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ICLON Research Ethics Committee

The IREC provides advice on matters relating to ethical conduct in research by ICLON staff. All research involving the collection, analysis, and/or storage of data from individuals must be submitted to IREC. IREC reviews research proposals against criteria for research ethics.

Please submit your application by the deadlines below. Applications submitted later will be advanced to the next meeting. If for logistical reasons your application cannot be processed at the next meeting, you will be notified.

Roadmap

See also the detailed roadmap.

In outline:

  • Take ample time to obtain approval for your application. Data collection should not begin until your application has been approved.
  • Use the most current questionnaire for your application - see right in the margin.
  • Compile a draft application and then make an appointment with ICLON's Privacy Officer (Carla den Hartog), to conduct a Data Protection Impact Assessment (DPIA).
  • Draft the final application and send it by email to IREC (irec@iclon.leidenuniv.nl). The application will be discussed at the next IREC meeting if submitted before the deadline.
  • Note: Do not forget to submit the Data Management Plan in addition to the ethics application. This can be done at the same time as the ethics application, but no later than 3 months after the start of the study.

Deadlines

IREC meeting

Application submitted by 9 a.m.

Friday, November 11, 2022

Monday, October 31, 2022

Friday, January 20, 2023

Monday, January 9, 2023

Friday, March 10, 2023

Monday, February 20, 2023

Friday, May 26, 2023

Monday, May 15, 2023

Friday, July 7, 2023

Monday, June 26, 2023

Examples of completed application forms:

Examples of consent forms:

In reviewing applications, IREC bases its decisions on, among other things:

Members

Contact

irec@iclon.leidenuniv.nl

Tasks

Specific:

  • To review and assess research ethics applications from ICLON researchers who are conducting research that involves data collection, data analyses and/or storage or (re-)use of data;
  • To provide feedback to researchers about the ethical conduct of their proposed projects;
  • To review and assess any proposed amendments to approved projects that may change the ethical status of the project.

Generic:

  • To provide advice related to issues arising from the ethical conduct of ICLON research to the ICLON Scientific Committee;
  • To serve an educative function within ICLON, providing information and guidance related to policies and principles related to the conduct of ethical academic research.

Frequently asked questions

General

Yes. They are available on the IREC websiteShould you have questions regarding the completion of the form, please contact the Secretary of the IREC.

Timeline/schedule

6 times a year, so roughly once every 2 months. The dates of upcoming meetings can be found on the IREC website.

IREC meetings are on Fridays. To be handled on time, applications must be submitted no later than the Monday of the week before the next IREC meeting. See the schedule for deadlines. 

The committee will do its best to respond to applications within 5 working days after the meeting. Occasionally, it might take a bit longer.

After that, the length of time it will take to obtain approval depends on any issues raised in the initial response and, where applicable, the alterations or additions requested of the researcher.

The completed Application Form and appendices have to be submitted to IREC as soon as possible after the start of the project and always before the start of data collection. A research project must be approved by IREC before any data collection can start.

Information and consent

This may not be necessary, although it is recommended.

Through their involvement in the grant application, schools have implicitly given their consent for the research to take place. It is important, however, that the schools have been actively involved in the application, are sufficiently informed regarding, and have agreed to the research design (e.g. planned activities, involvement of groups/individuals, data collection, time commitment, benefits for school). This involvement should be apparent in the grant application.

It is possible to refer to (passages from) the grant proposal in the IREC application form. It is possible that this already refers explicitly to what is expected of schools and when, etc., and states that the schools have agreed to the conditions for participation.

These measures will most likely be sufficient for the provision of information to schools and respondents. We cannot know for certain whether journals will also find it satisfactory, although it is likely that they will. A consent form would be a way of making certain, although it is recommended only to do this if there are questions of consent that are not covered in other ways.

The same as for schools as partners. Implied consent can be presumed when the external collaborator has signed the research proposal and IREC Application Form, on the condition of research involvement, full information, and agreement.

Yes, these can be found on the IREC website.

You are not obliged to communicate the research hypotheses, e.g. when conducting an intervention study; probably, this is in the interest of the research project. Grouping participants into different conditions and not being explicit about the test condition is not unethical as such. However, participants must be sufficiently informed about the reasons for conducting the research, what is expected from the participants, and possible benefits and costs.

When applying a research design with multiple conditions, you will have to indicate in the application if the participants will be allowed free choice for a condition; and if not, why not (possibly to avoid effects on outcomes). You will have to show that participants will be well-informed about the research and how this will be achieved (e.g. by information sheets or email messages, or explanatory statements in questionnaires; you will have to add those to the application).

