Welcome at the website of the Natural Sciences and Engineering Sciences Ethics Committee. This Committee facilitates and monitors the ethical conduct of all research in the field of the Natural Sciences and Engineering Sciences domain.
For general information and questions, please contact the secretary of the Ethics Committee Natural Sciences and Engineering Sciences: Maria Kamp
- Members Ethics Committee Natural Sciences and Engineering Sciences
ADVISORS OF THE ETHICS COMMITTEE
- When and how to submit a request for ethical approval
The Ethics Committee advises on ethical issues related to research projects involving human beings, human of animal materials including cells and cell lines, genetically modified organisms, or so called 'dual use' research where the product of the research could be utilized for harmful purposes, such as military use. If you plan to do research involving any of the above-mentioned materials or subjects that has not been previously approved by the Biological Safety Officer (Ir. Ilja Sitters), and/or use potentially sensitive data about individuals, groups or organizations, you have to submit your proposal for ethical assessment by the EC.
An increasing number of journals and funding organizations require an ethical review. Therefore it is important that the EC assesses whether the research proposed conforms to ethical standards. This applies to all research that falls within the domain of Natural Sciences and Engineering Sciences and that is conducted by staff, PhD students, postdocs and students (BA-/MA-thesis), regardless of where it is conducted. If research is conducted by students or trainees, the supervising staff member bears the ultimate responsibility.
In case of a research subject to WMO/non-WMO (Wet medisch-wetenschappelijk onderzoek met mensen) read further under 'Requirement of medical-ethical reviews'.
DO YOU NEED TO SUBMIT YOUR RESEARCH FOR ETHICAL REVIEW?
Does your research:
- involve human subjects (not previously approved by the Biological safety Officer Ir. Ilja Sitters) OR
- include the use of data (either new or existing), the collection and analysis of which might conflict with the interests of the individuals, groups or organizations to which these data pertain OR
- include the use of human or animal material (including cells and cell lines) that have not been previously approved by the Biological safety Officer OR
- include the use of genetically-modified cells or organisms that have not been previously approved by the Biological safety Officer OR
- can be classified as ‘dual use’ research, with potential applications in for instance military or police technology.
If you answered YES to any of the above questions then you DO need to submit your research for ethical review.
Examples of research projects that usually do NOT pose ethical problems include the following: literature research, document analysis of publicly available reports design/construction/testing of new technology outside the mentioned areas of application.
The researcher is responsible for the full and correct description of the research in the checklist and application, and positive advice is based only on the material that has been submitted.
- You can submit the request for ethical assessment of your research digitally by email to the Secretary of the Natural Sciences and Engineering Sciences Ethics Committee (email: email@example.com).
- Your application must contain at least the following three documents, which can be found below:
A) Checklist; The person responsible for the research fills in the checklist with a number of questions regarding the project. The questions in the checklist consisting of a general part and a specific part.
B) Information brochure; this must have been written in easily understandable English, without real technical terms.
C) Informed consent; The informed consent form is only required if that is relevant.
- The EC reviewer will assess whether the submitted research satisfies the characteristics and conditions for ethically responsible research. He or she may ask some further questions for clarification or suggest some improvements, to which the applicant/researcher is expected to respond.
- The final decision (approval/rejection) will be communicated via an email by the Secretary of the Ethics Committee. The intention is to complete the ethical review within 14 working days after the initial submission of the request.
If you are a bachelor or master student and your research is part of a course in your study, your teacher will take care for the ethical approval.
The researcher is responsible for the full and correct description of the research in the checklist and application, and a positive advice is based only on the material that has been submitted.
CHANGES TO YOUR RESEARCH AFTER THE ETHICAL REVIEW IS COMPLETED?
If any substantive changes (amendment) are made to the research proposal (eg., methods or design) after the ethical review has been completed, these changes must be submitted to the ethical committee. Send your changes to the Secretary of the Ethics Committee including your request number. The changes will be presented to the involved EC-member and it will be decided if they are approved or if the changes are too substantial such that a new research request should be submitted.
- Requirement of medical-ethical reviews
In the Netherlands, medical research involving human subjects is regulated by law: the Medical Research Involving Human Subjects Act (WMO). Research is subject to the WMO if:
- It concerns medical-scientific research, and
- Participants are subject to procedures or are required to follow rules of behavior.
Read more information to decide if your research falls under the WMO. (also in Dutch)
If your research satisfies these two criteria, you have to undergo a review by an accredited MREC or the CCMO, instead of a review by our Natural Sciences and Engineering Sciences Ethics Committee. In practice, there will always be cases in which it is not clear immediately if a study is or is not subject to the WMO: the so-called grey area. When in doubt it is best you contact the MREC or CCMO.
