Editorial Ethical Considerations of Clinical Research

1996 ◽  
Vol 9 (6) ◽  
pp. 402-405
Author(s):  
Lori A. Nesbitt

As the drug development process continues to mature and the health care industry places increasing demands for newer and safer drugs, ethical judgments of clinical research by society will be made. Already, many ethical dilemmas faced by the clinical research industry are gaining attention; examples include: (1) “true” informed consent for human subjects, (2) conflicts of interest in medical research, (3) data interpretation by pharmaceutical and bio-technology companies, and (4) the obligation to disclose financial agreements between the investigator and the study sponsor to the patient. The following editorial outlines these issues in further detail.

Author(s):  
Michael Tansey

Clinical research is heavily regulated and involves coordination of numerous pharmaceutical-related disciplines. Each individual trial involves contractual, regulatory, and ethics approval at each site and in each country. Clinical trials have become so complex and government requirements so stringent that researchers often approach trials too cautiously, convinced that the process is bound to be insurmountably complicated and riddled with roadblocks. A step back is needed, an objective examination of the drug development process as a whole, and recommendations made for streamlining the process at all stages. With Intelligent Drug Development, Michael Tansey systematically addresses the key elements that affect the quality, timeliness, and cost-effectiveness of the drug-development process, and identifies steps that can be adjusted and made more efficient. Tansey uses his own experiences conducting clinical trials to create a guide that provides flexible, adaptable ways of implementing the necessary processes of development. Moreover, the processes described in the book are not dependent either on a particular company structure or on any specific technology; thus, Tansey's approach can be implemented at any company, regardless of size. The book includes specific examples that illustrate some of the ways in which the principles can be applied, as well as suggestions for providing a better context in which the changes can be implemented. The protocols for drug development and clinical research have grown increasingly complex in recent years, making Intelligent Drug Development a needed examination of the pharmaceutical process.


Author(s):  
Daniel Groepper ◽  
Matt Bower

Ethical dilemmas are commonly encountered by genetic counselors, whether in the clinical or laboratory setting. This chapter describes common ethical dilemmas, conflicts, and challenges encountered in genetic testing laboratories. These situations include genetic testing of minors for adult-onset conditions, prenatal testing, the ethical impacts of incidental findings and unexpected test results, and conflicts of interest. This chapter also explores the genetic counselor’s role in addressing ethical issues. Resources are provided for managing these ethical dilemmas within the laboratory.


Author(s):  
Anchana Kuganesan

Artificial intelligence (AI) is a computer system used to model human cognitive functions, intelligence, and behaviour. Components include both, a virtual and a physical aspect. Virtual aspects of AI include algorithms and neural networks instilled within the system to execute its assignments. Physical components include the entity in conjunction with a code. 1 AI is currently being developed by Nvidia Corporation, Alphabet, Twilio, Amazon, Micron Technology, Microsoft Corp., Baidu, Intel Corp., Facebook, and Tencent. 2 Expanding AI into the health care system can be beneficial for preventative care, patient safety, and reducing treatment costs for families. AI has proven to be useful in machine learning, thus, it can be programmed to complete specific tasks. By performing tasks such as data interpretation, the amount of time that it takes for a physician to consult patients regarding their results will be reduced. In addition, AI is capable of analyzing medical images to identify tumours and it has previously been used in various other branches of medicine such as neurology and cardiology. Overall, AI has great potential to improve the health care industry in North America and worldwide. However, potential violations while utilizing personal patient data must be addressed whilst modifying this technology.


PLoS ONE ◽  
2021 ◽  
Vol 16 (7) ◽  
pp. e0253624
Author(s):  
Matthew S. McCoy ◽  
Matthew Bonci ◽  
Steven Joffe ◽  
Genevieve P. Kanter

Background Revelations that some members of Congress, including members of key health care committees, hold substantial personal investments in the health care industry have raised concerns about lawmakers’ financial conflicts of interest (COI) and their potential impact on health care legislation and oversight. Aims 1) To assess historical trends in both the number of legislators holding health care-related assets and the value and composition of those assets. 2) To compare the financial holdings of members of health care-focused committees and subcommittees to those of other members of the House and Senate. Methods We analyzed 11 years of personal financial disclosures by all members of the House and Senate. For each year, we calculated the percentage of members holding a health care-related asset (overall, by party, and by committee); the total value of all assets and health care-related assets held; the mean and median values of assets held per member; and the share of asset values attributable to 9 health asset categories. Findings During the study period, over a third of all members of Congress held health care-related assets. These assets were often substantial, with a median total value per member of over $43,000. Members of health care-focused committees and subcommittees in the House and Senate did not hold health care-related assets at a higher rate than other members of their respective chambers. Conclusions These findings suggest that lawmakers’ health care-related COI warrant the same level of attention that has been paid to the COI of other actors in the health care system.


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