Research Design 1: Minimising risk
Protecting your participants
Human Research Subjects – the participants in research who provide researchers with the data they need to advance knowledge – have made, and continue to make, a phenomenal contribution to science. Whether they’re involved in early trials for vaccine testing, or providing views on their proposed measures to address climate change, our collective knowledge could not advance without them. It goes without saying then, that, as a researcher, protecting your participants from any potential risks of their participation in your research, should be central to your research design.
Whatever the kinds of data you are collecting from your participants, and regardless of whether they include personal data as defined by GDPR (the General Data Protection Regulation), it is vital that:
- you are aware of the potential risks that your research might expose your participants to (both during the research and in the longer term)
- you have taken steps to minimize or mitigate these risks, and
- your participants are aware of, and have agreed to these risks and mitigation measures
- you execute precisely the agreements you make with your participants (normally via Informed Consent)
An effective way to incorporate Human Research Ethics into research design is to organise a risk-planning session early on in the design process (eg: in the early phases of drafting a proposal for funding or a Master’s thesis). Although you can do this by reflection on your own, a small group that can role-play different stakeholders will help to more effectively:
- reflect on any possible risks to your participants (both during and after your research)
- reconsider whether all of these risks are necessary to take, and if so how you might mitigate them
- prepare a gap analysis and follow-up plan for any unanswered queries emerging from your discussions
Try putting yourself in the position of thinking like one of your research participants and you might see any potential risks differently!
Historically, the risks for human participants unwittingly involved in (mostly clinical) research have sometimes been devastating, the worst of which ultimately led to drafting of the 1947 Nuremberg Code – the first formal ethical guidelines for medical research. But the risks associated with less controversial research methods or goals can also be devastating. What happens if there’s an accident which your research methods could have contributed to – or directly caused? Have you checked the relevant Health and Safety requirements, and are there any insurance and/or liability issues to take into account? Or if one of your participants has an adverse reaction to your experimental conditions, or finds themselves in a difficult situation in the field, do you have the necessary backup plans in place?
And then there’s the increasingly sensitive issue of personal data. How you handle the data your participants give to you – whether it’s basic personal data collected for administrative purposes or more sensitive personal data that contribute to your research – is also critical. Not just because it’s a legal requirement to do so, but because the consequences of a security breach for your participants can be devastating. Such consequences can include identity theft or fraud, while the consequences of re-identification, might include damage to reputation, loss of livelihood or investigation by the authorities.
Failure to protect personal data against loss or misuse can also have serious legal, reputational and financial consequences for researchers and research-performing organisations. Recent examples of unethical research practices have involved the unauthorised collection and/or (mis)use of personal data, resulting in enforcement action by regulators. In the Netherlands, a Research Subject may complain to the Dutch Supervisory Authority concerning a data breach of personal data, with the possibility of a penalty being imposed. A civil action may also be pursued for damages incurred.
Running a risk-planning session while you’re designing your research can help you to identify possible risks, develop proper steps to mitigate them, and work out how to clearly inform your participants of both what the study will involve and what possible risks it might bring. Later, once you’re ready to start your research, applying for Human Research Ethics approval is not only mandatory for Human Research at TU Delft, but provides a valuable opportunity to check that you’ve covered all your bases with respect to participant safety.
There are many ways to organise Research Ethics, which in practice are a combination of legal requirements and ethical and professional standards. As one example, the European Commission usefully recognizes ten areas of Research Ethics which are considered a basic prerequisite for high quality research. The majority of these are relevant to Human Research at TU Delft, and most are supported by national and European legal requirements as outlined in the following table.
Area of Research Ethics Resources Legal requirements 1. Human embryonic stem cells (hESCs) and human embryos (hEs)
- CCMO website (Centrale Commissie Mensgebonden Onderzoek)
yes 2. Humans 3. Human cells or tissues
- CCMO website (Centrale Commissie Mensgebonden Onderzoek)
yes 4. Personal data
- Ethics and Data Protection (European Commission 2021)
yes 5. Animals
Not applicable to HREC
TU Delft has a license to perform animal testing in the Faculty of Applied Sciences since 2009 but there has not been any animal testing since that time.
The HREC has no mandate to assess such research. In case of queries the TU Delft Internal Animal Welfare Authority (IVD) can be contacted via IVD@TUDelft.nl
yes 6. Non-EU countries
- Global Code of Conduct for Research in Resource Poor Settings (globalcodeofconduct.org)
yes 7. Environment, health and safety
- Contact your Faculty HSE advisor
yes 8. Artificial intelligence
- Ethics Guidelines for Trustworthy AI (EC - Independent High-Level Expert Group on Artificial Intelligence 2019)
- Ethics by design/operational use for Artificial Intelligence
9. Other ethics issues
Potential emerging Research Ethics include:
- Digital Sequence Information
- Citizen Science
- Do No Significant Harm
yes 10. Crosscutting issue: potential misuse of results yes
You can find additional guidance on identifying and mitigating risks here.