TiSEM IRB Information for Researchers

• There are four types of submission, each with its own review procedure:

1. ‘Proposals for a new Standard Research Protocol, in addition to the existing SRPs’. Submissions are reviewed by the entire IRB committee and the data representative. The IRB makes the decision about the outcome of the review by majority at a meeting at which at least half of the members of the committee are present. Review procedure.

2. 'Full review'. Submissions are reviewed independently by the data representative and two other members of the IRB. The chairperson makes the decision about the outcome of review. Review procedure.

3. 'Expedited review'. Submissions are reviewed by the data representative and the chairperson. The chairperson makes the ultimate decision about the outcome of the review. Review procedure.

4. 'Exempt from full review' including applications for research within an approved SRP. Submissions are reviewed by the data representative and the chairperson to check for adherence to approved SRP. The chairperson makes the ultimate decision about the outcome of the review. Review procedure.

5. 'Amendments to approved applications'. Submissions are reviewed by the chairperson and the data representative, if the changes are minor (all questions in part 3.3. of the submission form are answered with ‘no’). Submissions are reviewed by two members of the IRB committee and the data representative, if the changes are major (not all questions in part 3.3. of the submission form are answered with ‘no’). Review procedure.

• IRB members use the review form to review each application.
• All decisions of the IRB take into account the advice on GDPR and research data management.
• Status of reviewed applications is: approval, revision needed, or rejection.
• The IRB reviews "Standard Research Protocols" within a maximum of 30 working days from the date of application, first submissions for "full review" in 10 working days, submissions for "expedited review" in 10 working days, and submissions "exempt from full review" within 5 working days.
• The IRB will advise the applicant(s) to submit the application to a Medical Research Ethics Committee (MREC) if applicable.
• The IRB manager is the contact person during the review procedure: irb-tisem@tilburguniversity.edu

Researchers can appeal and complain about the outcome of the application process or the application procedure. The IRB treats these appeals and complaints in an open and solution-focused atmosphere.

The appeal and complaint procedure of the IRB is as follows:

• Step 1: The researcher discusses his/her appeal and/or complaint with his/her immediate supervisor and with the IRB manager to provide clarification and/or find a satisfactory solution.
• Step 2: If step 1 does not lead to a satisfactory solution, a written appeal and/or complaint is submitted to the IRB chairperson (irb-tisem@tilburguniversity.edu), who responds in writing within 5 working days.
• Step 3: If step 2 does not lead to a satisfactory solution, a written appeal and/or complaint is submitted to the Vice-Dean for Research, who makes a final decision and communicates this, including the reasoning, to the researcher involved and the IRB chairperson.

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.

1. All researchers (TiSEM faculty, PhD candidates and Research Master students) can submit an application for research within a SRP.
2. Researchers who plan to conduct research, submit the IRB submission form and add the required appendices, referring to a specific approved SRP, and complete only the 'general information' of the study and the relevant declaration. The declaration states adherence to the approved SRP.
3. The IRB checks adherence of the application to the approved SRP. The research is “exempt from full review” of further IRB review.
4. Research applications that do not fall in a SRP will be reviewed as normal (Full or Expedited, depending on features of the proposed research).

SRP-1 Incentivized Experiments in Economics and Business

If your research fits within SRP-1, you only need to fill out part 1 and part 3 of the submission form.

Experiments in this SRP have the following characteristics:

1. In the experiments, participants make choices between options.
2. Financial remuneration.
   1. Participants receive a financial remuneration based on their choices (incentive compatible). Minimum earnings are typically not lower than 5 Euros per hour and the maximum per hour is typically not higher than 5 times the average payment. Or sometimes in the form of tokens (such as gift coupons or lottery tickets) or material goods.
   2. Participants receive direct payment, or via a bank transfer. In all cases, the payment information is kept separate from the data collection to ensure anonymous research data. If needed, a separate survey (separate from the research data collection) for payment purposes is set up to execute payments.
3. The experimental procedures involve minimal risk to the participants.
4. The topics of the experiment are not sensitive.
5. The experiment does not involve deception.
6. Responses of participants are recorded and stored anonymously.
7. Participation is on a voluntary basis and only after obtaining informed consent from the participants.
8. Data collection predominantly takes place in the CentERLab of TiSEM, via the CentERLab registration, 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 a member of ESOMAR (www.esomar.org) (e.g. Kantar Group, Dynata, a panel of CentERdata of Tilburg University). If you need help assessing an online data collection platform or a different research organization is planned to be used, contact the IRB at irb-tisem@tilburguniversity.edu.
9. Participants are predominantly Tilburg University students.

