HUMAN RESEARCH IN KENYA:THE LAW, THE RULES AND REGULATIONS IN KENYA. BY CATHERINE NJOKI WAHOME,Advocate of the High Court of Kenya, MSc. Student International Health Research Ethics. At a Genome and Bio-banking Seminar, Noble Conference Centre, Eldoret. On 21 st February 2014.

THE CONSTITUTION OF KENYA.  GUARANTEE OF FUNDAMENTAL RIGHTS AND FREEDOMS.  INHUMAN OR DEGRADING TREATMENT OUTLAWED.  PROVISION FOR NON-DISCRIMINATION OF PERSONS ON ANY GROUND. THESE CAN BE APPLIED TO ANCHOR THE PRINCIPLES OF RESPECT FOR PERSONS, BENEFICENCE AND AUTONOMY IN ETHICS OF RESEARCH.

THE LEGAL ASPECTS OF HUMAN RESEARCH IN KENYA.  THIS IS GROUNDED BY MEANS OF: THE FUNDAMENTAL RIGHTS AND FREEDOMS THAT MAY NOT BE LIMITED NAMELY “FREEDOM FROM TORTURE AND CRUEL, INHUMAN OR DEGRADING TREATMENT OR PUNISHMENT” (Article 25(a) –The Constitution of Kenya)

THE CONSTITUTIONAL PROVISION FOR RIGHT TO LIFE: Article 26. i. EVERY PERSON HAS A RIGHT TO LIFE. ii. THE LIFE OF A PERSON BEGINS AT CONCEPTION. iii. A PERSON SHALL NOT BE DEPRIVED OF LIFE INTENTIONALLY EXCEPT TO THE EXTENT AUTHORISED BY THIS CONSTITUTION OR OTHER WRITTEN LAW. iv. ABORTION IS NOT PERMITTED UNLESS IN THE OPINION OF A TRAINED HEALTH PROFESSIONAL, THERE IS NEED FOR EMERGENCY TREATMENT OR THE LIFE OF OR HEALTH OF THE MOTHER IS IN DANGER, OR IF PERMITTED BY ANY OTHER WRITTEN LAW.

PROVISION FOR PROTECTION OF HUMAN DIGNITY AND PRIVACY. EVERY PERSON HAS INHERENT DIGNITY AND THE RIGHT TO HAVE THAT DIGNITY RESPECTED AND PROTECTED “(Article 28 of the Constitution) PROTECTION OF RIGHT TO PRIVACY (Article 31)  EVERY PERSON HAS THE RIGHT TO PRIVACY, WHICH INCLUDES THE RIGHT NOT TO HAVE;  INFORMATION RELATING TO THEIR FAMILY OR PRIVATE AFFAIRS UNNECESSARILY REQUIRED OR REVEALED OR  THE PRIVACY OF THEIR COMMUNICATIONS INFRINGED.

RECOGNITION OF CERTAIN ECONOMIC AND SOCIAL RIGHTS. ARTICLE 43 of the Kenyan Constitution. 1. EVERY PERSON HAS THE RIGHT: a. TO THE HIGHEST ATTAINABLE STANDARD OF HEALTH WHICH INCLUDES THE RIGHT TO HEALTH CARE SERVICES INCLUDING REPRODUCTIVE HEALTHCARE. b. TO ACCESSIBLE AND ADEQUATE HOUSING AND TO REASONABLE STANDARDS OF SANITATION. 2. A PERSON SHALL NOT BE DENIED EMERGENCY MEDICAL TREATMENT 3. THE STATE SHALL PROVIDE APPROPRIATE SOCIAL SECURITY TO PERSONS WHO ARE UNABLE TO SUPPORT THEMSELVES AND THEIR DEPENDANTS

EQUALITY AND FREEDOM FROM DISCRIMINATION. ARTICLE 27 (5). A PERSON SHALL NOT DISCRIMINATE DIRECTLY OR INDIRECTLY AGAINST ANY PERSON ON ANY GROUND INCLUDING RACE, SEX, PREGNANCY, MARITAL STATUS, HEALTH STATUS, ETHNIC OR SOCIAL ORIGIN,COLOUR, AGE, DISABILITY, RELIGION, CONSCIENCE, BELIEF,CULTURE, LANGUAGE OR BIRTH.

REGULATION OF BIOETHICS IN KENYA BY INTERNATIONAL GUIDANCE DOCUMENTS  THE GENERAL RULES OF INTERNATIONAL LAW SHALL FORM PART OF THE LAW OF KENYA” (Article 2(5) Of The Constitution)  SUCH RULES INCLUDE TREATIES TO WHICH KENYA WAS A SIGNATORY OR WHICH IT RATIFIED OR ACCEDED TO, ANY DECLARATIONS, PROTOCOLS, AND INTERNATIONAL GUIDANCE DOCUMENTS WHICH KENYA HAS DOMESTICATED.

