TiSEM IRB Questions and Answers

Yes, please send a request to irb-tisem@tilburguniversity.edu.

If data collection takes place by means of a different platform than CentERLab of TiSEM or via the CentERLab registration, or via an external online data collection platform (e.g. Amazon M-Turk, Prolific) that has practices demonstrably in line with data protection regulations, or via a market, opinion, or social research organization that is member of ESOMAR (www.esomar.org) (e.g. Kantar Group, Dynata, a panel of CentERdata of Tilburg University).

The IRB cannot provide post-hoc approval after research has started or has been completed.

• When research is carried out in collaboration with researchers from another school within Tilburg University or from an organization other than Tilburg University, the research proposal describes the role of each collaboration partner in the research.
• When the research falls within the scope of TiSEM IRB, IRB approval is required.
• When approval for (1) data collection, (2) data management and (3) GDPR for the proposed research is available from an IRB or Ethical Review Board (ERB) of another school within Tilburg University or of an accredited university (AACSB or equivalent), it is sufficient to submit the approval letter with the original research proposal to TiSEM IRB.
• When the content of the data collection (such as sample composition, sampling, measurement instrument) is at least partly determined by Tilburg University, the informed consent form and the information letter must be part of the research proposal.

Yes, all research with data relating to living persons or groups of living persons conducted by TiSEM faculty, TiSEM PhD candidates, and TiSEM Research Master students (from now on called researchers) need IRB approval except:
(1) research using anonymized existing data,
(2) research using pseudonymized, existing data for which the key to link the data to persons is not available in the research team, or
(3) research using existing data from a Tilburg University approved database. 
Obtaining IRB approval and these exemptions also hold when research is carried out in collaboration with organizations other than Tilburg University.

For details on whether you need TiSEM IRB approval and what to submit see the Flowchart 'Do I need IRB approval?'.

Yes, this is possible if the studies are part of the same research project, and if:

(1) the studies address the same research question(s),
(2) the research methods used for each study are described in sufficient detail to determine their potential risk for participants,
(3) the application is under a specific SRP, each of the studies should fall under that SRP.

If at least one answer to 1 to 3 is “no”, make a separate application for each study.

• In this case Category "B. No IRB Review required II" is not applicable.
• If the planned research uses existing data from TiU approved databases that is enriched with other data, the Flowchart 'Do I need IRB approval?' must be followed for this:
  • Enrichment with existing data: Category "E. Expedited".
  • Enrichment with data that will need to be collected: Category "H. Full Review II".

There are three main options to obtain informed consent.

• Option 1: With signature
  Prospective participants receive an informed consent form prior to participating in a study. The informed consent form provides information about the purpose, content and data use of the study, and what the task of participants is, and that they may decide to terminate the study at any time.
  Participants place their signature on the form to explicitly give their consent.
• Option 2: Without signature
  Prospective participants receive an informed consent form prior to participating in a study. The informed consent form provides information about the purpose, content and data use of the study, and what the task of participants is, and that they may decide to terminate the study at any time.
  The information explicitly indicates that participants give their "informed consent" by continuing the study, e.g. by clicking the “proceed” button, or a similar way.
• Option 3: No informed consent
  Sometimes it is not possible to obtain informed consent from each individual participant prior to data collection.
  This may, for instance, occur in large field studies where obtaining individual informed consent is impossible, too expensive or otherwise severely limited. Researchers can then still inform all participants about the planned project (e.g. via local or national media or online). In some cases, participants can be offered the possibility to opt-out of the study (for example by sending an e-mail), but this does not imply that those who didn’t opt-out, have consented to participating in the study.
  
  Conducting a study without informed consent may also occur when information about the planned research and/or the act of providing informed consent can bias or otherwise compromise participants’ reactions during the study. Sometimes providing informed consent could also increase the risk to participants (e.g. in research on deviant behavior). Then no informed consent is required.

Because being able to provide informed consent is an important right of participants, research proposals that rely on option 3 (no informed consent) need to provide evidence that informed consent (options 1 and 2) is not possible.

There are three general options of debriefing participants after data collection.

• Option 1: Immediate debriefing
  Each participant is debriefed immediately (individually or in a group) after his/her data collection session ends.
• Option 2: Generalized debriefing
  Participants are debriefed (individually or in a group) after data collection of the whole research has been completed. This is done, for instance, when debriefing individual participants immediately (individually or in a group) after their data collection session ends could compromise the reactions of prospective participants.
• Option 3: No debriefing
  No debriefing is required if the information letter and/or informed consent form provided all relevant information for the participants about the research.

This implies that participants are, in principle, never aware that they are going to or have taken part in a study.

If the research precludes an “informed consent” (Option 3: no informed consent) and informing the participants of the planned project is not feasible, then having “no debriefing” is impossible. A generalized debriefing, for instance, via local or national media, or online is almost always possible.

The IRB typically gives approval for a project. If a researcher wants to re-use data for a new idea, IRB approval is again required. In essence, IRB thus provides approval on the project level, and not on the data level. That is, if IRB approval is obtained for a previous project, researchers, cannot simply re-use that data from this previous project without asking for IRB approval.  

The default duration of the IRB approval is two years after the start date of data collection. IRB approval is granted for the time needed to implement the research proposal: data collection, data analysis, data management and data archiving.

• If the planned implementation of the research proposal requires more than two years, researchers can indicate this on the submission form (question 1.4 Time frame), with a brief explanation of the reasons for requiring the extended data collection period.
• If the IRB agrees with the argumentation, IRB approval is granted for the requested, extended period.
• If after obtaining IRB approval, implementing the research proposal turns out to require more time than originally planned, an amendment can be submitted to the IRB to request an extension of the end date of IRB approval.