The choice situation in experiments is sometimes abstract (e.g. choose between option A or B) and sometimes has a context (e.g. producers who are asked to set a price, case-based scenarios in which participants have to act as employee, non-professional investor or manager).

Sometimes participants fill out a survey at the end of the experiment measuring individual characteristics (e.g. gender, field of study, age) or measuring basic psychological constructs based on well-validated scales from prior research (e.g. big-5, locus of control, social value orientation). The information gathered is not sensitive. Moreover, the information is minimal and gathered in broadly defined categories such that it is not possible to allow tracking the identity of any of the participants. The experiments involve negligible risk.

Participants receive instructions that truthfully describe details of the task: the choice situation, how choices translate into financial remuneration, when financial remuneration will be provided, how long the experiment will take, etc.

Choices that participants enter remain anonymous to other participants and to the researcher and the personal identity of matched participants is not revealed. Researchers are not in the position to match choices to personal data. The choices of participants are connected to an anonymous participant code, which is not connected to personal data. The remuneration that participants receive depends on the choices they make and sometimes on other participants’ choices.

At the end of a session or shortly thereafter participants collect their earnings, and signed receipts are collected from them. The receipts include the names of the participants for financial administration, but they do not include anonymous participant codes. The receipts are transferred to the financial administration and are not kept by the researchers.

Participants are (Tilburg) University students. Occasionally, participants are recruited from other general subject pools (e.g. nearby high schools, the general population).

SRP-2 Studies on Judgement and Decision Making

If your research fits within SRP-2, you only need to fill out part 1 and part 3 of the submission form.

Experiments in this SRP have the following characteristics:

1. Participants provide judgments, including beliefs, feelings, evaluations, and preferences, about themselves or others or about choice options, and can make a choice between options.
2. Financial remuneration.
   1. Participants participate for a fixed monetary fee (equivalent to the market rate for the participants in the sample), or sometimes for a small tangible reward or for free.
   2. Participants receive direct payment, or via a bank transfer. In all cases, the payment information is kept separate from the data collection to ensure anonymous research data. If needed, a separate survey (separate from the research data collection) for payment purposes is set up to execute payments.
3. Participation in the study involves minimal risk to the participants, but never greater than what participants can encounter in normal day-to-day life.
   1. Research designs can be between-participants and within-participants such as in experiments, and can be a one-group design, such as in surveys.
   2. Topics and measures can include slightly sensitive topics such as, but not exclusively sensitive personal feelings, characteristics or consumption behaviors.
   3. Data collection procedures can include inductions of slight positive or negative mood or self-esteem by means of visual stimuli, verbal scenarios or feedback information.
4. When data collection procedures approach minimal risk, a post-evaluation questionnaire at the conclusion of the study assesses whether participants experience any residual negative feelings or other aversive states due to the study.
5. In the unlikely event that participants signal to experience residual negative feelings or aversive states, a remedial procedure is implemented to normalize these, the success of which is subsequently assessed.
6. Studies can contain mild forms of deception.
7. Responses of participants are recorded and stored anonymously.
8. Participation is on a voluntary basis.
9. Data collection takes place on the Tilburg University campus, in the CentERLab of TiSEM or a lecture hall/classroom, 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 a member of ESOMAR (www.esomar.org) (e.g. Kantar Group, Dynata, a panel of CentERdata of Tilburg University). If you need help assessing an online data collection platform or a different research organization is planned to be used, contact the IRB at irb-tisem@tilburguniversity.edu.
10. Participants have a Tilburg University student number or belong to general population samples (e.g. Qualtrics panel, LISS panel of CentERData at TiU).

The choice situation in experiments is sometimes abstract (e.g. choose between option A or B) and sometimes has a context (e.g. producers who are asked to set a price, case-based scenarios in which participants have to act as employee, non-professional investor or manager).

Individuals participate on a voluntary basis in the studies in this SRP. The study topics fall within the definition of “minimal risk” to participants; “Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” (U.S. Office of Human Research Protection, 45 C.F.R. § 46.102(i)).

