Due to the current coronavirus situation, the 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.
This is a temporary measure that will remain in place until such time when HREC feels it is acceptable again to execute such studies. In the meantime study proposals can, and should, be submitted to HREC for assessment. Please make sure that you refer to any corona measures that you will need to take in your submission – particularly, for example, in the HREC checklist and Informed Consent materials.
Vacation and full HREC meetings
Due to the holiday period there will be no weekly HREC meetings in weeks 24-25 or in weeks 30-33. The next full meetings of the HREC (for projects considered to be extended risk will take place as follows:
- 1 July
- 9 September
- 1 November
- 13 December
NOTE TO STUDENTS AND STUDENT RESEARCH SUPERVISORS
Master’s Students may submit applications for their Thesis research providing that have been approved and signed by their research supervisor (the responsible researcher). Any such applications at Bachelor level should be submitted by the supervisor.
NOTE TO DOCENTS
Where Bachelor/Master taught courses involve students in research (with human subjects) for teaching and learning purposes, the Education-Related Research HREC form should be submitted by a relevant member of staff.
All projects that include human participants, or 3rd party datasets collected from human participants, should submit a checklist to the HREC.
A. When should you submit your application?
Applications considered to be Minimal Risk will be assessed on a weekly basis (except during holidays). To ensure that your project is considered in a given week we would advise you to make sure your submission arrives before Close of Business on the Wednesday of that week. However, note that since submissions are considered in chronological order, earlier submissions will be prioritised for the meeting in a given week.
HREC submissions for projects which are, to have higher levels of risk will be considered in the periodic HREC Committee meetings which are held approximately every 6 weeks.
While Minimal Risk submissions are generally assessed within a week, incomplete or unclear submissions can require revision which will extend the turnaround time. Moreover in busy periods, turnaround times may also be longer. We would recommend that you:
- submit your application at least 4 weeks before you intend to start Minimal Risk research
- ensure that your submission is complete and clear, particularly on any potential risks to participants (including professional or reputational risks)
- ensure that your Data Management Plan, Check list and Informed Consent are consistent.
B: How should you prepare your application?
You will need to make sure you comply with the TU Delft Personal Research Data Workflow which has been set up to help our researchers ensure that any of our research involving human subjects and/or personally identifiable information (PII) meets the necessary legal, ethical and regulatory requirements. The PRDW combines three core processes:
- Data Management Planning
- General Data Protection Regulation (GDPR) Compliance
- Human Research Ethics Committee (HREC) Approval.
In order to complete the workflow you should start with your Faculty Data Steward. You may also need additional specialist advice – eg: from the TU Delft Privacy Team, your Faculty Health, Safety and Environment (HSE) expert, or an external Medical Research Ethics Committee (METC/MREC).
- This links to the current version of the Ethics Review Checklist – so please make sure this is the version you use!
- All research projects – including Master’s and Bachelor’s research projects – that include human participants, or 3rd party datasets collected from human participants, should submit a checklist to the HREC.
Where students carry out research with human subjects as part of taught courses, the GDPR regulations and guidelines for Human Research also apply. In this case teachers should submit the Education-Related Research HREC form verifying that students have been informed about the existing regulations and guidelines.
The key function of the Informed Consent (IC) process is that this is where you (the responsible researcher) come to an agreement with your participants about what they will do for your research and what you will do, both legally and ethically, to ensure their physical, emotional and reputational security. It is key that they know exactly what – and particularly what potential risks – they are agreeing to, and that this is clear in your agreement.
In most cases your IC process should include an opening statement or participant information which outlines the purpose of the research, what participants will do, what kinds of risks – including of identification – are involved and what steps you will be taking to mitigate against those risks. In general, good practice determines that IC forms should be granular, providing separate consent points as separate tick boxes.
If you are using an online platform, please provide an adequate opening statement to ensure informed consent from platform users who want to participate in your research.
You can find a template for your Informed Consent process here. Please make sure that your IC information/form can be easily understood by your target audience, and that it aligns with the information you have provided – and the mitigation measures you have described – in the Ethics Review Checklist and Data Management Plan.
To ensure HREC approval it is important that your IC materials:
- Make clear what it is that your participants are going to do
- Make clear whether the research will take place online and if not confirm that contemporary faculty covid protocols will be in place
- Make clear whether Personally Identifiable Information (PII) is collected and if so where and how long that will be stored
- Make clear what Personally Identifiable Research Data (PIRD), connected to that PII, you will collect
- Make clear when these PIRD will be anonymized and whether they will be fully anonymized, pseudoanonymised, aggregated etc
- Make clear where and how long the PIRD will be kept, and in what state of anonymization/aggregation, as well as who will have access to it, and how will it be used (including in theses or other potential publications)
- Make clear whether there are any specific potential risks related to your data/data management method. For example, where employees of a company are participants what are the risks in the event that their colleagues or employers access the data.
- Align with what you have in your Data Management Plan and HREC checklist in terms of GDPR compliance, Data analysis, storage and access, participant risk and ethical considerations.
Depending on your methodology and risk assessment you may also need to provide the following documents:
- Full Research Ethics Application
- You will only need to submit a Research Ethics Application if your research anticipates or is considered by the HREC to have more than Minimal Risk
- Device Report
- Your completed Device Report should be signed by the HSE Officer (safety officer) for your Faculty.
- A list of safety-officers is provided on this webpage.
- Full Research Ethics Application
C: How should you submit your application?
Before you submit your application documents, please make sure that the responsible researcher has signed and dated the HREC checklist. In the case of student research (Master’s or Bachelor’s) the responsible researcher must be the student’s project supervisor.
- Please go to https://labservant.tudelft.nl (login with your NetID)
- To access Lab Servant from a computer outside TU Delft campus, you must first login through eduVPN.
- Once in LabServant, select menu item: Risk evaluation > Research Ethics Application
- Follow the instructions on the screen and upload your application (please use PDF-files only).