1.1 I would like to change part of a previously approved application. Can I submit an amendment?

Unfortunately, due to the technical limitations of the UU-SER system, it is not currently possible to request amendments to approved applications. Any changes to the protocol necessitate the submission of a new application.

The only exception is adjusting the start and end dates of your study. In order to do this, please contact the FERB (fetc-fsw@uu.nl).

2.1 When is a study considered anonymous?

According to the UU Data Privacy Handbook, your study ‘can be considered anonymous if data subjects can only be re-identified with an unreasonable amount of effort, i.e., taking into account the costs, required time and technology, and future technological developments (rec. 26).

Basically, your data are not anonymous (personal) when they comply with any of the characteristics of personal data:

• There is directly identifiable information (e.g., name, email address, social security number, etc.).
• Data subjects can be singled out (i.e., you can tell one data subject from another within a known group of data subjects).
• It is possible to identify data subjects by linking records (“mosaic effect”), either within your own database or when using other data sources.
• It is possible to identify a data subject by inferring information about them (e.g., infer a disease by the variable “medication”), either within your own database or when using other data sources.
• It is possible to reverse the de-identification.

Whether data can be seen as anonymous strongly depends on the context of your research and how much information is available about the data subjects.’

For more information about working with personal data, please consult the FSBS Data Protection site.

2.2 Are students allowed to recruit research participants from their personal network?

In the past, students have indicated that it is not always possible to recruit enough participants for their research within the given timeframe. Because of this, they ask people they already know (family, friends, acquaintances) to participate in their study. Recruiting within an existing social network helps to prevent overburdening society with (student) research.

On the other hand, acquaintances may find it more difficult to decline participation, and the information they share during the study may be traced back to them by the student. As such, the FERB has set up a number of guidelines for recruiting research participants within your own social network:

• Recruiting participants from one’s personal network is allowed in case of non-sensitive topics and non-invasive methods. If possible, anonymous data collection and processing should remain standard practice. Students should avoid pressuring acquaintances to participate.
• If the topic of the research is sensitive (for example related to one’s sexual behavior or orientation, suicidal thoughts, drug use including alcohol, smoking, or soft drugs, religious or philosophical beliefs, political opinions, ethnic origin, trade union membership, violent experiences, personal health, criminal convictions, and offenses) it is recommended to carry out anonymous data collection within the network of a fellow student.
• If the research uses invasive methods (for example exposure to physical pain such as electrical or thermal shocks, shocking imagery/noises, following behavioral orders, deception, or new techniques for data collection), the FERB emphasizes that participants should not be acquaintances of the researcher as they may experience difficulty expressing the wish to stop participation.

2.3 When does a UU-SER application suffice, and in which cases is a PRIDE application required?

While students obtain ethics approval through UU-SER, UU staff members are required to submit their research projects for ethical review in an app called PRIDE. For most student research, a UU-SER application will suffice for obtaining ethics approval. However, in some cases it may be necessary for the thesis supervisor to submit an additional application themselves. A PRIDE application by the supervisor is required (and a UU‑SER application by the student is insufficient) when:

• Other publications – aside from the student’s own thesis – will result from the data collection for the study described. For instance, it is not permitted for a supervisor to have the student collect data for the supervisor’s own research without prior approval via the supervisor’s PRIDE application. The student must in turn refer to the PRIDE application of the supervisor in their UU-SER application.
• The study can be characterized as ‘invasive research.’

The thesis supervisor initially assesses whether the study qualifies as ‘invasive research.’ If research is invasive, the thesis supervisor takes the main responsibility for the study by submitting the research proposal as a PRIDE application. If the supervisor qualifies the study as non-invasive, the student takes the main responsibility and submits in UU-SER.

If the FERB, based on the information provided in the UU‑SER application (and despite the supervisor’s assessment), has doubts as to whether the study can indeed be classified as non-invasive, the committee will request additional information to make a proper assessment. If this additional information leads to the conclusion that the study is in fact invasive, the applicant’s supervisor will be asked to submit an additional PRIDE application instead. If not, the study can continue to be reviewed via the UU‑SER procedure.

2.4 When is a study considered invasive?

Studies are considered invasive research if they involve any of the following:

• Research to which the Dutch Wet Medisch-wetenschappelijk Onderzoek met mensen (WMO) may apply;
• Studies concerning a vulnerable population (e.g., individuals with intellectual or physical disabilities, trauma survivors, asylum seekers);
• Studies that use passive consent and that process personal data;
• Studies involving a (more or less) invasive intervention (physiological or psychological, e.g., EEG, fMRI, video recording, new techniques);
• Studies concerning socially sensitive or taboo topics (e.g., personal sexual activity or that of others’, drug use, suicidal ideation, religious beliefs, political views);
• Studies requiring a substantial time investment from participants or involving invasive tasks;
• Studies that employ deception.

The above list is not exhaustive; the supervisor or the FERB may also determine that a study qualifies as invasive research in other cases (for example based on a specific combination of research design, target population, and subject matter).

2.5 Can the ethical approval of a UU-SER application be used for publication in a scientific journal or book?

The standard ethical approval in UU-SER states that the document is not admissible for publication in a scientific article/book. If the student wishes to publish the study, it is necessary to request a supplementary statement from the Ethics Review Board.

The review procedure in UU-SER ensures ethically responsible research, provided that:

• Submission was precise and accurate, and the research was carried out in accordance with the submitted protocol;
• In the case of analysis of existing data, the research question falls within the scope of the original research question, and participants were informed that individuals other than the original researcher may also analyse the data;
• In the case of new data collection, the information provided to participants was accurate.

If, following completion of the research, the supervisor judges the study or the data to be of sufficiently high quality to warrant publication, then the FERB expects that the supervisor in question has verified the above-mentioned points. The supervisor should then contact the FERB to notify the committee of the student’s intention to publish. The FERB will subsequently issue a supplementary statement granting the student permission for publication.

The above policy highlights the importance of an accurate UU-SER submission, as is already emphasized in the educational context in which it was developed. The reassessment of an approved UU-SER protocol that has been carried out differently than in the original application is only possible to a limited extent, and is sometimes impossible from a practical standpoint. An example of this would be the discovery of an incorrect information letter provided to participants after the study has already been conducted.

In case of questions, please contact the FERB at fetc-fsw@uu.nl.