Does my data collection activity require ethics review?

The Office of Research Ethics receives inquiries on a regular basis from faculty, staff, and students asking if the survey or project they are planning requires ethics review.

We recognize it can be difficult to know if the activity you are planning falls within the scope of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS, 2nd edition).

This guideline attempts to provide additional information that will help in this determination. It is important to remember that not all data collection is research, not all research involves humans, and not all research involving humans requires ethics review.

Definition of "research" and "participant"

When is an individual a participant (or not) in research?

Decision tree for determining if research ethics review is required

Ethical considerations when planning activities such as surveys or other projects

Activities that may not require ethics review

Other factors that may influence if ethics review is required (or not)

Definition of "research" and "participant"

According to the TCPS2 the scope of REB review is limited to those activities defined in the TCPS2 as “research” and involving “human participants”.

Research is defined as:

an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation” and “a determination that research is the intended purpose of the undertaking is key for differentiating activities that require ethics review by an REB and those that do not (Article 2.1, p. 15).

Human participants are:

those individuals whose data, or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research question” (Article 2.1, p. 16).

Research ethics review and clearance is required for "research" which involves "human participants".

When is an individual a participant (or not) in research?

As outlined in the TCPS2, Chapter 2, Article and application 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.

A recent interpretation received in July 2012 from the Secretariat for Panel on Research Ethics states that:

Research ethics boards (REBs) have access to the detailed study and should examine the proposed interview questions in the study to have a sense of whether employees of an organization are asked (i) about their opinion whether professional or personal (and are therefore considered research participants), or (ii) to provide information in their professional role (and therefore would not be considered research participants). We recognize that it may be difficult to distinguish between a professional opinion and information provided by employees in their professional capacity given that in some cases a professional duty may include providing opinions.  In their assessment, REBs should consider the purpose of the interview questions, and in what capacity the researcher is seeking a response from the employees being interviewed.

Another distinguishing factor is the obligation of an employee to provide a response/opinion.  Under the above-mentioned scenario (i) employees may, but are not obliged to, provide their opinion (voluntary consent).  Under scenario (ii) employees are required to provide this information within their professional responsibility to respond to such requests. 

There is also the possibility that employees under the above scenario (ii) provide information that is then used to inform the research –but this does not in itself suggest that those employees are the focus of the research.

As a result, it is important to determine the objective of the research, the focus of the inquiry, the degree to which the people involved may feel obligated to provide this information as a result of their job responsibilities, and the specific nature of the questions which the people will be asked in order to determine if they are research participants (or not). 

Decision tree for determining if research ethics review is required

A decision treePDF version and accessible version, has been created to help faculty, staff, and students determine whether their project should be reviewed through a University of Waterloo Research Ethics Committee (REC) or through another mechanism such as the Survey Advisory Board with the office of Institutional Analysis and Planning. Begin by working through the questions in the decision yourself or your team/group. If after working through the decision tree you have questions or require further clarification contact the ORE.

The office of Institutional Analysis and Planning has established a Survey Advisory Board to review campus-wide activities that may be conducted with faculty, staff, students, alumni, and other stakeholders for quality assurance/improvement purposes. If you are conducting a survey or project for a quality assurance purpose you are encouraged to contact the IAP office to discuss your survey or project. The staff in IAP can provide advice on other quality assurance projects that have already been conducted and/or point you to other existing data sets that could aid you in the work you are doing.

Ethical considerations when data collection planning activities such as surveys or other projects

Although some surveys and projects carried out by members of the uWaterloo community may not be considered to be research nor require ethics review as defined by the TCPS2 since they do not involve “human participants”, these activities should still be conducted professionally and ethically following the core principles of the TCPS2. Quality assurance surveys can still contain ethical issues and dilemmas.

Similar to what is expected in research, surveys and projects that seek human involvement need to be conducted in a way which protects the interests of individuals or groups taking part in the activity from any risks such as bodily or psychological harm and be culturally appropriate. Moreover, the activity needs to ensure there is free and informed consent, that involvement is voluntary, and use no exercise of power of authority or undue influence (e.g., participation is a requirement to pass the course). Furthermore, the activity needs to respect an individual’s privacy and confidentiality (e.g., a person’s decision to participate along with their identity is not shared without their consent).

Activities NOT requiring ethics review

There are several categories of activities that do not require ethics review even though some of the activities may use methods and techniques similar to those used in research.

Making initial contact with individuals or communities to establish partnerships

Ethics review is not required for the “initial exploratory phase of the research where this phase involves “contact with individuals or communities intended to establish research partnerships or the design of a research proposal” (TCPS2, Article 6.11, p. 76). 

