Journal of Empirical Research on Human Research Ethics 2014, Vol. 9(3) 67 –73 © The Author(s) 2014 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1556264614540596 jre.sagepub.com
Long-Neglected Issues
We have seen in the case of medical research and its history of ethical lapses that researchers often fail, for entirely innocent reasons, to comprehend or extend ethical princi-ples to their treatment of subjects involved in their studies. The conduct of research necessarily involves new, untested materials, procedures, and techniques, and even researchers
themselves are often at risk. When research involves
partici-pants other than researchers, unknown and unanticipated risks may become a substantial ethical concern invoking the same principles that are now well-known in medical research. In medicine, devices, techniques, and chemicals are administered now under strictly controlled regimes involving ethics committee review, because in notable cases in the past, humans have been injured or died, or have had their rights infringed upon.
Human participants are employed in a broader range of basic and applied research than just medical science and technology. This is not a new development, but the ways in which human participants are being (perhaps increasingly) employed in non-medical research ought to cause us to at least consider whether the standards and principles that guide the treatment of human subjects in medical research are appropriate and necessary for human participants in non-medical research.
In our experience, research, both basic and applied, is being conducted with human participants in diverse ways,
including the testing of non-medical devices (for instance, aircraft control mechanisms, interfaces, prosthetics), simu-lations and virtual reality, surveys and videotaping of inter-actions with designs, appurtenances, and other people, and numerous other instances giving rise to potential ethical concerns. It would seem the standard principles of human research ethics, buttressed by regulatory and institutional arrangements, should be applied wherever there are risks to human dignity, autonomy, and safety regardless of the context.
We surveyed online the top 50 Technical Universities in the world under the Times Higher Education Rankings for 2013-2014 (http://www.timeshighereducation.co.uk/world-university-rankings/2013-14/subject-ranking/subj-ect/ engineering-and-IT). We found that unless the law requires it, even top technical universities generally do not use ethics committees. Based on our experience at Delft University of Technology, it is unlikely that such universities are not somehow using human subjects. The legal climate in
1Delft University, Delft, The Netherlands
Corresponding Author:
David Koepsell, Delft University, Jaffalaan 5 (Building 31) 2628 BX Delft, The Netherlands.
Email: drkoepsell@yahoo.com
Human Research Ethics Committees
in Technical Universities
David Koepsell
1, Willem-Paul Brinkman
1, and Sylvia Pont
1Abstract
Human research ethics has developed in both theory and practice mostly from experiences in medical research. Human participants, however, are used in a much broader range of research than ethics committees oversee, including both basic and applied research at technical universities. Although mandated in the United States, the United Kingdom, Canada, and Australia, non-medical research involving humans need not receive ethics review in much of Europe, Asia, Latin America, and Africa. Our survey of the top 50 technical universities in the world shows that, where not specifically mandated by law, most technical universities do not employ ethics committees to review human studies. As the domains of basic and applied sciences expand, ethics committees are increasingly needed to guide and oversee all such research regardless of legal requirements. We offer as examples, from our experience as an ethics committee in a major European technical university, ways in which such a committee provides needed services and can help ensure more ethical studies involving humans outside the standard medical context. We provide some arguments for creating such committees, and in our supplemental article, we provide specific examples of cases and concerns that may confront technical, engineering, and design research, as well as outline the general framework we have used in creating our committee.
Keywords
Europe and Asia appear to regard non-medical human research as outside the scope of the Helsinki Declaration.
Our survey of the top 50 technical universities in the world shows that where not specifically mandated by law, most technical universities do not employ ethics commit-tees to review human studies (see Table 1). The only coun-tries where it appears that all human research is mandated by law are Australia (http://www.nhmrc.gov.au/guidelines/ publications/e72), Sweden (http://www.epn.se/en/start/ regulations/), the United Kingdom (http://www.nres.nhs.uk/), and the United States (http://www.hhs.gov/ohrp/human subjects/commonrule/index.html). If science is to proceed in a manner that is socially responsible, and given that soci-ety both funds and benefits from it, then there is no apparent reason to restrict our concerns about ethics to medical research only.
