A Review of Current Events in Human Subjects Protection
- PDF / 544,302 Bytes
- 7 Pages / 504 x 719.759 pts Page_size
- 92 Downloads / 215 Views
Drug I n f o m i o n Journal, Vol. 36, pp. 261-267, 2002 Prinred in the USA. All rights reserved.
A REVIEW OF CURRENT EVENTS IN
HUMAN SUBJECTS PROTECTION LAURACOLEMAN, PHARMD Visiting Scientist, U.S.Regulatory Affairs, Eli Lilly and Company, Rockville, Maryland
STACYHOLDSWORTH, FHARMD,RAC Manager, US. Regulatory Affairs, Eli Lilly and Company, Indianapolis, Indiana
Bioethics is a subject that has been gaining increased attention through the last few years. Factors such as globalization of research, genetic medicine, and tragic events in clinical trials have drawn attention to the importance of protecting human participants in medical research. The October 2000 revision of the Declaration of Helsinki and the release of two reports by the National Bioethics Advisory Commission are just a few examples of the recent efforts by policymaking bodies to modernize bioethical standards. This review provides an introduction to several of the groups that are participating in the reshaping of bioethical policy in the United States and around the globe. Although there are multiple bioethical issues currently being debated, three specific topics are discussed: the use of placebo controls in clinical trials, posttrial access to medicines, and financial conflicts of interest. Key Words: Bioethics; Human subjects protection; Declaration of Helsinki; Informed consent; Financial conflicts of interest; Placebo control
THE MISSION TO DEVELOP new, innovative medicines remains a mainstay for pharmaceutical researchers everywhere. As technology advances and new drugs are discovered, more and more patients have access to medicines that can save or improve the quality of their lives. Discovering and testing new drugs requires people who are willing to participate in the testing of these new drugs. In order to assure that the people who volunteer are adequately protected, bioethical principles must be followed. Attention was first drawn to the ethical dilemmas involved in scientific research on humans during the Nuremberg War Crime
Reprint address: Stacy Holdsworth, PharmD, RAC, Eli Lilly and Company, Lilly Corporate Center, Drop Code 4008,Indianapolis, IN 46285.
Trials of World War 11. Horrifying experiments done by the Nazis on concentration camp prisoners prompted the development of the Nuremberg Code, which defined a set of ethical standards for research on humans. This code laid the groundwork for several future efforts to define the proper ethical behavior of researchers. Among the most significant of these efforts was the drafting of the Declaration of Helsinki in 1964 and the Belmont Report in 1979. Both documents established ethical principles for research involving human test subjects. Then, in 1991, the Common Rule was published in the United States as a national policy for human subject protections. This regulation applies to all federally-funded research or research being conducted in federally-funded institutions. Although basic ethical standards have been in existence and evolving for more than
261
262
50 years, ther
Data Loading...
