Writing Behavioural Ethics Applications: Guidance Notes

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 risesupport@ors.ubc.ca and provide the administrator with the following information:

1. First/Middle/Surname
2. Business Email Address
3. Business Telephone Number
4. UBC Department of Affiliation (if none, provide the name of your Institution and Department)
5. UBC Rank
6. UBC Employee ID (If applicable)
7. UBC Student ID (If applicable)

The RISe administrator will email you the researcher number upon receiving your request.

intro_2 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:

1. 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
2. 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.
3. 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.
4. 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.
5. 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.

intro_3 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 on behalf of 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.

intro_4 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.

intro_5 
 Application Submitted by PI

↓

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
Provisos (Amendments)
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.

intro_6 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.

Applications will not be approved if questions 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". Feel free to include a brief explanation of why it is believed that the question is not applicable to their research.

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.

1. 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.
   1. Approval – the Certificate of Approval is issued and the research may begin.
   2. Approval with a suggestion or request for information - the Certificate of Approval is issued with a memo providing advice or requesting minor clerical changes.
   3. 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.
2. 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.
3. 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.
4. 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."

intro_7 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 LR9.

intro_8 As noted above, Certificates of Approval are issued for a maximum period of one year. Please don't forget to close your study using a study closure PAA when ethics review is no longer needed.

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)."

1pt1 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 jean.ruiz@ors.ubc.ca (Point Grey campus) or lisa.shearer@ubc.ca (Okanagan campus).

1pt3 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.

1pt6 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.

1pt7 The title given in the application form must correspond to the title on all study documents, including the consent form.

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.

1pt8 The nickname will not be printed on the certificate. It will be used throughout the online application and review process to serve as a quick reference to identify the project.

2pt1 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.

2pt2 If a researcher answers “yes” in their grant application (or RPIF) to the question, “Will Human Subjects be used in this project?” the grants office will require confirmation of ethics approval before funds can be released. If you are asked for confirmation of ethics approval and your research does not involve human participants or data (including biological specimens, etc.), please send an email to your grants officer to have the record corrected.

If you do need to submit an ethics application and 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 the Ethics Application title is not required. You may list multiple grants (sponsors) in one ethics application. A single grant may also be referenced in multiple ethics applications. The ethics review will include a check to make sure that funds are being used as intended. The certificate of approval will display the full grant titles listed on page 2 of the ethics application.

Disclosure of Funding

Disclosure of funding to invitees and participants is a TCPS2 requirement (Article 3.2, Application b); the BREB requires that this information is provided in consent forms.

Disclosure enables participants to evaluate any perceived bias that may be inherent in the research. Examples include funding by a software developer for the purpose of testing one of its applications, or by a wheel chair company with the goal of preparing their product for market. More subtle influences may be present such as when an organization funds research that supports their organizational goals or values.  While a participant may be comfortable with the research topic, they may not share or want to further the values of the funding organization. 

Disclosure of funding is also important for ensuring researcher accountability and may offer assurance to participants that the researcher will be held accountable for their deliverables and use of public (or corporate) money.

Graduate student funding

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.

Post-approval amendments

The BREB will not request revisions to grant applications or to research proposals when an amendment (PAA) is submitted for ethics review. Updates to Box 9.1 will only be requested in the event of new funding being added to the research.

If recruitment is still in progress after new funding has been received, you will also be required to update your consent forms with details of the new funding.

2pt6 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.

4pt1 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 projects that study the relationship between people and their surroundings, including how people interact with each other, their communities, and institutional systems. These may include psychological phenomena such as emotions, biases, and motivations. Psychological therapy and counselling studies fall under behavioural research. Emergent design and community-based studies are considered social science and behavioural research unless a clinical intervention is involved. Common methods include, but are not limited to, interviews, focus groups, surveys, questionnaires, behavioural therapy workshops, experimental coaching, observations, and secondary use of data. Behavioural and social sciences studies can be about health and include health care providers and patients, where the goal is not to modify direct patient clinical care (i.e., does not involve diagnosis, medication, or treatment). When clinical charts are being accessed for a behavioural study, full patient consent is required. Retrospective medical chart review projects should be submitted using the Clinical application form.

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 studies that evaluate the effects of one or more health-related interventions such as drug administration, surgical procedures, radiologic procedures, devices, genetic therapies, cells and other biological products, radiopharmaceuticals, natural health products (NHPs), process-of-care changes, preventive care, manual therapies, and psychotherapies.

Health Canada and US FDA regulated research, research evaluating human anatomy, physiological outcomes and processes, medical chart reviews, secondary analysis of clinical data, biobanks and clinical data registries should be submitted as a Clinical application.

A clinical research project that also includes questionnaires or interviews as part of its methodology should be submitted to a Clinical Research Ethics Board.

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.

4pt2 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).

4pt3 If this proposal is closely linked to any other proposal previously or simultaneously submitted to the BREB please indicate here and describe the relationship of this proposal to the others.

4pt4 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.

4pt5 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.

4pt6 UBC's Policy LR9 "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.

