Litigation, protection from

The W3C was founded in October 1994 by Tim Berners-Lee at the Massachusetts Institute of Technology, Laboratory for Computer Science in collaboration with CERN, but it was later transformed to a different and very powerful body. The consortium issues many important standards that are available at http //www.w3.org/ TR/. The standardization process (Jacobs 2005) ends with voting, and because the voting rights are derived from financial contributions, big companies dominate the voting. Fortunately, protection from patent litigation is provided because any recommendation accepted by the W3C can be implemented on a royalty-free basis (Weitzner 2004). 

ICH GCP provides detailed guidance on the information and structure of both the subject information sheet and the informed consent form (ICF). Some lECs provide alternative requests to the international requirements, perhaps in an effort to reduce the length of the information sheet or to simplify the information. Some pharmaceutical companies provide too much information, particularly with reference to possible adverse events, to provide (debatably) protection from litigation. In fact, the language should be non-technical and only pertinent aspects of the trial provided, as described in Chapter 4 of the ICH guidelines (also see Section 6.4.6.3). 

Protection from product liability lawsuits, in the form of an immunity from such litigation, may come from satisfying the federal regulations which govern the design and manufacture of, as well as the warnings to be supplied with, medical products. 

My advice is to use empirically validated approaches to treating problems as much as you can so you can provide the best care available for your client. This will protect your client, but also may protect you as a professional from litigation. Using empirically validated strategies also helps instill confidence in your client that the care she or he receives will be the best available, which of course makes it more likely that the client will commit to the treatment plan. If there is a unique or unusual problem for which no known empirically validated strategy has been developed, then you may have to create a novel and creative approach for intervening upon the problem. In those cases, it is important to share this information... 

The continued viability of the Frye approach has been a subject of much debate, both before and after Daubert. The purpose of the Frye test was to prevent...the introduction into evidence of specious and unfounded scientific principles or conclusions based upon such principles. Advocates of this conservative approach argue that it protects the legal system from the junk science that plagues the litigation process. As E.A. Firestone has explained ... 

Trade secret provides a necessary supplement to other IPRs because it can be used to protect technical information and know how during research, development, and testing stages of a biotechnology project. Unlike other IPRs, trade secret is rarely rooted in statute, but is usually established by the collective history of judgments from litigated cases known as jurisprudence [12,13]. 

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