IT IS ON THIS BASIS THAT WE FOUND OUR RULES ON RESEARCH INVOLVING HUMANS ON: a. THE DECLARATION OF HELSINKI b. INTERNATIONAL ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH INVOLVING HUMAN SUBJECTS. (CIOMS GUIDELINES). c. THE WORLD HEALTH ORGANIZATION’S GUIDELINES FOR GOOD CLINICAL PRACTICE FOR TRIALS ON PHARMACEUTICAL PRODUCTS. d. THE INTERNATIONA CONFERENCE ON HARMONIZATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE (ICH). e. THE JOINT UNITED NATIONS PROGRAMME ON HIV/AIDS (UNAIDS)- ETHICAL CONSIDERATIONS IN HIV PREVENTIVE VACCINE RESEARCH. f. THE BELMONT REPORT. g. GUIDELINES FOR ETHICAL CONDUCT OF BIOMEDICAL RESEARCH INVOLVING HUMAN SUBJECTS IN KENYA. (Year of official publication 2004)

THE ABOVE GUIDELINES ADDRESSES THE FOLLOWING SALIENT PRINCIPLES: RESPECT FOR HUMAN DIGNITY, HUMAN RIGHTS AND FUNDAMENTAL FREEDOMS. THE INTEREST AND WELFARE OF THE INDIVIDUAL SHOULD HAVE PRIORITY OVER THE SOLE INTEREST OF SCIENCE OR SOCIETY. MAXIMISATION OF BENEFIT AND MINIMISATION OF HARM TO HUMAN RESEARCH PARTICIPANTS. THE RIGHT TO AUTONOMY AND INDIVIDUAL RESPONSIBILITY AND SPECIAL MEASURES FOR THOSE NOT CAPABLE OF EXERCISING AUTONOMY. THE NEED FOR PRIOR FREE AND INFORMED CONSENT OF THE PERSON BASED ON ADEQUATE INFORMATION IN ANY PREVENTIVE, DIAGNOSTIC AND THERAPEUTIC MEDICAL INTERVENTION OR SCIENTIFIC RESEARCH.

 PERSONS WITHOUT THE CAPACITY TO CONSENT.  RESPECT FOR HUMAN VULNERABILITY.  PRIVACY AND CONFIDENTIALITY.  EQUALITY, JUSTICE AND EQUITY.  NON-DISCRIMINATION AND NON-STIGMATIZATION.  THE ESTABLISHMENT OF INDEPENDENT, MULTIDISCIPLINARY AND PLURALISTIC ETHICS COMMITTEES IN ORDER TO ASSESS THE RELEVANT ETHICAL LEGAL SCIENTIFIC AND SOCIAL ISSUES RELATED TO RESEARCH PROJECTS INVOLVING HUMAN BEINGS.

TREATIES  INTERNATIONAL COVENANT ON ECONOMIC. SOCIAL AND CULTURAL RIGHTS KENYA:1 MAY ACCESSION  INTERNATIONAL COVENANT ON CIVIL AND POLITICAL RIGHTS KENYA:1 MAY 1972 – ACCESSION  INTERNATIONAL COVENANT ON ELIMINATION OF ALL FORMS OF RACIAL DISCRIMINATION KENYA 13TH SEPTEMBER ACCESION  CONVENTION ON THE ELIMINATION OF ALL FORMS OF DISCRIMINATION AGAINST WOMEN KENYA: 9 MARCH 1984 – ACCESSION  CONVENTION ON THE RIGHTS OF THE CHILD KENYA:30 JULY 1990 – RATIFICATION

DOMESTIC LEGISLATION IN KENYA.  THE SCIENCE AND TECHNOLOGY ACT (CHAPTER 250)  COMMENCEMENT 1 ST JULY 1997  PROVIDES REGULATORY FRAMEWORK FOR RESEARCH WITH HUMAN SUBJECTS INCLUDING ETHICAL APPROVAL  LAYS DOWN AN INSTITUTIONAL FRAMEWORK FOR RESEARCH AND  PROVIDES FOR DISSEMINATION OF DATA USE IN RESEARCH DEVELOPMENT

THE HIV AND AIDS PREVENTION AND CONTROL ACT, 2006 (ACT NO. 14 OF 2006)  COMMENCEMENT MARCH 2009  MAKES COMPLIANCE WITH THE SCIENCE AND TECHNOLOGY ACT IN BIOMEDICAL RESEARCH MANDATORY (SECTION 39)  LAYS DOWN REQUIREMENTS OF INFORMED CONSENT IN BIOMEDICAL RESEARCH AND INFORMATION ON RISKS, HAZARDS AND ANTICIPATED BENEFITS.

PUBLIC HEALTH ACT (CHAPTER 242  PROVIDES AN INSTITUTIONAL FRAMEWORK FOR CARRYING OUT RESEARCHES AND INVESTIGATIONS IN CONNECTION WITH THE PREVENTION OR TREATMENT OF HUMAN DISEASES  ALSO PROVIDES FOR DISSEMINATION OF RESEARCH FINDINGS AND DATA

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