GCP's Finality: Personal Integrity

During the past 15 years, good clinical practice (GCP) has developed from operational guidelines for industry-sponsored research to national legal and ethical frameworks against which all research involving human subjects is measured and appreciated. During the same period science and industry witnessed a rapid globalization of stakeholders and contributors to pharmaceutical, genetic, and indeed all biomedical research. GCP has become the common denominator for regulating, carrying out, and evaluating research around the world.

Francis P. Crawley

As an evolving standard for science and ethics in the implementation and execution of research, GCP represents a shared understanding of correct procedures for arriving at sound research conclusions for public health decisions while protecting the dignity and well-being of research participants. It is GCP's ability to marry science and ethics in research that makes it so convincing for society and the organizations and individuals engaged in research.

Concrete pillar of trust

The ongoing development and implementation of GCP into all aspects of research involving human participants, in all regions and areas of research, provides the fundamental pillar on which society can build trust in the research process and its results. Trust in research and in researchers has been seriously shaken over the past few years, however legitimately, by a growing list of reports of failures to follow appropriate standards and procedures in clinical trials. Behind each of these failures, whether viewed as an anomaly or as systemic, society senses a fundamental failure in individuals to accept or exercise certain responsibilities.

Amid all of today's skepticism, controversy, and finger pointing regarding trials, GCP provides the only complete framework for industry, academic, and government accountability. GCP is fundamentally concerned with identifying and assigning responsibilities in clinical trials: the ethics committee's responsibilities, the investigator's responsibilities, the sponsor's responsibilities, and even the regulator's (government's) responsibilities. To paraphrase the FDA, GCP makes all parties in research responsible for science and ethics.

However, the responsibilities so clearly outlined in GCP mean very little in the abstract. They are most cogent and convincing, but also extremely difficult, in the concrete: "What is my responsibility?"

Results and protection

As a research director, monitor, or auditor—or as an investigator or GCP inspector—you need to ask yourself: "How do my activities in this specific research project contribute to accurate scientific results while providing the highest concern and protection for participant safety and well-being?" As an educator or member of an ethics committee, DSMB, or an international association dedicated to promoting and developing clinical research, you should ask: "What is my responsibility toward the protection of research participants and the promotion of science in the interest of public health?" and "What is my bottom line?"

Perhaps the first paragraph of every GCP guideline (law or handbook) should read, paraphrasing Helsinki, "The duty of every person engaged in biomedical research is to promote and safeguard the health of the people. His or her knowledge and conscience are dedicated to the fulfillment of this duty."

"My responsibility" is the most challenging and, at times, the most disturbing part of the GCP equation. No amount of oversight or review can substitute in clinical trials for individual commitment to reconciling knowledge and conscience in each step of the research engagement. Good research organizational and systematic structures cannot substitute for personal integrity; rather, these structures need to be built on responsible engagement in ways that promote transparency and accountability.

And what if this reconciliation eludes us? What if alongside the demand to fulfill this duty, our jobs or our organizations somehow threaten to put our engagements in conflict with good science or good ethics? What then is my responsibility? How should I decide?

Personal integrity is the finality of GCP. Personal integrity is also an achievement; it cannot be found in a guideline or regulation. Perhaps it is only one achievement among others. From the points of view of science and ethics, however precarious, GCP remains my responsibility.

Francis P. Crawley, Director General, Good Clinical Practice Alliance-Europe, fpc@gcpalliance.org