4pt7 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.

4pt8 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."

5pt1a Describe your study in lay language (that anyone can understand) in less than 100 words. If you are a graduate student conducting research for dissertation purposes, it is important to state this in section 5.1.A.

5pt1b 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.

5pt2 The TCPS 2 (2018) states that “Taking into account the scope and objectives of their research, researchers should be inclusive in selecting participants. 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." (Article 4.1)

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.

Where First Nations, Inuit and Métis people in Canada are the focus of analysis, the BREB takes direction from Chapter 9 of the TCPS 2. See more discussion in the BREB guidance on ensuring participant inclusivity in relation to ethnicity and race (see below).

While the Behavioural Research Ethics Board (BREB) considers the principles of inclusion during the review of research ethics applications, it does not typically prescribe language usage. BREB members review descriptions in the ethics application of gender identity, sex, sexual orientation, ethnicity and race, among other factors, in the context of the research being proposed. Research that addresses particular participant groups should use language that is most appropriate and acceptable for that group.

Researchers are encouraged to consider ways in which language might unintentionally be exclusionary, and to stay current with community standards in order to ensure that the language they use to describe inclusion criteria and recruitment activities — as well as the terminology used in supporting documents and research instruments — does not unintentionally exclude or stigmatize particular groups. It is the researcher’s responsibility to ensure that the terms they use can be justified.

Further reading and links

• BREB Guidance on Participant Inclusivity in Research 
  Ethnicity and race | Gender, sex and sexual orientation
• Chapter 4 TCPS 2 (2018) | Fairness and Equity in Research Participation
• Chapter 9 TCPS 2 (2018) | Research Involving the First Nations, Inuit and Métis Peoples of Canada

Article 4.1 of 5pt3 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.

5pt4

5pt5 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."

5pt6 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).

If you would like to discuss a particular research context or have questions about whether an activity requires review, please reach out to the BREB: Contact page.

6pt1 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".

6pt2 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".

6pt3 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.

6pt4 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.

6pt5

Article 3.12 of 6pt6 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.

6pt7 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.

6pt8

6pt9 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).

6pt10 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.

6pt11 Describe any restrictions regarding the disclosure of information to research participants (during or at the end of the study) that the funder or sponsor has placed on investigators, including those related to the publication of results.

7pt1

7pt2 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.

7pt3 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: https://tcps2core.ca/welcome/ 

8pt1 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. Researchers will need to explain 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: encryption and password protection of electronic files; storage of hard copy-data 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.

UBC provides cloud services for faculty, undergraduate, and graduate research that is FIPPA compliant. OneDrive offers storage and the ability to share files within and outside of UBC (https://it.ubc.ca/services/web-servers-storage/microsoft-onedrive). Please confirm whether the researcher will be using UBC's secure cloud service or other means. Before using cloud-based services not offered by UBC (such as Dropbox) to store or share your study data, please ensure you are aware of their disclosure practices (e.g. https://www.dropbox.com/privacy). Use of any non-FIPPA compliant cloud storage platform must be explained to participants in the consent form.

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):

1. Directly identifying information – the information identifies a specific individual through direct identifiers (e.g., name, social insurance number, personal health number).
2. 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).
3. 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).
4. 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.
5. 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.

Patient Interviews
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.

8pt2 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.

8pt3

8pt5 UBC Policy SC6 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. The principal investigator is responsible for the collection, maintenance and retention of research data. Records of data should normally be retained in the unit in which they are produced for at least five years after the work is published or otherwise presented (if the form of the record or data permits this, and subject to any assurances that data would be destroyed to assure anonymity).

Original data may be retained for a longer period provided that they are stored securely. “Complete records” includes signed consent forms and other research communications. UBC has no explicit requirement for the shredding of data at the end of the five-year period; however, destruction of the data is the best way of ensuring that confidentiality (if required) will not be breached. The ethics application should explicitly state that the PI will remain responsible for data storage. The BREB recommends that researchers review the most current information about data storage options provided by UBC IT Services before confirming where and how data will be stored after a study has closed.

Also note that the requirements to store data at UBC does not preclude its transfer and/or storage to other locations, including a co-investigator’s or community partner’s repository – as long as the confidentiality and privacy commitments made to participants are upheld.

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.

8pt6 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.

Providing open access to research results

Open access requirements come from both funders and journals. Researchers may be required to make their data accessible in a research repository (for other research purposes). Funders also generally require researchers to make their findings available.

Access to research data

Journals may decline to publish papers unless the data is made accessible to other researchers. Participants must be informed when data will be made available in this manner. Please include the following details in the consent form. Use non-technical/lay language suitable for the intended recipients.

1. Describe what open access means, i.e. who will have access, and where/how data will be stored.
2. Describe the data that will be made available, e.g. that identifiers will be removed.
3. Acknowledge (if applicable) that opening access to data has the potential for increasing participant risk.
4. Explain that once the data is made available, the participant will not be able to withdraw their data.

Public access to research findings

The Tri-Councils require that all findings resulting from funded research be made available (outside a pay wall) within 12 months of publication.

