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PrzeglÄ…d stron zagranicznych :
Badania kliniczne :
Badania biomedyczne :
Bioetyka / Etyka medyczna :
Etyka stosowana i zawodowa :
Etyka :
powrót
Instytucje i organizacje
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- EFGCP – “The European
Forum for Good Clinical Practice (EFGCP) was founded during a conference at the
European Parliament in 1993 with the support of the European Commission. Since
its creation, EFGCP has functioned as a leading European think tank for
discussion, research, and critical evaluation in the development of European
health research.”
- European
Network for Research Ethics Committees ( EURECENT) – “EURECENT is a network
that brings together national Research Ethics Committees (REC) associations,
networks or comparable initiatives on the European level. The network
interlinks European RECs with other bodies relevant in the field of research
involving human participants like National Ethics Councils and the European
Commission`s ethical review system. Such a network forms the infrastructural
basis to promote awareness of specific working practices of RECs across Europe, to enhance the shared knowledge base of European RECs, to support coherent reviews
and opinions and to meet new challenges and emerging ethical issues. The central
objective of EUREC as a Coordinating Action is to foster the already existing
network of European REC networks.”
- FDA – The website of U.S.
Food and Drug Administration.
- NIH Human Research
Protections Program – “The National Institutes of Health (NIH) established
the Human Research Protections Program (HRPP) to protect the rights and
safeguard the welfare of human subjects who participate in the NIH Intramural
Research Program (IRP). The NIH IRP HRPP is made of NIH officials, 27 NIH
Institutes and Centers, 12 Institutional Review Boards (IRBs), and researchers
and staff who conduct and support research involving human subjects.”
- CIOMS – “The Council for
International Organizations of Medical Sciences (CIOMS) is an international,
non-governmental, non-profit organization established jointly by WHO and UNESCO
in 1949. (...) Through its membership, CIOMS is representative of a substantial
proportion of the biomedical scientific community. The membership of CIOMS in
2010 includes over 55 international, national and associate member
organizations, representing many of the biomedical disciplines, national
academies of sciences and medical research councils.”
- NIH
Clinical Center Department of Bioethics – “The NIH Clinical Center is the world`s largest
research hospital and has been the site of NIH clinical research for over 50
years. A bioethicist first served the needs of the NIH research community in
1977. However, when John Gallin became director of the Clinical Center in 1995, bioethics became a major initiative. This single ethics position became a
full-fledged program, with the goal of creating a premier center for bioethics
that would complement and inform the NIH`s cutting-edge program of biomedical
research. In this stimulating environment of scientific discovery and
burgeoning new technologies, the Department of Bioethics has flourished,
wrestling with major policy issues, offering educational and clinical services,
and developing numerous research projects to help advance and inform public
policy debate.”
- The
Department of Energy (DOE) and its Human Subjects Protection Program – “The
protection of human subjects in all the research performed under Department of
Energy (DOE) authorities is of prime importance to the Department. All research
conducted at DOE institutions, supported with DOE funds, or performed by DOE
employees, including research that is classified and proprietary, whether done
domestically or in an international environment, must comply with all federal
regulations and DOE requirements that address the protection of human
subjects.”
- IRB forum –
“(previously known as "MCWIRB") promotes the discussion of ethical,
regulatory and policy concerns with human subjects research. The IRB Forum
strives to create an atmosphere for open and respectful conversation about
issues of mutual interest to the members.”
- clinicaltrials.gov
– “ClinicalTrials.gov is a registry and results database of
federally and privately supported clinical trials conducted in the United
States and around the world. ClinicalTrials.gov gives you information about a
trial`s purpose, who may participate, locations, and phone numbers for more
details.”
- SoCRA – “The Society of
Clinical Research Associates, Inc. is a non-profit, professional organization
dedicated to the continuing education and development of clinical research
professionals.”
- CenterWatch – “At
CenterWatch, our mission is to be the leading source of clinical trials
information for both clinical research professionals and patients. To support
our mission, we offer several professional, educational and informative
services and resources from news and analysis on the industry to trial listings
seeking study volunteers.”
- CDISC
– “CDISC is a global, open, multidisciplinary, non-profit organization that has
established standards to support the acquisition, exchange, submission and
archive of clinical research data and metadata. The CDISC mission is to develop
and support global, platform-independent data standards that enable information
system interoperability to improve medical research and related areas of
healthcare. CDISC standards are vendor-neutral, platform-independent and freely
available via the CDISC website.”
- OHRP – “The Office
for Human Research Protections (OHRP) provides leadership in the protection of
the rights, welfare, and wellbeing of subjects involved in research conducted
or supported by the U.S. Department of Health and Human Services (HHS). OHRP helps
ensure this by providing clarification and guidance, developing educational
programs and materials, maintaining regulatory oversight, and providing advice
on ethical and regulatory issues in biomedical and social-behavioral research.”
- ClinicalTrials.com
– “ClinicalTrials.com is a comprehensive resource for trusted information about
medical research studies, also called clinical trials. Whether you’re
interested in participating in a clinical trial or want to become a clinical
trial investigator, find out how you can help advance health.”
- Office
of Good Clinical Practice – “The Office of Good Clinical Practice is the
focal point within FDA for Good Clinical Practice (GCP) and Human Subject
Protection (HSP) issues arising in human research trials regulated by FDA.”
- ICTRP – “The
mission of the WHO International Clinical Trials Registry Platform is to ensure
that a complete view of research is accessible to all those involved in health
care decision making. This will improve research transparency and will
ultimately strengthen the validity and value of the scientific evidence base. The
registration of all interventional trials is a scientific, ethical and moral
responsibility.”
- Clinical
Research Administrative Office (CRAO) – “This portal is intended as a
resource for the clinical research programs of the Case Comprehensive Cancer
Center. The portal gives researchers access to the necessary forms and
information about the requirements to conduct clinical research as well as links
to a number of useful sites.”
- KCR – “KCR is a leading
European CRO headquartered in Warsaw, Poland. We have extensive experience in
conducting clinical trials for pharmaceutical, biotechnology, medical device and
food supplement companies.”
- Wojewódzki
Szpital Specjalistyczny we WrocÅ‚awiu – “Our aim is to conduct clinical
trials according to the Good Clinical Practice (GCP) guidelines developed by
the International Conference on Harmonisation (ICH) and the principles
contained in the World Medical Association Declaration of Helsinki on the
‘Ethical Principles for Medical Research Involving Human Subjects’.”
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