Re-Emphasizing African Bioethics in Light of Potential CRISPR-Based Treatment for HIV and Sickle Cell Disease.

• Author: Daniel, Taylor

TABLE OF CONTENTS I. INTRODUCTION 460 IT. BACKGROUND 463 A. International Human Rights Develops into Bioethics of Genetic Modifications 463 B. The Severity of HIV and Sickle Cell Disease in 466 C. The Advent of CRISPR and Its Use in HIV and Sickle Cell Treatment 468 D. The International Bioethics Community Responds to CRISPR 471 III. ANALYSIS 473 A. Academic Debate about African Bioethics 474 B. International Frameworks Do Not Properly 477 1. Traditional Communitarianism and Accepted Individualism 478 2. Informewd Consent 480 C. Examination of Bioethics in Three African Nations 481 1. Nigeria--Push for Ethical Infrastructure Following Pfizer 482 2. Cameroon--Educational Lag and Dispersed Leadership 483 3. Tanzania--Economic Disparity and Concerning Views of Women 484 IV. SOLUTION 485 A. Incorporating Communitarianism, Modifying Informed Consent, and Rejecting Global Outsourcing 486 B. Accelerating Domestic Bioethics Laws and Education 490 V. CONCLUSION 493 I. INTRODUCTION

A 1996 Pfizer study of unapproved drugs in Nigeria resulted in the deaths of several children and injured many more. (1) In 1996, Nigeria was struggling with a severe outbreak of spinal meningitis. (2) Seizing this opportunity for clinical research, Pfizer began to test its experimental drug, Trovan, on Nigerian children. (3) The group exposed to the experimental drug was comprised of children between infancy and eleven years of age, a group that traditionally cannot give consent. (4) The parents of these children were largely illiterate and were only given incomplete oral translations of the consent documents. (5) By the end of the Trovan trial, eleven Nigerian children died and many more suffered brain damage and paralysis. (6) The Pfizer trial illustrated the evasion of ethical ideals that is acute in Africa's developing countries, where researchers can avoid stringent ethics regulations due to lagging bioethics regulations and education. (7) The 1996 Pfizer trials tragedy, coupled with the incredibly high incidence of Human Immunodeficiency Virus (HIV) and Sickle Cell Disease (SCD) in African nations, suggests that African research participants could be vulnerable to premature or unethical use of technology to treat HIV and SCD. (8)

The global regulatory scheme of bioethics, which was born out of international human rights law, has attempted to keep pace with increasingly complicated biotechnology. (9) Currently, drafters of international bioethics frameworks have been struggling to address the use of CRISPR-Cas9 (CRISPR) as a potential treatment for some of the world's most prevalent diseases. (10) Ethically contentious experiments, like the 2018 "designer baby" experiment in China, prove that the world needs cognizable and culturally-applicable regulations regarding both somatic and germline use of CRISPR. (11) When adjusting the current ethics frameworks to address this challenge, global bodies should reassess the underlying assumptions of "global" ideas of ethics to ensure easy applicability throughout the world. In this reassessment, the countries that are at the forefront of ethics discussions (Western countries, generally) should listen to and incorporate non-Western ethics.

CRISPR-based treatment for HIV and SCD must be regulated at a global level that incorporates African ethics because this ethically sensitive topic will strongly affect Africa. Although it is difficult to develop a distinctly African view of ethics, as African nations contain many different cultures, some generalized concepts can be drawn from traditional African cultures. (12) One central concept is communitarianism, which is much more prevalent in African cultures than in Western countries. (13) Rather than focusing solely on individual rights, communitarianism emphasizes the role and responsibilities of the individual as a member of many different communities. (14) Most international bioethics agreements foundationally prioritize individualism. (15) However, it is imperative that drafters of future international bioethics agreements thoroughly consider African ideas, such as communitarianism, if CRISPR treatments will be used to treat HIV and SCD. (16) Complicating this view, however, is intense disagreement about African bioethics itself.