As outlined in the TCPS2, “some types of research using quantitative, qualitative research, or a combination of these methods, as well as collaborative or community-based research may require prior contact and dialogue with individuals or communities as a normal and integral component to establish research collaborations or partnerships prior to the actual design of the research” (p. 77). Furthermore, “other research may, at their initial stages, not involve humans, but require engaging the research team, setting up equipment and other preparatory stages” (TCPS2, p. 77). All of these activities do NOT require ethics review.

Creative practice

Ethics review is not required for creative practice activities involving the “process which an artist makes or interprets a work or works of art”. This “may also include a study of the processes of how a work of art is generated” (TCPS2, Article 2.6, p. 20).

However, “research that employs creative practice to obtain responses from participants that will be analyzed to answer a research questions is subject to REB review” (p. 20). For example, when the individuals become the focus of the research such as asking observers or art exhibit patrons to provide comments on a work of art and/or provide their personal opinion or analysis of the work this is considered research.

Research that relies exclusively on publicly available information

Information that is legally accessible to the public and appropriately protected by law does not require ethics review. “Publicly available information is any existing stored documentary material, records or publications, which may or may not include identifiable information” according to the TCPS2 (p. 17).

However, “some types of information are legally accessible to the public in a certain form and for a certain purpose, as specified by law or regulations” such as registries of deaths, court judgments, or public archives and publicly available statistics including Statistics Canada public use files (p. 17). Publicly available archives in Canada or other countries at either the national, provincial, or municipal level may have policies that outline certain restrictions or access rights.

Information that is publicly accessible where there is no reasonable expectation of privacy does not require ethics review. “Research that uses exclusively publicly available information and may contain identifiable information, and for which there is no reasonable expectation of privacy”, does NOT require ethics review. Examples include: identifiable information that may be disseminated publicly through print or electronic publications, film or digital recordings, exhibitions or events open for attendance by the public, etc.

Ethics review is also not required for “research that is non-intrusive, and does not involve direct interaction between the researcher and individuals through the Internet” and “for which there is no expectation of privacy” (p. 18). Examples include uncontrolled public access via the Internet to cyber-material such as documents, records, performances, online archival materials or published third-party interviews. Uncontrolled access means there is no login or password required to access the information, video, etc.

Observation of people in public places

Ethics review is not required for the observation of people in public places where:

  • it does not involve any interventions 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.

The TCPS2 defines observational research as the “study of acts or behaviour in a natural environment” however, this definition excludes “observational methods used in epidemiological studies” (Article 2.3, p. 18 and 19).

Care must be taken when conducting observational activities and researchers need to pay close attention to the location and environment in which the observation is to take place to determine if it might qualify as a public place and, even if it is a public place, if people might have an expectation of privacy. In certain locations people can have an expectation of privacy (e.g., sacred ceremonies, religious services, clubs, classrooms, chat rooms)  In addition, permission from a gatekeeper may need to be sought in order to conduct the research.

Furthermore, researchers need to take care in how they disseminate their study results as some methods, such as photographs, video- and audio-recordings, will identify individuals. In some cases, ethics review may be required because of the lack of privacy and possible identification of individuals. Researchers should contact the ORE to discuss their proposed observation activity to determine if the activity requires ethics review or not. 

Quality assurance/improvement activities for administrative or operational purposes

Quality assurance/improvement activities tend to be surveys conducted by University administration, faculty, staff, or student groups who are looking to assess how the University, faculty, department, program, or group is doing on a particular issue or activity, or are undertaken for administrative or operational reasons.

At the University of Waterloo, these surveys and performance reviews or testing within normal educational requirements when used exclusively for assessment, management, or improvement purposes, do not constitute research, and do not fall within the scope of REB review. This position is consistent with the TCPS2 (Article 2.5, p. 20). However, projects that combine research with quality assurance/improvement activities may require ethics review. View the decision tree to determine if your activity is research or quality assurance.

For a quality assurance/improvement activity to not require ethics review, ALL of the following must apply. The activity must:

  • be within the mandate of the University of Waterloo or according to the terms and conditions of employment or training,
  • be a systematic review of practice(s) and procedure(s) designed to identify possible improvements to an existing policy, program or process,  
  • only involve participation of University of Waterloo employees, students and/or alumni and relate only to the specific site or area such as the department, program, school, faculty, employee group, or key informants such as co-op employers, and
  • report results locally such that dissemination and publication of results or findings are not generally available for public release outside the University of Waterloo however in some instances dissemination or publication may mean the results are shared at a conference or other public means or with a  governmental Ministry/department or accrediting body.

If the activity is quality assurance/improvement you need to ensure that when reporting the results, such as in a poster or publication,  you do so within the context of your quality assurance/improvement activity and not refer to the activity or project as research.

Fraser Health outlines the differences and several of the key characteristics of research in comparison to quality assurance/improvement activities.

