Ethics Institute

Research Ethics
Ethical Reflection on Human Subjects Research
The Ethics Institute, Utrecht University and Julius Center of the UMC Utrecht jointly
offer an advanced course in research ethics, for students and professionals of various
backgrounds.

Research in medicine, nutrition and in social sciences is widely recognized as important and
valuable. The outcomes of it might ultimately improve the health and wellbeing of present and
future persons. In medicine, nutrition science and clinical psychology it is often necessary to
study the effects of new interventions in human beings. At the same time, it is not self-evident
that human beings participate. Burdens and risks of research are for the participants,
whereas the potential benefits of research are primarily for others. How can we morally justify
the use of human beings for research purposes? In research ethics, we systematically reflect
on this question.

Historically, scandals and controversial cases have created a need for research ethics.
Notorious scandals are the atrocities of the Nazi doctors during the Second World War and
the Tuskegee syphilis study in the USA (1932-1972). Scandals keep coming to light.
Research ethics is however more than pointing at scandals and controversial cases.

Research ethics does also not coincide with mere application of moral principles of ethical
guidelines to research projects. Many requirements for human subjects research like
informed consent, a favourable risk-benefit balance and scientific validity of a study are
incorporated in guidelines, like the Nuremberg Code (1949), the Belmont Report (1979) and
the Declaration of Helsinki (2008). The guidelines are however often problematic. They are
for instance not exhaustive and are frequently contradictory in detail. Rather, the guidelines
are a starting point for reflection on the moral justification of using human beings for research
purposes.

Course description
In this course participants from different backgrounds jointly study issues in research ethics.
Master students in applied ethics, researchers, members of Research Ethics Committees,
and research master and PhD students in biomedical sciences or social sciences jointly
reflect on moral problems in research with human subjects. Although the focus will be on
medical and epidemiological studies, the course will be relevant to persons working in social
sciences as well. The idea is to exploit the different backgrounds of participants in such a way
that each participant also contributes to the learning process of co-participants. The objective
is to explore and clarify basic ethical problems in research; hence the course goes well
beyond applying and interpreting ethical and legal regulations. In every meeting theoretical
aspects will be applied to two or three specific cases. Participants may bring in their own
cases. Participants will receive a syllabus with readings prior to the course.

Course objectives
Upon completion of this course,
 participants are capable to discern the morally salient dimensions of a research project,
and to come to a well-considered judgment about the acceptability of such a project
 if applicable, participants can rewrite their research protocol (including informed consent
sheets) in such a way that criticism from a research ethics committee can be minimized
 participants are capable to reflect on moral dilemmas for researchers (or research ethics
committees) and systematically analyse such dilemmas, which involves
o applying knowledge of ethical debates in research ethics, and critically reviewing
arguments in these debates, and
o arguing for a specific moral points of view
 Participants can discuss on which learning outcomes they want to focus in particular.
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Location
De Uithof, Utrecht

Eligibility
Entry requirement: any relevant undergraduate degree or equivalent (Medicine, Law, Social
Sciences, Theology, Philosophy/Ethics, etc.). PhD students in biomedical and social sciences
and members of Research Ethics Committees are specifically invited to participate.
Participants should be able to follow this course without a background in Philosophy or
Ethics. Participants can negotiate with the course coordinators to follow only parts of the
program, in relation to their self-chosen learning outcomes.

Credits
After successful completion of the course,
- master students receive 7,5 ECTS
- researchers and REC members receive a certificate
- Accreditation for physicians has been requested at ABAN

Assignments
Participants are expected to prepare each session by reading the relevant literature (reader).
Assessment will be based upon active participation (including at least one presentation) and a
case discussion that is written jointly by two participants.

Course fee and application

All eligible master students can do the course as part of their master's program. Participation
costs for PhD students, researchers and Research Ethics Committee members are € 350
(reader not included). NOTE: this is a pilot for a course we intend to offer on a yearly
basis. For that reason, the participation costs this year will be very low. Please apply
before April 1st! The maximum number of participants is 25.

Initial application and more information about practical matters

Ethics Institute; Judith Zijm and/or Suzanne van Vliet; 030-2534399; info@ethics.uu.nl

Lecturers
Prof Dr. JJM van Delden, Dr. M Verweij, Dr. R van der Graaf, Dr. GJMW van Thiel, Dr.
Bredenoord and others.

Preliminary program

Tuesdays 17.15h -21.00h with a break for dinner (at own cost)

1. April 26, 2010: Why research ethics?

Which historical scandals and controversial cases have led to the practice of ethically
reflecting on human subjects research? What are basic ethical requirements for human
subjects research? Which main ethical codes, guidelines and declarations do apply to human
subjects research? What is the importance and necessity of medical research?

2. May 3, 2010: Philosophical reflection on human subjects research

What do we owe to research subjects? Is there a duty to participate in medical research?
Questioning “Helsinki 6”: must well-being of individuals always take precedence over all other
interests?

3. May 10, 2010: Informed consent

What do participants need to understand in order to participate in medical research? What is
the therapeutic misconception (in particular with regard to phase I research)? Is it acceptable
to pay human beings to participate in research? When do we speak of undue inducements?
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4. May 17, 2010: Risk-benefit analysis

How do we have to weigh risks and burdens of research to the benefit for science and
society? Is it useful to distinguish between therapeutic and non-therapeutic research?

5. May 24, 2010: Ethical issues in randomized controlled trials

Is clinical equipoise a necessary and sufficient requirement for RCTs? What do we owe to
control groups in an RCT? When is it allowed to use placebo as a comparator? Are RCTs
also ethically the ‘gold standard’ for clinical research, when do we have to consider
alternatives to the RCT design? What is the dual role dilemma and to what extent can it be
solved?

6. May 31, 2010: Scientific integrity

What are the rights and duties of clinical investigators? How to manage conflicts of interest in
clinical research? What are important codes of conduct?

7. June 7, 2010: Vulnerable groups

What are the ethical issues in international research in developing countries? When can we
say that a research project is responsive to the health needs of a host community? What
does it mean not to exploit participants? Do we have to provide research participants with
ancillary care? How can the burdens and benefits be equally distributed on research
populations? Should children and women in research be included or excluded? Which notions
of justice do play a role with regard to vulnerable groups?

8. June 14, 2010: Biobanks, bodily material and further use

What ethical issues play a role in biobanking, genetics/genomics research, and in the use of
stored tissue and genetic data? Can bodily tissue be owned by donors? How do we have to
deal with unexpected (medical, psychological) findings?