دليل اللجنة


Research Ethics Committee Guidelines 

Faculty of Medicine Ain Shams University 

Standard Operating Procedures  

The 7 Ethical Requirements for Health Research 


Diaa Marzouk, Prof. Public Health  

Faculty of Medicine Ain Shams University 


The overarching objective of clinical research is to develop generalizable knowledge to improve health and/or increase understanding of human biology Ethical
requirements for clinical research aim to minimize the possibility of
exploitation by ensuring that research subjects are not merely used but
are treated with respect while they contribute to
the social good 1 

These 7 requirements for
considering the ethics of clinical research provide a systematic
framework to guide researchers and IRBs (Institutional Review Boards) in
their assessments of individual clinical research protocols. Like a
constitution, these requirements can be reinterpreted, refined, and
revised with changes in science and experience. Yet these requirements
must all be considered and met to ensure that clinical  research—
wherever it is practiced—is ethical.


  1. Valuable Research 

Society should gain knowledge, which requires sharing results, whether positive or negative, Can exposing human subjects to risk in clinical research be justified.  

Thus, evaluation of clinical research should ensure that the results will be disseminated,  

although publication in peer-reviewed journals need not be the primary or only mechanism. 

There are 2 fundamental reasons why social, scientific, or clinical value should be an ethical requirement:  

  • responsible use of finite resources and  

  • avoidance of exploitation of the research participants 


  1. Scientific Validity: 

According to COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES (CIOMs) guidelines; Scientifically unsound research on human subjects is ipso facto unethical in that it may expose subjects  to risks or  inconvenience to no purpose 3 

For a clinical research protocol to be ethical it must fulfill the following4:  

  • the methods must be valid and practically feasible: 

  • the research must have a clear scientific objective;  

  • be designed using accepted principles, methods, and reliable practices;  

  • have sufficient power to definitively test the objective;  

  • and offer a plausible data analysis plan. 

            Clinical research protocol that cannot generate valid scientific knowledge is unethical 1,4 if it uses: 

  • biased samples, questions  

  • underpowered statistical evaluations  

  • neglects critical end points  

  • that could not possibly enroll sufficient subjects  


         Clinical research that compares therapies must have “an honest null hypothesis” or “clinical equipoise.1  

That is, there must be controversy within the scientific community about whether the new intervention is better than
standard therapy, including placebo, either because most clinicians and
researchers are uncertain about whether the new treatment is better, or
because some believe the standard therapy is better while others
believe the investigational intervention superior.


justification of validity as an ethical requirement relies on the same 2
principles that apply to value— limited resources and the avoidance of
Invalid research is unethical because it is a waste of resources 1  


  1. Fair Subject Selection  

The selection of subjects must be fair.1,6
Subject selection encompasses decisions about who will be included both
through the development of specific inclusion and exclusion criteria
and the strategy adopted for recruiting subjects

  • Inclusion Criteria: Fair subject selection requires that the scientific goals of the study, not vulnerability, privilege, or convenience, be the primary basis for determining the groups and individuals that will be recruited and enrolled.7  

  • Exclusion Criteria: 
    groups or individuals should not be excluded from the opportunity to
    participate in research without a good scientific reason or
    susceptibility to risk that justifies their exclusion.

  1. Favorable Risk-Benefit Ratio 

  • Proper design 

  • Inclusion/exclusion criteria 

  • exclude high risk/vulnerable subjects  

  • Withdrawal criteria 

  • Alternatives to invasive procedures 

  • Availability to emergency medication to side effects 

  • Availability of resources 

  • Well equipped research center 

  • Confidentiality protections 

  • Qualified personnel for implementing invasive procedures 

  • Safety monitoring by the REC of the participants of the ongoing projects 

  • Supply the participants with the results of investigations 

  • Moderate compensation for the time wasted by the participants of moderate incentives  


  1. Independent Review 

Investigators have multiple interests: 