A two year period for data collection may be insufficient, for instance, in case of longitudinal data collection across multiple years, or when data collection depends on a future event of an unforeseen date, or when multiple separate data collection efforts need to be combined.

More time than originally planned might be needed due to unforeseen events taking place and/or foreseen events not taking place, which delay implementation of the research proposal.

A Standard Research Protocol (SRP) is a typical way of doing research in a specific Department, (sub)discipline, or across Departments. Individual studies conducted in the context of a Standard Research Protocol share methodological and data characteristics, and can – but need not – share substantive (content) characteristics. Thus, individual studies conducted as part of a Standard Research Protocol make use of similar data collection procedures, data management procedures, and have similar GDPR characteristics.

All researchers (TiSEM faculty, PhD candidates and Research Master students) can submit an application for research within a SRP and such an application is exempt from full review.

At this moment there are three approved SRPs:

• SRP-1: Incentivized experiments in economics and business
• SRP-2: Studies on judgement and decision making
• SRP-3: Qualitative research in business and economics

You can find the detail information on these three SRPs on the IRB website under Standard Research Protocol (SRP).

You can submit the research proposal, after providing additional information, for Full Review by the IRB.

An external online data collection platform is a third-party service that enables you to conduct surveys or experiments on their platform. Once you have set up the study, the platform collects data from participants on your behalf. Because the platform collects data under your instructions, it is your responsibility to ensure the platform complies with data protection regulations and handles data from participants appropriately – even if you only receive pseudonymized or anonymized data from the platform! If you need help assessing if a data collection platform has adequate data practices, please contact the Data Representative at irb-tisem@tilburguniversity.edu.

For data collection using Qualtrics to be considered anonymous and to comply with SRP-1 and SRP-2, you need to do the following:

1. Ensure the questions in the survey cannot lead to an identified or identifiable individual. Do not ask for direct identifying information (like a name, (e-mail) address, etc.), but also be mindful that without direct identifiers a lot and/or very specific information can potentially lead to identification of an individual.
2. Before any responses are given in Qualtrics go to ‘Survey’, click on ‘Survey Options’ and ‘Security’, scroll down to ‘Anonymize responses’ and turn this item to ‘on’.

Enabling this setting will remove the respondents’ IP address and location data from your results, leaving your research data anonymous. The removal of the IP address (which is personal data) by Qualtrics is viewed as processing according to the GDPR, therefore Tilburg University has concluded a data processor agreement with Qualtrics.

3. As soon as the data collection is completed, remove the research data from Qualtrics to a TiU approved storage location, deleting the data at Qualtrics.

If you have questions, you can find more information about handling personal data and the GDPR or contact the TiSEM Data Representative: dm.tisem@tilburguniversity.edu.

An amendment to an approved SRP or full review can be done if you want to propose some follow-up studies on the existing research question, with some slight changes in the manipulation, or with a new way of measuring the DV. Alternatively, it might also be done if major changes are made to certain variables important for a mediation analyses, or additional co-variates or important new constructs that do not fall in the spirit of the initial request. Also significant changes in anonymity, the way consent is being asked for, the platforms being used or the ways of approaching participants may require an amendment.

In case additional studies are required for a paper, one might also need to evaluate if the additional studies would qualify for an amendment or a new SRP (or full review). If the design is quite different from the original study or there is a significant change to the hypothesis being examined, it is sometimes much easier to apply for an SRP or a new full review, than to amend an existing proposal.

You can also submit an amendment if a new co-researcher is added to the research team or if the initially approved period for data collection proves insufficient, indicating a new end date and why this longer period for data collection is needed. However, a new proposal might be necessary if you want to collect new types of data or data from new sources that significantly expand the scope of the original proposal.

Please note that minor changes in sample size, in incentives, in wording or adding additional (non-sensitive) questions or constructs, or new questions in a semi-structured interview may not need amendment. This would be the case if these changes all fall in the scope of the already approved SRP or full review.

Audio- and video-recordings are the raw data of your research and according to the Research Data Management Regulations need to remain safely stored for at least 10 years. Since audio- and video-recordings contain personal data and are difficult to anonymize or pseudonymize, encryption of the files is required. For this 7Zip is recommended. Be aware that "key" management is essential when using encryption; when you lose the key, your data are no longer readable and become unusable! Key management is the responsibility of the Principal Investigator and at least one other person should have the key. For key management you can use the tool Keeper.

The encrypted audio- and video-recordings should be securely stored in a folder separate from your research data files. You can use the data storage locations recommended by Tilburg University.

In principle, the research data needs to be stored and archived at TiU approved locations. If this is not possible and the research data remains with another trusted party with whom an agreement has been made regarding data retention, availability and security of the data in accordance with the Netherlands Code of Conduct for Research Integrity, this will be reviewed and potentially approved by the Data Representative. The type of agreement (data processor agreement, joint controller agreement, data sharing agreement, collaboration agreement, etc.) will depend on the type of data and collaboration. The Data Representative is available to support you with concluding the required agreement.

In case of questions related to the IRB, check the IRB website or contact the IRB manager (Juliana Thomazini, irb-tisem@tilburguniversity.edu).

Read more information about personal data and the GDPR or contact the TiSEM Data Representative: dm.tisem@tilburguniversity.edu.

Read more information about responsible research, research data management and/or research contracts or contact the TiSEM Data Representative: dm.tisem@tilburguniversity.edu.