations of abuse will be reported to the authorities.
Legislation or judicial rulings may require other information collected in the course of research to be made available to appropriate authorities.
Please see the Informed Consent Form Guidelines for recommended language.
UBC Policy #85 states that researchers have a duty to keep "complete and accurate records of data, methodologies and findings, including graphs and images, in a manner that will allow verification or replication of the work by others. This includes recording all primary data in clear, adequate, original and chronological form, and retaining it in a repository from which it cannot be removed."
Original data for a given study should be retained in the unit of origin for at least five years after the work is published or otherwise presented (if the form of the data permits this, and if assurances have not been given that data would be destroyed to assure anonymity)".
This means original data should be stored for at least 5 years within a UBC facility after the study results have been published or otherwise presented, but may be retained for a longer period provided that they are stored securely. UBC has no explicit requirement for the shredding of data at the end of this period; however, destruction of the data is the best way of ensuring that confidentiality will not be breached. Please note that the responsibility for the security of the data rests with the Principal Investigator.
In some cases, data are of such value that they should not be destroyed – (for example: oral history interviews). In these cases, please describe your plans to preserve this material. The consent process should outline these plans and describe how and when it may be appropriate for others to have access to this information.
Describe any known future use of the data beyond the conclusion of this research project, and indicate whether participant consent will be obtained in the current consent procedure or if the participant will be contacted later to obtain consent. Either possibility must be described in the consent process. If consent is to be obtained now, future use of data must also be described in full in the current consent form. If consent will be obtained later, an amendment will be needed that includes the full details and updated consent form before the additional use of data begins.
Researchers may be required to make their data publicly available at the time of publication. This requirement is coming from both funders such as the Tri-Councils, and journals - which may decline to publish papers unless the data is publicly accessible. If you intend to make your research data publicly available in the future, please add to the consent form:
- A statement about the potential for future use and what that means within the context of the research.
- A statement about the nature of the data that will be publicly available, e.g. that it will be de-identified. Ensure terms and definitions are provided in lay language.
- An acknowledgement, if making data public has the potential for increasing participant risk.
- A statement indicating that once the data is made publicly available, the participant will not be able to withdraw their data.
The BREB acknowledges that in the case of ethnographic field notes and interviews, researchers cannot be expected to know all the uses they plan to make of the data. The BREB also understands that attempting to get informed consent many years later may place an undue burden on the researcher and may become impossible. Therefore, researchers should inform the peoples they are studying of the potential for future use of the data during the consent process.
Whenever possible, an offer should be made to provide research participants with feedback on the findings/results of the research. Please provide specific details on how such feedback will be provided or an explanation of why it is not appropriate to your research. In the context of community-based research, mechanisms to disseminate results to the community should generally be demonstrated.
Assign a version date to all attached documents created by the researcher and ensure that the UBC logo is attached to any documents the research participant will see. This version date must be included as a footnote on each page of the study documents. Pagination of attached documents should be in the form 'page X of XX'.
Graduate students - Include a copy of your research proposal for your dissertation. This should include the following elements: a title, names and academic credentials of the investigators, background and justification (e.g., a statement of the problem or need to conduct the study), a comprehensive literature review, description of the research design and methods, methods of analysis, instruments or tools being used, project timeline, resources, and references.
Participant Consent Document – Informed consent is often documented by means of a written, signed, and dated informed consent form, following a process by which a participant voluntarily confirms his or her willingness to participate in a particular study, after having been informed of all aspects of the study that are relevant to the participant's decision to participate. For details, see Consent Form Guidelines. Please note that a choice for "I do not consent" should only be used in parent consent forms for classroom research.
If you are obtaining oral rather than written consent, you must describe the procedures you will use to obtain consent (Box 6.6), and include a script that will be used to explain and request participant oral consent. Please note that even if you obtain oral consent, it may be advisable to leave a written statement of the information conveyed in the consent process with the participant. However, researchers should not leave any documentation with a participant if it may compromise their safety or confidentiality or if it is culturally inappropriate to do so. See TCPS 2 Article 3.12 and Article 10.2 for further discussion.
Other Consent Documents – For example: translated versions if available.
Assent Document – TCPS 2 Article 3.10 stipulates that the assent of a participant is required in situations where free and informed consent has been obtained from an authorized third party, and where the individual substantially understands the nature and consequences of the research.
Advertisement to Recruit Participants – This includes any type of communication (e.g., flyer, radio/television script, poster, newspaper ad, Internet message) that is directed to potential participants for the purpose of recruitment.
The minimum information that should be included in an advertisement is that it is "a UBC study", the official name (or the short name in RISe) of the study, the PI's or a Co-I's name and affiliation, and a contact number /e-mail address/URL. Beyond that, researchers can include what they deem to be necessary and appropriate as long as it is true/honest, not ambiguous, not coercive, and the information is consistent with that provided in the consent form.
Questionnaires, Tests, Interview Scripts, etc.
Attach copies of all relevant study materials to the application in view 9. Indicate whether the questionnaire is a standardized, validated instrument or whether it is in development. If the latter, please provide a copy of the finalized questionnaire as soon as it is available. Please ensure that qualitative data collection tools are also included, when appropriate (see TCPS 2 Article 10.5 for further discussion). Please note that researchers are expected to have permission from the authors to use copyrighted tests, although they do not need to provide evidence of this for the BREB.
Cover letter for the questionnaire
If the study is limited to a questionnaire that is completed by the participant, a covering letter may be used in lieu of a consent form, provided it includes essentially the same information as a consent form, plus a sentence that states that "If the questionnaire is completed, it will be assumed that consent has been given". If a study involves other procedures and a consent form, a covering letter is not required, unless the questionnaire is completed or sent to the participant at a later date.
Deception form and written or verbal debriefing – If the research depends on a temporary exception to the general requirements for full disclosure in the consent process, complete the Deception Form. Also read TCPS 2 Article 3.7A.
Agency Approval Form(s) – These are required when permission must be obtained from the appropriate institution (such as a school board) to undertake the study at a particular site.
A fee of $1,000 is charged for applications requiring ethical review by the UBC Behavioural Research Ethics Board that are funded by a commercial sponsor or for-profit agency for whose benefit the study is being conducted. If this applies to your project, please complete appendix 6.
The fee is not required for review of applications that are:
- not funded
- funded internally (including teaching)
- funded by grants from external granting agencies (federal/ provincial)
- charitable or not-for-profit organizations
Aboriginal research 5.2, 7.1G
Action research 5.7.1
- level of risk 4.5
- consent 6.8.1
- assent 6.8.2
Data linkage 5.7.8
Ethnographic fieldwork 5.7.4
- Contacting participants 5.4
- Impact on community 6.4
- Future uses of data 8.6
Expert interviews 5.7.5
- Review exemptions introduction
Focus groups 8.3.2
Honorarium/Incentives (see payments) 6.5
Informed consent 6.6
- And children 6.8
- Waiver of 6.6A
- Naturalistic observation and 5.7.6
- Secondary use of data and 5.7.7
- Qualitative research and 6.6
Minors (see children)
Naturalistic observation 5.7.6
- Exemptions from review 5.7.6
Online data storage 8.1
Saliva samples 5.7.10
Secondary use of data 5.7.7
- Exemptions from review introduction
- Obtaining consent 5.7.7
Snowball sampling 5.4.5
- Online 5.4.7
- Phone/Skype 5.4.2
Video recording 5.7.9, 8.1