Ethical questions no rule settles in research on people
Not every ethical question in research on people is decided by a code or a regulation. Some fall to the professionals who conduct, market and recruit for a study, such as whether to disclose an investigator's conflict of interest or whether to become a whistleblower, and some to physicians, such as whether to report an adverse event. One view holds that how regulations work, and whether they bring better quality to science, is itself a question that needs more research. Long-term space research raises questions that turn on neither money nor access to basic resources. A writer meets such a question in deciding whether to use or cite a scientifically valid source of unethical origin.
Decisions left to professionals and physicians
One view holds that some ethical challenges have very few right and wrong answers. Everyone brings their own perspectives, lenses and life experiences to these challenges. Sharing those perspectives may give a broader view and an understanding of how perspectives vary.
Research involving human subjects is often riddled with ethical issues and decisions. In one view, ethical issues in clinical trials and other scientific research are not always based on black-and-white facts but on shades of gray. The professionals who conduct research, market it, recruit participants and communicate findings are often involved in deciding the procedural and ethical issues that fall in this gray zone. There are regulations protecting human subjects in the research process, but few protections for the professionals who conduct and market a study.
Recruitment shows how a gray-zone question arises. An investigator's potential conflict of interest is not always disclosed to study participants during recruitment. Research staff commonly recruit participants who may ask for that information. No regulation requires the disclosure during marketing and recruitment, and the staff then have an ethical decision to make: provide the information or not.
A research professional confronted with an ethical issue must make thoughtful and sometimes gut-wrenching decisions about becoming a whistleblower. The United States Supreme Court has ruled that whistleblowers have no protection under the First Amendment of the Constitution. One lawyer who works on human subject research holds that being a whistleblower is difficult, that no one likes to be one, and that since that ruling fewer people will step forward to expose problems. In the same view, a comprehensive set of regulations protecting those who work in trials is needed, although crafting protections for categories of professional is very difficult because trials are conducted in private, government and academic settings. A unified set of protections based on core ethical principles could protect research professionals when they must speak out.
Physicians are not always compelled to report adverse events in the clinical setting, and there are few legal requirements to do so. It has been suggested that more regulation and education on reporting adverse events are needed, with the caveat that no amount of regulation can ensure that ethical practices are carried out.
Research on how regulations work
One researcher of regulatory science holds that more research should study how regulations work and whether they bring better quality to science. The same researcher believes that regulatory research is under-theorised and lacks appropriate funding, and that these two conditions create a barrier to good research.
Questions in long-term space research
Some questions are unique to the longer-term space environment. In space programmes the fundamental ethical concerns are unlike those on earth: they are not related to money or to access to basic resources. One academic who speaks on space-based research holds that for an ethicist the questions are therefore pure.
One such question is whether astronauts have a right to the confidentiality of their personal medical information. Astronauts' rights over their own medical records are limited, and the same limits, applied to terminally ill end-stage cancer patients instead, raise the question of whether they are ethical. The same academic holds that suspending the privacy rights of astronauts, who are healthy volunteers, may not be a good idea. But if astronauts do not share their medical information after taking part in billion-dollar research programmes, an opportunity to learn about human physiological adaptation in space is lost. In that view the issue is therefore complex and needs to be sorted out.
Space-based research raises further ethical questions. Health threats in long-duration space flight include progressive disease, traumatic injury, nutritional deficiency, sleep disturbance, biohazards in the spacecraft environment, psychiatric or cognitive crisis, and failure of life support. If more than one person becomes ill and there is a finite amount of medication, who decides who should get the painkiller? If one person becomes ill, another has to serve as caretaker, and both are then left out of the mission.
The same academic holds that the most important question is how much risk is enough risk. In that view, decisions about such risks need established policies rather than ad hoc ones, and there should be consensus on the ethical principles not only among astronauts and stakeholders but also among astronauts' families. The same view holds that goals should be articulated with a balance between individual health safety and mission safety, that acceptable levels of risk must be determined and not exceeded, and that a toolbox of values needs to be pulled up before decisions are made.
A valid source of unethical origin
A source can be scientifically valid and ethically questionable at once. During an operation, a surgeon had to consult the Pernkopf Topographic Anatomy of Man to finish a rather tricky emergency procedure. Apparently no other medical source, printed or digital, can match the accuracy and detailed illustrations of human anatomy in this volume. It was compiled at an Austrian medical school during the Nazi era and based largely on the bodies of victims of that era. The volume raises three questions: whether it is ethically correct to use such material, whether it is allowable to cite such material in scientific papers, and whether the end justifies the means.