EUROPE
Training and Resources in Research Ethics Evaluation (TRREE)
Type of training/training methods
TRREE is a free and open access online training program on research ethics and regulation. TRREE's learning material is currently available in English, French, German, Polish and Portuguese. It also provides access to the national regulation in the participating countries. The training is modular. It includes an introduction to research ethics (module 1), a module on the role and responsibilities of Research Ethics Committees (module 2.1), several modules on the national regulation in given countries from the North and the South (module 3) and a detailed module on informed consent (module 4). TRREE has been recognized as continuing program by the Swiss Medical Association (FMH) and the Swiss Pharmacists Association (FPH).
Target audience and charges
While some modules may focus on more specific training needs of research ethics committee members, or research teams including investigators, nurses, or study coordinators, the training is open to all and may be of interest to health authorities, funding agencies and universities, as well as to political authorities, patients and the media. Free of charges.
External Links
English and Portuguese Research Ethics Training Programs
Type of training/training methods
Online training (lectures, case studies, self-test multiple choice questions). Each module has its own case studies.
Target audience and charges
All the interested parties, the target groups are not specified. Free of charge.
External Links
The Vienna School of Clinical Research (Austria)
Type of training/training methods
Training courses (lectures, workshops) on different topics related to clinical research. ("The course modules have been designed to offer as broad a range of subjects within clinical research to as many different disciplines working within this field as possible").
Target audience and charges
Investigative Staff - Physicians, Nurses and Support Staff ; Industry Personnel - Clinical Research Associates, Industry Physicians; Ethics Committee Members Healthcare Decision Makers. Free access to the contents and description of the courses; paid participation.
External Link
Educational and Training materials in Polish
A free and open access online training program on research ethics and regulation in Polish is available at: elearning.trree.org
Guidelines:
- Deklaracja Helsińska wersja 2013
- Europejska Konwencja Bioetyczna (Oviedo Convention)
- Protokół Dodatkowy do Europejskiej Konwencji Bioetycznej w sprawie zakazu klonowania istot ludzkich
- Zasady Prawidłowego Prowadzenia Badań Klinicznych (Good Clinical Practice)
- Raport z Belmont (Belmont Report)
- Kodeks Etyki Lekarskiej, 2003
- Kodeks Etyki Pracownika Naukowego
- Dobra Praktyka badań naukowych – Rekomendacje, 2004
Handbooks and manuals:
- Poradnik dla członków komisji etycznych do spraw badań naukowych
- Galewicz W. (red.) Badania z udziałem ludzi, Universitas, 2011, Kraków
- Różyńska J, Waligóra M.(red): Badania naukowe z udziałem ludzi w biomedycynie. Standardy międzynarodowe. Lex, 2012, Warszawa
- Galewicz W. Status ludzkiego zarodka a etyka badań biomedycznych. Wydawnictwo Uniwersytetu Jagiellońskiego, Kraków 2013
- Galewicz W. (red.) Etyczne i prawne granice badań naukowych, Universitas, 2009, Kraków
- Wnukiewicz-Kozłowska A. Eksperyment medyczny na organizmie ludzkim w prawie międzynarodowym i europejskim. Dom Wydawniczy ABC, 2004, Warszawa
- Grzymkowska M Standardy bioetyczna w prawie europejskim, Oficyna, 2009, Warszawa
- Walter M.(red) Badania kliniczne. Organizacja, nadzór, monitorowanie. Oinpharma, 2004, Warszawa
- Śliwka M. (red) Prawo badań klinicznych w zarysie. TNOiK Dom Organizatora, Toruń, 2013
- Czarkowski M, Różyńska J: Poradnik dla badacza: Świadoma zgoda na udział w eksperymencie medycznym, Ośrodek Bioetyki NIL 2008 Warszawa
- Łagocka I, Maciejczyk A.(red.): Nadzór nad bezpieczeństwem farmakoterapii. Pharmacovigilance. Oinpharma, 2008, Warszawa
- Czarkowski M. Zasady prowadzenia badań na ludzkim materiale biologicznym Polski Merkuriusz Lekarski 2009, 160: 349-352
- Encyklopedia bioetyki. Polwen, 2009, Radom.
- Czarkowski M. Analiza działalności polskich komisji bioetycznych opiniujących projekty eksperymentów medycznych, Warszawski Uniwersytet Medyczny, 2010, Warszawa
NORTH AMERICA
Family Health International, USA
Type of training/training methods
On-line tutorial. 4 hours. Covers cases on:
- Respect for Persons
- Beneficence and Justice
- Informed Consent
- Ethics Committee Considerations
- Research with Minors
- Principles of Research Ethics
- Community participation
- Inducement / Compensation
- Social risks
- Individual versus Community Consent (All cases are available on the web)
Target audience and charges
Researchers and all other interested parties. Free of charge.
External Link
http://www.fhi.org/training/en/RETC2/RETCTraditional/intro.html
University of Maryland School of Medicine MERETI program
Type of training/training methods
On-site training (lectures, workshops, practical assignments) 2 months of on-site studies (4 hours a day) and 10 months performance of a project in research ethics in trainee's home country. Covers cases on practical experiences in the ethical review of research protocols.
Target audience and charges
Physicians, nurses, scientists, members of research ethics committees, social scientists, philosophers, and other individuals with appropriate backgrounds and interests in health research or ethics, Research investigators, IRB/Ethics Committee members and research staff. Free access to the contents and description of the course. Scholarships are available to fund travel, living expenses, and course fees, but are limited.
External Link
CITI program
Type of training/training methods
On-line course (more than 20 thematic modules; includes self-test quiz). About one hour to read one module and answer the quiz questions. Each module includes cases.
Target audience and charges
Investigators and all other interested parties. Paid participation.
External Link
National Institute of Health (NIH) Department of Bioethics
Type of training/training methods
On-site training (Lectures, discussions, readings, CD) 7 sessions of 3 hours. Several presentations include case analysis.
Target audience and charges
The course is offered to anyone interested or involved in clinical research involving human subjects. Free access to the contents and description of the course and to the presentation slides, free participation.
External Link
Québec health and social services network Canada
Type of training/training methods
On-line tutorial (lectures, case studies, normative texts, tools for decision making). Each module takes approx. 20 minutes. Each course module includes cases adapted to the topic.
Target audience and charges
Research ethics board (REB) members and support staff who work in the institutions of the Québec health and social services network as well as the institutions, administrators, government who are involved research ethics review for the purpose of ensuring the protection of research participants and promoting ethical conduct that demonstrates respect for individuals. Free participation.
External Link
http://ethique.msss.gouv.qc.ca/didacticiel/index.php?lang=en
