Ever wondered how it would be if a part of you actually continue to live forever? Would you be comfortable with that and would you want to exercise some form of control over it still? Or how it would affect your loved ones left behind? Henrietta Lacks never dreamt of immortality or even thought that it was possible, but is her cells, that are still alive today almost 70 years after her death, still causing lively legal and ethical debates around the world.
Human bio-specimens have played a critical role in scientific and medical research. It has provided insight into the workings of human biology, lead to targeted approaches to detect and treat health conditions and how to reduce the risk of future disease. In recent decades it has also given momentum to precision medicine and the development of innovative treatment methods. The application areas are almost limitless and is it easy to see the eventual benefits for greater society.
However, the collection, storage, use and sharing of bio-specimens have raised serious concerns about informed consent, oversight, large-scale data sharing, privacy, confidentiality and commercialisation of research results, amongst others. Legal and ethical debates about all of the mentioned issues will probably continue for ever, but has the story of Henrietta Lacks and the medical profession’s failure to obtain consent struck a nerve with academics, legal and medical professionals and the general population alike.
Henrietta Lacks, an African-American women, coming from a poor tobacco farming community, was diagnosed with a particularly aggressive form of cervical cancer at Johns Hopkins Hospital in 1951. During her diagnosis and treatment tissue samples were given to a researcher without her knowledge or consent. At that time researchers have long endeavoured to grow human cells outside the body to enable further research on cells, but without success. It soon became clear that Henrietta’s cancer cells, labelled as “HeLa”, being the first two letters of her name and surname, were capable of not only surviving outside her body, but were profusely dividing in culture indefinitely! This was a major scientific breakthrough and did Dr George Gey shared his breakthrough by giving numerous vials of cells away. Since then HeLa cells have been lucratively commercialised on large scale.
It was only in 1973, two years after Henrietta’s real name was published as the source of the HeLa cells in a scientific journal that her family learnt about the HeLa cells. Notwithstanding the dismay of the Lacks family of not being acknowledged in the development of the immortal cell line and without consultation or notification, scientists from the European Molecular Biology Laboratory in Heidelberg, Germany published the entire genomic sequence of the HeLa cell line in March 2013 in an on-line open access database. This caused an uproar and over the following four months the National Institutes of Health (NIH), with the assistance of Rebecca Skloot, the writer who persevered for 10 years with the Lacks family to eventually win their trust and published the HeLa story as “The Immortal Life of Henrietta Lacks”, the Lacks family was engaged in extensive discussions. A solution was found that culminated in a consent agreement setting forth how genome sequence data from HeLa cell lines may be published and shared for additional research. A HeLa Genome Data Access Working Group was created to serve as watchdog to consider applications for access to and the use of the HeLa sequence, always on condition that the necessary acknowledgement be given to Henrietta Lacks and her family.
It must, however, be borne in mind that at the time when Henrietta’s tissue samples were collected, there was absolutely no laws or regulations available for biomedical research. The collection, use and sharing of her tissue sample and cells have thus been completely legal. The Nuremberg Code, laying down principles for medical research to be conducted on human participants, resulting from the Nuremberg Military Tribunal hearings in United States v Brandt in 1947, formalised consent but did not touch on biomedical research. Henrietta’s story clearly demonstrates the difference between law (researchers having legally obtained her tissue samples) and ethics (her human dignity and respect being disregarded with respect being the foundation of informed consent). The same action can thus be legal, but ethically unacceptable. A law can thus be unethical. Numerous examples of laws disregarding ethics can be found in history, both locally and internationally. In an age where scientific development progresses so much faster than any law can ever keep up, bioethics (and industry self-regulation) becomes increasingly important.
Informed consent is described as the process of enabling individuals to make voluntary decisions about participating in research with an understanding of the purpose, procedures, risks, benefits and alternatives. Informed consent is established on the premises of well-established ethical principles which include respect for persons, beneficence and justice. Following from this, the key aspects of informed consent entails the provision of information about the research that a reasonable person would want to know, in a manner and language understandable to that person and under conditions that are free from coercion or undue influence. Informed consent could easily have been obtained from Henrietta – if it was the norm of the day. Although not legally required, ethical principles should be ingrained and considered during the delivery of all professional services.
In South Africa individuals’ rights to bodily integrity are constitutionally protected as section 12(2)(c) of our Constitution requires informed consent from any individual who is subjected to medical or scientific experiments. Section 71 of the National Health Act 61 of 2003 specifically prohibits any research or experimentation on a living person without such a person’s written informed consent, after being adequately informed of the positive or negative consequences of the proposed research to his or her health. Unfortunately the only definition of informed consent in the National Health Act is found is section 7(3) according to which it means “… consent for the provision of a specified health service given by a person with legal capacity to do so and who has been informed as contemplated in section 6.” Section 6(1) then sets out the nature and scope of the information that should be disclosed to a patient. In May 2008 the Health Profession Council of South Africa (HPCSA) issued general ethical guidelines for health researchers to serve as reference for research institutions, organisations and researchers registered with the HPCSA who are involved in biomedical or scientific research. Guideline 6.3 thereof specifically deals in detail with the researcher’s responsibilities in respect of obtaining informed consent from participants. It states that researchers must provide information to participants “…in a language that the participant understands and in a manner that takes into account the participant’s level of literacy, understanding, values and personal belief systems.” And in 2006 the South African Department of Health also issued guidelines for good practice in the conduct of clinical trials with human participants in South Africa, which purpose is to provide South Africa with clear standards of clinical practice in research in accordance with sound scientific and ethical standards.
If Henrietta has been diagnosed and treated today in South Africa, and if researchers were still interested in her tissue samples for research purposes her informed consent would be required … whether she would truly understand the research risks, goals and aims is yet another ethical debate.
Today we have numerous pieces of legislation, regulations, guidelines and policies that require and regulate the actual content of informed consent to protect research participants. But as so often happen, legislation is a mere symptom or consequence of a disease and in the fast developing world of biomedical research adequate legal regulation almost always comes after the fact. It took a brave writer, Rebecca Skloot, to tell the story of Henrietta Lacks. A story that served as the catalyst for policy change. Laws may not always exist to protect the vulnerable, but bioethics have been around for as long as there has been life and should serve as a guide in the absence of law.
By Marietjie Botes