By Ademola J. Ajuwon, MPH, PhD African Regional Health Education Center, College of Medicine, University of Ibadan Email: ajajuwon@yahoo.

com

Regulations that guide how research involving humans should be conducted

Codes were developed in direct response to some abuses of research participants or lapses that occurred in the past
Examples of history of abuse include
Horrors of Nazi Germany (WW2) Tuskegee Syphilis study (1930s in the USA) Trovan Drug Trial among children with meningitis in Kano

Nuremberg Code 1948

Helsinki Declaration originally developed in 1964; amended in 1979, 1983, 1989, 1996, 2000, 2008. Belmont Report of 1974 in the USA

CIOMS (Council for International Organizations of Medical Sciences): 1993 (revised 2002

This consists of a set of 35 regulations and guidelines written by the World Medical Association International code by and for physicians who conduct research The well being and interests of research participants must always prevail over interests of science and society (code 5)

Research must be reviewed by an independent committee (IRB) before it is conducted (code 13)

35 short clauses, no elaboration

Advisory only, but recognized in national legislation and WHO practices. Has no legal weight: mere guidelines that appeal to the conscience of physicians Principles not relevant to the needs of other researchers

Spells out the principles that should guide all research involving human participants:
Respect for persons (individuals are autonomous persons who can decide to voluntarily take part in research) Beneficence (maximize benefit, minimize harm)

 Non-maleficence (first do no harm) (one should not injure one person regardless of the benefits that may come to others (Claude Bernard)
Justice (both the benefits and burden of research must be distributed fairly)

Developed in 2007. The code is 68 pages long; has 16 sections (A-P) including Definition of research Requirements for registration of an ERC Role of ERC Responsibilities of researchers What makes research ethics Sanctions for erring researchers

1. Research must have social or scientific value to research participants, local community, country or world 2. Scientific validity_ clear objectives, valid methodology 3. Fair selection of research participants 4. Minimize risks and maximise benefits 5. Respect for potential and enrolled participants

6. Independent review by a properly constituted Committee

7. Valid informed consent

8. Promote trust relationship between researchers and participants (transparency) 9. Interests of participants, researchers, sponsors and communities must be protected 10. Research must be conducted in accordance with good clinical and laboratory practices

1.

All codes emphasize the principles of research ethics as being universal

Emphasis on protection of safety of research participants Ignorance is no excuse for misconduct Nigerian code addresses needs of local researchers

2.

3. 4.

There is a challenge in the applications of international regulations to local context

Despite the availability of regulations, abuse of research participants continue to occur in both developing and developed countries Convenient interpretations of regulations by investigators Weak mechanism for monitoring compliance with regulations

www.nhrec.net
www.cioms.org www.wma.org

The Nuremberg code

Belmont Report

 Thanks

for listening