Post-trial access to study medication: a Brazilian e-survey with major stakeholders in clinical research

Objectives To analyse the perspective of clinical research stakeholders concerning post-trial access to study medication. Methods Questionnaires and informed consents were sent through e-mail to 599 ethics committee (EC) members, 290 clinical investigators (HIV/AIDS and Diabetes) and 53 sponsors in Brazil. Investigators were also asked to submit the questionnaire to their research patients. Two reminders were sent to participants. Results The response rate was 21%, 20% and 45% in EC, investigators and sponsors' groups, respectively. 54 patients answered the questionnaire through their doctors. The least informative item in the consent form was how to obtain the study medication after trial. If a benefit were demonstrated in the study, 60% of research participants and 35% of EC answered that all patients should continue receiving study medication after trial; 43% of investigators believed the medication should be given to participants, and 40% to subjects who participated and benefited from treatment. For 50% of the sponsors, study medication should be assured to participants who had benefited from treatment. The majority of responders answered that medication should be provided free by sponsors; investigators and sponsors believed the medication should be kept until available in the public health sector; EC members said that the patient should keep the benefit; patients answered that benefits should be assured for life. Conclusions Due to the study limitations, the results cannot be generalised; however, the data can contribute to discussion of this complex topic through analysing the views of stakeholders in clinical research in Brazil.

Das Biobankgeheimnis : Schutz der Persönlichkeitsrechte in der biomedizinischen Forschung

Biobanken sind Sammlungen von Körpersubstanzen, die mit umfangreichen gesundheits- und lebensstilbezogenen sowie geneologischen Daten ihrer Spender verknüpft sind. Sie dienen der Erforschung weit verbreiteter Krankheiten. Diese sog. Volkskrankheiten sind multifaktoriell bedingte Krankheiten. Dies bedeutet, dass diese Krankheiten das Ergebnis eines komplizierten Zusammenspiels von umwelt- und verhaltensrelevanten Faktoren mit individuellen genetischen Prädispositionen sind. Forschungen im Bereich von Pharmakogenomik und Pharmakogenetik untersuchen den Einfluss von Genen und Genexpressionen auf die individuelle Wirksamkeit von Medikamenten sowie auf die Entstehung ungewollter Nebenwirkungen und könnten so den Weg zu einer individualisierten Medizin ebnen. Menschliches Material ist ein wichtiger Bestandteil dieser Forschungen und die Nachfrage nach Sammlungen, die Proben mit Daten verknüpfen, steigt. Einerseits sehen Mediziner in Biobanken eine Chance für die Weiterentwicklung der medizinischen Forschung und des Gesundheitswesens. Andererseits lösen Biobanken auch Ängste und Misstrauen aus. Insbesondere wird befürchtet, dass Proben und Daten unkontrolliert verwendet werden und sensible Bereiche des Persönlichkeitsrechts und der persönlichen Identität betroffen sind. Diese Gefahren und Befürchtungen sind nicht neu, sondern bestanden schon in der Vergangenheit bei jeglicher Form der Spende von Körpersubstanzen. Neu ist aber der Umfang an Informationen, der durch die Genanalyse entsteht und den Spender in ganz besonderer Weise betreffen kann. Bei der Speicherung und Nutzung der medizinischen und genetischen Daten ergibt sich somit ein Spannungsfeld insbesondere zwischen dem Recht der betroffenen Datenspender auf informationelle Selbstbestimmung und den Forschungsinteressen der Datennutzer. Im Kern dreht sich die ethisch-rechtliche Bewertung der Biobanken um die Frage, ob diese Forschung zusätzliche Regeln braucht, und falls ja, wie umfassend diese sein müssten. Im Zentrum dieser Diskussion stehen dabei v.a. ethische Fragen im Zusammenhang mit der informierten Einwilligung, dem Datenschutz, der Wiederverwendung von Proben und Daten, der Information der Spender über Forschungsergebnisse und der Nutzungsrechte an den Daten. Ziel dieser Arbeit ist es, vor dem Hintergrund des Verfassungsrechts, insbesondere dem Recht auf informationelle Selbstbestimmung, das Datenschutzrecht im Hinblick auf die Risiken zu untersuchen, die sich aus der Speicherung, Verarbeitung und Kommunikation von persönlichen genetischen Informationen beim Aufbau von Biobanken ergeben. Daraus ergibt sich die weitere Untersuchung, ob und unter welchen Voraussetzungen die sich entgegenstehenden Interessen und Rechte aus verfassungsrechtlichem Blickwinkel in Einklang zu bringen sind. Eine wesentliche Frage lautet, ob die bisherigen rechtlichen Rahmenbedingungen ausreichen, um den Schutz der gespeicherten höchstpersönlichen Daten und zugleich ihre angemessene Nutzung zu gewährleisten. Das Thema ist interdisziplinär im Schnittfeld von Datenschutz, Verfassungsrecht sowie Rechts- und Medizinethik angelegt. Aus dem Inhalt: Naturwissenschaftliche und empirische Grundlagen von Biobanken – Überblick über Biobankprojekte in Europa und im außereuropäischen Ausland – Rechtsgrundlagen für Biobanken - Recht auf informationelle Selbstbestimmung - Recht auf Nichtwissen - Forschungsfreiheit - Qualitätssicherung und Verfahren – informierte Einwilligung – globale Einwilligung - Datenschutzkonzepte - Forschungsgeheimnis –– Biobankgeheimnis - Biobankgesetz

