“Moral Science”

Key findings from The Presidential Commission for BioEthics:
“In assessing the current regulations that protect human subjects, the Commission learned that there is no central source with information about the overall size, scope, and cost of the government’s research involving human subjects. The Commission requested information from 18 individual agencies that conduct most federal human subjects research, but discovered that many federal offices could not provide basic data about the research they support. The Pentagon, for example, required more than seven months to prepare information on specific studies supported by the Department of Defense. In its report, the Commission found that the federal government supported more than 55,000 projects involving human subjects around the globe in Fiscal Year 2010, mostly in health-related research, but also in other fields such as education, engineering and social science.”

http://bioethics.gov/cms/node/559

a link to the wiki definition of Moral Oral:
https://secure.wikimedia.org/wikipedia/en/wiki/Moral_Orel

“The first season of the show followed a standard formula: Orel would hear a sermon in church on Sunday, then proceed to have some sort of misadventure based on his attempts to live by his (usually warped) interpretation of the lesson. At the end of each episode, his father would sternly put a halt to the proceedings and “correct” Orel — only to offer an even more warped interpretation (in the first season this would be one of the “Lost Commandments”). Before the end titles, Clay Puppington’s trousers would fall down as a running gag, because he had removed his belt to “correct” Orel beforehand. Throughout the season, the series’ primary characters were introduced and various subplots were established, such as Orel’s father being a closeted bisexual in love with Orel’s gym teacher, and Orel’s mother being an unhappily married housewife feeling trapped in her marriage.”

“moral” from the Devil’s Dictionary:

MORAL, adj.
Conforming to a local and mutable standard of right. Having the quality of general expediency.

It is sayd there be a raunge of mountaynes in the Easte, on
one syde of the which certayn conducts are immorall, yet on the other
syde they are holden in good esteeme; wherebye the mountayneer is much
conveenyenced, for it is given to him to goe downe eyther way and act
as it shall suite his moode, withouten offence.
Gooke’s Meditations

http://www.alcyone.com/max/lit/devils/m.html

“The consequence of this misunderstanding is a failure to understand that different research enterprises involve different ethical principles. In 1978, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research’s Belmont Report ignored warnings that medical ethics were not appropriate for all fields. Today’s Commission still wants to shove everyone into the Belmont box:”
—“Presidential Commission Prescribes Medical Ethics for Everyone”
from the Institutional Review Blog:
http://www.institutionalreviewblog.com/2011/12/presidential-commission-prescribes.html

“Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators”
proposed rule from the FDA, on the Federal Register:
http://www.federalregister.gov/articles/2011/07/26/2011-18792/human-subjects-research-protections-enhancing-protections-for-research-subjects-and-reducing-burden

“The current regulations governing human subjects research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site. Although the regulations have been amended over the years, they have not kept pace with the evolving human research enterprise, the proliferation of multi-site clinical trials and observational studies, the expansion of health services research, research in the social and behavioral sciences, and research involving databases, the Internet, and biological specimen repositories, and the use of advanced technologies, such as genomics. Revisions to the current human subjects regulations are being considered because OSTP and HHS believe these changes would strengthen protections for research subjects.”

this continues:
“The Common Rule requires that Federally funded investigators in most instances obtain and document the informed consent of research subjects, and describes requirements for institutional review board (IRB) membership, function, operations, research review, and recordkeeping. The regulations also delineate criteria for, and levels of, IRB review. Currently, except for human subjects research that is determined to be exempt from the regulations, Federally funded research involving human subjects is reviewed by an IRB in one of two ways: (1) By a convened IRB, or (2) through an expedited review process.

Since the Common Rule was developed, the landscape of research activities has changed dramatically, accompanied by a marked increase in the volume of research. It is estimated that total spending on health-related research and development by the drug industry and the Federal government has tripled since 1990. [2] While traditional biomedical research conducted in academic medical centers continues to flourish, many studies are now also conducted at community hospitals, outpatient clinics, or physician-based practices. Clinical research is regularly conducted at multiple institutions across the U.S. and other countries. Recruitment firms, bioinformatics specialists, clinical trial coordinating centers, protocol developers, data analysts, contract research organizations (CROs), data and safety monitoring committees, community-based organizations, and other entities have joined investigators and sponsors as part of the clinical research enterprise.

Research has also increased, evolved, and diversified in other areas, such as national security, crime and crime prevention, economics, education, and the environment, using a wide array of methodologies in the social sciences and multidisciplinary studies. The application of technologies such as functional magnetic resonance imaging in neuroscience has led to substantial advances in the understanding of human physiology, cognition, and behavior. The advent of sophisticated computer software programs, the Internet, and mobile technology have created new areas of research activity, particularly within the social and behavioral sciences, exponentially increasing the amount of information available to researchers, while providing the means to access and analyze that information. In many areas of society, researchers are being called upon to provide evidence to more effectively guide social policy and practices.

The rapid growth and expansion of human subjects research has led to many questions about whether the current regulatory framework is adequate and appropriate for the protection of human subjects in the 21st century. Furthermore, decades of experience have revealed a great deal about the functioning—and limitations—of existing regulations, and prompted critical evaluations by the Institute of Medicine (IOM), [3] [4] the U.S. Government Accountability Office, [5] [6] [7] and many scholars. [8] [9] [10] Federal consideration of such revisions to the regulatory schema, in addition to the issues that suggest a need for revision, is not without precedent. In its 2001 concluding report, the National Bioethics Advisory Commission (NBAC) made 30 recommendations that addressed areas including the scope and structure of the oversight system, the level of review applied to research, emphasizing the informed consent process, documentation and waiver of informed consent, protecting privacy and confidentiality, adverse event reporting, and review of cooperative or multi-site research studies. [11] NBAC’s recommendations are one source for the revisions in the Common Rule currently being considered. Addressing these considerations now is timely and consistent with the President’s Executive Order requiring Federal agencies to review existing significant regulations to determine whether they should be modified, streamlined, expanded, or repealed to make the agency’s regulatory program more effective or less burdensome in achieving the regulatory objective. [12] “

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