HREC Approval 1: Application

All researchers, PhD candidates and Master’s students conducting research for their thesis need to submit an application for any research involving data obtained from Human Research Subjects. This will occasionally also be true for the supervisors of Bachelor students who are conducting a research these involving Human Research Subjects. This includes research involving human participants directly, data collected from the internet and social media, and 3rd party datasets collected from human participants.

Who should submit an HREC application?

You can consult this graphic to determine who should submit your application and the core documents that will usually be required.

Preparing your HREC application

A standard HREC application normally requires three core documents. These are: 
a)    A completed, HREC Checklist that has been signed by the Responsible Researcher
b)    (in most cases) completed Informed Consent materials, and
c)    Your Data Management Plan

Depending on the exact nature of your research, you may need to provide additional documentation in your HREC application. The most common of these are listed below, including the relevant experts who can advise you further.
 

Completing your HREC checklist

The main goal of the HREC checklist is to assess the potential risks that your participants may face as a consequence of participating in your research – and to outline what steps you will take to mitigate them. These risks could be linked, for example, to direct physical or emotional repercussions of the study, or to being re-identified and linked to specific comments, performance metrics or views. They may also arise immediately (during the study) or later on (e.g.: due to a data breach, or to a change in circumstances, such as a new manager or government). 

You can find the template for your HREC checklist here and a brief guide to completing this checklist here.

Preparing your Informed Consent materials

You can find more about Informed Consent, along with templates for your Informed Consent materials here. You can also find Dutch language versions of the Informed Consent templates here.

Your Data Management Plan

You can contact your Faculty Data Steward to discuss your Data Management Plan, or find out more about data management at TU Delft here.

Submitting 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, occasionally, Bachelor’s) the Responsible Researcher is usually the student’s project supervisor. You can find out more about student submissions here.

• 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).

Your HREC application should be submitted and approved before potential participants (Research Subjects) are approached to take part in your study. We recommend that you submit your application at least 4 weeks before you intend to start recruiting participants for research which is expected to be assessed as Minimal Risk. Projects with higher levels of risk will be considered in the periodic HREC Committee meetings which are held approximately every 6 weeks. You can find the dates of these meetings for the current year here.

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 there may be delays during vacations and particularly busy periods, and that submissions are considered in chronological order.

Newly submitted HREC applications are assessed weekly by two or more members of the HREC Team, including either the Chair or Vice Chair of the Committee. Where submissions are considered to be of Minimal Risk  (see below) to participants, any revisions or decisions will be communicated to applicants following these weekly meetings.

Where submissions are considered to pose an Extended Risk (see below) to participants, these applications will go to the full Committee for consideration. The full Committee meets approximately every 6 weeks.

Once approved, a letter is issued from the committee which is increasingly necessary for funding agencies and journal publications indicating that the study has been reviewed and approved. 

What is the HREC looking for in your application?

The committee will consider the following points:

• Are participants subjected to a greater than acceptable risk given the potential benefits?
• Have subjects or participants been adequately informed and given free consent? Can they withdraw without any implications? 
• Are vulnerable populations targeted and have special precautions been taken to protect them?
• Is the equipment safe?
• How will personal data – and particularly personally identifiable research data (PIRD) relating to sensitive topics – be protected?
• Are the risks and measures addressed in your checklist, Informed Consent and Data Management Plan consistent and aligned?

See also Article 6 of the TU Delft Regulations on Human Trials (2016).

Minimal and Extended Risk

The vast majority (more than 90%) of submissions to the HREC are considered to be Minimal Risk providing they are conducted in a way which protects participants against possible risks. Indeed most risks identified on the HREC checklist can be dealt with using standard measures such as producing device reports for non-CE-certified devices, preparing and executing Data Management Plans which align with what’s agreed in the Informed Consent. Extended Risk usually arises only where particularly sensitive topics and/or vulnerable participants are involved, or where  a combination of different risks give rise to significant potential risks for participants.

Possible HREC Decisions

The Committee can decide to:

• Approve the application
• Approve under a number of conditions (Conditional Accept) and/or recommendations (Accept with Note/s)
• Provisionally Approve the application – such that the research has been approved but that an outstanding piece of information (such as a valid device report) must be submitted prior to final approval.
• Ask for a Resubmission. This is usually the case where the information is insufficient to demonstrate that risks to participants have been fully considered and are reflected in the Informed Consent, along with the steps that will be taken to mitigate them.
• In rare cases: to Disapprove the application. In this case we will have further discussions with the applicant. 
• Other decisions include Withdraw (where for example an application has been duplicated) and to mark as Overdue. This latter happens when an application has been dormant in LabServant for 3 months. In this case all applicants can simply start a new submission process if they wish to continue with their application.

You can see more about the HREC’s work here: https://youtu.be/fXuW1MdsqiM 

Submissions requiring revision

If your application is returned to you marked “sent back for revision” you will receive a list of queries or clarifications from the HREC Team. Unless you are instructed otherwise you should use the HREC Revisions template to respond to each of these queries and add this additional document to your existing submission.

• We generally assess all applications received before 17.00 CE(S)T on a Wednesday, on the Friday of that same week. 
• Since the vast majority of HREC submissions are considered Minimal Risk, submissions which require no revision or additional documentation are generally assessed in around a week.
• However, if you submit during busy periods or vacation periods, particularly over the summer, you should plan for possible delays of 2-3 weeks.
• The small proportion of submissions which are considered to be of Extended Risk will be submitted to the full Committee for assessment.
• The full HREC meets approximately every 6 weeks throughout the year. In 2022 the dates of these meetings are as follows: