What can Bioethics do for you?Ester Moya. Human Biologist

Human research is conducted by using tissue data or directparticipation of volunteers. This practice seeks to obtainadvances by the conclusions resulting from the study to seekthe common good. Since there may be other outside interestscapable of compromising the security, the respect and theintegrity of people; throughout history they have been createddifferent codes and laws to regulate the ethical aspects ofresearch in humans.

Bioethical foundations

The first international document that advocated for voluntaryparticipation and informed consent was the Nuremberg Code. Thiscode was established in 1948 after several trials carried out by someNazi investigators who were suited for war crimes and crimes againsthumanity. These scientists conducted experiments that causeddeath or serious long term physical damage in thousands ofprisoners of the concentration camps.

In 1964 the World Medical Association laid the foundations ofinternational human experimentation by the Declaration ofHelsinki, which has been updated several times (1975, 1983, 1989and 1996). This document provides that research studies withhumans: must be based on previous studies performed on animals,must be carried out by qualified personnel, their benefits mustexceed their risks, must provide the information of realize consentto the volunteers of the study, procedure guidelines must be checkedby an external bioethical committee.

Historical perspective

· Nuremberg Code

· Declaration of Helsinki

In 1979 the Belmont Study was formulated. This documentsummarizes the 4 basic principles that should underpinany study in humans. The ethical principles are:

-Respect for the autonomy of the participants and theprotection of non-competent people (infants, people withmental problems...)

- Beneficence (benefits must outweigh risks and theresearcher must always seek the best for the patient)

- Non-maleficence (the research must seek the leastsuffering for the patient or volunteer)

- Justice (participants must be chosen equitably andbenefits and risks should be distributed in a balanced way.For example: If a drug trial is performed in anunderdeveloped community, this community should haveaccess to the drug in the future)

· Belmont Study

The principle of autonomy implemented through informedconsent should contemplate: explaining objectively of therisks and benefits of the study, explaining this informationin an understandable way and getting the final voluntaryparticipation of the person. However, sometimes theconflict of violating this this principle on the pretext thatthe results could benefit thousands of people arises.

An example of the contrast of different principles can beillustrated through the case of HeLa cells. These areimmortalized cells which have a worldwide use forresearch. They were drawn from the African-Americanpatient Henrietta Lacks while she was due to receive atreatment for her ovarian cancer in the departmentintended to segregation in John Hopkins Hospital in 1951.Herietta did not received informed consent for thewithdrawal and posterior use of her cells; however, theyhave been used for the development of in vitrofertilization, vaccines against polio, cancer drugs, cloningtechniques...

HeLa Cells: Contrast between principles

Her family knew of the existence of such cells 20 years afterHerietta´s death. Her genome was sequenced and the patient´s genetic code and family information was publishedaffecting the privacy of her descendants. Her family has beenharassed for years by the scientific community. In addition,they can suffer from social and job stigmatization. Thisgenetic information can be used to know whether the person(and also her descendats) has a predisposition of sufferingdifferent pathologies: of having cancer, be addicted to certaindrugs, suffering from premature heart disease ... If she wouldhave been informed properly about the use of her cells, shecould have had the free election of proudly accept servinghumanity without a withdrawal of her rigths.

Despite progress achieved obviating her informed consentand having an accepted of use of the cells by the scientificcommunity regardless of bioethical guidelines, we must askourselves:

Would we like to get up one day and see our data publishedin scientific journals around the world without ourapproval?

World Health Organization. Geneva: WHO Document Production Services;2009. Research ethics committees: Basic concepts for capacity building.

Nanivadekar AS. Ethics of clinical research. Indian J Pharmacol.2004;36:275–6

Jharna Mandal, Ajay Halder,1 and Subhash Chandra Parija. Ethics and clinicalresearch. Trop Parasitol. 2011 Jul-Dec; 1(2): 54–56.

Jharna Mandal, Srinivas Acharya, and Subhash Chandra Parija. Ethics inhuman research. Trop Parasitol. 2011 Jan-Jun; 1(1): 2–3.

Laura Ciaccia. The Immortal Life of Henrietta Lacks. Yale J Biol Med. 2010Sep; 83(3): 165

Bioethics Research Library at Georgetown University [Web Page]*.Washington D.C. [1st of March, 2016]. Human Research Ethics [3 pages].https://bioethics.georgetown.edu/explore-bioethics/human-research-ethics/

Bibliography

https://es.linkedin.com/in/ester-moya-boix-06396796

Ester Moya