  • Interests to conduct high quality research 

  • Complete the research efficiently  

  • Protect research subjects 

  • Obtain funding 

  • Advance their career 

Independent review by individuals unaffiliated with the clinical research helps to minimize such conflicts of interest 

  • REC protects: 

  • the research subjects 

  • the researchers 

  • the institutes 

  • the community 


  • REC DO NOT hinder research but help researcher to conduct research ethically  

  • Management of conflicts of interest 

  • Building up of TRUST between the public and the research team 

  • Trust and mutual benefit in case of multi-center/ international research 

  • Transparency among all parties involved 


  1. Informed Consent 

  • Who will conduct the informed consent? The investigator….  

  • Quality of the informed consent 

  • Contents 

  • Understandability 

  • Documentation 

Contents of informed consent: 

  1. Purpose of the research 

  1. Procedures 

  1. Risks 

  1. Benefits 

  1. Alternatives 

  1. Confidentiality 

  1. Withdrawal 

  1. Compensation 

  1. Who will contact   



Respect for Enrolled Subjects: 

The ethics of clinical research do not end with the signing of a consent document but encompass: 

 the actual implementation 


Dissemination of research 


Belmont Report:   

Belmont report is meant to provide broad principles that could be used to generate specific rules 

and regulations in response to US research (9,10) 


Belmont Ethical Principles 

  1. Respect for persons  

  1. Beneficence/non-maleficence  

  1. Justice  


Respect for subjects by: 

  • Permitting withdrawal 

  • Protecting confidentiality 

  • Informing of new risks & benefits 

  • Informing of results of clinical research 

  • Maintaining welfare of subjects  



  1. Community Partnership 

  • To be ethical clinical research must involve the community in which it occurs 

  • Research in certain fields, as epidemiology, genetics or sociology, may present risks to the interests of     


  • Information might be published that stigmatize or expose its members to discrimination 




Research Ethics Committees (RECs) Should Provide 

  • Independent, Competent and Timely review of the ethics of proposed studies 

  • RECs should establish written (SOPs) to ensure:  

  • Transparency,  

  • Consistency, and  

  • Efficiency in their operations 

Other functions of an REC include  

  • Review of changes in the approved research proposal  

  • Review adverse events that occur during the research  

  • Suspend or terminate approval.  

  • Review research procedures during the conduct of the research, including the informed consent process. 

  • Ensure
    that research is in compliance with the laws and regulations of the
    community, especially in relation with the protection of human subjects.

  • Conduct educational exercises so as to inform researchers of their role, function and requirements 



RECs decisions regarding its review of research  proposals 

















1-Levine RJ. Ethics and Regulation of Clinical Research. 

2nd ed. New Haven, Conn: Yale University 

Press; 1988. 

2- Ezekiel J. Emanuel, MD, PhD 

David Wendler, PhD 

Christine Grady, PhD 


3-Council for International Organizations of Medical 

Sciences. International Ethical Guidelines for Biomedical 

Research Involving Human Subjects. Geneva, 

Switzerland: CIOMS; 1993. 

4-Vanderpool HY, ed. The Ethics of Research Involving 

Human Subjects. Frederick, Md: University Publishing 

Group; 1996:45-58. 

5-Freedman B. Equipoise and the ethics of clinical 

research. N Engl J Med. 1987;317:141-145. 

6-Advisory Committee on Human Radiation Experiments. 

The Human Radiation Experiments. New 

York, NY: Oxford University Press; 1996. 

7-Beauchamp TL, Childress J. The Principles of Biomedical 

Ethics. New York, NY: Oxford University Press; 

1996:chap 3. 

8– National Institutes of Health. NIH policy and guidelines 

on the inclusion of children as participants in research 

involving human subjects. Available at: http:// 


024.html. Accessed April 28, 2000. 

10- http://ohsr.od.nih.gov/guidelines/belmont.html