Season 3, Episode 3: Strangers in the Night
Believing they may have stumbled onto a cure for the “Sinatra” virus, David and Carlos give a dying patient an experimental treatment – interferon. Meanwhile, Owen is having a very tough time coping with life in juvenile detention. Seeing an opportunity to get out of his terrible situation, he plans to accept an invitation to become a research subject in a scientist’s experimental attempt to cure addiction…
Research with Human Subjects
There seems to be a lot of human experimentation going on in ReGenesis so far this season. Last episode, we saw David experimenting on himself when he injected the nano-predator virus into his gut and now, in this episode, we see one experiment tried on a dying patient and another being considered.
The purpose of clinical research - the testing of new treatments and procedures in people - is to develop generalizable knowledge to improve health through increased understanding of human biology and disease. That sounds a lot like the purpose of laboratory-based biomedical research, doesn't it? It's not a coincidence - they are part of the same "bench to bedside" continuum, though there are some very important steps that must be taken to get from the lab into the clinic.
Scientists develop and test promising new treatments extensively in their labs, on cells and tissues in culture and in "model organisms" like mice and rats. If these "pre-clinical" lab results are promising, an experimental treatment may then be tested in people in a clinical trial.
In the case of David's self-injection and the administration of interferon to the dying patient, there wasn't enough time to do experiments in mice - the NorBAC team was desperate! But should desperate times call for desperate measures? In the 1996 film, Extreme Measures, Gene Hackman's character asked: "If you could cure cancer by killing one person, wouldn't you have to do that?" Where do we draw the line?
There are innumerable types of illness, infirmity and disease, and for each one there are people who are eager - or even desperate - for an effective treatment or cure. However, new treatments must first be tested in people, and that testing should be done correctly and ethically regardless of how badly those treatments are wanted.
What does it mean to do clinical research ethically? Basically, it all comes down respecting the rights and the dignity of the people who volunteer to be research subjects. People are not lab rats. Unfortunately, history has witnessed numerous situations in which people were treated as such, if not much worse; the painful and often fatal experiments performed by Nazi doctors and scientists on prisoners of war during World War II are among the most infamous of these.
The Nazi experiments, along with other very troubling examples of unethical research - including several in North America in the late twentieth century - led to the development of guidelines that, to this day, help ensure the ethical conduct of clinical research.
Guidelines for Ethical Research Involving Humans
The first set of guidelines for ethical research involving human subjects was the Nuremburg Code, named for the German city in which the Nazi doctors were put on trial in 1946 and '47 for their actions during the war. The Nuremburg Code states that there are certain things that are absolutely necessary for clinical research to be ethical, the first and arguably most important of which is that research subjects must know what the research involves and must give permission - or "consent" - to participate.
In some cases, if a person can't give consent for him or herself, a family member may provide consent for them. We saw an example of this in this episode, when the doctor agreed to try giving interferon to an unconscious patient, but only if he could "get the family to okay it."
Other guidelines followed not long after the Nuremburg Code, including the World Medical Association's Declaration of Helsinki, the US Belmont Report, and the Canadian Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS). While each is unique, they all outline what makes ethical research ethical.
In TCPS, the guiding principles are respect for human dignity, free and informed consent, vulnerable persons, privacy and confidentiality, and justice and inclusiveness, as well as the need to consider foreseeable harms and benefits.
With these in mind, let's take a quick look at Owen's situation. Owen is hoping for a cure, but should take into account that the proposed treatment is still experimental. It may not work, and as David says, it could be dangerous. The researcher should make this clear to Owen. To do otherwise - to promise a cure, for example - would be unethical.
Also, the researcher must consider the fact that Owen is a "vulnerable person." Because he's locked up, there is an increased likelihood that a researcher could coerce or manipulate him into taking part in a study. We don't see any evidence that the researcher in this case is pressuring Owen, but we can't overlook the fact that Owen is desperate to get out of juvenile detention and, according to him, "if I volunteer to be a test subject, then I have a shot at getting out of here." Being as desperate as he is, will he really be able to consider the risks of getting involved, or might his judgment be clouded by thoughts of being released? Again, we ask: should desperate times call for desperate measures?
Researchers and groups that oversee clinical research, namely Research Ethics Boards (REBs) in Canada or Institutional Review Boards (IRBs) in the US, must weigh these and other considerations in deciding whether research can proceed in an ethical manner.
Without clinical research, there would be no new drugs or treatments; but without ethical clinical research, those same new drugs and treatments would come at far too great a cost.
More food for thought
Q: How do the various guidelines listed above, such as the Nuremburg Code or TCPS, differ from one another? Are the differences significant?
Q: In the context of clinical research, what other people or groups of people might be considered “vulnerable”?
Q: Are there people or groups of people who generally should be excluded from participating in clinical research? Why or why not?
Want to read and learn more?
Here are some key sources of guidance on ethical conduct in research involving human subjects:
Nuremburg Code –
http://www.hhs.gov/ohrp/references/nurcode.htm
Declaration of Helsinki –
http://www.wma.net/e/policy/b3.htm
Belmont Report –
http://ohsr.od.nih.gov/guidelines/belmont.html
Tri-Council Policy Statement (Canada) –
http://www.pre.ethics.gc.ca/english/policystatement/policystatement.cfm
