Experts are Looking to Redefine Research Ethics Concepts

Vanguard and Science Daily reported the intention of healthcare experts, including bioethicists from Johns Hopkins, to redefine existing research ethics terms which have guided research in the USA since the 70s. The y believe the much emphasized distinction between research and health care should be revisited in the digital era and a morally obliging ‘learning healthcare system’ should replace it.  They argue that ethical principles applied in research are not different from ones implemented in the clinical practice and being part of research does not necessarily indicate  research participants acquire less benefits and are exposed to greater risks. In actual practice, the distinction between the 2 does not exists, particularly since 50% of medical treatments, currently in use, are not supported with adequate evidence of effectiveness and almost 100,000 die annually from healthcare system related infections. Nancy E. Kass, deputy director for public health at the Johns Hopkins Berman Institute of Bioethics, believe patients are exposed to greater risks in medical care while overprotected in research which is essential to improve quality of healthcare.

In another article, the experts proposed 7 points ethical framework to integrate both clinical care with research. They include;

1. ‘Respect the rights and dignity of patients
2. Respect the clinical judgment of clinicians
3. Provide optimal care to each patient
4. Avoid imposing nonclinical risks and burdens on patients
5. Address health inequalities among populations
6. Conduct continuous learning activities that improve the quality of clinical care and health care systems
7. Contribute to the common purpose of improving the quality and value of clinical care and health care systems’

Six points of the framework explain the responsibility of health professionals and one point highlight patients’ obligation. In the new framework, emphasis is put on overcoming inequality of evidence-based decision-making in clinical practice in certain health conditions such as pregnant women. In addition to obligation of health professionals, sponsors and administrators to conduct research to improve healthcare quality, there is also a moral obligation on patients to enroll in such research. However, the obligation is not absolute and patients should not expose themselves to higher risks than what their current treatments do. Informed consent is still a requirement and patients’ free will in withdrawing from research anytime is still maintained.

‘The patient obligation is focused on research that poses no additional risk beyond what patients face in clinical care, and would also exclude research that compares different types of treatments, for example, surgery to medical management’, the authors explained.

To read more please follow the link Experts Aim to Redefine Healthcare and Research Ethics