In our experience as researchers at a technical university, human participants are involved with a significant amount of research, and it is not always clear that despite real risks of both physical and other harms, the rights of the partici-pants or ethical duties of researchers have been properly considered (Koepsell, 2010). By what logic should we sub-ject research participants to risks without some level of oversight, prevention, or training?
Moral Reasons for Ethics Review
The principles that have developed to protect human sub-jects in medical research are no less applicable to human participants in any research. Rights to dignity, autonomy, duties to scientific inquiry, beneficence, and justice are not contingent on any particular field of research; they are owed and to be respected regardless of the field of study as long as humans are involved. If some area of research poses risks to any of these values or principles, and if the institutional forms that we have created in medical research are effective means of protecting the rights and safety of human partici-pants, then we should be open, or perhaps even compelled, to extend those arrangements to other venues (Van de Poel, 2001).
Technical universities are not the only venues in which human participants are routinely used to test devices, proce-dures, and materials, but they are certainly one important test case for extending the principles used in human research ethics beyond purely medical science. At our technical uni-versity, a variety of studies involve human participants with varying levels of risk, including testing of new devices, sur-veys, simulations, and even architectural innovations, among others. In these studies, ethical concerns that ought to be considered include potential conflicts of interest, pri-vacy concerns, use of vulnerable populations, properly informed consent, and management of risks, to name a few.
There are a growing number and range of practical con-cerns that also compel seriously considering institutional
arrangements to guide ethical research in non-medical con-texts. Despite objections about the efficiency and effect of ethics committees on the conduct of research (Guillemin, Gillam, Rosenthal, & Bolitho, 2012), harmonization of international standards, application of the precautionary principle, and various practical reasons suggest they are here to stay, and their reach is growing.
Practical Reasons for Ethics Review
Applying ethics to human research in non-medical contexts is an increasingly good idea for a number of practical as well as moral reasons. These reasons include requirements of funding entities, publishing requirements, and liability concern. Ethics committees at technical universities may help to enable both basic and applied research to proceed more smoothly, and meet a list of emerging and established practical requirements for scientists and researchers. Because some rather important jurisdictions already require ethical review, when collaborative research involves European or other research centers without such mandatory review, the duties and liabilities involved may become quite complicated. Establishing systems of review in the absence of legal requirements may facilitate collaborative efforts and avoid complications for multi-center studies. Moreover, greater harmonization of ethical standards may be achieved as efforts to provide accreditation are perfected and interna-tionalized (see, for example, AAHRPP.ORG).
Increasingly, both basic and applied science as ducted at technical universities are being conducted in con-junction with other research institutes and even private, for-profit entities. Complex relationships among collaborat-ing research groups may not only lend themselves to poten-tial ethical issues such as conflicts of interest but also pose new potential requirements relating both to the funding of such research and publication of results.
More and more journals are demanding proof that sub-missions of research involving human participants were conducted under the supervision and approval of ethics committees. We have seen that in multi-center research pro-grams in which our technical university may be involved, publications do not differentiate when asking whether the studies have been approved and whether the elements con-ducted by our researchers were medical. The blanket requirement by an increasing number of journals publishing the results of such studies is that there must be ethical com-mittee approval where human participants are involved (Rowan-Legg, Weijer, Gao, & Fernandez, 2009). If techni-cal universities wish to accommodate their researcher’s needs for publication, they need to have in place some mechanisms for ethics committee review, advice, and approval for studies, whether local or multi-center, where human participants are used. This means either establishing permanent committees, having a mechanism for ad hoc
Table 1. Institutions Surveyed.
