Practical insights for compliance and ethics professionals and commentary on the intersection of compliance and culture.

Round-up on bioethics in scientific research

Considerations from bioethics are prevalent throughout scientific research.  As bio-technology innovations advance in both science and medicine, research methodology standards and practices become more ethically complex.  Bioethics is traditionally centered on the link between humans and the sciences.  The far reach of bieothics into health and human sciences reflects how pervasive the ethical obligations and moral choices in scientific research can be.  As humans continue to explore the far boundaries of existing science knowledge for their own benefit, these transformations to all areas of human life will also change the ethical choices and challenges involved.

  • Clinical trial transparency – Disclosure by major pharmaceutical companies about their clinical trials has long been an area for improvement in the industry. Making results from clinical trials public is an important component of ensuring that all stakeholders in the industry can get more information and serve future clients more effectively.  Clinical trial transparency is crucial to encourage innovation and communication throughout the pharmaceutical industry.  Higher standards throughout the sector for disclosure will encourage dialogs and openness that are very important for trust and transparency upon which the future development of the industry and patient care relies:  Pharma Ups Its Game On Trial Transparency But There’s “Room For Improvement”
  • Disclosure and public transparency – On the same token as the above, the consequences of not raising the standards for public transparency in the clinical trials process can be dangerous. When the trials concern the FDA approval of drugs for use by the public, pharmaceutical companies sometimes cherry-pick research studies to release in order to promote positive results and obscure results indicating that the drugs might not work for the marketed purposes or identifying concerning side effects.  Due to this, doctors and researchers cannot truly get an accurate picture of all the possible effects of and issues with drugs, putting public health at potential risk from inadequate or unsafe medications:  A surprising amount of medical research isn’t made public.  That’s dangerous.
  • Gene editing development – One of the major concerns of bioethics is in its ability to keep pace with rapidly advancing technological innovation and exploration. In the genre of research science, thinkers are often concerned that achievements will extend technological capabilities to areas beyond that which design ethics have already considered.  Ethicists and academics often question “where to draw the line” as the field of biological sciences seeks new ground on which to pioneer.  Scientific desire for discovery often has a much quicker speed than ethical deliberation, in which there are often no strict or easy answers and too frequently choices are forced by scientific events that have already pre-determined the path of the decision’s outcome.  Gene editing is one area where debate has already been heated, and while the ethical arguments are still rehashing the old discussions, newer technologies are constantly within reach.  While these ethical choices will always be hard ones, it is morally necessary that ethicists make assessments along the way away, and avoid being left behind by scientific research that won’t wait for a definitive, difficult judgment:  Gene editing is now outpacing ethics
  • Gender bias in result reporting – Conclusions in scientific research should be free of biases and should not reflect the pre-judgement of the people reporting the results or any sort of flawed reasoning based upon the characteristics of the participants in the study that are not germane to its purpose. When evidence across multiple studies conflicts concerning the impact of the differences between participants, conclusions cannot be drawn on the materiality of those disparate characteristics.  Reporting of results from scientific research can have major consequences on treatment protocols, reliability of self-disclosure, and controls against emotional or subjective measures that could cause future harm:  On Gender and Concussion Recovery: Let’s Not Jump to Conclusions
  • Ethics dumping – Exploitative research, where scientists purposefully harm human beings to conduct their studies, violates all human rights and ethical standards. Indeed, medical students study how not to conduct research from cases where humans grievously harmed each other in scientific experiments, such as the Nazi medical procedures performed in concentration camps and the exploitation of black Americans to observe how syphilis advanced without treatment in the Tuskegee trials.  However, early efforts by ethics committees to ensure humane research practices, and continuing oversight in countries and communities with vulnerable populations, have lacked sufficient compliance controls to ensure that abuses do not take place.  Taking advantage of these more lax supervisory regimes is referred to as “ethics dumping,” where unethical research is moved abroad where exploitative practices will not be discovered or punished:  “Ethics dumping” – the dark side of international research

For more on bioethics, check out this post for selection of TED and TEDx talks on bioethics with compliance commentary alongside, or this post on bioethics in medicine.  For a look at ethical and integrity issues with scholarly research and writing, check out this post on retractions by scientific journals from the academic watchdog blog Retraction Watch.

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