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Center For The Right To Health


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Abuja

HISTORY

Health is not just a blessing one wishes for, but a fundamental human right recognized Constitutionally and in regional and international covenants, some of which Nigeria has ratified. Accordingly, the Government of the Federal Republic of Nigeria is required not only to implement schemes that will improve the health status of the citizens but also to institutionalize systems that will ensure, promote and protect their right to good health.

Sadly, the country has not made any appreciable progress in the realization of her citizens right to good and affordable health care. The healthcare system is grossly under-funded and poorly managed. Access to safe essential drugs and facilities is severely limited Staff morale is low while ethics and professionalism hardly drive the provision of healthcare services. The human rights of patients are violated with impunity. Respect for privacy, confidentiality and patients right to participate in decisions concerning their care is almost non-existent.

At times patients are given drugs with the label peeled off, necessary education about the drugs denied them, leading sometimes to adverse drug reactions and death. Youths and women seeking reproductive health care are treated with scorn and disdain depending on the disposition of the health care provider. They are rarely consulted about their diagnosis or in making decisions about their treatment. This is more so for vulnerable groups such as the uneducated, the poor, women, children and patients with stigmatizing diseases like HIV/AIDS.

Most often, violation of rights in healthcare institutions, leads to violation of other rights such as the right to life, work, housing and education among others. Opportunities for redress of these violations are mostly lacking. Patients are reluctant to seek redress for fear of negative reprisals.

The need to properly address the diverse and complex problems associated with healthcare delivery in Nigeria provided the impetus to the founding in 1999, of the ‘Center for the Right to Health’- a non-profit, non-governmental organization.

VISION

A Nigeria in which quality healthcare is affordable and accessible; where patients are treated with dignity and their human rights respected irrespective of gender, age, social status or disease condition.

MISSION

To advocate for the full realization of the right to health in Nigeria and to promote respect for ethics and human rights in healthcare policies and practices, especially for vulnerable groups such as People Living With HIV/AIDS, women, youths and children.

OBJECTIVES

To research, monitor and document policies and practices that influence the right to health in Nigeria.
To inform the public of their right’s to health, and to secure the enforcement of such rights through change in policies, institutions and legal remedies in Nigeria.
To promote professional ethics in healthcare delivery and to secure patients rights.
To promote and protect the human rights of People Living with HIV/AIDS (PLWHA) in health care institutions, work places, and within the community.
To empower and mobilize defenseless groups, such as PLWHA to assert their rights.
To provide counseling, care and support to PLWHA and their families.
To provide legal counseling and litigation for PLWHA and other defenceless groups.
To advocate good health and emphasize preventive measures through health education.
To network with professionals, advocacy groups and activist groups who are established in the global movement for health as a fundamental human right.

OUR STRATEGIES INCLUDE

Research and Documentation
Mobilization and Education
Advocacy
Legal Support Services
Care and Support
Economic Empowerment.

HIV/AIDS AND HUMAN RIGHTS:
Your Rights: 
In Clinical Trials 

Center for the Right to Health (CRH) is a non-profit, non-governmental organization, which is concerned with improving the standard of healthcare in Nigeria using the human rights paradigm. It is committed to empowering vulnerable people like people living with HIV/AIDS, women, children and youths to assert their right to health.


© CRH publication, July, 2002 All Rights Reserved


No part of this publication may be reproduced or transmitted in any form or by any means without the written permission of the organization. For further information and enquiries, please contact:

Center for the Right to Health (CRH)
3, Obanle-Aro Avenue
off Coker Road Roundabout
Ilupeju, Lagos, Nigeria.
Tel: 234-1-7743816
E-mail: mailto:crhaids@yahoo.com,iwuagwus@yahoo.co.uk 


This research is carried out with support from the Ford Foundation Office for West Africa.

Introduction

 

For over three decades, man has continued to engage in scientific research for drug development or biotechnological purpose. However the critical issue in the conduct of the se researches is the ethical consideration of such research especially when human being are involved. Many a time the outcome of the research has often been loss of lives or deformity experienced by human beings that participated in such experiments. Worse still many of the participants may never have been informed or have a clear picture of what they were going into. Examples abound of the negative outcome of biomedical research. 

As far back as 1900, the Prussia vaccination trials were conducted on poor and vulnerable people without their consent thereby causing grave havoc to their lives. The great loss of human lives at the Tuskegee, Wiillbrook and the Allan Memorial Hospital are a mere reminder to us of how research can go wrong and cause inconsequential havoc to humanity. 