Attitudes of Parents at risk of inheriting Li-Fraumeni Syndrome towards predictive genetic testing in their minor-aged children.

Li-Fraumeni Syndrome (LFS) is a hereditary cancer syndrome which predisposes individuals to cancer beginning in childhood. These risks are spread across a lifetime, from early childhood to adulthood. Mutations in the p53 tumor suppressor gene are known to cause the majority of cases of LFS. The risk for early onset cancer in individuals with Li-Fraumeni Syndrome is high. Studies have shown that individuals with LFS have a 90% lifetime cancer risk. Children under 18 have up to a 15% chance of cancer development. Effectiveness of cancer screening and management in individuals with Li-Fraumeni Syndrome is unclear. Screening for LFS-associated cancers has not been shown to reduce mortality. Due to the lack of effective screening techniques for childhood cancers, institutions vary with regard to their policies on testing children for LFS. There are currently no national guidelines regarding predictive testing of children who are at risk of inheriting LFS. No studies have looked at parental attitudes towards predictive p53 genetic testing in their children. This was a cross-sectional pilot study aimed at describing these attitudes. We identified individuals whose children were at risk for inheriting p53 genetic mutations. These individuals were provided with surveys which included validated measures addressing attitudes and beliefs towards genetic testing. The questionnaire included qualitative and quantitative measures. Six individuals completed and returned the questionnaire with a response rate of 28.57%. In general, respondents agreed that parents should have the opportunity to obtain p53 genetic testing for their child. Parents vary in regard to their attitudes towards who should be involved in the decision making process and at what time and under what considerations testing should occur. Testing motivations cited most important by respondents included family history, planning for the future and health management. Concern for insurance genetic discrimination was cited as the most important “con” to genetic testing. Although limited by a poor response rate, this study can give health care practitioners insight into testing attitudes and beliefs of families considering pediatric genetic testing.

