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Lesson 3) Did You Forget To Take Your Meds? (Research Ethics)

I’m sure you have all noticed some of the cauldrons are looking rather overlarge today. This is due to an overzealous Fourth Year practicing Engorgement Charms in the last class. Which provides me with the perfect opportunity to warn you all that spellwork not related to potions is forbidden in my classroom and will not be tolerated. Although our lessons have been quite lengthy so far this term, I implore you to pay attention to the material and not practice spells if your mind begins to wander. I could have used the Shrinking Charm to immediately restore the tools to their proper size, but visual examples never hurt when trying to convey a point.

Moving on, we will be wrapping up our ethics discussion in our lesson today. I will give an overview of the ethical considerations involved in professional research of new potions and of general theoretical applications of potions. Of course, it is currently still legal for witches and wizards to experiment however they want on their own at home with legal ingredients, provided they cause no harm to other living creatures. However, when a researcher hopes to utilize Ministry support and funding, access to public clinical testing and formal recognition at international conferences, there are certain points that he or she must keep in mind in order to comply with current research standards. If you ever have any questions or need a refresher on the major points that the Ministry requests researchers keep in mind when researching or testing new potions, the Ministry keeps printed information on hand. While some of these points are a little less well-defined than others, if you ever find yourself involved with research and questioning whether your actions are falling within the scope of these points, immediately take a step back and reassess your methodology.

Why It Matters To Us
The first is the overall value of the research to society as a whole. What benefits does this research offer healers or magical society? While discovering something simply for the sake of knowledge (or to have one’s name attached to a discovery) may have its own appeal, it becomes crucial when utilizing public resources to consider what benefits the discovery or innovation could have for the wizarding community. Of course, some researchers will always stretch this a little for the sake of getting funding or attention, saying that research into a potion that would give the average person the legs of a Chihuahua could have incredible potential for new potion induced wizard-dog hybrid dog shows or something similar, but this violates the spirit of research for the betterment of magical society.

Along with this value, it is crucial when undertaking research to have a hypothesis or theory from which to work. There are researchers who worked tirelessly on projects with no conception of the direction in which they should head, or even how to begin to uncover the answers to the questions they have. Ultimately, while many of these questions are worth eventually answering, it becomes somewhat unfair and unethical to waste Ministry resources without any direction or hypothesis from which to work. When undertaking research using the time and support of agencies other than oneself, it becomes an ethical imperative to have some sort of theoretical validity to support the question you are trying to answer or the problem you are trying to solve.

On the other hand, if you are utilizing only your own resources, time, and livelihood in order to create a new potion, there are not the same moral and ethical obligations to which you should hold yourself to. This moral conundrum is only applicable when using public resources, such as Ministry funding and tools.

A Rare Glimpse of Leonardo da Vinci's Anatomical Drawings – Brain ...Another consideration that has drawn a good deal of disagreement and scandal is the originality of your idea. Even the most highly respected minds who undertake spell and potion research have been accused of copying or stealing ideas or practical applications of concepts from their colleagues, and occasionally those accusations have even proven valid. This may seem like an obvious statement, but it is completely against any ethical considerations to steal an idea from a friend or coworker. At the same time, accurately documenting your own theoretical processes can both preclude such accusations as well as make it much more difficult for these questions of who had which idea first to arise.

Passers By Were Looking At Me
After this initial original theoretical and experimental research has been completed, you will hopefully have a potion with the effects that you desire. Sometimes these effects can be tested on oneself, if so desired, but in the case of creating a potion that treats a specific ailment from which the researcher him or herself does not suffer, it becomes necessary to have clinical trials where the potion can be tested to confirm it works on those who do suffer from that problem or malady. It is important that this step comes relatively far down the line after it has been confirmed that the potion is moderately safe for the general population to take.

Some researchers will test potions on themselves to confirm that. Even if they do not have the symptoms they are trying to correct, taking the potion should not have any immediate negative consequences. Previously, potions were almost exclusively tested on magical or mundane creatures first to ensure safety before witches and wizards ever consumed a new potion. However, increasingly, beasts’ rights activists have encouraged the research community to move away from these testing methods and have called on the Ministry to create regulations regarding testing on beasts to make it more voluntary in nature. Many researchers have begun to follow suit, and even in regions where testing on magical beasts is still legal will try to find other means of testing the safety of potions before moving on to public trials.

Who Gets Involved?
Initially, experimental potions will be tested on the healthy population to establish an appropriate dose while also minimizing side effects. The target population for the potion, which includes those suffering from a specific ailment, are not part of the testing until later; this is so that the potion can be perfected before being given to those with potentially compromised immune systems. Once this has been done, the experiment moves onto the next phase of testing, where the impacted population will be studied. Typically those whose ailments are so severe, to the point even possible negative consequences are preferable to their current predicament, are likely to sign up or request to take part in these trials. Also, there are some who believe that, even if their symptoms are not so intolerable, they have an obligation to be part of research that will allow those in the future to avoid whatever symptoms or ailments they currently face. Please note that it is never an imperative to be part of any experimental potions trials regardless of any illness or issues you may be battling. While it may be offered as an alternative option to traditional therapies, if you ever feel as though you are being manipulated by a healer to take part in such a trial and not being given a fair assortment of other treatment options, contact the Ministry directly.

When a researcher conducts a trial for a potion, it is tempting to simply use one’s family and friends who may be suffering from that illness. This is a natural inclination, as a researcher would want the opportunity to save loved ones ahead of strangers. However, when conducting a public trial, fair subject selection is an ethical imperative. The selection process must be open and inclusive: as long as the applicants meet the required standards to join the trial, they should be given the opportunity to participate. While it is not necessary to turn away persons who meet the criteria simply owing to their connection to the researcher, these acquaintances must be taken and evaluated in the same way as anyone else taking part in the trial.

