May 29, 2020
When it comes to ethics in the digital health product development space, there are many grey areas.
Some organizations are required to have their research approved by an Institutional Review Board before any data collection or experimentation. These Institutional Review Boards (IRBs) evaluate the research process to ensure ethical practices are upheld and participants are treated fairly.
However, there are many organizations developing digital health solutions that collect, store, or leverage personal information, but they don’t require official IRB approval.
IRB or not, all organizations developing digital health solutions that handle users’ personal information should implement some standard of ethics as a best practice in product development. But how can product teams integrate ethical best practices when what is ethical is subjectively decided by their own team?
Without an official IRB, ethics can vary depending on circumstances or team members, thus, treatment of users and participants, or their data, may be inconsistent across teams and projects. Compound this with the additional complexity of a crisis, be it a global pandemic or a natural disaster. How does your team integrate ethics into product development while rapidly deploying solutions in response to a crisis?
To help your team prioritize ethics during the product development process, we share actionable tips to get you started and highlight the impact ethics has on digital health products.
Practical Tips for Implementing Ethics in the Product Development Process
With the number of ethics-centered publications at an all-time high, the general understanding of what ethics is continues to grow. Although these resources may leave us inspired, they often lack actionable insight on how product teams can apply ethics to the development of their own digital health solutions.
Though we often think of ethical practices solely at the research stage, the role of ethics starts with product ideation and it extends far after product deployment. Let’s walk through the product development process and explain how ethics is weaved throughout. The following tips resonate closely with IRB requirements and are rooted in years of experience in healthcare and academia, as well as in conversations with ethical stakeholders.
Product Ideation
Product teams should implement ethical thinking as early as the ideation of a digital health solution. Drawing from the field of architecture, new products should optimize human well-being and benefit not only their users, but also the community at large. This can be achieved by answering a series of questions including:
- How does the proposed product impact the lives of its users?
- How does the product impact the community at large?
The questions above are, to some degree, subjective. So how do we ensure our products are rooted in ethical considerations? Our first two tips tell you how to tackle these seemingly hard questions:
Tip #1: Surround yourself by a diverse team
Your everyday team should consist of people from all walks of life, with different backgrounds and a wide range of experience.
While a diverse team is a great first step, our teams’ voices must be complemented by experts in the domain for which we are developing. Product teams often learn of defects or missed opportunities after products have been released into the market. These are then addressed by implementing changes in a future product version. This can be avoided by asking the right people the right questions early on, which leads to our next tip:
Tip #2: Bring in product-specific experts
Throughout the product development process, engage experts and stakeholders to complement your team’s expertise. For example, if you are developing a diabetes app, you’ll want to engage individuals living with diabetes, their families and/or caregivers, physicians, diabetes educators, and insurance/payor representatives at different stages of research and development.
A both diverse and specialized team allows you to create holistic products by bringing in unique perspectives and ensures product scalability.
Research (Pre, During & Post)
Research activities are not confined solely to hands-on data collection. The decisions made before and after data collection are equally important. To that end, we’re encouraging you to think of ethical research practices before engaging with participants, during, and after.
The pre-research activity is mulling time to define the research goal and decide what information is needed to accomplish that goal. With expertise in academia, healthcare and industry, projects across the board have often left us wondering “Why do they need this?”. For example, why does research on diabetes require the participants’ address? So here’s a tip to consider before beginning research:
Tip #3: Only collect strictly necessary information
Minimizing the personal information collected during research makes the process less invasive for participants and reduces the impact of a possible data breach (e.g. Is asking for the birthday really necessary or would an age range suffice?)
Consider reimbursement methods that minimize the personal information required. Gift cards, PayPal, and Interac all require only an email, whereas direct deposit requires a ton of personal information. If you must do direct deposit, limit the number of employees who can access the data. Your cybersecurity team will thank you!
Recruiting is sometimes viewed as the “easy” part in comparison to the hands-on research and data analysis. However, who you recruit can have an immense impact on the product. In addition to the aforementioned considerations around diversity and domain expertise, consider the broader ecosystem of stakeholders impacted by the product.
Tip #4: Recruit your research participants thoughtfully
Simply recruiting research participants that fall within your target user base isn’t enough. For example, if you’re developing an app for individuals living with epilepsy, you can’t assume that patients with epilepsy are a homogeneous group. Your recruitment criteria should account for the heterogeneity within the group (e.g. diversity in age, gender, digital literacy, overall trust in apps, the nature of their jobs). All of these factors can impact the users’ interaction with the app. Participants diagnosed with the same condition can’t be lumped under the same umbrella.
Given we’re in the midst of the digital era, the next tip should be no surprise.