Operationalizing Professionalism: A Course in Ethical Decision Making

All U.S. medical schools require some medical ethics education and must now ensure that their graduates, residents, and faculty exhibit competence in the area of professionalism and professional medical ethics. However, there remain many challenges to implementing formal ethics and professionalism education into medical school curricula. [See PDF for complete abstract]

Suicide tourism: a pilot study on the swiss phenomenon

While assisted suicide (AS) is strictly restricted in many countries, it is not clearly regulated by law in Switzerland. This imbalance leads to an influx of people —‘suicide tourists’—coming to Switzerland, mainly to the Canton of Zurich, for the sole purpose of committing suicide. Political debate regarding ‘suicide tourism’ is taking place in many countries. Swiss medicolegal experts are confronted with these cases almost daily, which prompted our scientific investigation of the phenomenon. The present study has three aims: (1) to determine selected details about AS in the study group (age, gender and country of residence of the suicide tourists, the organisation involved, the ingested substance leading to death and any diseases that were the main reason for AS); (2) to find out the countries from which suicide tourists come and to review existing laws in the top three in order to test the hypothesis that suicide tourism leads to the amendment of existing regulations in foreign countries; and (3) to compare our results with those of earlier studies in Zurich. We did a retrospective data analysis of the Zurich Institute of Legal Medicine database on AS of on-Swiss residents in the last 5 years (2008–2012), and internet research for current legislation and political debate in the three foreign countries most concerned. We analysed 611 cases from 31 countries all over the world. Non-terminal conditions such as neurological and rheumatic diseases are increasing among suicide tourists. The unique phenomenon of suicide tourism in Switzerland may indeed result in the amendment or supplementary guidelines to existing regulations in foreign countries.

The movement toward patient safety: State action related to reporting and disclosure of healthcare-associated infections

Increasing attention has been given to the problem of medical errors over the past decade. Included within that focused attention has been a strong interest in reducing the occurrence of healthcare-associated infections (HAIs). Acting concurrently with federal initiatives, the majority of U.S. states have statutorily required reporting and public disclosure of HAI data. Although the occurrence of these state statutory enactments and other state initiatives represent a recognition of the strong concern pertaining to HAIs, vast differences in each state’s HAI reporting and public disclosure requirements creates a varied and unequal response to what has become a national problem.^ The purpose of this research was to explore the variations in state HAI legal requirements and other state mandates. State actions, including statutory enactments, regulations, and other initiatives related to state reporting and public disclosure mechanisms were compared, discussed, and analyzed in an effort to illustrate the impact of the lack of uniformity as a public health concern.^ The HAI statutes, administrative requirements, and other mandates of each state and two U.S. territories were reviewed to answer the following seven research questions: How far has the state progressed in its HAI initiative? If the state has a HAI reporting requirement, is it mandatory or voluntary? What healthcare entities are subject to the reporting requirements? What data collection system is utilized? What measures are required to be reported? What is the public disclosure mechanism? How is the underlying reported information protected from public disclosure or other legal release?^ Secondary publicly available data, including state statutes, administrative rules, and other initiatives, were utilized to examine the current HAI-related legislative and administrative activity of the study subjects. The information was reviewed and analyzed to determine variations in HAI reporting and public disclosure laws. Particular attention was given to the seven key research questions.^ The research revealed that considerable progress has been achieved in state HAI initiatives since 2004. Despite this progress, however, when reviewing the state laws and HAI programs comparatively, considerable variations were found to exist with regards to the type of reporting requirements, healthcare facilities subject to the reporting laws, data collection systems utilized, reportable measures, public disclosure requirements, and confidentiality and privilege provisions. The wide variations in state statutes, administrative rules, and other agency directives create a fragmented and inconsistent approach to addressing the nationwide occurrence of HAIs in the U.S. healthcare system. ^

Obstetrical Forceps: History, Mystery, and Morality

The history of obstetrical forceps has almost always been one cloaked in controversy after a long history of being shrouded in mystery. Forceps have a long history and have evolved from facilitating the delivery of dead fetuses to aiding in the delivery and survival of live babies. In the middle of all of this arises the story of the Chamberlain family whose contribution was enormous but whose behaviors pushed at the envelope of (at least) our present-day concepts of medical ethics. This lecture traces an interesting story that spans a millennium.

