Ethical appraisal

Research ethics appraisal: a brief history

Although ethics has been a formal branch of philosophy since many centuries, the idea that scientific researchers should seek independent ethics advice goes back to 1947, when, in response to Nazi atrocities disguised as scientific experiments, the Nuremberg code was written. That code defined a set of principles for experiments with humans and included principles such as informed consent, absence of coercion, properly formulated scientific experimentation and beneficence towards study participants.[1] In 1964, these principles were extended in the World Medical Association’s Helsinki Declaration of ethical principles for medical research involving human subjects, now in its 10th edition.[2] To emphasize that these principles go beyond medical research alone, we draw attention to (article 7 of) the United Nations International Covenant on Civil and Political Rights which prohibits medical and scientific experimentation without consent (1976).[3] In the Netherlands, the Wet medisch-wetenschappelijk onderzoek met mensen (WMO) came into effect in 1998.[4]

Although the roots of research ethics appraisal are in the medical field, modern research ethics committees (REC, or ECO in Dutch) at UASs appraise research protocols in all kinds of disciplines. Therefore, these committees may see it as their task to advise on broader societal implications of research plans, such as studies’ effects on society, culture and climate.

The revision of the Netherlands Code of Scientific Integrity (2018) features five leading principles: honesty, scrupulousness, transparency, independence and responsibility. The code led to the founding of research ethics committees at many Dutch Universities of Applied Sciences, including at the AUAS since 2020.[5]

Why ethics appraisal?

The why question can be answered commonsensically, with the applicable laws in mind, and pragmatically. First, teams consisting of human investigators with similar research interests often suffer from tunnel vision. Therefore, it is, generally speaking, wise to ask a panel of independent experts to assess if the balance between the likelihood of gaining new and potentially useful knowledge and the likelihood of harm to people, culture, animals or the environment justify the study. Opinions on that balance are not mathematics and opinions can, and do, differ between people and between committees.

Second and legalistically, the Dutch WMO law stipulates that ethics appraisal is required if it concerns medical scientific research and individuals are being subjected to actions or having rules of conduct imposed on them.[4] At AUAS, most research is non-medical and the WMO does not apply. Therefore, we think that the commonsense motivation to have one’s research plans appraised before the start of a study should be seriously considered. Finally, there are other laws relevant to scientific research, the most well-known being the European privacy law, GDPR ((U)AVG). It will usually be prudent to get expert advice on how your study plans adhere to these laws beyond the WMO.

Third and pragmatically, if you aspire to publish your work in a scientific journal, chances are that the journal’s Editor will ask for a formal approval letter by an ethics committee. Currently, AUAS’ research ethics committee (ECO) does not provide a letter of approval after the study has begun. So, to avoid complications during the publication process, it may be better to seek ECO’s advice before you start your study.

When to seek ethics appraisal?

Highly impractical, but perhaps the most ethically correct time-point to seek ethics appraisal is the time before funding for research has been obtained, if (external) funding is involved at all. We say this because even an independent REC may find it difficult to prevent the conduct of a study, given the administrative complications of giving back funds and the frustrations of the submitting investigators (often colleagues of ECO members). But, given that the number of research grants written considerably exceeds the number granted, the conduct of ethics appraisals before the funding is secured is considered highly inefficient. In addition, at the research proposal stage, the detailed documents that the ethics committee (ECO) needs in order to make an assessment are usually not available (study protocol, data protection review, data management plan and a participant information letter).

Therefore, in practice, ethics appraisal should be sought after funding has been secured, after the grant proposal has been turned into a detailed study protocol that includes a data protection review (DPR), a data management plan (DMP) and a participant information letter, and before the study’s data collection has started. Studies without (external) funding should, in our opinion, still seriously consider seeking ethics advice.

How to obtain ethics appraisal at the Amsterdam University of Applied Sciences?

Detailed instructions on how to submit research protocols to the Ethische Commissie Onderzoek (ECO) of the hogeschool van Amsterdam, can be found here . Please ensure that you make use of the AUAS/HvA’s Research Management Services (RMS), since that’s the portal for all submissions. The AUAS websites on research ethics also provide guidance for those who are uncertain whether the WMO law for scientific medical research applies to their research plan(s).[6 ] The ECO’s secretaries are open to queries, should the website not provide the information you need.

The Urban Vitality Open Science Support Desk can support you with: