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US IRBs face challenges in applying ethical principles and regulations regarding research being conducted in the developing world, highlighting needs for education.

Dear Colleagues,

The June 2012 issue of Bioethics Links, the CBEC newsletter, is now available at the following link: http://www.siut.org/bioethics/NewsletterJune2012.html

For this issue of Bioethics Links we invited our international teaching faculty (Dr. Ramanathan, India) and students (Dr. Bukusi, Kenya, Dr. Kolambage, Sri Lanka) to write about their impressions of CBEC programs and being in Karachi. Also included are commentaries by Dr. Khan (AKU, Karachi) and Dr. Ismatullah (International Islamic University, Islamabad) who audited our Research Ethics module, an essay by PGD student Dr. Faheem, and reports about bioethics activities in Peshawar.

Happy Reading!

Aamir Jafarey
Associate Professor
Centre of Biomedical Ethics and Culture, SIUT
Karachi 74200, Pakistan
Phone (92 21) 3272 6338
Fax (92 21) 3520 6738

Anika Khan
Senior Lecturer
Centre of Biomedical Ethics and Culture, SIUT
Karachi 74200, Pakistan
Phone (92 21) 3272 6338
Fax (92 21) 3520 6738

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