Factors in Ethical Biomedical Factors in Ethical Biomedical

ResearchResearch Human Rights & Humanity

Scientific & Technical Competence

Ethical design &conduct of research

THE MORAL PRINCIPLES PARTICULARLY RELEVANT TO THE

PRACTICE OF MEDICINE ARE:

-Beneficence – the duty where possible to do good-Non-maleficence – the duty to do no harm-Autonomy – the right of individuals to make decisions on their own behalf-Justice – a broad principle which includes notions of equity

THE ROLE OF ETHICS IN RESEARCH INCLUDES TWO

MAJOR POINTS

one in relation to research itself

the other to the subject on which the research is done , whether human , animal or fetus .

THE FIRST POINT RELATED TO THE RESEARCH INCLUDES

The responsible performance of researchThe responsible reporting of research Confidentiality Honesty

THE RESPONSIBLE PERFORMANCE OF

RESEARCH :

Certain points should be noted :When putting the research design , subjectivity should be avoided . Data selection and analysis should be unbiased Data management , storage , retrieval and ownership should be honest . The research material and information should be shared

THE RESPONSIBLE REPORTING OF RESEARCH (PUBLICATION

ETHICS)The authorship criteria should be respected .The contribution of others should be recognized .Previous work in the same subject should be credited and acknowledged . Premature reporting or publishing should be avoided , otherwise problems would be flared

HONESTY

in every step of the research . If you are not honest ?

Definition of intellectual property: الملكية الفكرية

Rights resulting from intellectual creativity.• Intellectual property is divided into:• 1 - Literary and artistic property. • 2 - Industrial property.

• Law No. 82 of year 2002 protects the rights of authors particularly:• 1. Written Works• 2. Computer programs. • 3. Lectures and speeches• 4. Data bases.• 5. Works of art.

• Why do we use information resources مصادر in (e.g. references – internet)المعلوماتresearch and assignment?

Methods to use information resources:I-Quotations are the exact words of an author, copied directly from a source, word for word. There must be quotation marks or at least phrase that introduces the quotation Quotations must be cited! (A citation is a line of text that uniquely identifies a source / reference)

• Example “Ethics is a discipline that examines moral aspects of human nature.”[references]• Example: Roberts et al describes ethics as a

discipline that examines moral aspects of human nature. .”[references] Ethics can explain the moral values . [1]Ethics can explain the moral values

• II-Paraphrasing means rephrasing the words of an author, putting his/her thoughts in your own words. When you paraphrase, you rework the source’s ideas, words, phrases, and sentence structures with your own. Like quotations, paraphrased material must be followed by citation.

• III- Summarizing involves putting the main idea(s) of one or several writers into your own words, including only the main point(s).

•Academic misconduct سوء السلوك is any type of cheating األكاديميthat occurs in relation to a formal academic work e.g. plagiarism• Plagiarism سرقة أدبية /علمية : The adoption or reproduction of ideas or words or statements of another person without acknowledgment and proper citation.

How can academic misconduct be avoided?

The following ethical guidelines should be applied:

1-Do not copy word for word anyone else’s work unless that person is given credit for his work.

2-When citing a source, if you directly quote, use quotation marks and give the author credit. If you paraphrase or summarize also make a proper citation.

3-Learn how to correctly cite4-Use your own words and ideas .

Penalties of violation of intellectual property:• Imprisonment for not less than a month and a fine of not less than five thousand pounds and not exceeding ten thousand pounds or both .

The sale or rental of a workbook or audio recording protected by the law without prior written permission of the author or owner of the related rights.

Publishing a workbook or audio recording or performance protected by law through the hardware or networks, telecommunication networks or other means without prior written permission of the author or owner of the related rights.

The removal of any protection technology used by the author or owner of the related rights.

SUBJECT OF RESEARCH

HumanAnimalMedical geneticsGenomeCloningFetal tissues

Human research ethicsHuman research ethics

““To ensure that the rights To ensure that the rights of individuals are of individuals are respected and take respected and take precedence over the precedence over the expected benefits of expected benefits of research”research”

““Protecting the rights Protecting the rights and welfare of those and welfare of those who volunteer to who volunteer to participate in research participate in research is a fundamental tenet is a fundamental tenet of ethical research.”of ethical research.”