The committee is of the view that letters of consent are essential, even where there is a standing agreement in school. We assume that researchers will be aware of the arrangements within the school. Despite this, even in cases where the means of data collection falls within the scope of the standing agreement, pupils should be fully and clearly informed regarding the research, and this information must be provided at an appropriate time.

Data management plan/audit trail

IREC can conditionally approve an application, under the restriction that the Data Management Plan will be signed and submitted within 3 months after the actual start of the project and this DMP will have been approved by IREC.

Furthermore, research will have to follow the Data Management Regulations Leiden University 2021.

When a paper is accepted for publication by a journal, a process document has to be written that in principle allows for an audit trail. However, in practice, this audit will not take place in most cases.

PhD students will produce such an audit trail for their project in one go, at the time when their thesis has been approved by the promotion committee (so, not for every single publication).

Data collection

In general, an online questionnaire DOES NOT require a consent form since filling out the survey in itself implies consent.

However, it is necessary to include an Explanatory Statement. This will be adapted according to the method of data collection, but should contain at least the following information:

  • The nature and purpose of the research;
  • The type of participation required;
  • That participation is voluntary.

The opportunity to withdraw from the study should be realistic (see elsewhere in these FAQs).

An interview DOES need a consent form. The explanatory and consent forms should be tailored to the interviews, explaining the nature and purpose of the research, and the participation required. Opportunity to withdraw from the study should be included and realistic (see other entries in these FAQs).

In most cases, participants have the right to withdraw from the research at any time. They do not need to explain this decision. It is the case, however, that withdrawal may not be possible at all times, for example, during data processing.

The right to withdraw should be made clear in the Explanatory Statement and/or Consent Form. It should, however, also be realistic, i.e. is it possible to withdraw from the study once the data have been collected? After the data have been analysed? Published? Please include a sentence about at what point withdrawal is no longer possible.

Yes. If your research includes more than one form of data collection, e.g. an online survey and an interview, then you will need to explain the procedures for each form of data collection separately.

Data storage

Yes, under the following circumstances:

  • Access to (the relevant folders on) your P-drive is protected following the current guidelines from Leiden University (e.g. with a password known only to you);
  • Folders are only shared with people who are authorised to read their contents, and who use the data only for the agreed purposes;
  • At the point of termination of employment (and therefore deletion of the P-drive), the data should be transferred to a different location and authorised person.

External storage of research data (e.g. on an external hard drive, USB stick, etc.) must adhere to the same storage and privacy guidelines as for internal storage. The greatest care must be taken in this respect.

It is a legal requirement that all instances of a data breach, either confirmed or suspected, be reported. A data breach is where third parties come into possession and are in a position to misuse personal information. It is important to be aware of security breaches, for example where passwords become publicly known or a laptop or USB stick containing research data is lost. For more information, see Data protection/personal data.

Where research data need to be shared, it is required to use Surfdrive, SurfFilesender, and/or OneDrive instead of Dropbox, WeTransfer, or other cloud services. Surfdrive is run via servers within the Netherlands, while other cloud services are often based in other countries (in particular the USA).

In Surfdrive and Onedrive, it is possible to use the ‘Share’ function to provide specific external users (including students) with access to folders or individual documents for a restricted period, e.g. the duration of the period of analysis. Once their input is no longer required, their access can be blocked.

If in doubt, consult with IREC or ICLON’s Privacy Officer

In line with the Netherlands Universities Code of Conduct for Scientific Integrity data must be kept for 10 years after the last publication that made use of the data. On request, they are made available for other researchers, unless protected by law. These regulations apply to all researchers at Dutch universities.

For more information, see the RDM checklist

Student researchers

Yes, this should be mentioned in the application form. Furthermore, before they start to participate in the project, the principal researcher will have to inform them that they have to sign a form in which they agree to abide by the rules of good scientific conduct, as outlined in the:

  • Netherlands Code of Conduct for Scientific Practice (VSNU, 2012);
  • Gedragscode voor onderwijsonderzoekers (VOR, 1990/2009);

and additional conditions, specified by ICLON.

Assistants must fill out this form.

Special cases?

No. It is therefore important to bear the IREC meeting dates in mind. Forgetfulness and/or lack of awareness are not considered to be valid excuses.

There is one standard ethics committee application form. The process of completing the form will be more straightforward for shorter-term, simpler research projects.

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