Rom J Morphol Embryol 2014, 55(2 Suppl):719–722

RJME
BIOMEDICAL RESEARCH ETHICS Romanian Journal of
Morphology & Embryology
http://www.rjme.ro/

Biomedical research – opportunities and ethical challenges

LILIANA ROGOZEA, DANIEL PURCARU, FLORIN LEAŞU, CODRUŢA NEMET

Department of Basic, Preventive and Clinical Sciences, “Transilvania” University of Brasov, Romania

Abstract
Purpose: The principal purpose of this paper is to analyze the main opportunities and challenges in biomedical research, thus contributing
to improving compliance with ethical norms within the context of continuously expanding research, such as to ensure better quality of
patient care and reduce the risk of research not observing the totality of patient rights. Background: Since antiquity finding ways to give
care to people has represented not only an opportunity, but also a challenge materialized in experimenting and self-experimenting – a
constant part of caregivers’ activity. Medical research, whether fundamental or applied, is not only essential to evolution in medicine, but
also the way towards increasing the quality of individual lives. Content: The article undertakes to analyze the main ethical norms governing
medical research, starting from historical experience and literature search. Discussion: The growing number of people engaged in medical
research over the last years has turned bioethics into an increasingly applicative science, capable of developing practical standards to
ensure the moral advancement of the medical profession. Conclusions: The bioethics of the last years has been more and more tied to the
reality of medical practice, as well as to that of scientific research, contributing increasingly to the integration of moral elements into
medical activity and to the development of research in interdisciplinary bioethics. Bioethics and more so bioethical education need to be
correlated with the transition from research itself for the purpose of publishing and career advancement to research based on altruism and
the desire to contribute to the wellbeing of patients.
Keywords: bioethics, medical research, ethical norms.

 Introduction desire to obtain results as any cost and under any

circumstances have yielded the need to define universally
Biomedical research unfolds in an area where progress valid moral values.
is not a purpose in itself, in a field where the individual Recently the field of bioethics has evolved due to the
and not the community as an abstract concept is of necessity of establishing a balance between the rights of
importance. For this reason, even if enthusiasm and the individual and those of the community within the
ambition could determine researchers to become less context of globalization. Bioethics has become increasingly
careful about their behavior towards their fellow human a modality of improving the ways humanity seeks solutions
beings, the development over time of clear ethical to the global health issues [1].
rules has prevented scientists from turning into research The current evolution of bioethics is tied to the
machines that neglect the main purpose of medical emergence and growth of a body of experts in the field,
research, which is ensuring optimum care conditions for whose development is related to the standards that need
each individual. to underlie medical ethics and mostly to the moral values
Bioethics, although appearing to be a relatively new that need to be the milestones of our entire life (Figure 1).
science, that over the last decades was structured on the
fundamentals of scientific research in the filed [1], is
 Bioethical aspects in interdisciplinary
based in reality on concepts defined as early as the
research
age of Hippocrates [2]. The increasingly acute need for
knowledge in health care, for producing new drugs, the Documents like the Magna Charta Libertatum, the
development of new surgical techniques, as well as the Habeas Corpus Act, the Universal Declaration of Human
appearance of new diseases determined bio-ethics to Rights and other relevant documents of the European
move towards the central concern of those involved in Commission do nothing but regulate the moral dimension
both fundamental and applicative medical research [3], of medical ethics, as formulated over the centuries by
thus rendering bioethics an integral part of day-to-day personalities like René Descartes, Hans Selye, Jeremy
activity. Bentham, Tom Beauchamp or James Childress [6]. After
Warren Thomas Reich, editor-in-chief of the World War II and more so after the unfolding of certain
“Encyclopaedia of Bioethics” defined bioethics as “the abusive research the acute need arose for regulations,
systematic study of the moral dimensions – including for moral barriers and even organizations, bodies to
moral vision, decisions, conduct, and policies – of the ensure compliance with ethical standards, particularly in
life sciences and health care, employing a variety of the case of interdisciplinary research [7, 8].
ethical methodologies in an interdisciplinary setting” [4]. In the last years, medical scientific research has
As Selye [5] pointed out, researchers are concerned become increasingly interdisciplinary, and the interest in
about the impact of their activity from the ethics point medical bioresearch has remained no longer an attribute
of view, as the constant struggle for visibility and the of physicians, but has included biologists, sociologists,

