In December, 2014, the Health Design Lab submitted a “blanket” Ethics Application to Emily Carr’s Research Ethics Board (reb) in order to summarize and explain our overall methodology. The goal of this application was streamlining the ethics application process for projects the Lab manages that are very similar in methodology. The following text excerpts some of that application.
The Health Design Lab at Emily Carr is committed to providing design opportunities to students and faculty through collaborative partnerships that apply solution-focused, human-centred research methodologies to complex problems in health care.
The Lab typically collaborates with a range of different partners—health authorities, research teams at other universities, private industry, etc. to consider design problems that range from simple product ergonomics, to larger so-called “wicked problems” that require design interventions that could facilitate behavioural or cultural change within a specific environment. What links these projects is their focus on human-centred design to put people at the core of the design and research process.
The aim of this design process is outcome focused. We apply the knowledge learned from a range of research methodologies to specific designs or recommendations for systemic change. These outcomes range from CAD modeled product prototypes to web sites or mobile apps or print based solutions. In most cases, projects are accompanied by a design process book. This book documents the full design and research process, grounding the outcomes in evidence. In some cases, a secondary outcome of the project is a paper, often written by students and/or the faculty lead, which is submitted to either Current, Emily Carr’s design research journal, or an external publication. Where this is an intended outcome, it is included as an outcome in the participant consent form.
Most projects are funded directly by the partners, but we have also been supported by grants, including the Natural Sciences and Engineering Research Council (NSERC) and the Canadian Institutes of Health Research (CIHR). Where partners are private and outcomes are intended for commercialization, an Intellectual Property (IP) Agreement is included with the Memo of Understanding and all research collaborators and students are made aware of the terms of the agreement. Research participants are also briefed on the potential application to a commercialized product.
While our methodology is by necessity project specific, we draw upon a common set of “tools” and we follow a similar research trajectory for most of our work.
First, a full review of current literature is undertaken to educate the project researchers, to understand the problem, to identify what is known and how it was studied, and to ensure that any existing work is not duplicated. This also encompasses a contextual survey, to see how other research teams or designers have approached the problem space. This literature review is often followed by an exploratory research phase, where we talk to partners and stakeholders informally to gain a better understanding of the problem space. From here, we typically generate a series of research questions and a thesis statement.
To address these questions, we consider how generative research techniques could be applied to gain a deeper understanding of the challenges and attitudes of the stakeholders, as well as developing empathy for users. These methods, largely based on the work of Sanders and Stappers in their seminal work Convivial Toolbox (2012), include co-creation activities, focus groups, ethnographic probes, job shadowing, direct observation, user testing, interviews, and surveys.
From the results generated by this “soft” research process, we use an affinity mapping technique to look for areas of commonality from different participants. We group information into common themes. From these themes we create a set of guiding design principles to help inform the iterative stage of our process. This iterative phase can also be inclusive, bringing partners into the brainstorming process. Last we move from iterations through refinement to a prototype design. Where feasible, we re-engage with stakeholders to evaluate the success of the proposed design in user testing.
Current Ethics Process
Established formally as a research centre in 2012, the Health Design Lab (HDL) has engaged with Emily Carr’s Research Ethics Board on many project and course-based applications. From this experience, researchers in the Lab have developed a strong understanding of the ethics landscape, particularly as it applies to design and research for healthcare. This knowledge has proven highly useful, particularly in collaborations with the health authorities, as they have an understandably rigorous process of their own, also based on TCPS2 (Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans). Students who are engaged with any HDL project are required to complete the TCPS2 tutorial. But further, all Research Assistants participate in discussions about ethics and learn how to apply their knowledge to their engagements with participants. In all cases, students are closely monitored and supervised by faculty.
Proposed Ethics ProcessS
The HDL is proposing a revised process where the HDL and the REB would agree on a set of protocols that would inform whether a full project-based application is required or HDL would proceed with its own vested authority for simple projects. If all protocols are met, then HDL would be empowered to commence research without a formal ethics submission, and submit all documentation at the end of each project. The following protocols are suggested:
1. Projects that engage adults capable of informed consent participating in activities that are minimal risk (defined as not more than participants would encounter in everyday life) would fall within HDL’s scope of approval. These would include:
A. Co-creation B. Interviews C. Surveys D. User testing
E. Ethnographic probes F. Observation G. Job shadowing
2. All principles of informed consent to be followed on all projects.
3. HDL faculty will ensure that all project researchers have completed the TCPS2 tutorial, and will take on educating students around ethical practices in research.
4. The HDL Lead Researchers will assess HDL projects for REB protocols and will work with partners, students and faculty in determining the nature of risk and benefits for any given project.
5. Lead HDL Researchers will oversee all projects, ensuring all ethics protocols met.
6. All ethics-related materials (consent forms, model release agreements, etc.) will be delivered to the REB office for safekeeping at the end of the academic year, or completion of the project.
7. Any data will be given to the REB office for secure storage (note, HDL “data” is usually ephemeral and not able to be stored. Such items as sticky notes on kraft paper are reassembled from their original context and destroyed after design principles have been extrapolated).
