The Code of Ethics gives guidelines for research in social and behavioural sciences involving theories. Guiding theme: apply or explain.

What are the principles?

Code of ethics is based on the following principles:

• Respect the dignity of humans and their environment. Avoiding exploitation, treating participants with respect/care, protecting those with diminished autonomy.
• Strive towards minimization of harm. Just distribution of benefits and burden, respecting potentially conflicting interest of diverse participants, communities etc.
• Adopt an ethical attitude where researchers are mindful of the meaning, implications, and consequences of research for anyone affected by it.
• Demonstrate the ethical attitude by:
  • Active reflection on potential ethical issues during or consequently of research.
  • Initiating assessment of potential drawbacks of research for individuals, communities, and society.
  • Monitoring for developments that could impact ethical aspects of the research.
• Account for and communicate on ethical reflection vis-à-vis different stakeholders, e.g. participants and communities, peers, students, funders etc.
• Conduct scientifically valid research, plausibly leading to relevant insights in social and behavioural sciences.

How these principles are safeguarded vary depending on the field of research.

What are some definitions?

• Social and behavioural sciences: field of science studying patterns/causes of human behaviour.
• Participant: person taking part in research where data is collected from them.
• Institute: university faculty, research institute, or graduate school in the social sciences adhering to the code of ethics.
• Board: board of the instate.
• Research plan: document addressing the rationale, background, objective, methodology, analyses, and relevant ethical aspects of a research project involving human participants.
• Ethics review committee: committee of experts assigned by the board responsible of reviewing research plans on ethical aspects.
• Personal data: data that can identify a person (participant).

What are the general procedures?

• All institutes of social and behavioural sciences at Dutch universities subscribe to the guidelines.
• Research on humans must be carried out according to a research plan.
• Research plan identifies potential costs and benefits to all stake holders – emphasizes consequences to participants/communities.
• Positive review of a research plan must be obtained from an ethics review committee established by the institute where the research is conducted, or those who carry main responsibility for the research.
• Ethics review must be done before research starts. When this isn’t possible, it has to be done as soon as possible. Researcher is responsible for acting according to ethical principles.
• Ethics review committee evaluates the research plan based on ethical guidelines/local implementations. Based on this: either approval/positive advice is issued or withheld.
• Ethics review is conducted in line with relevant laws. Abroad: principal investigator is responsible for ensuring that research is conducted with regard for local laws, habits, and customs.
• In case of unclear/conflicting laws or values, nature and circumstances of the dilemma are clearly documented, together with a resolution plan.
• Ethics review committee can suspend/evoke a positive review of a research plan if there are reasonable grounds to assume that continuation would lead to unacceptable harm/burden to human participants involved.
• Research must be covered by the regular legal liability insurance of the instate where the research is conducted or the body with primary responsibility for conducting the research.

What is the scientific relevance, necessity, and validity?

• Research conducted will lead to relevant insights.
• Research can be done for training purposes if participants are informed of the training purpose.
• Insights can’t be gained by less intrusive means.
• Research is carried out in suitable locations and supervised by people with necessary skills.
• Research uses sound methodology.

How does informed consent work?

• Participants must be given the chance to understand the nature, purpose, and consequences of participation, voluntariness of participation etc.
• Consent must be obtained to collect and register personal data.
• Mentally incompetent participant: informed consent obtained from their legal representative.
• Minors
• Minors 11-16: informed consent from both minor and parent/legal representative.
• Minors: consent from one parent is enough.
• >16: consent only from participant, good practice to inform parent/legal representative.
• Participants are monitored for signs of discontent before, during, and where possible after research – alleviated appropriately.
• Informed consent should be obtained for recording voices or images of participants.
• Information is provided to the participant sufficiently in advance. The higher the impact/burden, the longer the time period.
• Information is provided and consent asked in a comprehensible way for participant.
• Informed consent is active (deliberate act of the participant – ‘opt-in’) unless there are special circumstances that call for passive consent – ‘opt-out’.
• Deliberate or plausibly demonstrable acts of consent can be valid – writing, digitally, verbally etc.
• Keep adequate records of when, how, and by whom, informed consent was given.
• Indicate how the interest of this parties are protected – those not actively participating and informed consent is not obtained.
• Additional informed consent must be obtained when there are changes in the nature, duration, focus etc. of a study.

Exceptions: when is withholding information, deception, passive consent, or no consent acceptable?

• When preserving the integrity of research outweighs participant’s interest or is shown to be in the public interest. If information is withheld, participant will be given information after participation in a way that their consent remains intact.
• Deception can only be employed if no other option is available and is justified by the value of the study.
• Deception or withholding information isn’t allowed with procedures that are expected to cause physical/mental harm.
• Any deception/withheld information must be explained to the participant s early as possible (right after participation). Participants must then be informed of their right to withdraw their data without negative consequences.
• Passive consent is possible if: (a) active consent leads to disadvantages of validity or to the participants’ interest, (b) there’s little risk/burden, (c) participants are informed, (d) the opt-out procedure is straightforward.
• No consent necessary for public observations if data collection happens anonymously – no registration of personal data.
• Observation of specific groups only need consent from group members or an appropriate representative.
• Collection of personal data calls for informed consent of the individual unless there’s a justified cause. This cause is justified by the institute’s legal office.
• Re-use of data for new research when informed consent can’t be given by original participants calls for review to the ethics review committee, who decide whether re-use is justified.

How does compensation work?

• Any compensation/benefits offered is fair.
• Compensation doesn’t have a disproportionate effect on whether participants decide to participate.
• Adequate compensation is provided when local resources are used.
• Person conducting research and the instate where it’s being conducted receive reasonable compensation.

What about data protection and privacy?

• Processing, storage, and publication that can lead to identification is guarded by relevant laws. Special care regarding highly sensitive personal data.
• Protect those extra vulnerable to harm from being identified.

What is the ethics review committee?

• Advisory body with at least 5 members, established by and reports to the board of an instate.
• Board appoint executive secretary to committee.
• Board responsible for instrumentation, financial support, and proper recording of all ethical reviews done.
• Chair (vice chair if appointed0 and executive secretary form an executive board on the committee.
• Expertise of members must cover major disciplines of instate and typical ethical issues involved.
• Committee is responsible for acquiring/maintaining knowledge about current ethical issues and evaluate new developments.
• Committee strives towards raising ethical awareness through constructive dialogue and timely information.
• Committee must have access to ethical and legal expertise.
• Working methods and procedure must be specified in regulation available to all stakeholders.

What is the complaints procedure?

• Filed with the board, appeal can be lodged against a committee’s advice or decision according to the institute’s regulations.
• There’s a publicly available complaints procedure for participants.

How does it work with generalized validity, multi-center research, and research at external institutions or locations?

• If a decision is reached, it’s valid for all other Dutch institutes of behavioural and social sciences. No new review is necessary if research moves to another institute.
• Ethical review responsibility lies mainly with principal investigator.
• Multi-center research: review of different parts can be obtained separately from different institutes.
• If research is conducted at an external organization, the research should (a) get permission from responsible authorities of external organization, or explain why unnecessary, and (b) check local ethical guidelines and procedures, in case of conflicting values, principles etc. check with the ethics review committee of home institute.
• If there is an absent local scientific and ethical infrastructure – assess how the research plan fits with local values, customs, traditions etc.