Tip #5: Consider access to technologies when conducting research digitally
We’re experiencing a ramp-up towards conducting research through digital formats. On one hand, we can now access users all around the world. On the other hand, some users may be left behind when recruiting digitally. To address this, we must consider varying levels of access. In some communities, cell reception and wifi aren’t a norm, but a privilege.
An example relevant today involves COVID-19 solutions. Most COVID-related solutions are digital, yet some of the most at-risk individuals have low digital literacy. Additionally, there have been great digital visualizations that illustrate how social distancing works to “flatten the curve”. But how do people living with visual difficulties access this information?
In the research stage of product development, some aspects to consider include informed consent, participants’ rights, compensation and data storage/confidentiality.
If done right, informed consent is the cornerstone of ethics. Participants should understand what they are signing up for and participate free of coercion. One tip immediately comes to mind:
Tip #6: Use plain language
Write the informed consent form (and any communication with participants) in a “consumable” fashion for people from all walks of life. Formal IRBs recommend writing at a grade 5-8 level. A practical alternative is to run the document by colleagues from different fields and see what questions/misunderstandings they have.
Writing for all literacy levels is hard. To facilitate the participants’ understanding, here’s an additional tip:
Tip #7: Provide the informed consent form in advance
Whether you prefer verbal or written consent, always give the informed consent form to participants in advance so they can review it unrushed. Encourage them to read it over with a friend or family member and to reach out with any questions they may have. Though verbal consent has its merits, asking for consent on the spot, especially when a financial incentive is involved, may pressure participants to agree despite potential doubts.
Participants’ rights should be kept in mind across all stages. An often skipped step is their right to withdrawal. Be sure to include in your consent form that participants are able to withdraw from the study at any point. If a participant does withdraw, here’s another tip:
Tip #8: If possible, grant reimbursement despite withdrawal
If your budget permits, reimburse participants in full even if they decide to withdraw during the experimental session. Otherwise, the minimum you should be doing is prorated reimbursement.
Participants should receive fair compensation for their time. However, in some situations, compensation may be a form of external pressure. For example, with the current COVID-19 pandemic, many are experiencing layoffs. The financial relief offered by reimbursement may incentivize participants to agree to studies they otherwise may not. Here’s a suggestion to avoid coercion:
Tip #9: Compensate participants with a charitable donation in their name
If you can, compensate participants by making a donation to a charity of their choice in their name. You can provide them with a tax receipt as well. This compensation option relieves any potential financial pressure of accepting the terms of a research study.
We’ve already reviewed the first step towards protecting participants’ identity by collecting strictly necessary information (Tip #2). Additional measures to ensure data confidentiality include the following two tips:
Tip #10: Use anonymized codes and labels
Use anonymized codes that can’t be easily traced back to the participant (e.g., “m_a” to indicate the first male participant and “f_b” to indicate the second female participant). This is your chance to be creative and this creativity pays, particularly in the case of a data breach.
Tip #11: Disassociate user information
If you must keep the participants’ identifying information, make sure the personal information and the data collected (e.g. interview responses, other medical information) are stored separately, with different layers of protection. This will minimize the risk that someone may access both and associate data with an identified research participant.
Deployment & Monitoring
Our ethical responsibilities do not end when the product is on the market. New research questions may emerge and prompt us to revisit the data collected to answer them. Using data we already have to answer a new set of questions is known as secondary data use.
Secondary data use is a cost-effective and convenient way to gain new insights, however, one often forgotten step is that this, too, requires consent. Here’s an easy way to avoid using participants’ data without their consent:
Tip #12: Ask permission for future uses of the data in the informed consent form
Include a “data use” section in the informed consent form where you explicitly ask participants whether their data can be kept and used in any future research. Ideally, the options you provide should be “no” or “maybe, we will contact you regarding any future use of your data”. A binary yes/no option is tricky because no one can anticipate all potential future uses of their data and whether they’d be comfortable.
Finally, though this last tip may not strike you as an ethics “must”, it’s rooted in the idea that research participants are not our subjects, but rather, our collaborators. This mindset is crucial to strengthen the bridge between the research community and the general public. To put this mentality in practice, you can:
Tip #13: Keep research collaborators in the loop
Similarly to how you keep team members informed, you should keep participants or “collaborators” in the loop as well. Whether it’s once the product is on the market, or as you’re finalizing the insights report, it’s always good practice to communicate findings and next steps to participants.
The Impact of Ethics in the Product Development Process
Why Ethics Matters in Product Development
Long gone are the days when product functionality was sufficient to ensure customer satisfaction. In a user-centric world, functionality must be complemented by a positive experience. Ethical product research and design practices go a long way in creating a holistic experience. In essence, ethics are nothing but principles ensuring the well-being and protection of everyone involved including participants, users, researchers and product owners.
The ethical considerations in conceiving an idea translate into how we select and treat participants during research, which then carry into how the product serves its users and how it impacts the community at large. Aside from being the right thing to do, ethical practices can also positively impact the product’s success on the market.
An Example to Illustrate: Inclusive Design of a Diabetes Management App
Inclusivity is an important, yet often overlooked, element of conducting ethical research. Inclusive research and design help ensure a variety of unique groups are represented fairly in each step of the product development process. Capturing underrepresented perspectives during product ideation, testing and data collection is key to maximizing the reach of the product and its benefits.
How you select the people you talk to during the research recruiting stage has unimaginable ramifications. In an analysis of user reviews for 18 diabetes apps, we learned that complaints related to inclusivity were prominent. Here’s two that can impact the market success of a diabetes app:
- Fasting: Many diabetes apps do not account for fasting. The text field where you input the number of calories has a minimum value allowed, and someone fasting would be below that value. This affects calorie tracking overall and leads to user frustration. A pragmatic product owner may say “It’s impossible for a product to account for everyone.” While that may be true, this particular complaint could be addressed by changing a single line of code (e.g., if the code says minimum number of calories allowed equals 1200, replacing 1200 with a lower value such as 0 would solve the issue). This change would add immense value to the product at virtually no cost.
- Pregnancy: Many diabetes apps do not account for pregnancies. As someone advances in their pregnancy, the number of calories required increases. Many apps do not account for this and suggest an insufficient calorie intake. Aside from being frustrating, this app limitation may end up hurting some users rather than helping them.
Implications of Inclusive Design
The above example highlights the implications of inclusivity on product development:
1. Intentionally integrating inclusivity can prevent costly product limitations.
Product limitations are often discovered after product deployment when changes are more costly than if they would’ve been considered in the first place. The ideal time to identify these limitations is during product ideation and research stages. Tips 1 and 2 above highlight how to identify these potential problems before they arise.
2. Inclusive design can be low cost, low effort, and can expand your user base.
While we can’t expect all products to serve everyone, some steps towards inclusiveness don’t cost a penny despite the immense value they add.
3. Neglecting inclusivity and other ethical considerations can put users at risk.
Though some digital health organizations do not have to go through an IRB, patient safety is our foremost concern. The pregnancy example illustrates how a well-intended app may provide advice against someone’s well-being when ethics isn’t integrated during product development.
4. Inclusive design can be a market differentiator.
Product owners often assume that the value added by inclusivity impacts only a handful of people. This is not the case; those people have friends and acquaintances. Even if the product may not influence someone directly, if it impacts their close ones, it’s likely many would make a switch to an alternative product because of an emotional or sentimental association. After all, aren’t humans emotional buyers at heart?
When to Consider a Neutral Research Party
It can bring teams confidence knowing that their product’s development has been informed by ethically responsible research and practices. If you think there is a conflict of interest at hand too great for your team to conduct product and user research yourselves, then consider bringing on a neutral third party to research on your behalf. This will help minimize the risk of biases impacting your research results.
We’ve worked with a variety of MedTech clients, some with and some without official ethics review boards, to conduct product research and testing that keeps participants’ best interests in mind. Our experience in conducting ethical product research has helped organizations develop thoughtful, user-centric products that offer real value to their customers.
Fresenius Medical Care is the world’s leading provider of products and services for people with chronic kidney failure. We conducted an ethnographic research study to help them better understand a major client group and apply the insights from the study to develop solutions that address their needs.
Siemens Healthineers also sought us out to conduct objective research on the usability of one of their ultrasound machines. Their team had recently launched a new machine with enhanced features and they were looking to validate the new and improved product design with first-hand feedback from sonographers.
In both of these projects, our team conducted informative research in a way that respected consent, protected participant privacy and ultimately, put users first. Our roots in user experience design and data analytics helped us communicate research results so that they could be understood and applied easily by our clients. Finally, our technical healthcare expertise enabled us to present findings in a way that adhered to regulatory requirements. If your team requires support in integrating ethics into the product development process, contact our team today!
Acknowledgments
Creating content is never a singular effort! We’d like to thank Dr. Thibaudeau for sharing his views on research as collaboration; Juhan Sonin for paving a path towards ethics in industry and his generous sharing of resources on the use of plain language and the importance of diversity; Ken McMillan, for highlighting how minimizing data collection minimizes the impact of a data breach; and Dr. Salt whose experience with individuals living with autism gave us food for thought.
A special thank you goes out to Cathy Agyemang, Dr. Chunyun Ma, and Florida Doci for fueling endless ethics conversations across fields and across cultures.