The Limits of Disclosure: What Research Subjects Want to Know about Investigator Financial Interests

Research participants' views about investigator financial interests were explored. Reactions ranged from concern to acceptance, indifference, and even encouragement. Although most wanted such information, some said it did not matter, was private, or was burdensome, and other factors were more important to research decisions. Very few said it would affect their research decisions, and many assumed that institutions managed potential conflicts of interest. Although disclosure of investigator financial interest information to research participants is often recommended, its usefulness is limited, especially when participation is desired because of illness.     

Knowledge of police and court procedures and respect for the law a survey

Data were collected measuring knowledge of procedures and civil liberty protections in the juvenile justice system. In addition, questions from the Rundquist-Sletto Respect for Law Scale were used to assess attitudes toward the system. Three hundred ninety-six subjects, selected through stratified random sampling, were instructed to answer twenty-eight forced-choice questions on procedures and six Guttman-type scale questions on attitudes toward authority, all presented in the context of a brief scenario. Subjects were also asked to indicate age, sex, race, and previous arrest. Several questions were identified as applications of the Miranda decision, and the hypothesis was confirmed that these would be most often answered correctly by all subjects.A brief survey of the development of a separate juvenile justice system is presented. The authors concluded that by relying on informal channels of communication about its role, the court does not meet its obligation to educate the public.     

Advisory committees at FDA: the Hinchey Amendment and "conflict of interest" waivers

In approving the Food and Drug Administration's (FDA) Fiscal Year 2007 budget, the House approved an amendment that would prevent the agency from using appropriated funds to waive certain conflicts of interest identified by members of its advisory committees. The amendment, introduced by Representative Hinchey and known as the Hinchey Amendment, provides that no funds may be used to: waive a conflict of interest under Section 505(n)(4) of the Federal Food, Drug, and Cosmetic Act (FDCA) for any voting member of an FDA advisory committee or panel; or make a certification under Section 208(b)(3) of Title 18 of the U.S. Code for any such voting member. This creates a problem, as ties to industry create the very expertise that FDA values in its outside advisors-under the Hinchey Amendment, these very ties would prevent them from serving as advisors to FDA during the drug approval process. The author opposes this change in the law and argues that the Hinchey Amendment would undermine congressional efforts in 1962 and 1989 to carefully balance the goals of attracting qualified experts and protecting agency decisionmaking. Further, the author argues, this change is unnecessary at FDA, because experts on FDA advisory committees divulge their connections to the industry, because the committees offer only advice and do not make agency decisions, and because the agency is under the watchful eye of Congress, the public, and public interest groups. The Article concludes that although FDA's advisory committee conflict-of-interest process can be improved, congressional action is unnecessary, and a change in the law through amendment to an appropriations bill that does not go through the ordinary legislative process (as an amendment to the FDCA or Title 18 would) is inappropriate. Instead, recommendations from organizations studying FDA practice, such as the OIG, GAO, and IOM, should be used to carefully and reflectively amend the process at the agency level, within the existing statutory framework.     

Genetic variation of 15 STR autosomal loci in the Maracaibo population from Venezuela

Allele frequencies for 15 short tandem repeats (STRs) autosomal loci (D8S1179, D21S11, D7S820, CSF1PO, D3S1358, TH01, D13S317, D16S539, D2S1338, D19S433, vWA, TPOX, D18S51, D5S818 and FGA, included in the AmpFLSTR Identifiler, Applied Biosystems) were studied in the city of Maracaibo, Venezuela and were compared with other published Latin-American populations for the same loci. Population and forensic parameters were estimated.