Ethics in Research involving Human Subjects

Dr. Walid S. AbdelkaderHead of Preventive Medicine

and Primary Care DivisionIMC

Feb. 2009www.imceg.com

Nazi Medical War Crimes (1939–1945)

Medical Research involving human beings have created a lot of potential pitfalls that led to tragedies in the last century.

Tuskegee Syphilis Study - Alabama

• The study was stopped in 1973 by the U.S. Department of Health, Education, and Welfare only after its existence was publicized and it became a political embarrassment. In 1997, under mounting pressure, President Clinton apologized to the study subjects and their families.

Other Major Violations to Human Research Subjects

• 1963 -- Brooklyn - Jewish Chronic Diseases Hospital: Cancer cells were injected into debilitated elderly patients to see if they would immunologically reject the cells.

• 1972 - Willowbrook State Hospital in New York: Retarded children were deliberately infected with viral hepatitis to study its natural history.

• It is clear that Various cultures such as ancient Egypt , Persia , Babylonia and Greece have attempted to regulate medicine and protect patient rights.

• One of the earliest written provisions in the field is that comes about 1750 BC is the Code of Hammurabi.

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The Nuremberg Code

– Voluntary informed consent– Likelihood of some good resulting– Based on prior research (animal models)– Avoidance of physical or psychological injury or harm– Benefits should outweigh risks– Proper experience of researcher– Right to withdraw consent– Research must stop if harm is resulting

(no specific mention of children, unconscious people, or others who may not be competent to give consent)

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1974 .

•Respect for persons •Beneficence •Justice

Helsinki Declaration

The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. The first version was adopted in 1964 and has been amended six times since, most recently at the General Assembly in October 2008. The current (2008) version is the only official one.

Other International Guidelines

• 1982 - International Ethical Guidelines for Biomedical Research Involving Human Subjects by World Health Organization (WHO) and Council for International Organizations of Medical Sciences (CIOMS)

• This 2002 text supersedes the 1993 Guidelines. It is the third in the series of biomedical-research ethical guidelines issued by CIOMS since 1982. Its core consists of 21 guidelines with commentaries.

The Four Principles of Ethics

1 - Autonomy (Respect for the person) 2 - Beneficence (Do Good) 3 - Non-malfeasance (Do No Harm) 4 - Justice

Institutional Review Board (IRB)

• Also known as an Independent Ethics Committee (IEC) or Ethical Review Board (ERB) is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the research subjects .

– The IRB must have at least five members.

– The members must have enough experience, expertise, and diversity

– If the IRB works with studies that include vulnerable populations, the IRB should have members who are familiar with these groups.

– The IRB should include both men and women.

– The members of the IRB must not be all of the same profession.

– The IRB must include at least one scientist and at least one non-scientist. These terms are not defined in the regulations.

– The IRB must include at least one person who is not affiliated with the institution or in the immediate family of a person affiliated with the institution. These are commonly called "Community Members.”

– IRB members may not vote on their own projects.

– The IRB may include consultants in their discussions to meet requirements for expertise or diversity, but only actual IRB members may vote.

Responsibilities of IRB

– Risks to study participants are minimized– Risks are reasonable in relation to

anticipated benefits– Selection of study participants is equitable– Informed consent is obtained and

appropriately documented for each participant– Adequate provisions for monitoring data

collection to ensure safety of the study participants

– Participant privacy and confidentiality is protected

The IRB/IEC should obtain the following documents

– Trial protocol(s)/amendment(s),– Written informed consent form(s) – Consent form updates that the investigator

proposes for use in the trial – subject recruitment procedures (e.g.,

advertisements), written information to be provided to subjects, Investigator's Brochure (IB),

– Available safety information, – Information about payments and

compensation available to subjects, the investigator's current curriculum vitae and/or other documentation evidencing qualifications,

– Any other documents that the IRB/IEC may need to fulfill its responsibilities.

The Situation in Egypt

– Most medical research that have been conducted in Egypt were done without the knowledge or consent of whom the research was carried out.

– Culture is progressively changing towards this issue and many IRBS have been constructed in many Governmental and some NGO in Egypt

Egypt is an excellent pool for medical research due to :

• Large population size• Diversity of population composition• High prevalence of some chronic disorders such as

chronic hepatitis C and DM

• Every health organization directly or indirectly involved in medical research should have an IRB

Thank You