Rank Institution Location Ethics committee found? mandatory?Review Source 1 Massachusetts Institute of
Technology United States Yes Yes http://web.mit.edu/committees/couhes/ 2 Stanford University United States Yes Yes http://humansubjects.stanford.edu/new/
resources/researchers/index.html 3 University of California,
Berkeley United States Yes Yes http://cphs.berkeley.edu/ 4 California Institute of
Technology United States Yes Yes http://irb.caltech.edu/
5 Princeton University United States Yes Yes http://www.princeton.edu/ria/human-research-protection/
6 University of Cambridge United Kingdom Yes, per
department Partially; self-review can be sufficient
http://www.admin.cam.ac.uk/offices/ research/research/ethics.aspx http://www.tech.cam.ac.uk/document/
terms/ethics.pdf
7 University of Oxford United Kingdom Yes Yes http://www.admin.ox.ac.uk/curec/ http://www.admin.ox.ac.uk/curec/
approval/ 8 ETH Zürich—Swiss
Federal Institute of Technology Zürich
Switzerland Yes Yes http://www.vpf.ethz.ch/about/ commissions/EK
9 Imperial College London United Kingdom Yes Yes http://www3.imperial.ac.uk/ researchethicscommittee 10 University of California,
Los Angeles United States Yes Yes http://ora.research.ucla.edu/OHRPP/Pages/IRB.aspx 11 Georgia Institute of
Technology United States Yes Yes http://researchintegrity.gatech.edu/about-irb/ 12 Carnegie Mellon
University United States Yes Yes http://www.cmu.edu/research-compliance/human-subject-research/ 13 National University of
Singapore Singapore Yes Yes http://www.nus.edu.sg/irb/ 14 University of Texas at
Austin United States Yes Yes http://www.utexas.edu/research/rsc/humansubjects/ 15 École Polytechnique
Fédérale de Lausanne Switzerland Only biomedical http://www.unil.ch/fbm/page36053.html 16 University of Michigan United States Yes Yes http://www.irb.umich.edu/
17 Cornell University United States Yes Yes http://www.irb.cornell.edu/ 18 University of Illinois at
Urbana Champaign United States Yes Yes http://irb.illinois.edu/ 19 Northwestern University United States Yes Yes http://irb.northwestern.edu/ 20 University of California,
Santa Barbara United States Yes Yes http://www.research.ucsb.edu/compliance/human-subjects/ 21 Hong Kong University of
Science and Technology Hong Kong No No
22 University of Toronto Canada Yes Yes http://www.research.utoronto.ca/ about/boards-and-committees/ research-ethics-boards-reb/ http://www.research.utoronto.ca/ faculty-and-staff/research-ethics-and-protections/humans-in-research/ 23 Delft University of
Technology Netherlands Yes Yes http://www.hrec.tudelft.nl/
24 Tsinghua University China No No
25 Korea Advanced Institute of Science and Technology
reviews by trained experts, or sending studies out to ethics committees established at other institutions. Because tech-nical universities have on their faculty the particular exper-tise in engineering and design needed to assess risk in protocols, there is an obvious argument for creating a per-manent, expert committee within one’s institution.
Increasingly, funding agencies require prior ethical approval of study proposals, or at least the assurance that proper ethical review procedures are in place and will be used if the project is funded. Requirements by funding agencies, especially for multi-center, international studies, tend not to distinguish medical from non-medical research
Rank Institution Location Ethics committee found? mandatory?Review Source 26 Technische Universität
München Germany Only medical http://www.ek.med.tum.de/ 27 The University of Tokyo Japan Only medical http://www.m.u-tokyo.ac.jp/english/
research/rinri.html 28 University of Wisconsin–
Madison United States Yes Yes http://grad.wisc.edu/respolcomp/hrpp/ 29 Seoul National University Republic of Korea Only biomedical http://www.useoul.edu/research/
services
30 Columbia University United States Yes Yes http://www.columbia.edu/cu/irb/ 31 University of Washington United States Yes Yes http://www.washington.edu/research/
hsd/
32 University of Melbourne Australia Yes Yes http://www.orei.unimelb.edu.au/ content/human-ethics 33 Nanyang Technological
University Singapore Yes Yes http://research.ntu.edu.sg/GuidelinesnForms/Pages/default.aspx 34a KTH Royal Institute of
Technology Sweden Yes, run by state Yes http://intra.kth.se/en/regelverk/policyer/etisk-policy-1.27141 http://www.epn.se/en/start/application/ 34a Technical University of
Denmark Denmark No No
36 KU Leuven Belgium No No
37 University of Manchester United Kingdom Yes Yes http://www.manchester.edu/ committees/IRB/index.htm 38 University of Minnesota United States Yes Yes http://www.irb.umn.edu/
39a RWTH Aachen University Germany Only medical http://www.medizin.rwth-aachen.de/
go/id/coeq
39a Kyoto University Japan Only medical http://www.med.kyoto-u.ac.jp/E/links/
links.htm 41 Pohang University of
Science and Technology Republic of Korea No No 42 The University of Hong
Kong Hong Kong Yes Yes http://www.rss.hku.hk/integrity/ethics-compliance/hrecncf 43 University of California,
San Diego United States Yes Yes http://irb.ucsd.edu/ 43 University of Queensland
Australia Australia Yes Yes http://www.usq.edu.au/research/ethics/human 45 University of California,
Davis United States Yes Yes http://research.ucdavis.edu/c/cs/hrp 46 Rice University United States Yes Yes http://comp.rice.edu/Content.