ISSN (print) 1220–0522 ISSN (on-line) 2066–8279

720 Liliana Rogozea et al.
psychologists, anthropologists and even engineers. The increasing patient lifespan and quality of life, but also to
area of research has expanded from producing new drugs the raising of new ethics issues.
to the development of new materials used for medical Ethical codes need to be further adapted such as to
equipment, the design of new laboratory tests, the regulate fields like human genetics, cloning, transplant
development of medical software applicable in current or assisted reproduction, ensuring protection to any
practice and research. The emergence of nanomaterials and individual from unjustified risks and the strong interests
nanotechnologies, the inclusion of artificial intelligence prevailing in the commercial area [7].
and robots into medical practice has led not only to

Figure 1 – Medical ethics and research: standards and expertise.

 Conflict of interest, inadequate conduct informed consent is “a consent based on autonomy,

and informed consent authorizing in an individual way a medical intervention
or involvement in a particular research, being the one that
As Lemmens and Singer mention: “A conflict of must be legally obtained in institutions, as social rule…”
interest occurs in a situation in which professional [11–13].
judgment regarding a primary interest, such as research, Electronic informed consent has the advantage of
education or patient care, may be unduly influenced by ensuring access to information over the entire span of
a secondary interest, such as financial gain or personal the study.
prestige. Conflicts of interest exist in every walk of life, Securing the agreement of the ethics commission for
including medicine and science” [9]. the modality of obtaining informed consent and the design
Revealing possible sources of conflict of interest is of the study remains one of the principal ways to avoid
not only proof of correctness in scientific research, but the conducting of abusive studies or of studies entailing a
also an element of reassurance related to the thoroughness clear unbalance of the benefits – adverse effects relation.
of the conducted research and proving the researcher’s
awareness of the need to separate financial benefit from
 Confidentiality – a fundamental right
the involved financial resources.
and at the same time an obligation of
A conflict of interest exists only when values like
honesty, objectivity, altruism or social benefit are not researchers
assumed by the researchers, and thus financial resources Access during research to individual personal data
made available by companies or individuals can influence needs to be limited such as to ensure confidentiality and
research and the way results are presented [4, 10]. the individual’s right to privacy. International legislation
In order to ensure that ethically adequate research is provides clear rules prohibiting including of identification
conducted, each involved person needs to express their data (name, telephone number, address, photographs
informed consent, even though this sometimes may revealing facial traits, etc.) in studies [7].
prove difficult to obtain [7]. While patients believe that their personal identification
Informed consent obtained prior to initiating any data are made anonymous within the study, in reality
study needs to be followed – over the entire duration of their personal information reaches a much larger number
that study – by assurance that all new information will of people, beyond their physician.
be made available to the person involved in the study, as Because of the risk of such information reaching also
well as by the possibility of this person to resume the other persons, many data concerning the person involved
initially received information. in the study need to be removed: personal numerical
The development of alternative mechanisms like the codes, names, addresses, telephone numbers and e-mail
electronic informed consent can facilitate the under- addresses. Such data have to be stored securely, and if
standing process of the benefits and disadvantages brought transmitted electronically a secured medium needs to be
about by the participation in medical research, as the provided [14].
 Biomedical research – opportunities and ethical challenges 721
Conscious of the necessity of ensuring the balance research-development staff, elaborated by the national
of the individual’s right to confidentiality and the authority for research-development” [22].
possibility of using information for the greater good of Indirect regulations concerning medical research can
communities’ health, those responsible for ethics need be found also in the Civil Code that provides: “The interest
to ensure an optimum climate so that research provides and wellbeing of humans need to prevail over the sole
a balance of the two research directions that sometimes interest of society or of science” [23].