Bioethics Advisory Commission, USA, August Bioethics Advisory Commission, USA, August 20012001

Broken Rules - HistoryBroken Rules - History1776:1776: Jenner injects cowpox into 8y Jenner injects cowpox into 8y boyboy1900: Walter Reed injects Spanish 1900: Walter Reed injects Spanish immigrants with yellow feverimmigrants with yellow fever1915: USPHS induces pellegra in 1915: USPHS induces pellegra in Miss. PrisonersMiss. Prisoners1919-22: Testicular transplants on 1919-22: Testicular transplants on prisoners in San Quentinprisoners in San Quentin1931: “Regulation on New Therapy 1931: “Regulation on New Therapy and Experimentation” (Ger)and Experimentation” (Ger)1932-1972: USPHS 1932-1972: USPHS TuskegeeTuskegee syphilis studysyphilis study

This study was conducted in the United States and was designed to determine the natural history of untreated latent syphilis.

Over 400 black men with syphilis and about 200 men without syphilis, who served as the controls, were the subjects. The men were recruited without informed consent. In fact, they were misinformed and told that some of the procedures done in the interests of research (e.g., spinal taps) were actually “special free treatments.”

1939-1945: Nazi human experimentation of “the condemned”1947: Nuremberg Doctors Trial1944-45: US malaria experiments on prisoners1953-1970: US Radiation Experimentation1953-1970: LSD Experiments by US Army1990s: AIDS trials in AfricaSeptember 1999: Jesse Gelsinger dies of fulminating hepatitis

Development of Codes to Development of Codes to Protect Human SubjectsProtect Human Subjects

Nuremburg Code Nuremburg Code (1947)(1947): : “…“…voluntary voluntary consent of the human consent of the human subject is absolutely essential.”subject is absolutely essential.”

Declaration of Helsinki Declaration of Helsinki (1964, (1964, 1975, 1983, 1989, 1996,2000)1975, 1983, 1989, 1996,2000): : World Medical AssociationWorld Medical Association

Geneva (2002)Geneva (2002)

Nuremberg codeNuremberg code

The main points in this code are :The voluntary consent of the human subject is absolutely essential .The experiment should be such as to yield fruitful results for the good of the society .The experiment should be so designed and based on the results of animal experimentation .

Avoid unnecessary physical and mental suffering and injury during conduction of experimentation .No experiment should be done if there is any reason to believe that there is risk of disabling injury .The risk should be minimal in relation to the importance of the problem to be solved by the experiment .Proper preparations should be made and adequate facilities provided to protect the subject to experiment .

The experiment should be conducted only by scientifically qualified persons .The human subject to research has the right to terminate the experiment at any time .Be able to terminate the experiment at any stage if there is any risk observed .

INFORMED CONSENT

The Declaration of Helsinki in 1964 states :

“In any research on human beings , each potential

subject must be adequately informed of the aims , methods , anticipated benefits and potential

hazards of the study and discomfort it may entail .

He should be informed that he is at liberty to abstain from

participation in the study and that he is free to withdraw his consent to participation at any

time . The physician should then obtain the subject’s

freely given informed consent , preferably in writing

.”

Informed consent should entail :A statement that the study involves researchAn explanation of the purposes of the research The expected duration of the subject participationThe description of the procedures to be followed

Identification of any procedures which are experimentalA description of any reasonable foreseeable risks or discomforts to the subject

A description of any benefits to the subject or to others which may reasonably be expected from the research

A disclosure of appropriate alternative procedures or courses of treatment , if any , that might be advantageous to the subject

A statement describing the extent , if any , to which confidentiality of records identifying the subject will be maintained For research involving more than minimal risk , an explanation as to whether any compensation , and an explanation as to whether any medical treatments are available , if injury occurs, and , if so , what they consist of , or where further information may be obtained

An explanation of whom to contact for answers to questions about the research and research subject’s rights , and whom to contact in the event of research-related injury to the subject A statement that participation is voluntary , refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled , and the subject may discontinue participation at any time without penalty or loss of benefits , to which the subject is otherwise entitled

PARTICIPATION OF CHILDREN IN RESEARCH:

• Informed consent should be taken from parents or guardians.•Children should not be exposed to unnecessary risks in any research strategy.

Ethics CommitteeEthics Committee

It is composed of It is composed of physicians and other physicians and other qualified persons such as qualified persons such as pharmacologists , pharmacologists , theologians , attorneys , theologians , attorneys , and lay persons of and lay persons of prominence in public life , prominence in public life , none of whom may be none of whom may be directly involved with the directly involved with the research project under research project under review .review .

