Concordance of International Regulation of Pediatric Health Research.

OBJECTIVE: To assess the comparability of international ethics principles and practices used in regulating pediatric research as a first step in determining whether reciprocal deference for international ethics review is feasible. Prior studies by the authors focused on other aspects of international health research, such as biobanks and direct-to-participant genomic research. The unique nature of pediatric research and its distinctive regulation by many countries warranted a separate study. STUDY DESIGN: A representative sample of 21 countries was selected, with geographical, ethnic, cultural, political, and economic diversity. A leading expert on pediatric research ethics and law was selected to summarize the ethics review of pediatric research in each country. To ensure the comparability of the responses, a 5-part summary of pediatric research ethics principles in the US was developed by the investigators and distributed to all country representatives. The international experts were asked to assess and describe whether principles in their country and the US were congruent. Results were obtained and compiled in the spring and summer of 2022. RESULTS: Some of the countries varied in their conceptualization or description of one or more ethical principles for pediatric research, but overall, the countries in the study demonstrated a fundamental concordance. CONCLUSIONS: Similar regulation of pediatric research in 21 countries suggests that international reciprocity is a viable strategy.

Streamlining ethics review for international health research.

Single-site review means protection and efficiency.

H3Africa: An Africa exemplar? Exploring its framework on protecting human research participants.

The Human Heredity and Health in Africa (H3Africa) Consortium is a conglomeration of research and infrastructure projects spread throughout Africa whose aim is to apply genomic methodology to diseases affecting the people in the region. Its operation is innovative in the sense that it is doing something new; that is, filling a hitherto existing void in genomic research capability of African scientists and infusing resources and manpower to institutions and investigators across Africa. But aside from developing and sustaining capacity in genomic research and biorepositories, H3Africa is also invested in developing appropriate ethical regulatory regime to govern research in these areas. This latter concern -research ethics governance - is the major subject of this paper. Specifically, the paper discusses protection of research participants as envisaged by H3Africa in the area of consent, safeguarding privacy, maintaining confidentiality of health information and sharing of data/biospecimens. The ultimate goal is to determine whether H3Africa initiatives and processes are consistent or at odds with international guidelines and best practices.

Biobank and Genomic Research in Uganda: Are Extant Privacy and Confidentiality Regimes Adequate?

Not many African countries have been able to develop a robust system for regulating health research within their respective jurisdictions, particularly in the realm of biobanking and genomics. This is not without reason. Aside from underdevelopment and all that it entails or perhaps in consequence thereof, countries in the region have been unable to make significant strides in medical research. But there are exceptions. Amongst the few seeming success stories is Uganda. Nonetheless, although the country has developed what appears to be a functional framework to govern genomic research and biobanking, the consistency of key provisions with international standards, especially those pertaining to privacy of research participants and confidentiality of their health information, is not at all clear. Yet, making this determination - the main objective of this article - is critical in determining the adequacy of protection available to human research subjects in the country.

Biobank/Genomic Research in Nigeria: Examining Relevant Privacy and Confidentiality Frameworks.

Nigeria's commitment to genomic research and biobanking is beyond dispute. Proof, if there is need for one, is that the country is one of only six nations (others are Canada, China, Japan, the United Kingdom, and the United States) involved in the International HapMap Project. The HapMap Project is an innovative enterprise aimed at developing a haplotype map of the human genome, a tool that is helpful to studying the genetic basis of disease as well as the genetic or hereditary factors that contribute to variation in response to environmental factors, in susceptibility to infection, and in the effectiveness of, and adverse responses to, drugs and vaccines. In addition, the country is home to H3Africa biobank (with 45, 358 human samples in storage), affiliated with the Institute of Human Virology of Nigeria (IHVN), and several others. Benefits accruing from genomic research and biobanking are enormous; so also is protection of research subjects. The protection envisaged centers primarily on, inter alia, securing informed consent, safeguarding privacy and maintaining confidentiality of health information - all of which are enshrined in ethicolegal regimes in Nigeria. But whether these frameworks are consistent with international best practices is not at all clear, hence the need for this paper.

MATERNAL HEALTH AND MILLENNIUM DEVELOPMENT GOAL (MDG) 5 IN NIGERIA: ANY CATALYTIC ROLE FOR HUMAN RIGHTS?

Despite Nigeria's ratification of virtually all human rights instruments recognizing health as a human right and endorsement of the Millennium Declaration, the state of maternal health in the country remains atrocious. That the country is not on pace to meet its obligations under Millennium Development Goal (MDG) 5 (to reduce the maternal mortality ratio (MMR) by three quarters in 2015, using 1990 as a base year, and achieve univeral access to reproductive services) is no longer news. What is perhaps newsworthy and that is because of their significance to repositioning the country on course toward the MDG, are three concers, namely, the factors constratining progress to acceptable maternal health in the country; the interventions needed to reverse the status quo; and, finally, the question, thether and how human rights could play a catalytic role in the process. Addressing these concerns is the major objective of this paper.

UNITED NATION'S RESOLUTION ON ELIMINATION OF FEMALE GENITAL RITUAL: A LEGITIMATE RESPONSE TO A HUMAN RIGHTS PROBLEM OR WHAT?

A recent United Nations' (U.N.) Resolution, "Intensifying Global Efforts for the Elimination of Female Genital Mutilations," urging all countries to enact legislation outlawing female circumcision or female genital ritual (FGR) signals a disturbingly new frontier in the polemic surrounding the ancient cultural practice. Never before has the apex global institution lent its imprimatur to a project whose foundation is profoundly muddled in uncertainties and murkiness. That the Resolution received an instantaneous and near-universal acclaim as a necessary protective weapon against supposed assault on the human rights of women is not news. After all, aside from essentially validating extant legislative frameworks in several countries, the proclamation fits seamlessly with decades-long agitations of activists, scholars and media pundits of one stripe or the other. What is absurd--indeed, the real news--is continued neglect of calls for a rethinking of the criminalization fervor currently gripping the world, for a reassessment of the evidence trumpeted by abolitionists as justificatory of their unbridled interference in what practicing communities revere as a sacred cultural rite. Relying on the premise that claims regarding harmful impact of FGR, the fulcrum upon which eradication forces depend for their activism, cannot be substantiated, this paper argues that prohibitory regimes based thereon, whether at the U.N. or country level, is per se a violation of the human rights of the women purportedly sought to be protected. Human rights (including, in this case, its self-appointed "apostles"), cannot, as a popular Igbo maxim admonishes, become "outsiders who wept louder than the bereaved." This is the prism from which this paper analyzes the on-going supranational crusade to suppress FGR. It is a critique of extant FGR legal and policy regimes, an instance of which is the U.N. Resolution, as unrepresentative of legitimate advancement of human rights.