UBC’s cIRcle digital repository provides open access to research materials to anyone on the web.

The TCPS 2 (2018) also promotes the equitable distribution of research benefits: “Researchers, including student researchers, have an ethical responsibility to make reasonable efforts to publicly disseminate research findings in appropriate venues, in a timely manner and without undue restriction.” Making results publicly available could include not only publishing in a peer-reviewed journal but also uploading findings to a publicly available database, posting to a website, presenting at a conference, or sharing with research participants and other stakeholders during a community event. “Any prohibition or undue limitation on the publication or dissemination of findings from research is ethically unacceptable. Informing participants of the research results is as important as disseminating results to the research community.”

Further reading

Dissemination of Research Results (TCPS 2 (2018) Article 4.8

Access to Research Results: Guiding Principles (includes a list of additional resources)

Tri-Agency Open Access Policy on Publications

8pt7 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.

9pt1 Research proposals and grant applications – The BREB requires available research proposals and/or grant applications to be attached to the ethics application (in Box 9.1) for review. Researchers may be asked by the BREB to update their research proposal (but not grant applications) if there are significant discrepancies between the proposal and the ethics application, such as in research scope, purpose or methods.

Post-approval amendments – The BREB will not request revisions to grant applications or to research proposals when an amendment (PAA) is submitted for ethics review. Updates to Box 9.1 will only be requested in the event of new funding being added to the research.

Graduate students – Not all doctoral and master’s candidates produce a research proposal before embarking on research that supports their degree. Therefore, graduate students are asked to include a copy of their research proposal when available. If a separate document has not been developed, make a note in Box 4.4.B Internal peer review details confirming that the ethics application represents the full research plan and has been signed off by the student’s supervisor (or committee members), e.g. “This project is a graduate research project; the ethics application represents the full record of the research activity and has been reviewed and approved by the student’s supervisor [insert name].”

9pt2 Participant Consent Documents– For detailed requirements specific to behavioural studies, please see the Consent Form Guidelines.

Informed consent is a process that begins with the researcher sharing information with invitees through written or oral methods. Invitees should be given the chance to consider all aspects of the research that may have a bearing on their decision to participate. Once this has occurred, the invitee will be asked to confirm their consent to participate by signing a document or having their consent recorded orally by the researcher. Even when oral consenting methods are used, an information sheet should be provided to participants for their own records, unless to do so might compromise the safety of invitees or if it is culturally inappropriate to do so. See TCPS 2 Article 3.12 and Article 10.2 for further discussion.

Completing Box 6.6. Regardless of the method used to obtain consent (oral or written), describe all the steps being used to request and obtain consent. If used, attach oral consenting scripts to Box 9.2. 

The Consent Form Guidelines describe what information should be included in consent forms based on type of research being conducted.

Please note that a choice for "I do not consent" should only be used in parent consent forms for school-based research.

Other Consent Documents – If translated versions of consent forms are required, these will need to be attached to the ethics application before final approval can be granted.

9pt3 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.

9pt4 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.

9pt5 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.

9pt6 Letters of Initial Contact are the preferred method of recruitment when contact is initiated by the researcher rather than by the participant responding to an advertisement. Letters should use language appropriate for the intended recipient group and refrain from overly academic terms as much as possible.

Some research sites, organizations and communities may have their own standards, protocols and templates for creating and distributing letters of initial contact. (E.g. see the Vancouver Coastal Health Authority requirements: https://www.vchri.ca/services/developing-your-project/research-privacy.)

The BREB recommends that the following content is included:

1. Salutation (Dear [actual name] if known or role, e.g. Dear Community Member)
2. The full study title (as it appears in Box 1.7 of the ethics application) and name of the PI. Co-investigators’ names can be included if appropriate. Students should also indicate that they are completing the research project towards a course or degree requirement.
3. In the case of an organizational partner, the contact person in the organization should be named.
4. If the study is funded, include the sponsor name. 
5. How the research team obtained the recipient’s contact information (unless the participant has already responded to an ad or if their contact information is publicly available).
6. Why the potential participant is being invited to take part in the study (unless the participant has already responded to an ad).
7. A brief overview of the study (approximately 2-4 sentences).
8. A statement of any follow up to the letter that will occur and by whom (e.g. “We will contact you by phone/send a reminder email in 2 weeks if we have not heard from you.”)
9. If the researcher plans to recontact, a way for invitees to opt-out of further contact should be provided (e.g. “If you do not wish to hear from us, please ….”).
10. Next steps (i.e. “If you are interested in participating or learning more about this study, please contact ….”)
11. The PI’s and/or student’s signature line.

• Do not include Research Participant Complaint line details in the letter of invitation. (The text should only be in the consent form.)
• The Ethics ID number is also not required in letters of initial contact.
• A separate letter of initial contact is not required if the consent form will be sent at the same time, but the consent form should then include the above information as well as the regular consent information. (See the BEHAVIOURAL CONSENT FORM GUIDELINES for full details).

9pt7 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.