Background and aimsDespite advances in our knowledge of effective services for people who use drugs over the last decades globally, coverage remains poor in most countries, while quality is often unknown. This paper aims to discuss the historical development of successful epidemiological indicators and to present a framework for extending them with additional indicators of coverage and quality of harm reduction services, for monitoring and evaluation at international, national or subnational levels. The ultimate aim is to improve these services in order to reduce health and social problems among people who use drugs, such as human immunodeficiency virus (HIV) and hepatitis C virus (HCV) infection, crime and legal problems, overdose (death) and other morbidity and mortality.Methods and resultsThe framework was developed collaboratively using consensus methods involving nominal group meetings, review of existing quality standards, repeated email commenting rounds and qualitative analysis of opinions/experiences from a broad range of professionals/experts, including members of civil society and organisations representing people who use drugs. Twelve priority candidate indicators are proposed for opioid agonist therapy (OAT), needle and syringe programmes (NSP) and generic cross-cutting aspects of harm reduction (and potentially other drug) services. Under the specific OAT indicators, priority indicators included ‘coverage’, ‘waiting list time’, ‘dosage’ and ‘availability in prisons’. For the specific NSP indicators, the priority indicators included ‘coverage’, ‘number of needles/syringes distributed/collected’, ‘provision of other drug use paraphernalia’ and ‘availability in prisons’. Among the generic or cross-cutting indicators the priority indicators were ‘infectious diseases counselling and care’, ‘take away naloxone’, ‘information on safe use/sex’ and ‘condoms’. We discuss conditions for the successful development of the suggested indicators and constraints (e.g. funding, ideology). We propose conducting a pilot study to test the feasibility and applicability of the proposed indicators before their scaling up and routine implementation, to evaluate their effectiveness in comparing service coverage and quality across countries.ConclusionsThe establishment of an improved set of validated and internationally agreed upon best practice indicators for monitoring harm reduction service will provide a structural basis for public health and epidemiological studies and support evidence and human rights-based health policies, services and interventions.

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The report that follows, prepared by a subcommittee of the Association's Committee A on Academic Freedom and Tenure, was approved for publication by Committee A at its meeting in June 2006. The report takes issue with aspects of the federal government's regulations for research on human subjects that constitute a threat to academic freedom. The application of the federal regulations to research methodologies that present no serious risk of harm to research subjects has long been of concern to Committee A, which will continue to keep this matter and other troubling features of the regulations on its agenda. Committee A welcomes comments on the report from Association members and other interested parties and organizations. Research on human subjects conducted by college and university personnel has been governed by federal regulations since the 1960s. Revisions in the regulations have been made over the years; the most recent version was published on June 23, 2005. 1 What has been a constant since the outset is the requirement that-with a few exemptions-all research on human subjects conducted at, or sponsored by, colleges, universities, hospitals, and nonprofit organizations that is to be supported by any of the federal departments and agencies that have adopted the regulations must be approved in advance by a local Institutional Review Board (IRB). 2 A second requirement is currently in place, namely, that institutions at which, or under whose auspices, federally funded research on human subjects is to be conducted must provide assurance that they will protect the rights and welfare of the human subjects of all their research on human subjects, whatever its source of funding. This assurance must be approved by the federal Office of Human Research Protections. For a variety of reasons, which we will return to, most academic institutions have adopted the same protection for subjects of research that is not federally funded as for subjects of federally funded research, that is, they require advance approval of the research by an IRB. Those requirements have generated an increasing number of complaints over the years, and there is a by now enormous literature that points to their objectionable features. 3 In section one, we draw attention to some of the complaints. In sections two and three, we make two recommendations, one to policy makers, the other to academic institutions. In section four, we make a recommendation to the AAUP. 11. While we have no hard evidence on the matter, it is our impression that institutions' fear of lawsuits if they decline to require IRB approval for research that is not federally funded is not warranted by experience. Back to text 12. This information was provided by the U.S. Department of Health and Human Services in response to a Freedom of Information Act request submitted by the AAUP. For the names of other institutions, contact Jonathan Knight in the AAUP's Washington office. Back to text 13.

Recent controversies over scientific fraud and other disputed findings have raised questions over the way in which journals select papers for publication. Is there a problem? And what more could be done to weed out dubious results? David Adam and Jonathan Knight investigate. 772

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