can be antagonistic [15]. Even though it is still early days for differentiated
analysis systems of various types of scientific medical
 From theoretical to applicative ethics in research, and the number of specialists in this area is
scientific research small. Clinical experience needs to be completed by
theoretical one, and the arrival of ethics advisers available
While for a very long time medical ethics had been
to both researchers and patients can represent an efficient
considered a theoretical discipline, it subsequently proved
solution for supporting those engaged in scientific research.
to be an interdisciplinary research area itself, due to
technical progress and medicine including elements of Romania, like other countries too, undergoes a dynamic
robotics, artificial intelligence or nanotechnologies, as process of developing and strengthening structures that
well as to the use of classic research methods in bio- ensure the training of specialists in ethics, as well as the
medicine involving test animals or clinical trials [6, 16]. development of research complying not only with the
The main European and worldwide regulations legislation in force but also with the moral norms that
consequent to an analysis of bioethical situations are govern our life.
provided by documents like the declarations of Tokyo One of the most important ethical issues of medical
(1975), of Manila (1981) or of Hawaii (1983), the Belmont research that can raise severe problems is the possibility
Report (1979), Beauchamp and Childress’ “Principles of of Romania being used as a research base for foreign
Biomedical Ethics” (1979), the Oviedo Convention on corporations or bodies undertaking to avoid the restrictions
Human Rights and Biomedicine (1997), the International imposed in their own countries.
Ethical Guidelines for Biomedical Research Involving Within this context the role of legislation, of the
Human Subjects (2002), the UNESCO Universal Decla- ethics committees and of the specialists in this field is to
ration on Bioethics and Human Rights (2005), Animals minimize unethical research, and including people of
Deserve Absolute Protection Today and Tomorrow different backgrounds (clerics, sociologists, educationists,
(ADAPTT 2012), the European Union (EU) Directive etc.) into such ethics committees can ensure the inde-
2010/63/EU on the protection of animals used for scientific pendence of these structures.
purposes (2013) and WMA Ethics Manual [17–20].
Day to day ore data are included in medical research  Conclusions
area and de-identification must be made related to
Interdisciplinary medical research has become increa-
excluding the name, address, personal images, hospital
singly complex over the last years and the number of
discharge, and postal code. De-identification is a major
researchers has grown exponentially, requiring global
strategy for respecting the privacy of the patient, but in
and overarching approaches to the concepts of bioethics.
the same time is correlated to re-identifies data only in a
The main result of the evolution of science and of
very clear defined condition.
Related with HIPPA Privacy Rule identifier list globalization was the development of medical interdis-
elaborate by Iain Hrynaszkiewicz et al., the data that ciplinary research. It is the mission of bioethics to tie
must be protected are: names, postal address (including medical research to reality, increasingly based not only on
street, zip), telephone and fax numbers, all element of dates theoretical knowledge but also on personal experience.
(except year), e-mail, social security numbers, medical In a dynamic society like the one we live in, bioethics
records numbers, account numbers, vehicle numbers, cannot be but dynamic, and its evolution requires the
biometric identifiers, full face photographic images or development of increasingly complex guides to set the
other unique identify numbers [21]. milestones for the activity of us all [24].
Research ethics is strongly connected to respecting
 Romania – bioethical and legislative rules first stated by Charles Darwin: “… My success as
aspects in medical research a scientist, no matter how great, was determined by
spiritual qualities and complex and varied conditions.
Developing individual ethical abilities is essential, Among these, the most important were the love for
considering that human nature is often contradicting, science, unmeasured patience to reflect upon a certain
altruism, generosity, humanitarianism, charity, honesty subject, diligence in observing and gathering facts as
or respect for fellow human beings alternating with well as inventiveness and common sense…” [7].
egoism, lack of empathy and self-sufficiency. Bioethics plays the role of a “guide for the dialogue
In addition to the National Ethics Committee, at between positivist science and humanities” [25], ensuring
local level, in medical units, in universities of medicine a harmonic development in the interest of each individual,
