June 29, 2006
In June 2000, the Indian Minister of Health and Family Welfare and the U.S. Secretary of Health and Human Services (HHS) signed a Joint Statement on Maternal and Child Health and Human Development Research (MCHDR) to cover an initial five-year period. The success of the various programs undertaken under the umbrella of the Joint Statement demonstrates the value of this cooperation, including four workshops, four Joint Working Group meetings, and ten collaborative research projects.
This Joint Statement grew out of a shared commitment to improve the health and well-being of women, children, and adolescents in both countries through the expansion of cooperative biomedical and behavioral research. Although the health of women, children, and adolescents has improved in both countries, many important research questions need answers to help reduce morbidity and mortality. Therefore, HHS and the Ministry of Health and Family Welfare of the Republic of India, hereafter referred to as "the Participants," intend to renew the Joint Statement in the field of MCHDR, as outlined below:
The Participants intend to promote and develop cooperation in the fields of maternal and child health research, treatment and care, infrastructure development, training, and capacity-building, on the basis of reciprocity and mutual benefit. The following identifies the principal Government Departments and agencies on both sides:
Government of India Implementing Ministries and Agencies:
*Indian Council of Medical Research (nodal agency);
*National AIDS Control Organization;
*Ministry of Health and Family Welfare;
*Ministry of Science and Technology/Department of Biotechnology; and
*Ministry of Women and Child Development.
U.S. Government Implementing Departments and Agencies:
•U.S. Department of Health and Human Services
•HHS National Institute of Child Health and Human Development (lead agency);
In addition to the Government Departments and agencies identified above, there could be other participants in the program. These participants can include individuals and institutions in the public and private sectors, State and local Governments in both countries, and other entities, as identified by the Participants.
The goal of the MCHDR program is to facilitate collaboration on research into maternal and children's health and human development, in part, to contribute to the global understanding of the causes of morbidity and mortality in women, particularly mothers, children and adolescents. The main areas of cooperation are likely to include, but might not be limited to the following:
• The prevention and treatment of the leading causes of maternal, neonatal, and pediatric morbidity and mortality (including infection and its complications, toxemia, hemorrhage, sepsis, birth asphyxia and trauma, accidents, diarrhea and other infectious diseases, etc.);
• The prevention and treatment of low birth weight and intrauterine growth retardation;
• Maternal and child nutrition and the role of micronutrients in healthy child-bearing and pediatric and adolescent health and development;
• Birth defects, genetic disorders, developmental disabilities (e.g., autism spectrum disorders, conditions that contribute to mental retardation) and factors that affect normal cognitive/behavioral development;
• Improved understanding of the prevention and treatment of infectious diseases in women and children, including acute respiratory-tract infections, gastrointestinal infections, reproductive-tract infections, malignancies, and HIV/AIDS;
• Reproductive health, including socio-behavioral aspects and birth practices;
• Traditional systems of medicine and practices that have an important effect on the health and well-being of women, children, and adolescents;
• Emergency obstetric care for miscarriages and other problems of pregnancy, including severe pre-eclampsia, hemorrhage, and embolism;
• The relationship among maternal nutrition, fetal growth/development, and degenerative diseases in later life; and
• Analysis, consensus-building, and policy formulation on the public-health benefits of new approaches to improve maternal and child health.
In addition, since the 2000 Joint Statement, the Participants have suggested placing greater emphasis on "translational research," i.e. the development and delivery of high-priority MCH-related interventions and operational research, to identify best approaches for implementation as well as potential obstacles. Work under this Joint Statement should also emphasize studies that address social and behavioral factors that affect the prevention, care, and treatment of disease/poor health in women, infants, and children. Several potential areas of focus have emerged in this regard. These include studies that address risk factors, prevention, and treatment for the following:
•Conditions associated with maternal morbidity and mortality in India (e.g., pre- and
post-natal complications; infectious diseases, including HIV infection; and malnutrition);
•Adverse birth outcomes, including low birth weight, intrauterine growth retardation, and
other risk factors for infant morbidity and mortality; and
•Pediatric infection, including, but not limited to, respiratory-tract infections, diarrheal diseases, and HIV infection.
Cooperation between the Participants may include, but might not be limited to, the following:
a. Increased collaboration among scientists between the two countries to conduct research
and research training related to maternal and child health, including basic scientific,
clinical, and operational studies;
b. Information and scientific exchanges, and the sharing of experiences;
c. Attendance at professional and scientific meetings by specialists from both countries;
d. Direct links between appropriate institutes and institutions in both countries;
e. Increased bilateral cooperation on issues pertaining to maternal and child health, including strategies and interventions focused on the prevention and care of illness in women, mothers, infants, and children; and research at the global level;
f. Renewal of a Joint Working Group (JWG) to continue to develop strategic plans for collaboration and to ensure the expedited review and clearances of funded bilateral projects; and
g. Conceptualization of processes for the establishment of Centers of Excellence in research, training, and public health, which should foster collaboration in basic, applied, and epidemiologic investigations.
The Indo-U.S. MCHDR JWG should meet at least once a year. The JWG is to consist of
representatives from each of the Governmental Departments and agencies, and other individuals, as deemed necessary and appropriate. Each side should designate an individual to co-chair the JWG and communicate the names of the co-chairs in advance of each meeting. The JWG should do the following:
a. Review program plans and recommend new areas of cooperation, based on recommendations from technical workshops and collaborating scientists;
b. Recommend measures to both Governments to ensure the program operates smoothly; and
c. Address issues that require joint resolution that the Participants cannot address effectively outside of the JWG
The Participants should undertake all activities pursuant to this understanding in accordance with the laws and regulations of the United States of America and the Republic of India, subject to the availability of personnel, resources, and appropriated funds. The Participants expect to develop steps for implementing this understanding through mutual consultations to follow the signing of this Joint Statement.
Both Governments acknowledge the importance of the protection of human subjects in any research, public-health or medical program. In recognition of this, both the Republic of India and the United States of America have adopted laws and regulations on the protection of human subjects and intend to follow the same.
Both Participants recognize the work carried out under this Joint Statement can produce patentable results, and lead to the publication of scientific findings. The provisions of the Agreement on Science and Technology Cooperation between the Governments of the United States of America and the Republic of India, signed on October 17, 2005 should govern the allocation of such intellectual property, copyright, and patent rights.
Both Participants encourage scientists on both sides to publish, both jointly and as individuals, their findings. In any publication specifically related to work undertaken in areas covered by this Joint Statement, Participants should make an appropriate reference to the Joint Statement.
Both Participants recognize work under this Joint Statement can involve numerous exchanges of administrative and scientific personnel throughout each year. Both Participants should seek the necessary clearances (exit permission by the sending country and visa issuance by the receiving country) on a priority basis, subject to their respective laws and regulations.
This Joint Statement is effective on the date of signature, and will remain effective for five years, after which both Participants may renew it by written concurrence.
Signed on the 29th day of June, 2006, in Washington, D.C., with two originals in English language.
MINISTRY OF HEALTH AND FAMILY WELFARE OF THE FOR THE DEPARTMENT OF HEALTH REPUBLIC OF INDIA AND HUMAN SERVICES UNITED STATES OF AMERICA