How informed is consent in vulnerable populations? Experience using a continuous consent process during the MDP301 vaginal microbicide trial in Mwanza, Tanzania

BACKGROUND: HIV prevention trials conducted among disadvantaged vulnerable at-risk populations in developing countries present unique ethical dilemmas. A key concern in bioethics is the validity of informed consent for trial participation obtained from research subjects in such settings. The purpose of this study was to investigate the effectiveness of a continuous informed consent process adopted during the MDP301 phase III vaginal microbicide trial in Mwanza, Tanzania. METHODS: A total of 1146 women at increased risk of HIV acquisition working as alcohol and food vendors or in bars, restaurants, hotels and guesthouses have been recruited into the MDP301 phase III efficacy and safety trial in Mwanza. During preparations for the trial, participatory community research methods were used to develop a locally-appropriate pictorial flipchart in order to convey key messages about the trial to potential participants. Pre-recorded audio tapes were also developed to facilitate understanding and compliance with gel-use instructions. A comprehension checklist is administered by clinical staff to all participants at screening, enrolment, 12, 24, 40 and 50 week follow-up visits during the trial. To investigate women's perceptions and experiences of the trial, including how well participants internalize and retain key messages provided through a continuous informed consent process, a random sub-sample of 102 women were invited to participate in in-depth interviews (IDIs) conducted immediately after their 4, 24 and 52 week follow-up visits. RESULTS: 99 women completed interviews at 4-weeks, 83 at 24-weeks, and 74 at 52 weeks (a total of 256 interviews). In all interviews there was evidence of good comprehension and retention of key trial messages including that the gel is not currently know to be effective against HIV; that this is the key reason for conducting the trial; and that women should stop using gel in the event of pregnancy. CONCLUSIONS: Providing information to trial participants in a focussed, locally-appropriate manner, using methods developed in consultation with the community, and within a continuous informed-consent framework resulted in high levels of comprehension and message retention in this setting. This approach may represent a model for researchers conducting HIV prevention trials among other vulnerable populations in resource-poor settings. TRIAL REGISTRATION: Current Controlled Trials ISRCTN64716212

The German Banking System and the Global Financial Crisis: Causes, Developments and Policy Responses

Germany's banking sector has been severely hit by the global financial crisis. In a German context as of February, 2009, this paper reviews briefly the structure of the banking industry, quantifies effects of the crisis on banks and surveys responses of economic policy. It is argued that policy design needs to enhance transparency and enforce the liability principle. In addition, economic policy should not eclipse principles of competition policy.Der deutsche Bankensektor ist durch die internationale Finanzkrise schwer getroffen. Auf Deutschland und die im Februar 2009 verfügbaren Informationen bezogen, werden die Struktur des Bankensektors kurz umrissen, die Effekte auf die Banken quantifiziert und wirtschaftspolitische Reaktionen aufgezeigt. Ziel der Wirtschaftspolitik ist es, die Transparenz zu erhöhen und das Haftungsprinzip durchzusetzen. Darüber hinaus sollten Grundsätze der Wettbewerbspolitik nicht in den Hintergrund geraten

Did the crisis affect potential output?

Conventional Phillips-curve models that are used to estimate the output gap detect a substantial decline in potential output due to the present crisis. Using a multivariate state space model, we show that this result does not hold if the long-run role of excess liquidity (that we estimate endogenously) for inflation is taken into account.

PIGS or Lambs? The European Sovereign Debt Crisis and the Role of Rating Agencies

Rating agencies, Sovereign debt, Credit risk, Eurozone, Panel data, Debt crisis, G24, H63, F34,

Predicting financial crises: The (statistical) significance of the signals approach

The signals approach as an early warning system has been fairly successful in detecting crises, but it has so far failed to gain popularity in the scientific community because it does not distinguish between randomly achieved in-sample fit and true predictive power. To overcome this obstacle, we test the null hypothesis of no correlation between indicators and crisis probability in three applications of the signals approach to different crisis types. To that end, we propose bootstraps specifically tailored to the characteristics of the respective datasets. We find (1) that previous applications of the signals approach yield economically meaningful and statistically significant results and (2) that composite indicators aggregating information contained in individual indicators add value to the signals approach, even where most individual indicators are not statistically significant on their own.Während Signalansätze im Rahmen von Frühwarnsystemen recht erfolgreich angewendet werden, fehlt es ihnen bislang an akademischem Ansehen, da sie nicht zwischen der möglicherweise zufällig entstehenden und tatsächlich bestehenden Anpassungsgüte innerhalb einer Stichprobe unterscheiden können. Zur Überwindung dieses Problems testen wir für drei Anwendungsbeispiele des Signalansatzes die Nullhypothese, dass die Indikatoren und die Krisenwahrscheinlichkeit nicht korreliert sind. Dazu verwenden wir Bootstrap-Methoden, die individuell auf die Eigenschaften des Datensatzes angepasst sind. Die zentralen Ergebnisse der Untersuchung sind: (1) Die untersuchten Anwendungen des Signalansatzes liefern ökonomisch sinnvolle und statistisch signifikante Ergebnisse. (2) Die Verwendung von Gesamtindikatoren, die Informationen aus den einzelnen Indikatoren zusammenfassen, ist selbst dann sinnvoll, wenn die meisten Einzelindikatoren keine signifikanten Ergebnisse erzielen