and pharmacy and in faculties of medicine there exist while favoring the evolution of scientific research.
ethics committees capable of implementing Law No. 206
of 27 May 2004 that provides: “The moral principles and References
procedures designated to respect them are those stipulated [1] Nezhmetdinova F, Global challenges and globalization of
in the Code of ethics and professional deontology of the bioethics, Croat Med J, 2013, 54(1):83–85.
722 Liliana Rogozea et al.
[2] Rogozea L, Etică şi deontologie medicală [Medical Ethics [15] Ferguson AH, The evolution of confidentiality in the United
and Deontology], Ed. Universităţii “Transilvania”, Braşov, 2006, Kingdom and the West, Am Med Assoc J Ethics, 2012, 14(9):
29–50. 738–742.
[3] Mertz M, Inthorn J, Renz G, Rothenberger LG, Salloch S, [16] Ramalli Jr EL, Ho W, Alves M, Rocha EM, Progress in animal
Schildmann J, Wöhlke S, Schicktanz S, Research across the experimentation ethics: a case study from a Brazilian medical
disciplines: a road map for quality criteria in empirical ethics school and from the international medical literature, Acta Cir
research, BMC Med Ethics, 2014, 15:17. Bras, 2012, 27(9):659–663.
[4] Reich WT, The word “bioethics”: its birth and the legacies of [17] ***, International Guidelines on Bioethics, World Health
those who shaped it, Kennedy Inst Ethics J, 1994, 4(4):319– Organization (WHO), Geneva, 1999.
335. [18] ***, International Guidelines for Biomedical Research involving
[5] Săhleanu V, Etica cercetării ştiinţifice [Ethics of Scientific Human Subjects, Council for International Organizations of
Research], Ed. Ştiinţifică, Bucureşti, 1967, 1–206. Medical Sciences, World Health Organization (WHO), Geneva,
[6] ten Have HAMJ, Lelie A, Medical ethics research between 2002.
theory and practice, Theor Med Bioeth, 1998, 19(3):263–276. [19] ***, Ethical Principles for Medical Research Involving Human
[7] Pollock K, Procedure versus process: ethical paradigms and Subjects, World Medical Association (WMA), Helsinki, Tokyo,
the conduct of qualitative research, BMC Med Ethics, 2012, Venice, Hong Kong, Somerset West, Edinburgh, 1964, 1975,
13:25. 1996, 2000.
[8] Letkiewicz S, Criterion for determining legal and ethical [20] Deckers J, The New EU Directive on the Use of Animals for
boundaries in medical research with regard to realizing the Research and the Value of Moral Consistency, Bioethical
constitutional principle of sustainable development, Problemy Inquiry, 2012, 9(4):377–379.
Ekorozwoju (Problems of Sustainable Development), 2009, [21] Lowrance WW, Privacy, confidentiality, and health research,
4(2):49–60. Series “Cambridge Bioethics and Law” (No. 20), Cambridge
[9] Lemmens T, Singer PA, Bioethics for clinicians: 17. Conflict University Press, Cambridge, 2012, 87–109.
of interest in research, education and patient care, CMAJ, [22] ***, Legea 206/27.05.2004 privind buna conduită în cercetarea
1998, 159(8):960–965. ştiinţifică, dezvoltarea tehnologică şi inovare [Law 206/27.05.
[10] Savulescu J, Douglas T, Persson I, Autonomy and the 2004 on good conduct in scientific research, technological
ethics of biological behaviour modification. In: Akabayashi A development and innovation], Monitorul Oficial nr. 505/4.06.
(ed), The future of bioethics: international dialogues, Oxford 2004.
University Press, Oxford, 2013, 91. [23] Goicovici AJ, Etica activităţilor biomedicale, în reglementarea
[11] ***, Convention for the Protection of Human Rights and noului Cod Civil [Ethics of Biomedical Activities as Regulated
Dignity of the Human Being with regard to the Application of by the New Civil Code], Revista Română de Bioetică, 2012,
Biology and Medicine: Convention on Human Rights and 10(4):58–69.
Biomedicine, Council of Europe, Oviedo, Spain, 1997. [24] ***, National Bioethics Advisory Commission – Ethical and
[12] ***, Council of Europe/Working Party on Biomedical policy issues in research involving human participants, Bull
Research (CDBI-CO-GT2). Draft Explanatory Report to the Med Ethics, September 2001, 8–11.
Draft additional Protocol to the Convention on Human [25] Gavrilovici C, Oprea L, Etica clinică, etica cercetării şi etica
Rights and Biomedicine, on Biomedical Research, CDBI, comunitară – triada morală a societăţii contemporane [Clinical
Strasbourg, 2003. Ethics, Research Ethics and Community Ethics – the Moral
[13] Arojo O, Focus: research and clinical ethics. Introduction, Triad of Contemporary Society], Revista Română de Bioetică,
Yale J Biol Med, 2013, 86(3):287–289. 2013, 11(3):3–5.
[14] Breault JL, Bioethics in practice – a quarterly column about
medical ethics: ethics of chart review research, Ochsner J,
2013, 13(4):481–482.

Corresponding author
Florin Leaşu, University Assistant, MD, PhD student, Department of Basic, Preventive and Clinical Sciences,
“Transilvania” University of Braşov, 29 Eroilor Street, 500036 Braşov, Romania; Phone/Fax +40268–410 564,
e-mail: [email protected]

Received: March 10, 2014

Accepted: July 14, 2014