Participants receive detailed instructions about the study and their participation, including details of their task, the data collection procedure, and remuneration. In the studies, participants judge and potentially choose between certain objects, persons, situations, tasks. The stimulus, scenario or choice situation can be real (e.g. choose between option A or B, how much do you like this product? How do you feel when thinking about X?) or hypothetical (e.g. imagine being a producer who needs to set a price, imagine being a consumer who has to make a choice). As part of the task, participants can role-play to act as consumer, employee, non-professional investor or manager. Participation can be individual (e.g. evaluate a scenario, choose between two options) or interactive in pairs or small groups.

Studies can have a single-group (observational, “survey”) or multi-group data collection designs (“experimental”), and between-participants or within-participants (“repeated measures,” time-series).

Studies may involve minimal risk when covering somewhat sensitive topics (such as “economic and other cheating”) and/or assigning participants to conditions that involve temporary and slight negative mood or self-esteem changes (e.g. by providing them information about success and failure rates of others, firms, or countries).

Studies might employ minimal level of deception by withholding from participants some correct or providing them some incorrect information about the topic, task, or their performance. The risk and deception are not more than what participants might encounter in normal, daily life.

Studies do not assign participants to conditions where they have to taste food as part of the data collection procedure. Studies may involve a voluntary choice between food items.

In the unlikely event that participants indicate at the end of the study to be experiencing residual negative feelings or aversive states, the study implements a remedial procedure to normalize these, and it assesses the success of this procedure.

Participants receive a fixed, monetary amount (close to the market rate for the sampled participants) independent of the choices made during the study. Participants might voluntarily participate without remuneration, or for a small tangible reward such as a snack, when participation is very brief, such as in a 1-minute survey.

Participants have a Tilburg University student number or belong to general population samples. Data collection takes place in the CentERLab of TiSEM, a classroom/lecture hall on the Tilburg University campus, or via an online platform/panel. The judgments and choices that participants make during the study are anonymous, and cannot be traced back to individuals. Only anonymous participant codes and the responses during the study are retained.

In case participants receive a monetary remuneration for their participation, payout can be in cash or by bank transfer. In case of cash payouts, signed receipts are collected from the participants. The receipts include the names of the participants, and in some cases bank account numbers, but they do not include the anonymous participant codes. The receipts are transferred to the financial administration and are never kept by the researchers.

Participants typically fill out a general questionnaire assessing individual characteristics (e.g. gender, field of study, age), situational states (e.g. mood, stress), and/or personality characteristics (e.g. Big-5, social value orientation) based on validated scales. The amount of information that is gathered during the experiment is minimal relative to the research goals and does not enable tracking the identity of the participants.

SRP-3 Qualitative Research in Business and Economics

If your research fits within SRP-3, you only need (1) to fill out part 1 and part 3 of the submission form and (2) to provide a list of topics and the provisional questionnaire.

Experiments in this SRP have the following characteristics:

