International and National Regulations & Codes for Research

7/27/2019 International and National Regulations & Codes for Research

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Nuremberg Code 1948

Helsinki Declaration originally developed in1964; amended in 1979, 1983, 1989, 1996,

2000, 2008.Belmont Report of 1974 in the USA

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


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This consists of a set of 35 regulations andguidelines written by the World MedicalAssociation

International code by and for physicians who

conduct researchThe well being and interests of researchparticipants must always prevail over interests of science and society (code 5)

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


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35 short clauses, no elaboration

Advisory only, but recognized in nationallegislation and WHO practices.

Has no legal weight: mere guidelines thatappeal to the conscience of physicians

Principles not relevant to the needs of otherresearchers


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Spells out the principles that should guideall research involving human participants: Respect for persons (individuals are autonomous

persons who can decide to voluntarily take part inresearch)

Beneficence (maximize benefit, minimize harm)


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Non-maleficence (first do no harm) (one should not injure one personregardless of the benefits that may

come to others (Claude Bernard)

Justice (both the benefits and burden

of research must be distributedfairly)


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Developed in 2007. The code is 68 pages long; has 16sections (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


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1. Research must have social or scientific value toresearch participants, local community, country orworld

2. Scientific validity _ clear objectives, validmethodology

3 . Fair selection of research participants

4. Minimize risks and maximise benefits

5. Respect for potential and enrolled participants


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6. Independent review by a properly constitutedCommittee

7. Valid informed consent

8. Promote trust relationship between researchersand participants (transparency)

9 . Interests of participants, researchers, sponsorsand communities must be protected

10. Research must be conducted in accordance withgood clinical and laboratory practices


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1. All codes emphasize the principles of research ethics as being universal

2. Emphasis on protection of safety of research participants

3. Ignorance is no excuse for misconduct

4. Nigerian code addresses needs of localresearchers


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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 bothdeveloping and developed countries

Convenient interpretations of regulations byinvestigators

Weak mechanism for monitoring compliance withregulations


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www.nhrec.net

www.cioms.org

www.wma.org

The Nuremberg code

Belmont Report
http://www.nhrec.net/http://www.cioms.org/http://www.wma.org/http://www.wma.org/http://www.wma.org/http://www.cioms.org/http://www.cioms.org/http://www.nhrec.net/


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Thanks for listening

International and National Regulations & Codes for Research

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