chesapeake irb: the evolution of ethics in clinical research

The Declaration of Helsinki

Ethical Evolution During 50 Years of

Scientific and Societal Change

Jeffrey W. Wendel, CEO – Chesapeake IRB

Chair - AAHRPP Board of Directors

* Excerpted from Nov 7, 2014 presentation created by

Ellen Kelso, Executive Director, Chesapeake IRB for

TATA Memorial Hospital, Mumbai, India

Chesapeake IRB

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www.chesapeakeirb.com

Agenda: Declaration of Helsinki

• Historical Context

• Prior Evolution of Research Ethics

• Changes and Amendments

• Future Considerations

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Fifty Years of Social and Scientific Change

• Significant advancement in our scientific and technical ability is making way for us to envision, design, test and create solutions for earlier diagnoses and previously untreatable diseases.

– Multidisciplinary biomedical engineering

– Cancer immunotherapy

– Nanotechnology

– 3D printing

• Dramatic advancements in communication and collaboration tools

– Data warehouses, global coordination and linkage of registries

– Social media

– Emergence of disease -focused advocacy groups (rare diseases)

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• Ethics is a dynamic science that identifies

principles of behavior that best serve goals via

continual discovery and constant re-evaluation

– Result from careful study of generations of human

activity

– Observations over time of human nature and needs

• Behaviors that promote well-being

• Behaviors that inhibit or destroy it, and

– Identification of values that need to be maintained

Ethics Evolve to Match Societal Change



Bioethics

• Study of ethical controversies brought on by advances in biology and medicine

• Ethical issues that arise in relationships amongst:– Life sciences

– Biotechnology

– Medicine

– Politics

– Law

– Philosophy

– Theology

• Emerged as a formal discipline in the 1960s.



• 1900 and 1931 “guidelines” were directives that were ignored

• Resulted in many deaths from human experimentation

• Demonstrated the following:

– Legal protections insufficient to produce ethical research

– Guidelines need to be enforced

• Requirement for informed consent would not be realized for nearly 2 decades post WWII

First Attempts: Generally Unsuccessful



• Nuremberg Code– Informed consent from the subject is essential

– No provision for research with patients who could not consent for themselves (at face value, precludes any research with children or anyone else without full decision-making capacities).

• But…..– Human Radiation Experiments

– Thalidomide Tragedy

– Jewish Chronic Disease

– Willowbrook Study

– Tuskegee Study

First International Statement: Ignored



• 1964 – Declaration of Helsinki– Adapted from the Nuremberg Code by the World

Medical Association (representing 84 National Medical Associations)

– Linked to the Declaration of Geneva (1948) –statement of physicians ethical duties

– Specifically addresses and is considered a fundamental document in the ethics of medical research

– Internationally recognized

– Principles embodied in international guidance and regulation

First Authoritative Statement



• Significant additions in 1975

• Significant change in 1996

– Allowed placebo controlled trials; only where no proven treatment existed

• Major revision and reorganization in 2000

– Added clarifications regarding use of placebos, best proven current therapeutic interventions, and post-trial access

• Another major revision and reorganization 2013

• And, the evolution will continue…..

Declaration of Helsinki Evolution



• Our discovery and understanding will continue to grow with the evolution of research tools, technologies, and medical advancement

• Current evolutionary pressures include:– Astounding technologies and medical advances

– Complex clinical trial designs

– Electronic Consent

– Disease burden disparities between developed and emerging countries

• The key understanding that focus on protecting the rights and welfare of the participants will continue to guide us

Ongoing Lessons



• Like the Declaration of Helsinki, AAHRPP standards:

– Apply to all research regardless of funding source

– Are research participant-centric – involve research

participants and the community in the research process

– Recognize that optimal human subject protections is

achieved through building relationships with all

stakeholders (sponsors, investigators, participants, ERBs)

– Considered and adopted through peer review

– Continue to evolve in response to emerging issues

AAHRPP Standards



Chesapeake IRB

Bioethics and human subject protection are complex topics.

We want to help you understand and manage these essential responsibilities throughout your clinical research programs.

Contact us with your questions:

Ruth Boulter - VP Business Development

www.chesapeakeirb.com www.irbservices.com www.cirbi.net

Human Connection >>>Technology Driven

410-884-2900 or 609-731-8786



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