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H3 Africa: Ethical, Legal and Societal Issues (ELSI) Research Program

Notice of Intent to Publish Human Heredity and Health in Africa
(H3Africa): Ethical, Legal and Societal Issues (ELSI) Research Program FOA
--------------------------------------------------------------------------------

The NIH Common Fund, in collaboration with the Wellcome Trust, will
shortly be funding the Human Heredity and Health in Africa (H3Africa)
initiative which was launched in 2010. H3Africa was designed to
facilitate a contemporary research approach to the study of the genomic
and environmental determinants of common diseases in Africa, with the goal
of improving the health of African populations. The goals of H3Africa are
to enhance the necessary genomic expertise among African scientists, and
to establish networks of African investigators by supporting
infrastructure development and research projects to address health
inequities in both communicable and non-communicable diseases that will
eventually lead to health benefits in Africa. More information about the
H3Africa initiative and a white paper with recommendations for the program
can be found at www.h3africa.org.

This is a Notice of intent to publish a new FOA, the H3Africa ELSI
Research Program, which will be issued in late spring/early summer 2012.

The new FOA, RFA-RM-12-005, entitled Human Heredity and Health in Africa
(H3Africa): Ethical, Legal and Societal Issues (ELSI) Research Program
(U01) will be published in late spring/early summer 2012. The purpose of
the FOA entitled H3Africa ELSI Research Program, is to encourage
applications that identify, examine and address the ethical, legal and
societal issues likely to arise from genomic research and technology for
individuals, families, communities and societies throughout the African
continent. It is anticipated that the H3Africa ELSI Research Program will
help to minimize potential harm and maximize capacity of African
communities to partake of the expected benefits of improved prevention,
diagnosis, and treatment of disease that will potentially occur from
genomic research in Africa.

Finally, it is critical that all parties interested in applying for the
H3Africa FOA complete the required registrations now in order to be ready
to submit an application when the FOA is published. The following
registrations must be completed before an application can be submitted to
NIH: Data Universal Numbering System ( DUNS)
http://fedgov.dnb.com/webform/index.jsp, NATO Commercial and Government
Entity Code (NCAGE Code) http://www.dlis.dla.mil/Forms/Form_AC135.asp,
Central Contractor Registration (CCR)
https://bpn.gov/ccr/international.aspx , eRA Commons
https://public.era.nih.gov/commons/commonsInit.do and Grants.gov
http://grants.gov/applicants/get_registered.jsp .

There is no monetary fee
for any of the registrations. Applicants must allow at least 8 weeks for
the completion of all the required registrations. Applicants already
registered should verify that the principal investigator is registered in
eRA Commons and is affiliated with the institution and should ensure that
the institution's CCR registration, which must be renewed every 12 months,
is up to date. Additionally all institutions should ensure that the
Authorized Organization Representative/Signing Official has delegated
signatory authority to several institutional officials in order to assure
access to all required application systems throughout the application
process. Applicants who encounter difficulty during any of the
registrations should contact H3Africa staff immediately at
H3Africa@nih.gov for assistance. After successful completion of all
required registrations applicants should plan to begin the electronic
submission at least one week prior to the deadline in the FOA or if the
application must be submitted on paper must allow adequate time in order
to ship it to the United States to allow it to arrive by the deadline
stated in the FOA. Applicants should be aware of the timelines involved,
late applications WILL NOT be accepted, no exceptions will be made.

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all inquiries to:

Ebony Bookman, Ph.D.
Jean McEwen, Ph.D.
H3Africa Program Staff
National Human Genome Research Institute (NHGRI)
National Institutes of Health
Email: H3Africa@nih.gov

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Bookmarked by Editorial Team on 6 Jun 2012
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Global Forum Stakeholders Meeting in Rotterdam

The NIH Fogarty International Center, the Wellcome Trust, and the UK Medical Research Council are planning an informal stakeholders meeting to discuss reinstating the Global Forum on Bioethics in Research. The meeting is scheduled for 6 - 7.30pm on Thursday 28th June at the World Congress of Bioethics in Rotterdam.

ATTENDEES AT THE WORLD CONGRESS WHO WOULD LIKE TO JOIN THIS MEETING SHOULD EMAIL JOE MILLUM (JOSEPH.MILLUM@NIH.GOV).

The Global Forum on Bioethics in Research (GFBR) was established in 1999, and for 10 years served as the principal global platform for debate on ethical issues surrounding international health research. The Forum brought together researchers, policy makers, community members, and ethics experts from developing and developed nations at its meetings. Its purpose was to provide an open and transparent dialogue between delegates from the global north and south about the ethical challenges that they face. In 2008, the GFBR was put on hold, in order to re-think the role, format and governance of the GFBR.

We are now looking to discuss the future scope and direction of a re-instated GFBR with stakeholders and people who are likely to participate in or benefit from a revised GFBR. At the stakeholders meeting, we would like to explore what the function of the GFBR should be; what type of Forum is preferable and what are the current key ethical issues in global health that the GFBR might help to address. We would greatly welcome your views on the Forum and hope you will be able to attend.

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Bookmarked by Editorial Team on 25 Jun 2012
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ARESA Newsletter June 2012

In the link please find the second ARESA newsletter. It should be of interest to researchers and Research Ethics Committee members.

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Bookmarked by Editorial Team on 25 Jun 2012
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About MRCT | Multi-Regional Clinical Trials (MRCT)

The MRCT Center at Harvard is a new initiative to improve the design, conduct, and oversight of multi-regional clinical trials. The Center has a focus on trials involving the developing world:

To simplify research through the use of best practices;
To foster respect for research participants, efficacy, safety and fairness in transnational, trans-cultural human subject research.

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Bookmarked by Susan Bull on 29 Jan 2013
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Experts give top concerns on genetic tests

Written by John Donnelly on February 2, 2012

In the final session today before the Presidential Commission for the Study of Bioethical Issues, Chair Dr. Amy Gutmann asked all the experts who presented information to talk about their greatest concern with genetic tests.

Gutmann, the President of the University of Pennsylvania, told them: “The Commission is very likely to focus its report on issues of privacy broadly construed. Anything that is relevant to privacy would be of great interest to the Commission.”

Among the responses:

Jane Kaye, Director of the Centre for Law, Health and Emerging Technologies at Oxford University: “I would say I see the whole genome sequencing is another twist on things happening already on science. … What we need to do is make (privacy concerns) more nuanced and allow individuals to say how whole genomes are used.”

See link for the rest of this blogpost

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Bookmarked by Dina Bogecho on 9 Feb 2012
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