Patients=92 Organisations, Science & Industry - the information is on various
European websites. I thought there might be individuals who might be
interested in some basic advice regarding ethics in research. I'm appending
a little description of what a FP7 project from Wikipedia below but the
advice could probably apply to lots of research (although different
countries or ethics boards may have specific requirements). Tom]
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Ethics Help Desk for FP7 Projects
An Ethics Help Desk for FP7 projects, providing information on issues and
offering consultation regarding the ethical aspects of research funded
under the programme has recently been launched DG Research. The goal of the
Help Desk is to support research participants to meet the EU and
international ethical standards related to the issues outlined in the
standard FP7 Ethics check list (see below).
Using this service, participants can receive advice from the Ethics Review
Sector of DG Research and also from experts in the ethics field concerned,
in order to reach their research objectives and meet the ethical
requirements for their work. Questions should be addressed to the Ethics
Help Desk Contact person, Isidoros Karatzas Isidoros.Karatzas@ec.eurpa.eu .
--
Checklist for projects involving interventions on humans, human biological
samples or genomic data
=95Describe the necessity of using patients/volunteers, personal data or
biological samples to achieve the objectives of the project, inlcuding a
description of potential alternatives. For research involving more than
minimal risk, additionally describe alternative therapies and insurance
issues.
=95Desribe the benefit/burden balance of the intervention: the benefits and
risks to the participants and the impact of the research on science and
society.
=95Describe the fate of samples and data at the end of the project; if these
are kept after the termination of the study, it must be explicitly
mentioned in the information sheet and informed consent form.
=95Describe how incidental findings are handled.
=95State whether any incentives are given.
=95Attach draft information sheets (describing the purpose and procedures of
the study, the risks and benefits for the participants, stating that
participation is voluntary and neither refusal or discontinued
participation has any negative effects).
=95Attach draft informed consent forms.
=95State conditions of information and receipt of informed consent.
=95List the countries where the research is taking place, the applying
legislation and the identification of the relevant ethical authority; if
available former approval of similar studies.
For research involving people not able to give informed consent, inlcuding
children:
=95Mention that the results cannot be obtained with people able to give
informed consent.
=95Ideally there is minimal risk and a direct benefit to the participating
individuals.
For research involving human embryonic stem cells (hESC):
=95Explain why alternatives to hESC (e.g. adult stem cells) are not
appropriate to reach the project goals (obviously not necessary for
projects aiming at comparing different types of stem cells).
=95Statet that research activities do not include the procurement of hESC.
=95Mention the country of orgigin of hESC and that procurement is legal under
the relevant legislation.
=95Describe the source of hESC according to the conditions of information,
receipt of informed consent and incentives.
Checklist for projects involving animals
=95Describe the application of the 3R principle:
=95Replacing animal testing: Describe the necessity to use animals at all and
animals of the given neurophysiological sensitivity to achieve the project
objectives.
=95Reducing the number of animals: Demonstrate efforts to reduce the number
of animals through e.g. careful experimental design including optimal
statistical testing and multiple useage of animals.
=95Refining the procedures to minimize suffering: Describe steps taken and
what happens to the animals at the end of the study.
=95List the countries where research on animals is carried out, the applying
legislation and identification of the relevant ethical and animal welfare
authority, if available former approval of similar studies.
=95List the species and number of animals used with a breakdown for each
study centre.
Important note:
The desciption of ethical issues is extremely context-dependent. We
strongly advice you contact the respective NCP for advice with the
description of ethical issues in your proposal.
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http://en.wikipedia.org/wiki/Seventh_Framework_Programme
Seventh Framework Programme
The Seventh Framework Programme for research and technological development
(FP7) is the European Union's chief instrument for funding research over
the period 2007 to 2013. It brings together all research-related EU
initiatives under a common roof playing a crucial role in reaching the
goals of growth, competitiveness and employment. CORDIS is the official
portal for participating in FP7 and following related developments in
European science and technology. As was the case for FP6, its main
objective is to further the construction of the European Research Area. Its
specific goals are fourfold:
To gain leadership in key scientific and technology areas
To stimulate the creativity and excellence of European research
To develop and strengthen the human potential of European research
To enhance research and innovation capacity throughout Europe
The total budget for FP7, including the non-nuclear research of the Joint
Research Centre, is 51 Billion euros over 7 years. The overall budget is
fixed, and the split of it along thematic priorities and the content of
those priorities was decided in November 2006.
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