Medical Research Ethics in The Egyptian Profession Ethics Regulations Dr. Ahmed-Refat AG Refat

Dr Ahmed-Refat AG Refat

Medical Research Ethics

in The Egyptian Profession Ethics Regulations

Dr. Ahmed-Refat AG Refat


EGYPTIAN MEDICAL SYNDICATE

Profession Ethics

Regulations

Issued By the Resolution of the

Minister of Health & Population No. 238/2003



Medical Profession Ethics Regulations

Part Three

Medical Interventions of Special Nature

First : Gender Correction Procedure


Article 43 :The physician shall be prohibited from carrying

out gender change operations. As regards gender correction operations, it is conditional that the approval of the competent committee

at the syndicate would be obtained. The correction operations shall be carried out after

carrying out the hormonal analyses and inspecting the chromosomal map after

spending the accompanying psychiatric and hormonal treatment for a period not less than

two years.



Second : Assisted Reproductive Operations Article 44

The assisted reproductive operations for the wife’s ovum from the husband’s sperm

inside or outside the wife’s body (laboratory reproductive techniques or

intra cytoplasmic sperm injection) shall be subject to the moral guidelines which aim at preserving the human race and treating

infertility, while observing the purity of lineages and the legal criteria issued by

the competent quarters.


Article 45 :

It shall be unallowable to carry out the assisted reproductive operations inside or

outside the body of the wife except by using her husband’s sperm if there is

consummation of marriage between them.

It shall also be unallowable to transfer fertilized ova to transplant them in the

uteruses of women other than the legitimate mother of these ova.



Article 46 :

It shall be unallowable to establish ovum, spermatozoon or embryo

banks.



Article 47 :

It shall not be authorized to practice the assisted reproductive operations except in equipped centers licenced

to practice such operations.



Article 48 :

The center must keep a detailed register for each case containing all the data separately for a period that is not less than ten years. The file

must include contract and a declaration from both spouses.



Third : Human Organs & Tissues Removal and Transplant

Article 49 :

The human organs and tissues transplant operations shall be subject to the moral criteria and guidelines stipulated in the

legislation and regulations organizing the foregoing.


Article 50 : It shall be imperative upon the physician prior

to carrying out an organ transplant operation, pursuant to the legislation

organizing the foregoing, to notify the donor of the medical consequences and the risks to which he may be exposed as a result of

the transplant operation and to take the necessary declarations which state his

knowledge of all the consequences in this concern prior to carrying out the operation.



Article 51 :

It shall be prohibited to trade in the human organs, tissues and cells, and human

embryos. Under no circumstance shall the physician be allowed to take part in these operations, otherwise he shall be subject

to disciplinary accountability.



Part FourConducting Medical Research &

Experiments On Human Beings


First : General ProvisionsArticle 52 :

The physician shall comply with observing the implementation of all moral criteria and guidelines as well as the social and

religious values laid down by the competent authority for conducting medical research on human beings.


First : General Provisions

Article 53 :

The physician shall be prohibited from conducting any experiments for drugs and techniques on human

beings prior to being endorsed by the competent quarters.


Second : Procedures that Must be Taken Prior to Conducting any Research on

Human Beings


Article 54 :

Taking into consideration the provisions of the two previous articles, the researcher

physician shall comply prior to conducting any medical research on human beings

with acquiring a detailed study of the risks and burdens to which the individual or the

group will be exposed and comparing them with the benefits expected to be

obtained from the research.


Article 54 :

. Conducting such research shall be confined to the specialists

scientifically qualified to conduct them under the supervision of a highly efficient and specialized

physician.


Article 54 :

The responsibility of the health protection of the volunteers for

conducting the research shall be attached to the physician

supervising him.


Article 55 :

The researcher shall comply with fully informing the volunteers in a clear way of the targets of the research, the research approaches which will be used in it, the

benefits expected therefrom, the probable risks and the extent of their effect on the volunteers. The volunteers must also be informed of the sources of financing the research, the identity of the researcher in

charge and his institutional belonging.


The right of the volunteer to cease his voluntariness to conduct the

experiments and research or the full withdrawal from the research without

sustaining any negative consequences as a result of his cessation or withdrawal must be

emphasized.


Article 56 :

The researcher physician shall comply with obtaining a written consent (built on

knowledge) from the volunteer to conduct the research on him officially in the

presence of a prosecution witness. If the volunteer is a minor, a retarded or

incapacitated person the approval of the official guardian or curator must be

obtained, in which case it is conditional that the research would pertain to his sick

condition.


Article 57 :

The researcher shall comply with preparing a detailed and clear report

on the targets of the research and the justifications for conducting it on human beings. This report shall be

submitted to the quarter legally competent with approving to conduct the research in order to obtain such

approval.


Third : Procedures that Must be Taken During & After

Conducting the Research on Human Beings


Article 58 :

The researcher shall comply with immediately ceasing to complete any

experiments on human beings if it was established that the

accompanying risks exceed the benefits expected of the research.


Article 58 :

It is necessary to guarantee the privacy of the individuals, the

secrecy of the results and keeping them as well as minimizing the

negative effects on the physical, mental and psychological safety of

the volunteers


Article 59 :

The researcher shall comply with

ensuring the availability of all preventative, diagnostic and

therapeutic methods for each patient for conducting the study.


Article 60 :

The researcher shall be prohibited from conducting researches and practices that involve the suspicion of mixing lineages,

or participating in them in any way. He shall also be prohibited from carrying out or participating in medical research which

aim at cloning the human being.


Article 61 :

The physician shall comply with taking the required undertaking from the quarter financing the research to the effect of supplying the drug - which is being

experimented on patients and which has been proven to be effective - till the end of

the treatment program, free of charge.


Medical Medical Research Ethics Research Ethics

CommitteeCommittee

How & Why ?How & Why ?


Medical Ethics Committee, How & Why

A proposed guideline for establishing of

Medical Research Committee

in an Egyptian Newspaper (Al-Ahram) at 15 Aug 1995 and 17 July 1997




Ethics Ethics CommitteesCommittees

•Institutional Review Board ( I.R.B).

•Independent Ethics Committee (I.E.C).


• A committee that meet to review protocols and other

documentation used in clinical research; this independent body is responsible for verifying that the safety, integrity, and rights

of human subjects are protected.

Institutional Institutional Review Board ( I.R.B).Review Board ( I.R.B).


Independent Ethics Committee IEC

An independent multidisciplinary group drown from the institution and the local

community, whose responsibility is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial and to provide public

assurance of that protection, and among other things, reviewing and

approving/providing favorable opinion on the protocols and other documentation

used in clinical research.


Functions of EcsFunctions of Ecs1- Education

The profession have a responsibility to educate the public as well as the institutional community about what is good and bad in health care


Functions of ECs Functions of ECs --cont.cont.

2-Consultation Role2-Consultation Role

EC have a role to act as consultants in resolving conflicts and dilemmas about patient care



3- Watching over the operation of the institution

Ecs should watch over the operation of institution regarding..– How the institution functions as a system

– Its decision-making procedures,

– The flow of institutional power

– The effective use of resources



4- Writing Polices for their institution

Confidentiality policy

•Treatment policy

•Genetic Screening Policy


Misconduct in Misconduct in ScienceScience Misconduct means fabrication,

falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or

judgments of data.”


FabricationFabrication is making up data or results and recording or reporting them.

Falsification Falsification is manipulating the research’s data in a such way that the research is not accurately represented in the actual findings.

PlagiarismPlagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.


Thank YouThank You

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Medical Research Ethics in The Egyptian Profession Ethics Regulations Dr. Ahmed-Refat AG Refat

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