1. Goal: Research in this SRP is commonly inductive rather than hypothetico-inductive. A key goal is to understand and explain relevant business and economic phenomena by …
   (1) collecting large amounts of data from a comparatively small set of observational units sometimes “in vivo”,
   (2) condensing the data into a smaller set of meaningful variables, factors or constructs,
   (3) describing how these are causally, temporally or otherwise related,
   in order to …
   (1) provide a rich and deep (“thick”) contextualized description of the phenomena, and
   (2) provide explanations that are potentially transferable to other contexts or phenomena, and
   (3) propose policy recommendations for the firms, organizations, local and/or (inter)national governments.
2. Method: Data collection typically involves interactive, reflexive personal interviews (question-answer-question) between an interviewer and an interviewee or focus groups with a number of participants. Personal interviews are commonly semi-structured, with open and closed-ended questions, and sometimes with other techniques (e.g. free association, recounting personal history). At a minimum, the list of topics and a provisional (semi-structured) questionnaire is available when submitting the research proposal (see also point 11 below).
3. Small Sample Size: sample size tends to be small, typically between 10 to 60 participants, or less for intense case analyses. Sample size is typically based on a trade-off between sufficient “coverage” of the domain/question of interest and the cost (including timeliness) of data collection. This can imply using a sequential stopping rule (when an additional data collection effort probably does not add sufficiently new information).
4. Participants: Research participants report about themselves or are “informants” about others, such as others with a similar role, in a functional unit or in the firm. Participants are not part of the category of vulnerable persons (where there is an unequal balance of power between participant and interviewer or participant and the person about which he or she reports, for example minors, mentally ill persons, asylum seekers, the elderly, patients, etc.). Research with vulnerable persons requires Full Review.
5. Intense Data Collection: Data collection is typically intense, with a minimum of 30 minutes up to two (and occasionally) three hours in total, sometimes in multiple sessions. Interviews can be summarized by taking notes or can be audio recorded. Research using video recording of interviews requires Full Review.
6. Data Analysis: Data analysis typically relies on deep immersion to summarize or identify salient or emerging common themes, potential problems, solutions, opportunities, or threats. This can rely on data visualizations (collages, word clouds, conceptual mapping), text analysis, or data reduction and association data analysis techniques (such as cluster analysis, multidimensional scaling). It generally does not rely on inferential statistical (hypothesis testing) techniques. Audio recordings can only be used to transcribe the interviews and cannot be used for other purposes, such as to identify the emotional tone or other characteristics of the interview and/or the participant. Full Review is required when audio recordings are used for other purposes than to transcribe the interview.
7. Informed Consent: Prospective participants provide full informed consent before the start of data collection. The informed consent mentions the rights of participants including the right to not participate, withdraw during data collection, skip responses to questions, without the need to provide a reason, and the right to request access to their data and to ask for the rectification, erasure, or restriction of processing their personal data.
   The informed consent form explicitly asks participants to provide their informed consent, for instance, by marking a check-box and by placing their signature. When the interview is audio recorded, the informed consent form also explicitly asks participants to provide their informed consent that the interview is being recorded and stored for later transcription.
8. Compensation: Participation in interviews or focus groups may be part of a formal role, as member of the organization under study or of the organization commissioning the research. Then, usually no financial compensation is provided, except (sometimes) a management summary or other report of the research.
   If participation in interviews or focus groups is not part of regular role, it is common to compensate interviewees financially or with an equivalent token (e.g. gift voucher). In rare occasions, interviewees and focus group members participate for free, for instance, in case of charity or public good projects.
9. Sensitivity: The topic, questions, and data collection procedure itself are not sensitive. Sensitive topics and questions could include financial personal data (income, bonus, savings, or investments), health, medical or genetic personal data, political party or trade union memberships, ethnicity or sexual preferences. Questions about social relationships between participants and/or other persons are sensitive. Research on sensitive topics and/or with sensitive questions require(s) Full Review.
10. Confidentiality and Privacy protection: The data are anonymized or pseudonymized as soon and as much as possible. Measures (for example encryption) are taken to protect data that cannot be anonymized or pseudonymized (for example audio-recordings).
11. Data collection transparency: A full set of data collection materials, including the interview topics, questions or themes, follow-up questions, and other material is available and attached as an Appendix to the research proposal.
12. Data availability: Raw data (audio files, electronic checklist, questionnaires, etc.) and transcripts are saved and archived following Tilburg University recommended procedures.

• Format informed consent

1. All TiSEM faculty can propose an SRP with other researchers from the same or another Department in TiSEM.
2. A SRP description provides, in more detail than for a single study, the details of data collection, data management, and GDPR information of the typical studies conducted in its context. An extended TiSEM IRB form is used, and appendices for the relevant documents (consent form, debriefing, etc.) are added. Information about one or more typical, specific studies in the context of the program could be included.
3. The extended TiSEM IRB form has the same questions/items as the regular form but allows more space for details.
4. Each SRP has a coordinator who informs and supports researchers and the IRB when necessary.
5. The application for a SRP is evaluated by the full IRB committee, including the data representative. The committee uses the review form.
6. A SRP is re-evaluated and renewed every two years.

• Video vlog about the scope of TiSEM IRB by the chairperson (March 2022)
• Video vlog about the process of TiSEM IRB by the chairperson (March 2022)

• Submission Form individual research proposal
• Submission Form SRP 

• Flowchart 'Do I need IRB Approval?'
• Flowchart Review Procedure SRP 
• Flowchart Review Procedure Full Review 
• Flowchart Review Procedure Exempt
• Flowchart Review Procedure Expedited 
• Flowchart Review Procedure Amendments

• Submission Guide TiSEM IRB
• IRB Regulations
• IRB Operating procedure
• Review Form TiSEM IRB

• Policy GDPR: Strategy Data Protection, Privacy & Personal Data Protection Policy, Scientific Research thematic policy
• Research Support Portal
• Regulation Research Data Management
• Open Access Information Point

• Netherlands Code of Conduct for Research Integrity (Universities of The Netherlands, 2018)
• Uitvoeringswet Algemene verordening gegevensbescherming (AVG, 2021)
• The European Code of Conduct for Research Integrity (ALLEA, 2017)
• General Data Protection Regulation (2016/679, "GDPR")