ResponsibilityResponsibility of Ethics of Ethics CommitteeCommittee

To ascertain that :To ascertain that :

There is There is adequate needadequate need for such a for such a project not otherwise obtainable.project not otherwise obtainable.

The The benefits tobenefits to be derived there be derived there from outweigh the risks to the from outweigh the risks to the subjects therein .subjects therein .

The proposed The proposed methodsmethods and and techniques are proper ones techniques are proper ones scientifically with minimum risks to scientifically with minimum risks to the subjects the subjects

Those conducting the research Those conducting the research are properly are properly qualified andqualified and reliable .reliable .

An adequate An adequate informed consentinformed consent procedure , consistent with the procedure , consistent with the requirements of the project , to requirements of the project , to acquaint the subject with the acquaint the subject with the risks and obtain his consent risks and obtain his consent thereto is being established thereto is being established

It is charged with theIt is charged with the continuing continuing monitoringmonitoring responsibility responsibility

It considers the ethical or moral It considers the ethical or moral aspects of the proposed studies aspects of the proposed studies

Its review and approval is mandatory Its review and approval is mandatory prior to the commencementprior to the commencement of any of any study . study . In this way it is possible to In this way it is possible to facilitate medical research in the facilitate medical research in the interests of society interests of society , to protect from , to protect from possible harm the participating possible harm the participating subjects , to preserve the subject’s subjects , to preserve the subject’s rights while reassurance to the rights while reassurance to the public that all of these objectives public that all of these objectives have been achieved .have been achieved .

It ensures that the responsible investigator is appropriately experienced and has at his disposal the facilities to conduct the work with the utmost care and consideration .It is concerned with the protection of the vulnerable groups ( unemployed , students , elderly , poor ,etc. ) ,avoidance of volunteer over-utilization and examination of the source of volunteers and any proposed advertisements seeking volunteers

ETHICS OF MEDICAL RESEARCH :

•Stem cell research.•Cloning• Fetal research.•Cases.

ETHICAL CONSIDERATION OF USE OF FETAL TISSUE

RESEARCH • Tissue for transplant from dead embryo or

fetus• Do not keep intact embryo artificially alive or create embryos specifically for research.• Abortion is not related to the use of embryo• Informed consent of the mother• No profit from the procedure• The procedure must be after permission of

ethics committee

STEM CELL RESEARCH

Definition :Stem cells are cells that can divide to produce either cells like themselves or cells of one or several specific differentiated types.• It is used as vectors for the delivery of gene therapy.• Implanted in cases of organ failure to multiply and produce a functioning organ once again .

ETHICAL CONSIDERATION OF USE OF STEM CELL RESEARCH

Origin : excess fertilized eggs from IVF (surplus cells), placenta, umbilical cord , aborted fetusInformed consent For treatment purposes

CLONING RESEARCH

WHAT IS CLONING?

• It involves the process of somatic cell nuclear transfer in which the nucleus of a cell from a human patient's body is injected into a human ovum which has had its nucleus removed.

WHAT IS THE PURPOSE OF CLONING?

• Developing organs for transplant that have an identical DNA structure to the organ recipient. It does not involve the attempt to create a newborn.

LEGAL AND ETHICAL ASPECT OF CLONING

•Human cloning is prohibited by law & religion .•Conflicts of interest: special ethical problems would arise when researchers have a financial interest in the outcome of their studies.

CASES

CASE OF STEM CELL

• Parents have a daughter born with Fanconi's Anaemia ,a hopless disease except for stem cells transplantation.• -Thought of having an embryo using IVF to produce matching stem cells for treatment of their daughter.• -Several cycles of IVF and only two of 15 embryos were perfect tissue matches and free of the disease.

IS IT ETHICAL TO PRODUCE EMBRYO BY IVF NOT DUE TO INFERTILITY BUT JUST TO BE A DONOR IN GENE THERAPY?

CASE ABOUT ETHICS IN MEDICAL RESEARCH

• *In DNA lab: cancer breast patient give a blood sample for a genetic research about her disease.• *Another researcher wanted to use a small amount of the sample as a control in his own study on neurological diseases without consent of the patient.

WHAT SHOULD THE LAB DOCTOR DO?

• *Supposed that the lab doctor ignore the use of the sample of DNA by the other researcher, but later he hears that he planning to publish paper based on the results he obtained from the sample.

??DOES THIS DEVELOP CHANGE?

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