As you may guess, when opening up a trial to the public, it is important to revisit the topic of informed consent. Researchers should make all information about the trial transparent, including the ratio of risks to benefits. Subjects must be well aware of any known side effects or dangers, as well as any additional cautions when taking the potion. For example, those who are on a daily regimen of a certain type of supplement or potion for an entirely different purpose may have to avoid certain ingredients or potions for fear of them mixing poorly: if this is the case, it should be openly and transparently disclosed before they sign up for a clinical study.

This continued respect for those taking part in the trial should be maintained throughout the course of the potion trial. This includes not only the right of informed consent and transparency of information, but also individuals’ right to privacy. Researchers should not be sharing personal medical information with anyone outside the trial without the written and informed consent of that individual. Also, anyone taking part in the trial also has the right to change his or her mind and leave the trial at any time without rebuke. They must be informed of any negative consequences that may be associated with suddenly departing, of course, should any exist, but in the end it is up to them to decide whether to continue with the study or to leave and seek other methods of treatment.

Of course, the health and wellness of all those involved in the trial must be monitored throughout the duration of the trial. This includes mental well-being as well as physical, and any particularly concerning side effects should be noted and action taken immediately. Any new developments or new information learned throughout the trial that is appropriate to share should be divulged to those taking part in the trial, and once the trial is over, it is ethically correct to disclose the overall findings of the experiment to those who were involved. This may come in the form of a debrief after the fact, in which further information about the intent and background of the trial that was inappropriate to share in the beginning may be included, as well as any additional information that may be pertinent to those who took part in the trial.

The Consequences
As I hinted in the first lesson this year, another dimension of consideration when conducting research is the concept of the control group. When an individual takes part in a trial of some sort, there will almost always be a randomly selected control group. This is a group that, although they are not made aware of the situation, are given what is known as a placebo, or a harmless stand in that is usually composed of ineffective mundane ingredients. Some consider it cruel to essentially trick a patient into thinking they are getting treatment when, in fact, they are not, but that is why the concept of understanding and giving informed consent is so crucial even on the research side of potions. Every person taking part in experimental usage of a potion must be aware that he or she may or may not be receiving treatment, and that this is done in order to have vital data on the outcomes of those who do receive the specific potion being tested and those who do not.

For example, say you were looking for a drug to treat Merovingian Mumps, a nasty but typically non-fatal disease thought to have been derived from the sting of a very specific strain of the Australian insect known as the Billywig. You give every member of your test group the new experimental potion that is thought to cure the disease. Every person given the potion is cured between five and fourteen days after the regimen of potion has started. So they have all recovered from the disease, but how do you prove to those funding your continued research that it was the potion and not numerous other variables – or simply the average recovery time – that aided the patients? You also notice that a number of those suffering from the disease that took the potion also suffered an odd green discoloration of their nails: is this an odd side effect of the medication or is it an unexpected and new symptom associated with the disease itself?

However, if you have a control group that is given a placebo instead of the actual potion, you have a better sense of how the potion works for those who do take it as opposed to those who recover naturally. You see that the span of recovery time among those who do take the potion between five and fourteen days once again, and that odd greenish tinge once again appears on the nails of several undergoing the treatment. Meanwhile, for those who do not take any potion and are instead given a placebo, the span of recovery is between eight and eleven days. They have not developed this odd green tinge to their nails. Thus, this control group has proved that the potion is essentially useless in speeding the recovery, but has added an odd secondary effect in the form of the green tinged nails.

It would be possible, if the researcher prefers, to instead take generic research on effects and recovery time from Merovingian Mumps to include instead of running a control group. However, when the research is eventually reviewed, it is always preferable to have the most up-to-date, primary data on the illness the research is trying to treat, rather than often selectively collected data that was gathered from elsewhere.

The Powers That Be
This brings us to the next step for researchers: the independent review. In order for the Ministry to adopt a radically new treatment method or potion to be sold to the general public or used in institutions such as St. Mungo’s, the Ministry legally requires researchers to allow a separate team, often composed of Ministry-appointed reviewers, to review the study and the findings. If a Ministry reviewer was directly involved in the new research or has any ties that make it impossible to be an impartial judge of the validity of the experiment, he or she must excuse himself from the review process. This is to prevent any bias in determining the success or failure of a potion based on personal ties to the project. Once the independent review has been undertaken, if the reviewers find that everything is as the researchers claimed, then the next steps can be taken to formally recognize the discovery and implement the new potion or method into standard practice.

When dealing with unknown and new potions to aid those suffering from particular ailments, or simply those that wish to add favorable attributes to normally healthy individuals, there are an incredible number of ethical considerations that must be taken into account. Many of these may have something of a grey area, such as what information is truly necessary for test subjects to know? What must be discussed now, and what would be more appropriately discussed after the trial in the debriefing? However, should you ever have any questions about the ethical requirements of a particular study, the Ministry provides ample resources and experts to discuss the matter with young researchers as well as those who are simply interested in getting involved in a study and would like to know more information about what studies are available and what kind of time and health requirements exist.

For this week’s essay, I would like you to consider a particular symptom or even a positive outcome that could be derived from a potion. I will not ask you to go to all the work of trying to create a potion, as that takes a bit more background than you currently have. However, in at least 250 words, please describe the process you would take when testing the new potion. Please refer to the prompt for more explicit details as to what to include in your essay.


Original lesson written by Professor Lucrezia Batyaeva
Image credits
here, here, and here

In Year Two, Potions students will delve more deeply into potioneering, theory, and will explore in greater detail how certain potions can impact a witch or wizard's biological processes.
Course Prerequisites:
  • PTNS-101

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