Human Research Ethics
Please note that over the Christmas period there will be no weekly meetings (for all applications) from 21 December to 9 January. For 2023, the periodic full committee meetings (for extended risk applications) will take place on Thursday morning of the following weeks: 2, 8, 14, 21, 26, 36, 42 and 49.
Research and Corona Regulations
Due to the still changing coronavirus situation the Human Research Ethics Committee (HREC) will not approve any proposed studies that do not, or cannot, comply with RIVM-guidelines, specifically any set conditions on physical contact, physical proximity, and transportation. Make sure that you discuss the contemporary corona protocols with your Faculty HSE advisor before carrying out any research involving face-to-face activities with your participants – and make sure that you mention that you are doing this in your HREC application.
This is a temporary measure that will remain in place until it is acceptable again to execute such studies. In the meantime study proposals can, and should, be submitted to HREC for assessment. As usual, the HREC will communicate the results of its assessment to the applicants.
If you are a researcher, PhD candidate or Master’s student and you are planning to conduct research which involves human Research Subjects (ie: where human participants are the source your research data) there are two main things that you need to do:
The pages on Research Design provide information on identifying and minimizing potential risks to your participants, running a risk-planning session and preparing essential research tools such as your Informed Consent materials and Data Management plan. These are things to do at the start of your research design process.
All research projects involving Human Research need to seek approval from the Human Research Ethics Committee (HREC) before the research can go ahead. The pages on HREC Approval take you through the HREC application process, give tips on timing and what the HREC is looking for, and introduce you to the Committee and Team.
If you have planned for risks to participants from the start, then the application process should be pretty straight forward. Bear in mind that you are more likely to be asked to revise your application if you have failed to identify possible risks, than if you have identified possible risks and shown clearly how you will minimize, communicate and manage them.
The following pages will provide you with the tools and guidance you need to effectively incorporate research ethics into your research design, and eventually seek approval for your study to go ahead.
It’s easy to underestimate the potential harms arising from scientific research. After all, as researchers our intentions are generally good and the likelihood of most risks arising are small. But what happens if the unexpected does happen? And indeed, if your potential risks are associated with a data breach, how unexpected is “the unexpected” these days?
Research Ethics as a whole are about ensuring that your research is planned and executed in a way which will not generate undue harm, or take disproportionate risks, that could negatively impact Human Research Subjects, society, the environment or even researchers themselves. It involves a combination of meeting any legal requirements (particularly around Health, Safety & Environment, Medical or Animal Research, and Data Privacy), as well as any professional and ethical standards that are relevant to the research you intend to conduct.
As with any profession – just like lawyers, doctors, architects or engineers – being able to deal with professional and legal standards is a part of a researcher’s basic skillset, and fundamental to high quality research. It is also something that funding bodies and scholarly journals want to see in the research they fund or publish, and of course individual researchers want to be sure that their research methods or findings aren’t going to damage the environment, cause needless animal suffering, or expose human volunteers to loss of livelihood, security or freedom. Whether you’re an experienced researcher exercising your craft, a docent developing the skills of future researchers, or a thesis student learning the ropes, developing skills in research ethics is a fundamental to delivering responsible, high quality research.
Human Research is any research that involves humans, directly or indirectly, as Research Subjects – which is to say that your research data is specifically about them. Research data from Human Research Subjects can include a vast array of data types including medical data, political views, experiences of the world or professional knowledge. Equally it can include how a Human Research Subject works a test device or interacts with a new product. But it can also include data in datasets provided by a third party, and, increasingly, data derived from social media and internet forums.
The key to good research ethics lies in identifying potential risks and preparing appropriate mitigating measures early on in your research design. We recommend organizing a risk-planning session that can help you to elicit the possible risks associated with your research goals and methods, to identify mitigating measures, and to make sure you provide your Human Research Subjects with sufficient information to provide you with their consent to participate in your study.
While it’s your responsibility as a researcher to ensure that any relevant legal and ethical protections are in place, the right tools and training can help in meeting those responsibilities.
For research involving Human Research Subjects (human participants who act as the source of your research data), we’ve developed a series of tools to assist you in the essential activities of planning, minimizing and managing the possible risks arising from your research activities.
You can click on the links in the table below to take you to more information – and you can also download a PDF of this toolkit for sharing.
RESEARCH NEED TOOLS Research design Research Ethics Approval Research Execution Minimise risk
All research potentially carries some risk; your job as a researcher is to anticipate, mitigate and minimize any such risks for Human Research Subjects
- Ethics checklist for human research
- Course/module-related human research
- Brief Guide: Completing the HREC checklist
Regardless of whether your research involves collecting personal data (as enshrined in Privacy Law) you must inform your participants of what is expected of them, and of any potential risks arising from their participation.
Whatever you agree with your participants needs to managed in practice. For example physical risks must be addressed within Health & Safety legislation, and Data Protection issues can be dealt with by developing and executing an effective Data Management Plan
Ethics approval: amendments and revisions
You can use these templates to amend an existing approval or revise an ongoing application.
to be used when amending an existing approved project
to be used when revising a submission which is under evaluation
You can also let us know if you or your colleagues have any specific ethics guidance or tools needs here.
Ethics Approval for Human Research
At TU Delft, all research involving Human Research Subjects – including Master’s theses – requires approval from the Human Research Ethics Committee (HREC) before it can go ahead. Applications should in most cases be submitted and approved before potential participants (Research Subjects) are approached to take part in your study. Not only is this good research practice, but it’s something that most journals want to see before approving research articles for publication. The vast majority of research conducted at TU Delft is considered to be Minimal Risk, and if you’ve considered any risks to participants carefully in your research design, the application process will be pretty swift and easy.
You can find out everything you need to know about the HREC application process here.
Once an HREC application has received a final decision it is archived in LabServant and can no longer be amended. However, if you need to make an adjustment to an existing approved application – such as changing the kinds of participants you want to involve or extending the duration of the project – you can do this by submitting an HREC Project Amendment Form through LabServant in the same way as submitting a normal application.