aspx?id=422
47 Peking University China No No
48 University of British
Columbia Canada Yes Yes http://www.research.ubc.ca/ethics/should-i-apply-ethical-review aTwo institutions each are tied for 34th place and 39th place.
when seeking assurance of ethical conduct, review, and approval of study proposals (Wade, 2005).
Concerns about potential risks posed by studies involv-ing engineerinvolv-ing and technology usinvolv-ing human participants may prompt interest in developing more formal ethics review procedures. Although only part of the role of an eth-ics committee overlaps with legal responsibilities, and this differs from place to place, whenever human participants are injured or deprived of rights in scientific research, there is also a potential for legal liability. Obtaining informed consent, and undergoing full review does not always avert legal liability in case of harms; however, having a clear pro-cedure and acting in good faith to conduct studies ethically can certainly demonstrate that standards of good scientific conduct were attempted (Annas, 1991; Schrag, 2012). Ethics committees, combined with legal departments, safety personnel, and good training of researchers, may all help contribute to avoiding, most importantly, harms to human participants, and thus help contain costly legal liability. It is still an open question, empirically speaking, as to whether ultimately, institutional review boards (IRBs) actually pro-tect human subjects (Grady, 2010); however, given the increased reliance and role of such committees worldwide, and the benefits of helping to ensure coordination of multi-center research in disparate fields, establishing such com-mittees provides certain practical benefits.
A Permanent Ethics Committee at a
Technical University
Our survey of the top technical universities reveals that 80% of Asian universities among the top 50 do not mandate ethical review for non-medical research involving human subjects and 62% of European universities outside the United Kingdom do likewise (an even higher percentage if we exclude Scandinavian universities). For many of the reasons discussed, creating a per-manent ethics committee is a compelling solution for technical universities engaged in basic and applied research involving human participants (see Appendices A and B, available online at jre.sagepub.com/supplemental, for our application form and checklist). Once it becomes clear that human participants are being used in studies in some significant numbers, as indeed at our modestly sized university they are, ad hoc reviews may become unwieldy and inconvenient. Currently, we review about a dozen cases per month as a standing committee, with between two and four requiring discussion by the committee (the rest are considered minimal risk). Among the benefits of assembling a standing committee is that the members of the committee become familiar with their roles and expectations, and over time, develop their abilities to review studies for risks and ethical concerns. They also represent various faculties, all of which are eventually involved in having studies reviewed.
Once a permanent committee is created, representing as many faculties as possible, and composed of volunteers who are both interested and presumably educated in
relevant research ethics, procedures adopted from medical IRB procedures can be created and publicized so that researchers across the university may employ the commit-tee as necessary. Advantages of a permanent commitcommit-tee include its eventual professionalization, members’ increased familiarity with terms, principles, concepts and technolo-gies reviewed, consistency and predictability, regularity, and interest of those involved. To further facilitate good ethical practice, an ethics committee may best operate alongside education, where researchers, students, and fac-ulty are introduced to ethical issues, principles, and prac-tices, and given the basic ability to spot potential problems and use their own creative thinking to help avoid harms. Although there is no clear evidence that ethics education decreases the likelihood of ethical lapses, it may at least help facilitate the adoption and understanding of the con-cepts involved so that review procedures are better understood.
