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6 minute read

How to conduct compliant user research for your digital products in pharma and healthcare

When thinking about conducting user research for your digital products in highly regulated sectors like pharma and healthcare, concerns can be raised about whether this can be done in a way that meets regulatory requirements.

Here, we’ll explain some of the measures that can be put in place to conduct compliant user research for your digital products, whilst keeping the safety, privacy and wellbeing of research participants as the top priority.

Compliant user research
by Graphite Digital
28 June 23
  • User Research
  • Compliance
  • Digital Design

In all our work, we seek to educate our clients on the value of adopting a more user-centric approach when it comes to digital design. How? By conducting user research, then converting it into actionable insights that allow you to move forward.

By fully understanding your end users — whether patients or HCPs — you can ensure that your digital products are always aligned to their needs, leaving no room for doubt when it comes to decision-making.

But in a highly regulated sector like pharma, concerns can arise early about whether research projects will get signed off by compliance teams or can be conducted in a way that meets regulatory standards.

Good news — they can! Here, we’ll explain some of the ways that we ensure we as Graphite conduct compliant user research for your digital products, whilst keeping the safety, privacy and wellbeing of research participants as the number one priority.

Clearly defined scope and remit for all research

When conducting user research projects we ensure that all our research activities strictly adhere to the confinements of research within the pharma sector — meaning we do not inquire about drug-related topics or engage in randomised controlled trials (RCTs).

By clearly outlining the boundaries and scope of our research through our research plans, and ensuring that these research plans are always signed off by the client team before projects get underway, we maintain ethical practices and respect the regulations governing studies within the field.

Our research protocols are designed to focus on user experiences, usability, and feedback related to digital products, while avoiding discussions or inquiries that fall outside the approved scope — for example, about drug effectiveness or side effects. This approach ensures that our research is compliant, unbiased, and aligns with the specific needs and restrictions of the sector.

We take great care to ensure that our research methodologies are in line with industry standards, and we prioritise transparency in communicating the scope of our research activities to both participants and the clients we work with.

A fully-informed consent process

A fully informed, valid consent process is followed for all user research projects and participants are fully debriefed after research sessions are completed.

Our consent process ensures that participants have a clear understanding of the research project objectives, procedures, and potential risks or benefits involved. Prior to any research session participants are provided with detailed information about the purpose of the study, the data we collect, how it will be used, and any privacy measures in place. This is informed through documentation but also during the research session itself to reiterate information to participants. We emphasise to participants the transparency and encourage participants to ask questions and seek clarification before giving their consent to participate. Participants are made aware of how anonymity is prioritised within sessions, knowing that we ensure any personal identifiable information is kept confidential and anonymised.

Experienced Clinical UX Researchers

Our team of Clinical UX Researchers are highly experienced in conducting user research with both patients and HCPs. They have been trained in safeguarding, enabling them to identify and mitigate risks during research.

They've undergone enhanced Disclosure and Barring Service (DBS) checks, ensuring a clear record for research engagements with children or vulnerable adults. Data privacy and adherence to industry regulations are paramount throughout our research process. In collaboration with our wider internal and client teams, we create a secure and confidential environment, fostering trust and delivering valuable insights for user-centred digital products.

Adherence with British Psychological Society’s code of human research ethics

All research study designs and practices strictly adhere to the British Psychological Society’s code of human research ethics, which aims to actively prevent any psychological or physical harm to participants. It focuses on the BSP’s four primary ethical principles — respect, competence, responsibility, and integrity.

GDPR and HIPPA compliance

In order to protect the personal data and privacy rights of research participants, all our research is conducted and stored using GDPR and HIPAA compliant research tools.

Research data monitoring is actively maintained and all raw research data is regularly deleted according to GDPR and HIPPA guidelines.

Option to ‘white label’ digital products

To mitigate potential biases, we can create unbranded — or ‘white labelled’ — duplicates of digital products during the research process. This approach allows us to create a neutral and unbiased environment for research participants, ensuring that their responses and interactions are not influenced by pre-existing brand perceptions.

By removing any explicit branding elements from the research materials and digital products, we create a level playing field where participants can provide feedback and insights based solely on their personal experiences and preferences.

Our team carefully removes all identifiable branded elements such as logos, colours, and brand-related content from the research materials and digital products to create unbranded duplicates. This process allow us to maintain the integrity and neutrality of the research process while still leveraging the functionality and usability of our digital products in a realistic way.

Working with trusted recruitment partners

In some cases, our clients may choose to source research participants themselves from their own networks of patients, caregivers, HCPs or other stakeholders. In other cases, it may be necessary to source completely new research participants.

We collaborate with trusted recruitment partners who specialise in sourcing participants within the healthcare and pharmaceutical industries. These partners have a deep understanding of the unique requirements and considerations of healthcare and pharma research, ensuring that the recruited participants possess relevant backgrounds and expertise.

We carefully vet our recruitment partners, ensuring that they adhere to strict privacy and data protection standards, including compliance with HIPAA regulations and other relevant healthcare privacy laws. We work closely with them to screen participants for any potential conflicts of interest, ensuring unbiased and impartial research outcomes. They assist in identifying eligible individuals who meet specific criteria, such as patients with certain medical conditions or healthcare professionals with relevant expertise, demographics, or geographical locations.

Final reflections

Although there are some extra considerations to keep in mind when planning your research projects to ensure the process is both ethical and compliant, user research in the context of digital products and services is completely doable, and, we’d argue, essential.

Speaking to your end users first-hand will provide invaluable insight that can be used to inform your digital products and strategies, giving you the best chance of ‘getting it right first time’.

If you’re looking for an experienced partner to conduct user research and equip you with the insight needed to make an impact for your patients or HCPs, get in touch.

Contact us

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