It might seem obvious that people participating in research must agree to participate. This is what we call ‘informed consent’, where a participant is told of all the potential risks and benefits of participating, what being a participant entails, and details of the study. However, it took many, many, many, unethical studies to get to this point in research with guidelines and rules to adhere to, ensuring the safety of participants.
Being a participant a few decades ago was terrifying, mainly because people may not have even known they were participating in a study. In the 1950s, a group of people used women to lure ‘participants’ to safehouses, and they had no knowledge that they were about to be experimented on. The people lured to the safehouses were then injected with substances against their will, for example, LSD. You may be thinking that this sounds like another researcher from the past with no ethics, and definitely not a big, official, organisation operating under a superpower of the world. Unfortunately, you would be wrong, as this operation was carried out by the CIA, in an attempt to find a ‘mind-controlling’ combination of substances to use in warfare– uh, allegedly.
Of course, that experiment was extremely unethical as there was no form of consent given by participants at all. However, sometimes researchers receive consent from people who want to participate, and the experiment is still considered unethical. This could be because of the nature of the experiment itself, which will be touched upon in a different blog post, or because the participants gave consent but were not informed of all the details of the study. Participants need to give consent and also be informed, hence, ‘informed consent’.
A researcher named Albert Kligman is well-known for the creation of Retin-A, a topical substance that treats wrinkles, sun-damage and other skin conditions. He is not often brought up for negative reasons, despite conducting unethical research, and has worked for huge companies like Johnson & Johnson. He used a sample of prisoners in one of his experiments, and all of them provided consent for a topical treatment to be administered to them and were also paid some money for their participation. This would have been fine, if the topical substance hadn’t been one that posed many potential health risks and hazards. The treatment consisted of a component of Agent Orange. Agent Orange is a herbicide that has been utilised in warfare, and has been seen to cause birth defects, neurological and psychological issues, cancer and other medical conditions. The inmates were not made aware of these risks, and therefore, were not properly informed about the study. Due to this, we cannot say that informed consent was obtained by Albert Kligman.
To ensure that we obtain informed consent, we need a record of consent given by the participant, which can be verbal or written. Participants need to be made aware of any potential risks of the experiment (of course, the experiment must first be approved by an ethical board), and must be told of their right to withdraw from the study at any time. Their right to withdraw includes withdrawing their data once the experiment has been completed.
Of course, sometimes it would compromise the validity of research to tell participants everything about the study right off the bat, and deception might be used to keep participants in the dark about certain aspects of the treatment or research until the research has been conducted and they can be debriefed. However, there is still a protocol to follow in these cases, to ensure that participants are aware of the potential risks, and to ensure that researchers are not putting any participants in positions they do not want to be in.
In Part 2, we will create a checklist to obtain proper ‘informed consent’, and also touch upon deception!