At our university, all PhD students have mandatory train-ing in scientific integrity, includtrain-ing a module in human research ethics. Several faculties also mandate ethics courses for master’s students. Finally, with the introduction of a university-wide ethics code embracing issues in scientific integrity, faculty members are also being introduced to basic issues in human research ethics. Recently, it was shown that with some coordinated, standard training, greater consis-tency in applying ethical principles to research can be achieved (Stark, 2011). Ideally, as principal investigators become more familiar with issues relating to the ethical use of human participants in their research, better attention to protocol design, and better conformity to standards of ethi-cal research, will be adopted in submissions to the ethics committee so that the procedure itself operates as smoothly as possible to ensure more ethical research going forward.
Conducting Committee Review on
Technical Research Projects
If a study poses more than a minimal risk as determined by standard interrogatories in an incoming checklist, our next concern is not to overstep our role as an ethics committee for non-medical research. If a proposal involves medical research, we will refer it to a nearby medical ethics committee.
Of special concern to our committee are two broad areas that seem unique to technical and design research: devices built in-house and privacy concerns. To help us consider ethical implications of devices used in research, we ask in our intake forms the following:
Question: This experiment involves the use of a device not “CE” certified _ Yes _ No
if “yes” the device was built in-house _ Yes _ No
if “Yes” (it was built in-house) it was inspected and certified safe by a safety expert at XXXXX _ Yes _ No (please provide records of that inspection)
if “No” it was inspected by some other qualified authority in safety and approved _ Yes
No (please provide records of that inspection)
“CE” (Conformité Européenne) certification is generally required in Europe for devices sold on the open market. A fair amount of research that is conducted at our university uses standard, off-the-shelf equipment whose safety has been checked by those providing CE certification. However, to test hypotheses about the performance of subjects under certain conditions (for instance, their reactions to newly designed avionics controls), devices are often built in-house either to test the device itself or to create conditions necessary for other tests (for instance, inducing stress on a subject by blow-ing puffs of air at them). Where such devices have been built specifically for a study, and have not been tested by some independent testing agency, we inquire as to safety testing in the faculty in which the research is being conducted. Generally, safety personnel in those faculties have tested the equipment, and any reports of such test and data about its safety can help us to determine the potential risks to subjects. We advise our investigators that we are not ourselves a safety committee, and their cooperation in seeking the advice of safety experts is necessary so that we can more appropriately judge risks. Communication among investigators, safety experts at the university and in the faculties involved, and our committee seems to help us to better gauge the probable risks associated with the use of devices in technical research. We hope over time to develop a database of such devices to enable better and more efficient review of projects involving the same or similar devices. We also require that principal investigators inform us if they alter their protocols or the devices used in the course of their study.
Another major area of concern for our committee has been privacy. Whereas a fair amount of medical data gathered can be de-identified, data acquired in much of the technical research being conducted at our university involve videotape or photographs. Often, to measure the responses of partici-pants to conditions or devices, testing is recorded for later analysis. Because photographs and videotape are difficult to de-identify, we require detailed description of measures taken to ensure the data are not misused, and that they are destroyed after an appropriate time if possible. This is especially a con-cern where the subjects may be members of vulnerable groups. Lock and key, isolated hard drives with only one or a limited number of custodians are generally appropriate mea-sures that help to guarantee that identifiable data remain well contained and that the risk of misuse is minimized.
Because the research we review comes from a number of distinct research areas, unlike a medical ethics committee, we must rely on the expertise of our committee members from each faculty to help to educate us all about particular studies. Having a balanced committee with at least one member from each faculty may help ensure that reviewers are better informed about the sciences and studies that come before it.
Best Practices
Technical universities in legal jurisdictions that do not require all human research to be reviewed by an ethics com-mittee should nonetheless ask themselves whether and to what extent the moral and practical concerns we outline above concern them. Researchers working in an increasingly international milieu may be impeded unless universities throughout the world intending to collaborate on research involving human subjects harmonize their views on ethical reviews. The demands of funding agencies and publishers, even aside from the basic moral concerns impelling ethical review, ought to suggest that researchers who seek to col-laborate across borders will benefit from establishing ethical review committees for human subjects research in all techni-cal universities. Models for the composition and operations of such committees abound, and we have borrowed both from U.S. and European models in forming ours.