Global outsourcing--choosing to organize clinical trials in developing nations to both take advantage of lax ethics systems and evade the stricter ethics laws and regulations of developed nations--is of both historical and contemporary concern. (17) To ensure the safety of non-Western research participants, drafters must take care to incorporate African ethics and account for application in developing nations. Additionally, with the constant advancements of CRISPR technology, African nations should accelerate the passage of laws regulating the use of germline editing. (18) In conjunction with legal systems, African medical professionals should be increasingly aware of international frameworks and engage frequently in normative assessments of the nation's bioethical models. (19)

Following this brief introduction, this Note proceeds in four parts. First, this Note analyzes the development of international bioethics from its human rights origins, the HIV and SCD crises in Africa and the application of CRISPR to these diseases, and how international bioethics bodies have addressed CRISPR so far. The foundational tenets of international bioethics agreements are not particularly inclusive of traditional African beliefs, as evidenced by problems with bioethical research in Nigeria, Cameroon, and Tanzania. The proposed solution is multifaceted: a global reexamination and reclassification of the tenets of bioethics to better incorporate non-Western cultural ideas in conjunction with the accelerated establishment of domestic legal frameworks and education in developing African nations.

2. BACKGROUND

   One of many recent challenges facing bioethicists is the advent of CRISPR, a mechanism for cutting-and-pasting DNA that offers promise in curing many devastating diseases. (20) For example, CRISPR mechanisms offer a potential cure for the HIV/AIDS epidemic and SCD. (21) HIV and SCD are particularly prevalent in African nations, therefore, many future clinical trials will likely happen in Africa. (22)

   1. International Human Rights Develops into Bioethics of Genetic

      Modifications

      Bioethics explores the ethical concerns of medicine, biotechnology, and life sciences as applied to human beings. (23) Bioethical questions are inherently international questions because of the multidimensional and cross-cultural nature of the field. (24) Bioethics is closely intertwined with human rights and draws much of its strength from generally recognized human rights principles. (25) In the wake of the atrocities of World War II, the United Nations passed the Universal Declaration of Human Rights. (26) This Declaration included the "right to a standard of living adequate for the health and well-being of himself and his family." (27) As the international assurances of fundamental human rights were strengthened over time, international bodies were created to oversee specialized human rights concerns. (28) These organizations included the United Nations Educational, Scientific, and Cultural Organization (UNESCO) and the World Health Organization (WHO). (29)

      Contemporaneously with the development of human rights frameworks, the world sought to directly condemn the eugenic experiments performed on unwilling participants during the Holocaust. (30) A group of American judges overseeing the trials of Nazi doctors developed the Nuremberg Code, a set often principles designed to guide ethical research. (31) These ten principles essentially promote four values: autonomy, beneficence, nonmaleficence, and justice. (32) The conception of autonomy put forth in the Nuremberg Code has generally survived in subsequent agreements--primarily through the emphasis of the choice of the participant to end the experiment at his own will. (33) Beneficence and nonmaleficence, together, can be summarized as doing good and not causing harm. (34) The central contribution of the Nuremberg Code was to join medical views of ethics with the emerging realm of human rights law. (35)

      In 1964, the World Medical Association adopted the Declaration of Helsinki. (36) Although not legally binding, this Declaration strongly impacted the ethics of practitioners and became the foundational bioethics document. (37) This document established ethical standards for medical professionals and largely reiterated and expounded upon the same underlying tenants of the Nuremberg Code. (38) Specifically, the Declaration of Helsinki reinforced the researcher's responsibility to obtain informed consent from participants. (39) More broadly, the Declaration clarified that the ultimate responsibility is always on the researching physician, providing that "[t]he responsibility for clinical research always remains with the research worker; it never falls on the subject even after consent is obtained." (40)

      Several years and universal agreements later, the Council of Europe addressed human rights concerns as applied to increasingly sophisticated biotechnology. (41) In the Convention for the Protection of Human Rights and the Dignity of the Human Being with Regard to the Applications of Biology and Medicine: Convention on Human Rights and Biomedicine, the Council of Europe emphasized individualism. (42) In Article 2, member states agreed that "the interests and welfare of the human being shall prevail over the sole interests of society and science." (43) The Convention on Human Rights and Biomedicine was an important step toward governing biotechnology by relying on accepted human rights ideas. (44)

      Since the Council of Europe intertwined bioethics with human rights, framers of other international bioethics agreements often rely on universally recognized human rights to garner agreement on foundational...