Are there ever situations in which a painful sham procedure can be done (with analgesia) in order to increase the scientific rigour of the study?
Babies in neonatal intensive care units undergo many painful procedures.
The pain from these procedures has harmful long-term psychological effects.
There are simple ways to prevent and relieve pain. Babies who are given a little sugar water on a pacifier or who are held skin-to-skin while breastfeeding have less pain. These low-tech interventions are, or ought to be, universally used for babies who are undergoing painful procedures.
Shockingly, many research studies of analgesia for babies include a placebo arm in which babies who are undergoing painful procedures do not receive these safe, effective, and well-known analgesic treatments.
Harrison and colleagues noted, diplomatically, the need to select more ethically responsible control groups. Barrington, less diplomatically, criticized three such studies and the journals that published them. He wrote: “It is unacceptable to inflict pain on babies in order to complete a research project.” He demanded that the papers be retracted and editorial policies be put in place to prevent the publication of such unethical studies in the future.
I agree with Barrington but wonder why researchers do not make the obviously correct moral choice. Two explanations seem plausible. One is the outdated and thoroughly debunked view that babies do not feel pain. The other is that the temptations of science are so strong that they blunt ordinary moral instincts. Perhaps it is a combination of the two.
The history of neonatology is rife with examples of treatments that were inadequately studied and, though widely used, turned out to be harmful. That history should encourage rigorous scientific study of any new treatment. The treatment of severe pain requires riskier interventions than those noted above. So good research is essential.
But the history of neonatology is also rife with examples of situations in which neonatal pain is ignored. This is true when studies of analgesic interventions are compared to placebo or when the control arm of a study includes painful sham procedures. Our disturbing history should lead us to oppose any possibility of unnecessary untreated pain.
The history of research ethics is full of stories about scientists causing harm because their moral sensibilities were numbed by their intense desire to do good. Often, the stories involve vulnerable populations. Black men have had penicillin withheld so that scientists could study the natural history of untreated syphilis. Children with cognitive disabilities were deliberately infected with hepatitis to test preventive treatments. Elderly patients with dementia were exposed to ionizing radiation to see what doses are carcinogenic. Babies are subjected to painful procedures without adequate analgesia.
Codes of ethics try to restrain researchers who are constantly tempted to exploit and harm research participants in order to discover new knowledge and help other patients. It is the worst sort of bind – when the motivations for doing good are inextricably intertwined with the need to do harm. Pain is harm. We should not cause harm to babies unless that is the only way to provide some important benefit for the baby who is harmed.
This should not be controversial.