At the very least, members of as many relevant disciplines as possible ought to be represented because their expertise will facilitate discussion of research and technologies with which not every committee member may be familiar. Some sort of minimal risk evaluation ought to be conducted so that committee members are not burdened with evaluating every application and so that studies involving minimal risk may proceed with little hindrance. Depending on the volume of human research being conducted, faculty-wide (vs. university-wide) ethics committees may suffice and encourage effi-ciency. Distinctions between safety and ethics ought to be maintained so that the ethics committees do not become a safety-review or management body. And finally, dialogue among technical universities regarding the nature and role of ethics review in human research ought to be encouraged so that we may improve our processes and better protect human subjects’ rights and health.
Research Agenda
Given the relative lack of ethics review in non-medical contexts outside the United States, Canada, Australia, and the United Kingdom, as more technical universities in Europe, Asia, and presumably Africa adopt ethic review processes, empirical study of their operations, effective-ness, and the practical effects of their existence may prove revealing. Besides potentially interesting statistics on harms to human subjects in non-medical research contexts in the jurisdictions without legal mandates for ethical review (both before and after ethical committees may come to be formed), it would be especially valuable to note the effects, if any, on collaborative international research efforts and publication. Furthermore, more work is neces-sary to develop streamlined and context-relevant processes for ethical reviews in non-medical (technical and design) contexts in general. Merely adopting the methods of exist-ing IRBs and ECs (ethics committees) seems unlikely to be the most efficient course. Experiences of committees such
as ours would be helpful in helping us to create a better and more ethical experience for our universities and their researchers. Investigating the cultural and legal reasons why there exists the current disparity in treating non-med-ical human research would also be a valuable step in har-monizing norms. Finally, we have recently been collaborating with a software company that has developed a safety-software suite for the university and have helped develop a module for it specifically to move our ethics committee work online. In a future publication, we will report on the data we gather in using it and its effectiveness and adoption by the university community. Similar such projects would seem attractive to other technical universi-ties, and exchanging our experiences should prove valu-able for all ethics committees as well.
Educational Implications
Because, in our experience, engineers, designers, and archi-tects do not appear to view their use of human subjects in their research in the same vein as medical experimentation, teaching human research ethics at a technical university may at first appear to be a hard sell. We are collecting cases, and certainly, there is a plethora of experience among top techni-cal universities that help demonstrate the value of treating human subjects in non-medical research with the same degree of ethical care as in medical studies. Both positive and negative cases can help encourage researchers of the role of ethics in conducting studies in any number of con-texts. Our own experience is that, in engaging PhD students early on the history of research ethics, and cases involving harms that came from unmediated human research in non-medical contexts, their awareness and concern are height-ened, and this appears to trickle-up to their laboratories and mentors. Regular engagement by ethics committee mem-bers, who should after all come from each of the research faculties in a technical university, appears to help raise awareness and increase faculty adoption of ethical research standards as well as acceptance of review practices.
Teaching research and human subject ethics as part of a university-wide curriculum may well benefit researchers both medical and non-medical. Separate courses for non-medical research seem appropriate given that non-medical researchers will not be engaging in invasive surgeries, medical trials, drugs studies, and the like. Moreover, cases and concerns drawn from technical and design studies familiar to research-ers will prove both more interesting and relevant to their own research, and thus, more likely to engage their interest and notice as they consider the conduct of their own studies.
Acknowledgments
Many thanks to Hendrik vom Lehn, our assistant for the commit-tee, who helped create the table by researching the existence of ethics committees at top technical universities.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
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David Koepsell is an associate professor of philosophy in the Values and Technology section of the Faculty of Technology, Policy, and Management at the Delft University of Technology, the Netherlands. His research focuses on technical artifacts, socio-technical systems, ethics and technology, and research ethics. He also chairs the Human Research Ethics Committee (HREC) at Delft. He drafted the primary text.
Willem-Paul Brinkman is an assistant professor at Delft University of Technology in the Netherlands, working in the Interactive Intelligence group. His research focuses on human– computer interaction, specifically on behavioral change systems. He is a member and vice chair of the Delft HREC. He contributed in the writing and reviewing of this article.
Sylvia Pont is an associate professor at Delft University of Technology in the Netherlands working in the Perceptual Intelligence lab, Industrial Design. Her research focuses on design, perception and physics of light, materials, and shape, including their interactions. She also is a member of the HREC of TU Delft and contributed in the writing of this article on the basis of her experiences in that committee.