8. Any MOUs involving project partners will be forwarded to the ECU REB as they become available.
9. Student and faculty members Core Ethics Tutorial certification will be forwarded to the ECU REB for reference.
Projects that would trigger a full project-based review would include:
1. Those for which informed consent is sought from vulnerable populations such as children (minors) and the elderly (who may have physical or mental impairments).
2. Any activity deemed to be more than minimal risk such as a research inquiry that looks into diabetic self-care management wherein the research participant is asked to divulge information pertaining to diet, medications and exercise. This might necessitate seeking professional mediation by a healthcare practitioner to mitigate the risk.
Summary and Scope of Proposed Research
The overarching goal of the work of the Health Design Lab is to apply a human-centred design methodology to challenging problems in healthcare, offering outcomes that have the potential to effect real change within a specific environment. The primary goal of this work is therefore directed towards designed outcomes. These outcomes vary greatly and range across systems design, product design, interaction design, etc. The research that is conducted for this work is undertaken to directly inform the design process. Our value is in applying research to design, in innovation, not necessarily the research itself. Coupled with this service model, is a focus on the educational value of a project to students. Does the work provide a real learning opportunity where students can practice human-centred design methodologies and apply theory to practice. Our work dovetails with courses in research methodologies taught at Emily Carr and we have frequently embedded projects in those, and other courses.
At the Health Design Lab we use a human-centred and qualitative approach to study health related design problems. Our methodology allows stakeholders to become active participants in the design process. We interact with users and engage with them in discussions, conversations, explorations, evaluations and activities that help us to better understand their views, needs and preferences regarding specific problems, objects and situations.
In asking questions, the designer gains a deep understanding of the problem studied, for example the participants’ thoughts, feelings, needs, intentions, attitudes, views and experiences. The designer is an active participant in managing the interview process ensuring that the required subjects are covered, and respecting the participants’ views. Most frequently we conduct structured and semi-structured interviews in person, phone or video conferencing.
Observations enable designers to learn about events, activities, behaviours, and artifacts within their natural environment. Observations provide valuable information such as who interacts with whom, how is the interaction managed, how objects or artifacts are used, when are they used, and for how long. This method usually offers additional information in identifying events or activities that participants may not be aware of at the time. Most observations performed by designers in the Health Design Lab are passive. The participants are aware of the researchers’ observation activities, but the researchers are not members of the group studied and avoid disrupting normal activities.
Co-creation is the creative act of making, telling and enacting, where designers provides toolkits to participants to interpret ambiguous questions and answer them, to discuss problems, to describe future experiences, concerns or opportunities, to make artifacts or “things,” and to create prototypes. These toolkits are collections of physical elements conveniently organized for participatory modelling, visualization, or creative play by users, to inform and inspire design. Ideally participants engage in iterative cycles of making, telling and enacting.
Ethnographic or cultural probes provide a way of gathering information about people and their activities. Recipients of the probe are guided through a series of activities that span a time period and probe for people’s perceptions. Participants are given a kit of materials, and briefed about the requirements to record or note specific events, feelings or interactions over a day or another period of time.
Frequently the Health Design Lab engages in Quality Assurance studies. A Quality Assurance or Quality Improvement study aims at monitoring and evaluating services, facilities, employees, or aspects of projects (such as training or best practices applications) to ensure that standards of quality are being met. The study requires data collection and data analysis but, since this information is used to assess an organization’s performance, or the relevance or success of programs and projects, the study does not require Research Ethics Board review. The results are used to improve, redefine, or redirect future objectives and activities. Generally, results of quality assurance studies are not for public release.
Most of the research done at the Health Design Lab uses qualitative methodologies. Occasionally, researchers start with exploratory work before conducting the research to understand the main aspects of a problem or community they need to involve in their research. These explorations are open-ended. The aims are: to gain understanding rather than describing phenomena in detail, and to allow designers to become familiarized with situations, cultures, norms, or communities. The results allow designers to discuss the suitability of the research, consider possible collaborative partnerships, consider access to settings and populations, and to plan the research proposal (determining research question, methods, sample size, and data analysis). Research activities might include dialogues, passive observations, taking notes, and writing a diary.
Our research involves diverse groups of patients, healthcare personnel and administrators, older, younger, differently able, and multicultural populations. We select participants according to the scope, objectives, nature, and context of our research, as well as on the existing knowledge about the problem studied. When working with vulnerable populations we seek the advice of experts.
Frequently, recruitment is done through our partners given that they have easiest access to participants. Through dialogue with the partners we ensure and discuss the issues around voluntariness. During the consent process we make it clear to participants that they are free to withdraw their consent to participate at any time and without providing a reason.
Benefits to Participants
Our research produces benefits that may contribute to the care, treatment and well being of the participants and other members of society. Benefits to participants very from project to project, and might include: taking an active role in one’s own healthcare, helping combat feelings of helplessness, doing something interesting, talking with people that suffer from similar conditions or are in similar situations, exercising one’s autonomy and taking active role in society, and gaining understanding and ideas to improve one’s own condition, well being or quality of life.
Learn more about HDL at www.healthdesignlab.ca.