1. “In research involving human participants as trial subjects or tissue
donors, the wishes and wellbeing of the human participants should always
be paramount.”
Why do we need human participants?
Medical research is a required necessity to further scientific knowledge and to gain better
understanding of new treatments, preventative measures, drugs actions, pain management and
disease knowledge.
Unfortunately sometimes in the process of bettering our understanding, human research is often an
undesirable but required necessity. Strict guidelines that cover the ethics and human rights of
participants have been in place for many years to protect not only the people taking part but the
researchers too. Following World War Two and the many atrocities carried out during the Holocaust
involving human experimentation, the Declaration of Helsinki was adopted by the World Health
Authority in June 1964. It was designed as a set of guidelines for physicians worldwide regarding the
involvement of human subjects in scientific research. It was aimed to protect the welfare, privacy,
dignity and personal autonomy of the participant and their choice to participate or withdraw from the
research at any time (Woods and McCormack, 2013). Within these guidelines, the declaration details
reasons for carrying out research and why it may be necessary. For example if the objective of the
research has more weighting than any risks associated with it or if it could have serious benefits to
prevent loss of life or suffering in the future, this is deemed to be a good reason for proceeding with
research involving human participants. Equally if risks are found to be too high, the physician must
make the decision whether it is suitable to continue and if necessary forfeit the research for the benefit
of the participants (WHA, 2013).
Vulnerability
Some have deemed these guidelines altogether too restricting, outdated and paternalistic, even
though they have been revised several times, the latest revision being in 2000. It is even suggested
that they presume vulnerability of the research subject, with researchers having the potential to use
exploitative measures to further knowledge in the name of science (Woods and McCormack, 2013).
Whether guidelines are deemed too restricting or not, they are a definitive necessity for the wellbeing
and wishes of the human participant. Without guidelines subjects deemed vulnerable or those unable
to make decisions for themselves or people unaware and uneducated in the research they are taking
part in, would become at risk of being exploited for medical research. Vulnerability can stretch to many
different groups of people including, the mentally ill, children and elderly, but what if the research
being proposed could benefit many others?

2. In a study published in the British Medical Journal in 1998, a study was conducted on babies to
discover the effects of exposure to 15% oxygen on breathing patterns. The hypothesis for the
research originated following several incidents of Sudden Infant Death Syndrome (SIDS), which had
occurred following travel on intercontinental flights. Normal oxygen levels within air are around 21%
however, within an aeroplane cabin, “The partial pressure of inspired oxygen…is only 110 to 130 mm
Hg; this corresponds to a fraction of inspired oxygen of 0.15 to 0.17 at sea level” (Cottrell, 1988). It
was felt research using 34 infants (13 of which has siblings who had died of SIDS) would be beneficial
(Parkins et al., 1998). But how can an infant make a conscious decision to take part in such a
research study? It is obviously the decision of the parent to put forward their child to take part; but can
this really be justified as being ethical? The authors of the SIDS study answered criticism to the ethical
implications, by explaining their study was no more harmful to the child than taking them on a
commercial flight. However, this study purposely exposed the infants to a known possible danger in
the interests of research and not necessity to their own wellbeing (Leavitt, 2006).
Within the Declaration of Helsinki, it states that any vulnerable group “should stand to benefit from the
knowledge, practises or interventions that result from the research” (WHA, 2013), but how can the
infants within the Cottrell study benefit from a study about a disease process that may or may not
happen to them and which could expose them to danger? It could be argued that if the infants were
suffering from a disease and the research carried out could offer up potential curative benefits, that
this is a good enough reason to conduct it.
Children are not the only ones in danger of vulnerability, other groups such as the mentally ill, elderly
or uneducated can all be in danger of becoming involved in something they either do not fully
understand or are not in position to make a decision about.
Research into neurodegenerative and mental disorders is particularly challenging when it comes to
consent. In the case of progressive disorders such as dementia, medical practitioners make use of
advanced directives; legal documentation drawn up whilst the disease is in its early stages and the
person suffering from it can make an informed decision regarding taking part in medical research. But
what about mental disorders such as schizophrenia and depression which do not necessarily have a
steady disease progression? Patient’s suffering from these disorders may never be considered to be
in a state of competence to consent, especially is the risks outweigh any benefits to them as an
individual (Helmchen, 2012).
Do the dead have a say?
Vulnerability can clearly be seen in people who are alive but what about people who have died? A
change to UK legislation in 2004 was enforced, following inquiries at The Alder Hey Hospital and
Bristol Royal Infirmary, which found they had been retaining tissue without consent (Parker, 2011).
This scandal caused public outcry and resulted in a divide between the medical community the

3. general public (Plomer, 2005). But how does a medical practitioner class a piece of tissue and when
does consent need to be established? It is understandable when the tissue in question is of a sensitive
nature such as the brain or the heart, but what about pathological samples? Research on these
samples could be of great benefit to the general public’s health and the requirement of consent a
detail that hampers this. However beneficial the proposed medical research is, consent is still an
essential requirement in safeguarding human tissue samples after death and ensuring the continued
confidence of the general public in medical research.
Conclusion
When embarking upon medical research, it must be established, whether the use of human subjects
will give rise to benefits. All other avenues to the research must have been explored and the only way
to progress is with the use of human participants.
Establishing consent and guidelines to safeguard participants is essential, not only for the welfare of
the participants but also in ensuring that public confidence in the medical community is maintained so
that research of this nature can continue.

4. Reference List
COTTRELL, J. J. 1988. Altitude exposures during aircraft flight - flying higher. Chest, 93, 81-84.
HELMCHEN, H. 2012. Ethics of clinical research with mentally ill persons. European Archives of
Psychiatry and Clinical Neuroscience, 262, 441-452.
LEAVITT, F. J. 2006. Is any medical research population not vulnerable? Cambridge Quarterly of
Healthcare Ethics, 15, 81-88.
PARKER,L. 2011. Usinghumantissue:when do we need consent? Journal of Medical Ethics, 37, 759-
761.
PARKINS, K. J., POETS, C. F., O'BRIEN, L. M., STEBBENS, V. A. & SOUTHALL, D. P. 1998. Effect of
exposure to 15% oxygen on breathing patterns and oxygen saturation in infants:
interventional study. British Medical Journal, 316, 887-891.
PLOMER, A. 2005. The law and ethics of medical research : international bioethics & human rights,
London, Cavendish.
WHA 2013. WHA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human
Subjects. In: AUTHORITY, W. H. (ed.). France.
WOODS, S. & MCCORMACK, P. 2013. Disputing the ethics of research: the challenge from bioethics
and patient activism to the interpretation of the declaration of helsinki in clinical trials.
Bioethics, 27, 243-250.