Attitudes toward end-of-life decision making in South Texas

Advance care planning has the potential to create positive outcomes in the realm of end-of-life health care. The completion of advance directives and living wills are vital in equipping patients with autonomy and ensuring that their end-of-life wishes are respected. However, there remains a lack of knowledge and low completion rates of advance directives despite their possible improvements and ramifications on health care at the end of life. This study seeks to determine the knowledge of and attitudes towards end-of-life decision-making in South Texas. The study is designed as a cross-sectional, exploratory survey using a descriptive survey instrument to query 71 subjects in South Texas. The setting for the study includes three distinct groups, two in San Antonio, Texas and one in Brownsville, Texas. Unique differences in demographics between the three groups, such as variability in age, ethnicity, language and religious affiliation allowed for preliminary associations to be concluded in describing the results of the survey instrument. Ultimately, this study describes the attitudes and perceptions of advance care planning in South Texas and reveals the need for further education and awareness of the topic, perhaps indicating the need for a public health initiative in this regard.^

Attitudes and other barriers to the utilization of clinical research findings by American physicians: A systematic review

Background: The Institute of Medicine estimates that only a maximum of 25% of clinical research findings are incorporated into practice by physicians. To improve clinical practice, efforts have been made to promote evidence-based medicine and the use of clinical guidelines. Despite these efforts, the gap between research and clinical practice remains wide.^ Objective: To systematically review the literature describing the factors which influence the use of clinical research recommendations by American physicians.^ Hypothesis: Barriers exist in the application of clinical research into clinical practice, and are multifactorial. The establishment of the Clinical and Translational Awards (CTSA; special federal grants awarded to selected institutions to support clinical and translational research) has reduced the effect of these barriers and improved the process of clinical research translation into practice among American physicians.^ Aims: Identify barriers and facilitators of the use of research findings in clinical practice by American physicians. Contrast studies published six years before and after the creation of the CTSA.^ Methods: The sources of data include published literature from Medline, PubMed and PsycINFO. Selected studies must be qualitative, a survey of American clinicians, based on evidence-based medicine practice, clinical guidelines or treatment pathways. Systematic reviews and reports were excluded, as well as studies with less than 100 respondents.^ Results: In total, 1036 abstracts were reviewed; 115 full text potential articles were identified and reviewed, and a total of 31 studies met all criteria for inclusion in the final review.^ Conclusions: The barriers against the application of clinical research findings, in the forms of clinical guidelines, evidence-based medicine guides and clinical pathways, can be divided broadly into physician barriers, practice/system barriers and patient barriers. Physician barriers are the most common barriers, especially the lack of familiarity with guidelines and the lack of time. Of the factors which improve the use of research based guidelines, physician factors such as younger age, lower duration of clinical practice, specialty training, and practice in large group Health Maintenance Organization (HMO) settings with fewer patients seen were the most commonly cited.^

Clinical trials, informed consent, & emergency medicine: A systematic literature review

Background: In the United States, the Food and Drug Administration (FDA) regulates clinical trials. These regulations address good clinical practices as well as human subject protection (FDA, 2012). One of the most important legal and ethical concerns in clinical trials is informed consent. 21 CFR 50 governs human subjects research. Part 50.24 provides an emergency research exception to the informed consent requirement. Research was conducted to determine the appropriateness of this exception, whether the benefit justifies the exception, and its public health significance.^ Methods: A systematic literature review was conducted and articles were identified from peer-reviewed journals.^ Results: There is some variance in opinions regarding the appropriateness of the exception, but the literature reviewed found the study results of these trials justified the waiver.^ Conclusion: The exception to the informed consent requirement is likely appropriate and justified in emergency research when implemented within the specified guidelines.^

Ethical guidelines for the delivery of health services by DHEW : report and recommendations /

Includes bibliographical references

Ethical and legal considerations of patient care /

Mode of access: Internet.

Final report.

"October 1995"--p. iv. (supp. v. 1)

Health information resources.

Contains annotated bibliographies and directories of health care organizations.