Working as a health care researcher can be both rewarding and challenging, as daily we need to remember our commitment to our patients’ well-being and ethics to support treatment decisions.
We are all familiar with deplorable abuses of human subjects in research, such as medical interventions without informed consent, and experimentation in concentration camps during World War II. Salutary advances in medicine and medical technology and societal changes spawned the rapid evolution of bioethics from one concerned about professional conduct and codes to its present status with an extensive scope that includes research ethics, public health ethics, organizational ethics, and clinical ethics.
As a result we developed the four principles of health care ethics to support ourselves as we provide patient care. We need to remind ourselves that even if we have our own sense of morals there are some circumstances where ethical conflicts in healthcare may get in the way of caring for our patients. For example, we may have a patient who refuses care due to cultural/religious views, or may want an unnecessary treatment which may not be in his or her best interest. Euthanasia is an example of a provider’s sense of morals conflicting with his or her ethical obligations.
To navigate this challenge, we scientists and all regulatory bodies involved in research, such as the Association of Clinical Research Professionals (ACRP), developed principles of clinical ethics and their application to clinical practice, research and clinical trials:
- Autonomy is the control that you exercise when making individual decisions, especially regarding your well-being. In health care, autonomy is the right or freedom of our patient to maintain control of their body before and after treatment. The practice of autonomy prevents us from potentially coercing or persuading the patient to take a specific action or treatment plan that might not be in their best interest.
- Beneficence acts as an obligation for (mostly) nurses to protect their patients from harm by removing and preventing bad situations and promoting good ones. The principle encourages us to consciously invest the time and effort to make sure that each of our patients benefits in each situation.
- Non-maleficence means that we must do no harm. According to the American Nurses Association ANA code of ethics, all health care workers and researchers should carefully evaluate each situation before making decisions. Whether knowingly or unknowingly, some decisions can cause harm to patients, to the community, or even other health care workers, and it’s up to us, as professionals, to be aware of how each of our decisions can impact others.
Non-maleficence covers four factors: a) an act should not be truly wrong, b) every action should have a positive benefit, c) a good effect should never be a result of the wrong action, d) good outcomes should always outweigh the bad.
- The justice principle states that there should be fairness in all our medical decisions. Patients deserve advanced health care delivery regardless of their situation. In order to be able to answer if clinical providers/researchers are equipped to fulfill this ethical obligation and if our ethical skills can be improved, we need to make clear the importance of informed consent. It creates trust between doctors/researchers and patients by ensuring good understanding about risks and options so patients can make choices which are best for them.
The requirements of informed consent for a medical, research, clinical trial, or surgical procedures are that our patient must be competent to understand, decide, receive a full disclosure, comprehend the disclosure, act voluntarily and provide consent to the proposed action of care or research.
Our job is not to convince our patients to enroll in a clinical trial; our job is to obtain an informed consent after providing all the pros and cons, truthfully and transparently.
Dr. Vasiliki E. Kalodimou is director of the Flow Cytometry-Research and Regenerative Medicine Department at IASO Maternity-Pediatric and Research Hospital in Athens, Greece. She completed her PhD at the University of Medicine in Athens, Greece, with an emphasis on stem cells. She is on the editorial board and a reviewer in several scientific international journals as well as a board member in scientific organizing committees for medical conferences worldwide. Find her on Twitter at @DKalodimou.
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Health care research may be both exciting and hard, as we must constantly remind ourselves of our patients’ well-being and ethics in order to support treatment plans. Scientific and regulatory groups like the Association of Clinical Research Professionals (ACRP) have formulated principles of clinical ethics and their application to the practice, research and the design, conduct and evaluation of medical research. Nice blog.