But perhaps the gravest wound ever inflicted on humanity was the horrific experiments conducted on human beings by German doctors under the Nazi regime during the Second World War. That experience has left a dent in our mouth till today. Several lives were lost in crude circumstances 

Here in Nigeria, the case of Pfizer, a drug company in Kano, which conducted experiments on human beings with meningitis and the loss of lives recorded sometime ago is still fresh in our memory. 

Our country, Nigeria has witnessed a high prevalence of HIV/AIDS of 5.8% as at 2001, translating to 3.47million people already infected. Most People Living with HIV/AIDS [PLWHA] look forward to the discovery of a cure for the virus. All hands had been on deck to discover a cure for HIV/AIDS. Both orthodox and unorthodox medical practitioners and scientists have been working hard to find a cure and there had been many claims of discovering a cure. This led to a clinical trial of some of these drugs to verify how genuine these claims are most of the drugs purported to be herbs.

Many People Living with HIV/AIDS [PLWHA] who were recruited for this purpose reported to the Center for the Right to Health (CRH), alleging unethical practices in relation to the trial. Many complained of severe side effects that they did not anticipate neither were they consistently given medical treatment for the side effects. Some felt coerced by their desperation for cure, lacking full understanding of what they were volunteering for. Many complained that they were not treated in dignity. 

It has therefore become necessary that a publication of this nature be produced to educate the public and in particular PLWHA- who might be willing to participate in future trials on the ethical and human rights issues raised by drug trial. It is written in simple language to empower PLWHA and others on their rights in clinical trial.

 

WHEN A CLINICAL TRIAL ENDS

 

As the trial comes to an end, you may be wondering how you will take care of your HIV/AIDS status. You might not need to worry too much as members of the research team are expected to work with you and your doctor to determine the best plan for your HIV treatment. You should be informed of the result of the trial the moment it is out. 


Some international rules and standard on clinical trials: 

The Nuremberg Code, 1947

The Nuremberg Code identifies informed consent as an absolute pre-condition for the conduct of research involving human subjects. Its usefulness today is limited, other than to remind us of the dangers of unchecked medical experimentation. 

Declaration of Helsinki, 1964 (last amended 1996)

The Declaration of Helsinki provides basic principles for the conduct of medical research on human subjects. The principles in the Declaration are reviewed and revised from time to time. In 2000, a working group prepared amendments that provided: “In any medical study, every patient – including those of a control group, if any should be assured of proven effective prophylactic, diagnostic and therapeutic methods.

Ethical Principles and Guidelines for the Protection of Human Subjects in Research (the Belmont Report), 1979

The Belmont Report was prepared by the US National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research. Because of its clarity and authority, the Belmont Report is a standard reference on ethics in research involving human subjects. The Report sets out three basic ethical principles to guide research namely: respect for persons, beneficence, and justice.

International Ethical Guidelines for Biomedical Research involving Human Subjects (the CIOMS Guidelines), 1982 (last amended 1992)

These Guidelines are published by the Council for International Organisations of Medical Sciences (CIOMS). They expanded and extended the ethical principles embodied in the Declaration of Helsinki, particularly to research in developing countries. 
The CIOMS Guidelines were revised in 1992, in part to address specific concerns about HIV/AIDS research, and are again under revision. Preliminary consultation was held in March 2000. Background papers were published later in 2000.

Ethical Considerations in HIV Preventive Vaccine Research: UNAIDS uidance document 2000

In 1998, UNAIDS conducted a series of regional and international consultations to try to achieve a global consensus on key ethical issues in HIV preventive vaccine research. The UNAIDS guidance document sets out UNAIDS’ policy in 18 guidance points that address a wide range of issues, including: international response, access, capacity development, community representation, benefits, harms, consent, care and treatment. 

An international code of ethics for business: The Global Compact

The Global Compact challenges individual corporations and representative business associations to support nine key principles relating to human rights, labour and the environment, ‘which emanate from universally agreed standards found in United Nations documents.’ The application of the Global Compact to the HIV vaccine research and development is yet to be explored.

Phone Phone: +234 9 4132462, 85
Email crhaids@yahoo.com
Website http://www.crhonline.org
Address Address: Suite 12, Dmk House Plot 735 Kadoe St, Off Aminu Kano Crescent Wuse II,

 

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