Research that relies exclusively on secondary use of anonymous information or anonymous human biological materials

Anonymous information is data or materials that never had identifiers associated with them. Identifiers are information that could potentially identify an individual; alone or in combination with other information that was collected.

For information to be anonymous no direct or indirect identifiers were ever collected therefore the “risk of identification of individuals is low or very low” (TCPS2, Chapter 5, p. 57). This is different than anonymized data in which the information or materials have been “irrevocably stripped of direct or indirect identifiers, a code is not kept to allow future re-linkage, and risk of re-identification of individuals from remaining identifiers is low or very low” (TCPS2, Chapter 5, p. 57). More information can be found in Security of Research Participants Data.

Research that relies exclusively on secondary use of anonymous information, or anonymous human biological materials, may not require ethics review so long as there is no process of data linkage and the recording or dissemination of results does not generate identifiable information.

It is important to note that given current technology and advancements most information associated with human biological materials such as genetic material is anonymized (not anonymous) meaning ethics review is required. However, making this determination can be challenging due to many factors. More information on human biological material can be found in Collection of Human Biological Material.

Researchers are strongly encouraged to contact the staff in the ORE to discuss their proposed project and analysis. Together, the ORE staff and the researcher will make a determination if the proposed research and secondary analysis will require ethics review.

Skill development

Undergraduate and graduate courses may include class projects and activities designed to develop research skills. These projects may be carried out by individual students, small groups or as a single class project.

Skill development would involve individuals (such as other students/classmates) pretending to be study participants; but, are not actual research participants.

These skill development activities may include the following and do not require ethics review:

  • learning to develop and conduct interviews,
  • learning to develop and distribute surveys of questionnaires,
  • learning to administer standard instruments or equipment, or
  • learning to analyze data and write a section for a pretend presentation or paper.

All graduate and undergraduate thesis projects involving human participants are considered research and do require ethics review.

Other factors that may influence if ethics review is required (or not)

  • Disseminating or publishing findings

Where findings may be disseminated or published does not determine whether something is research or requires ethics review. If you wish to publish the findings from your project be sure to contact the intended journal or publication to determine whether they require ethics review as one of the conditions of publication. If there is any doubt as to whether your activity or project requires review, it is recommended that you consult with the staff in the ORE.

  • Generalizability of findings

How generalizable your findings may be is also not a determining factor whether something is research or requires ethics review. Some types of activities that would be viewed as quality assurance/improvement can be broadly generalizable whereas some types of research are not generalizable because of the specific or small study sample or population. Researchers are encouraged to consult with the staff in the ORE to determine if the activity or project they are planning fits the definition of research according to the TCPS2 and whether that activity requires ethics review.

  • Action or Applied Research Activities

Action research, sometimes referred to as applied research, is commonly conducted in the fields of education, organizational and community development, and various forms of work-life research. Action research describes a kind of research that often combines social science approaches with the delivery of programs to address or solve a current or ongoing social issue or practical problem, usually in an organization or community. The focus is not necessarily to produce theoretical knowledge or scientific findings, although that may be an unintended outcome, but rather to improve practices or processes.

Action research tends to involve a team of individuals, including employees and clients of the program, who treat each other as colleagues. Other labels for action research include: action inquiry, action science, cooperative inquiry, and participatory action research. Various methods for collecting data can include observation, interviews, surveys/questionnaires, interviews, and focus groups.

Social science researchers, such as those in psychology, may conduct applied research to study various human factors. Others in the field of industrial/organizational psychology, business, and engineering may use applied research to try and solve practical work problems. At times, quality assurance/improvement activities can be associated with or seen as a form of action or applied research. Individuals who plan a quality assurance/improvement project that includes action or applied research are encouraged to consult with the staff in the ORE to determine if the activity or project they are planning requires ethics review.

References

Alberta Research Ethics Community Consensus Initiative (ARECCI) Network (2010). ARECCI Ethics Screening Tool. Retrieved February 6, 2013 from http://www.aihealthsolutions.ca/arecci/screening/22909/d476cf4c8605b6bb8586024d58ad6f2f

Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada (2010). Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. Retrieved October 2012 from http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/

Eikeland, O. (2012). Action Research – Applied Research, Intervention Research, Collaborative Research, Practitioner Research, or Praxis Research? International Journal of Action Research, 8 (1), 9-44.

Schwandt, T.A. (2007). The SAGE Dictionary of Qualitative Inquiry (3rd ed.) Los Angeles, USA: Sage Publications.

University of Toronto (2010). Screening guide to determine whether ethics review is required at the University of Toronto. Retrieved February 5, 2013 from http://www.research.utoronto.ca/for-researchers-administrators/ethics/human/policy-related-to-ethics/

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