Suchergebnisse

We surveyed irb chairs in the United States to ascertain whether their IRBs have clarity regarding their FDA-mandated role in reviewing humanitarian use device (HUD) applications, which are neither research devices nor fully tested treatments. Of 2,588 Chairs, 469 (18%) completed the survey, almost half of whom (44%) reported review of a HUD application within the previous five years. Findings suggest that many IRB Chairs are confused about what HUDs are, how to review HUD applications, and why IRBs should review them. We recommend that the FDA clarify their policies so that Chairs can provide the guidance necessary for IRBs to more effectively and consistently review HUD applications, and thereby better protect HUD-treated patients.

Part of a series that deals with papers and multi-authored volumes that advance the field of bioethics either by exploring new areas, or by taking new approaches to traditional areas, this book - divided in three sections - discusses the issues surrounding the topic in question and combines a theoretical thought process with practical application

The post-Communist countries of Central and Eastern Europe and Central Asia are at various stages of development with respect to their capacity to protect human research participants. We examined the impact of two Fogarty-funded programs in this region, the Union Graduate College–Vilnius University Advanced Certificate Program and the Case Western Reserve University Master's Degree Program, by surveying these programs' graduates and by examining alumni activities. Alumni have served in leadership roles on research ethics committees, developed and taught new courses in research ethics, and contributed to scholarship. However, political, social, and economic challenges impede the ability of graduates to maximize their effectiveness. Additional curricular attention is needed in research methodology, policy development and implementation, and the interplay between research ethics and human rights.

The post-Communist countries of Central and Eastern Europe and Central Asia are at various stages of development with respect to their capacity to protect human research participants. We examined the impact of two Fogarty-funded programs in this region, the Union Graduate College–Vilnius University Advanced Certificate Program and the Case Western Reserve University Master's Degree Program, by surveying these programs' graduates and by examining alumni activities. Alumni have served in leadership roles on research ethics committees, developed and taught new courses in research ethics, and contributed to scholarship. However, political, social, and economic challenges impede the ability of graduates to maximize their effectiveness. Additional curricular attention is needed in research methodology, policy development and implementation, and the interplay between research ethics and human rights.

Several training programs sponsored by the NIH/Fogarty International Center's International Research Ethics Education and Curriculum Development Program offer online graduate-level courses in research ethics to participants in low- and middle-income countries. This paper describes the evaluation of four of these online courses and recommendations for improvements to achieve the highest-quality design and delivery. We used an evaluation matrix consisting of 95 criteria based on recommended best practices in eLearning. Our results showed that these courses are developing or meeting nearly 73% of the criteria, while they are not meeting approximately 21% of the criteria. Together, one or more of the courses are developing or meeting 89 of the 95 criteria. These results suggest that the necessary skills and expertise exist in these programs to bring all of the eLearning courses close to 100% proficiency by sharing a common set of best practices. This paper is part of a collection of articles analyzing the Fogarty International Center's International Research Ethics Education and Curriculum Development Program.

Abstract Background In India, approximately 49,000 women living with HIV become pregnant and deliver each year. While the government of India has made progress increasing the availability of prevention of mother-to-child transmission of HIV (PMTCT) services, only about one quarter of pregnant women received an HIV test in 2010, and about one-in-five that were found positive for HIV received interventions to prevent vertical transmission of HIV. Methods Between February 2012 to March 2013, 14 HIV-positive women who had recently delivered a baby were recruited from HIV positive women support groups, Government of India Integrated Counseling and Testing Centers, and nongovernmental organizations in Mysore and Pune, India. In-depth interviews were conducted to examine their general experiences with antenatal healthcare; specific experiences around HIV counseling and testing; and perceptions about their care and follow-up treatment. Data were analyzed thematically using the human rights framework for HIV testing adopted by the United Nations and India's National AIDS Control Organization. Results While all of the HIV-positive women in the study received HIV and PMTCT services at a government hospital or antiretroviral therapy center, almost all reported attending a private clinic or hospital at some point in their pregnancy. According to the participants, HIV testing often occurred without consent; there was little privacy; breaches of confidentiality were commonplace; and denial of medical treatment occurred routinely. Among women living with HIV in this study, violations of their human rights occurred more commonly in private rather than public healthcare settings. Conclusions There is an urgent need for capacity building among private healthcare providers to improve standards of practice with regard to informed consent process, HIV testing, patient confidentiality, treatment, and referral of pregnant women living with HIV.