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RESEARCH ETHICS: BACKGROUND AND DEFINITION

RESEARCH ETHICS: BACKGROUND AND DEFINITION

Research ethics provides guidelines for the responsible conduct of biomedical research. In addition, research ethics educates and monitors scientists conducting research to ensure a high ethical standard.

BRIEF HISTORY

The birth of modern research ethics began with a desire to protect human subjects involved in research projects. The first attempt to craft regulations began during the Doctors Trial of 1946-1947.    

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RESEARCH ETHICS: BACKGROUND AND DEFINITION

SEARCH ETHIRECS BACKGROUND AND DEFINITION

Research ethics provides guidelines for the responsible conduct of biomedical research. In addition, research ethics educates and monitors scientists conducting research to ensure a high ethical standard.

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ERC secretary message

ERC secretary message

 

Dr.Faiza Mohamed Osman

Dear Visitors
You are Welcome to our Website

One of the main objectives of the institute of endemic diseases at the University of Khartoum is to undertake research in the major endemic diseases in the Sudan and train professionals in different fields including biochemical research.

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RESEARCH WITH HUMAN SUBJECTS

RESEARCH WITH HUMAN SUBJECTS

The issues concerning research with human subjects involve topics ranging from voluntary participation in research to fair selection and justice. This variety makes the topics surrounding research ethics with human subjects a challenging but important charge.

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Scientific and ethical reviews

Scientific and ethical reviews

All proposals to conduct research involving human subjects must be submitted for review of their scientific merit and ethical acceptability to one or more scientific review and ethical review committees. The review committees must be independent of the research team, and any direct financial or other material benefit they may derive from the research should not be dependent on the outcome of their review.
The investigator must obtain their approval or clearance before undertaking the research. The ethical review committee should conduct further reviews as necessary in the course of the research, including monitoring of the progress of the study.

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The ethics review flowchart

How should I submit my project for review?

You need to complete an ethics application form (Request for Ethics Approval form ) and submit it with any supporting documentation – such as  the scientific committee approval  and consent forms.. You should discuss your ethics application with your supervisor who will decide if it is low risk or potentially high risk, and advise you how to submit for review accordingly. The standard ethics application form and other forms can be found and downloaded at this website

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Student Corner

RESEARCH ETHICS: BACKGROUND AND DEFINITION

Research ethics provides guidelines for the responsible conduct of biomedical research. In addition, research ethics educates and monitors scientists conducting research to ensure a high ethical standard.

BRIEF HISTORY

The birth of modern research ethics began with a desire to protect human subjects involved in research projects. The first attempt to craft regulations began during the Doctors Trial of 1946-1947.    

 The Doctors Trial was a segment of the Nuremberg Trials for Nazi war criminals. In the Doctors Trial, 23 German Nazi physicians were accused of conducting abhorrent and torturous “experiments” with concentration camp inmates. The accused physicians tortured, brutalized, crippled, and murdered thousands of  victims in the name of research. Some of their experiments involved gathering scientific information about the limits of the human body by exposing victims to extreme temperatures and altitudes. The most gruesome and destructive experiments tested how quickly a human could be euthanatized in order to carry out the Nazi racial purification policies most efficiently.To prosecute the accused Nazi doctors for the atrocities they committed, a list of ethical guidelines for the conduct of research – the Nuremberg Code – were developed.

The Nuremberg Code consisted of ten basic ethical principles that the accused violated. The 10 guidelines were as follows:

1. Research participants must voluntarily consent to research

participation

2. Research aims should contribute to the good of society

3. Research must be based on sound theory and prior animal testing

4. Research must avoid unnecessary physical and mental suffering

5. No research projects can go forward where serious injury and/or

death are potential outcomes

6. The degree of risk taken with research participants cannot exceed

anticipated benefits of results

7. Proper environment and protection for participants is necessary

8. Experiments can be conducted only by scientifically qualified persons

9. Human subjects must be allowed to discontinue their participation at any time

10. Scientists must be prepared to terminate the experiment if there is cause to believe that continuation will be harmful or result in injury or death

The Nuremberg Guidelines paved the way for the next major initiative designed to promote responsible research with human subjects,

 

The Helsinki Declaration.

The Helsinki Declaration was developed by the World Medical Association and has been revised and updated periodically since 1964, with the last update occurring in 2000. The document lays out basic ethical principles for conducting biomedical research and specifies guidelines for research conducted either by a physician, in conjunction with medical care, or within a clinical setting.

The Helsinki Declaration contains all the basic ethical elements specified in the Nuremberg Code but then advances further guidelines specifically designed to address the unique vulnerabilities of human subjects solicited to participate in clinical research projects. The unique principles developed within the Helsinki Declaration include:

• The necessity of using an independent investigator to review potential research projects

• Employing a medically qualified person to supervise the research and assume responsibility for the health and welfare of human subjects

• The importance of preserving the accuracy of research results

• Suggestions on how to obtain informed consent from research participants

• Rules concerning research with children and mentally incompetent persons

• Evaluating and using experimental treatments on patients

• The importance of determining which medical situations and conditions are appropriate and safe for research

Following the Helsinki Declaration, the next set of research ethics guidelines came out in the Belmont Report of 1979 for the Protection of Human Subjects of Biomedical and Behavioral Research.

The report outlines:

1. The ethical principles for research with human subjects

2. Boundaries between medical practice and research

3. The concepts of respect for persons, beneficence, and justice

4. Applications of these principles in informed consent (respect for persons), assessing risks and benefits (beneficence), and subject selection

(justice)

The Nuremberg, Helsinki, and Belmont guidelines provided the foundation of more ethically uniform research to which stringent rules and consequences for violation were attached. Governmental laws and regulations concerning the responsible conduct of research have since been developed for research that involves both human and animal subjects.