COOPERATION BETWEEN THE UNIVERSITY OF TWENTE AND CMO ARNHEM-NIJMEGEN
The University of Twente and Rehabilitation Centre Het Roessingh cooperate with the accredited MREC 'Research Ethics Committee in the region Arnhem-Nijmegen (CMO A/N)' and stimulate research to submit there. You can submit your research dossier to the CMO A/N through their online portal. There is an instruction manual available for submission to CMO A/N. This procedure can also be used for advice on WMO applicability (non-WMO statement).
TechMed supports UT researchers with this type of research. Get in contact.
If your research does not fall under the scope of the WMO then it does not have to be reviewed by an accredited MREC or the CCMO. However, please note you may need a non-WMO declaration in case you carry out your research in a hospital or another medical institution. Both METCs can provide this statement: CMO A/N or MEC-U.
Also, identify whether the organization with which you will be working has its own requirements and policy for the ethical review of research. If it does, submit your proposal to this organization, and provide us with a copy of your application and the resulting decision.
- Informed Consent
WHY CARE ABOUT INFORMED PARTICIPATION PROCEDURES IN RESEARCH?
Informed participation is an ethical and legal requirement for research involving human participants. It is the process where a participant is informed beforehand about all aspects of your research to enable the participant to make an informed decision on their willingness to participate in your research.
Informed participation is an essential requirement prior to every research involving people as subjects for research. It involves informing the subject about his or her rights, the purpose of the research, procedures to be undertaken, potential risks and benefits of participation, expected duration of the research, the extent of confidentiality of personal identification and demographic data, so that the participation of subjects in your research is entirely voluntary.
Informed consent - when a person actively provides consent to participate in your research - is also increasingly important for use of data after your research, as failure to properly address issues of consent may restrict the opportunities for initial use of data, the publishing of your results and the sharing of the data.
NOTE: you always have to inform people who participate in your research about your research. Obtaining explicit consent (e.g. signing a form or tick a box) is not always required; if research data is gathered completely anonymously you do not need to register the participants' consent
WHO IS CAPABLE TO GIVE CONSENT?
Participants, or their legal representatives, must be given ample opportunity to understand the nature, purpose and anticipated consequences of research participation. So that they will be able to give informed consent to the extent to which they are capable of doing so. Please note that not all human beings are capable of consent. Individuals with the capacity or competence to consent:
- are 16 years or older (adult);
- have the capacity to make choices about a proposed course of action;
- know about the risks, benefits, and alternatives;
- understand that consent is ‘voluntary and continuing permission’;
- understand that consent ‘can be withdrawn at any time’.
CONSENT UNDER THE GDPR (EU PRIVACY LAW)
Consent is one of the six legal grounds for lawful processing of personal data, often consent is the most appropriate legal basis in research. If personally identifiable information of individuals will be processed in your research, active consent is required, according to EU General Data Protection Regulation GDPR. Consent under the GDPR is: valid, freely given, unambiguous, specific, informed and explicit actively given consent. The 'consent' requires action: it needs to be given by a written(signed)/oral statement or by clear affirmative action. Silent consent, inactivity or pre-ticked boxes are not valid.
If you process sensitive personal data than explicit consent is required for collecting those data. For an explanation on personally identifiable information check the UT Personal Data website on privacy rules and definitions.
WHAT DOES 'INFORMED CONSENT PROCEDURE' ENTAIL?
The informed consent procedure consists of an information sheet AND an informed consent form
Specifically, the information provided in advance addresses (where applicable):
- the voluntariness of participation;
- the nature and purpose of the investigation, including if the data collection is meant only for training purposes
- any reasonably foreseeable factors regarding the nature, purpose, and duration of the research that may influence participants’ willingness to participate (such as the extent of strain, potential risks, and discomfort)
- the right to decline to participate and withdraw from the research at any time, without any negative consequences, and without providing any reasons;
- any recording of voices and images (where applicable);
- confidentiality protection and the limitations thereof;
- procedures for incidental findings (where applicable);
- additional insurance guarantees (where applicable);
- period of time to which the consent applies;
- time and nature of data storage
- re-use of specified data in the current, future or other research;
- incentives for participation;
- names and details of the responsible researcher and contact person(s) for questions about the research and rights of research participants;
INFORMED CONSENT FORMS
Here you can find several informed consent forms. They are examples, which can be used as a template for your own, customized version. Before signing the informed consent form, participants need to be provided with sufficiently detailed information on the study so that they can make an informed, voluntary and rational decision to participate.
Interviews and experiments
See the download below for a template for an Informed Consent you may use for interviews and experiments.