medical research ethics in the egyptian regulation
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Dr Ahmed-Refat AG Refat
Medical Research Ethics
in The Egyptian Profession Ethics Regulations
Dr. Ahmed-Refat AG Refat
Dr Ahmed-Refat AG Refat
EGYPTIAN MEDICAL SYNDICATE
Profession Ethics
Regulations
Issued By the Resolution of the
Minister of Health & Population No. 238/2003
Dr Ahmed-Refat AG Refat
Dr Ahmed-Refat AG Refat
Medical Profession Ethics Regulations
Part Three
Medical Interventions of Special Nature
First : Gender Correction Procedure
Dr Ahmed-Refat AG Refat
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.
Medical Profession Ethics Regulations
Dr Ahmed-Refat AG Refat
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.
Dr Ahmed-Refat AG Refat
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.
Medical Profession Ethics Regulations
Dr Ahmed-Refat AG Refat
Article 46 :
It shall be unallowable to establish ovum, spermatozoon or embryo
banks.
Medical Profession Ethics Regulations
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Article 47 :
It shall not be authorized to practice the assisted reproductive operations except in equipped centers licenced
to practice such operations.
Medical Profession Ethics Regulations
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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.
Medical Profession Ethics Regulations
Dr Ahmed-Refat AG Refat
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.
Dr Ahmed-Refat AG Refat
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.
Third : Human Organs & Tissues Removal and Transplant
Dr Ahmed-Refat AG Refat
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.
Third : Human Organs & Tissues Removal and Transplant
Dr Ahmed-Refat AG Refat
Part FourConducting Medical Research &
Experiments On Human Beings
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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.
Dr Ahmed-Refat AG Refat
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.
Dr Ahmed-Refat AG Refat
Second : Procedures that Must be Taken Prior to Conducting any Research on
Human Beings
Dr Ahmed-Refat AG Refat
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.
Dr Ahmed-Refat AG Refat
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.
Dr Ahmed-Refat AG Refat
Article 54 :
The responsibility of the health protection of the volunteers for
conducting the research shall be attached to the physician
supervising him.
Dr Ahmed-Refat AG Refat
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.
Dr Ahmed-Refat AG Refat
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.
Dr Ahmed-Refat AG Refat
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.
Dr Ahmed-Refat AG Refat
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.
Dr Ahmed-Refat AG Refat
Third : Procedures that Must be Taken During & After
Conducting the Research on Human Beings
Dr Ahmed-Refat AG Refat
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.
Dr Ahmed-Refat AG Refat
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
Dr Ahmed-Refat AG Refat
Article 59 :
The researcher shall comply with
ensuring the availability of all preventative, diagnostic and
therapeutic methods for each patient for conducting the study.
Dr Ahmed-Refat AG Refat
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.
Dr Ahmed-Refat AG Refat
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.
Dr Ahmed-Refat AG Refat
Medical Medical Research Ethics Research Ethics
CommitteeCommittee
How & Why ?How & Why ?
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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
Dr Ahmed-Refat AG Refat
Dr Ahmed-Refat AG Refat
Dr Ahmed-Refat AG Refat
Ethics Ethics CommitteesCommittees
•Institutional Review Board ( I.R.B).
•Independent Ethics Committee (I.E.C).
Dr Ahmed-Refat AG Refat
• 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).
Dr Ahmed-Refat AG Refat
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.
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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
Dr Ahmed-Refat AG Refat
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
Dr Ahmed-Refat AG Refat
Functions of ECs Functions of ECs --cont.cont.
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
Dr Ahmed-Refat AG Refat
Functions of ECs Functions of ECs --cont.cont.
4- Writing Polices for their institution
Confidentiality policy
•Treatment policy
•Genetic Screening Policy
Dr Ahmed-Refat AG Refat
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.”
Dr Ahmed-Refat AG Refat
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.
Dr Ahmed-Refat AG Refat
Thank YouThank You
. شكراشكرا رفعت أحمــد د2004 الكشمـــيـــرى
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