Research on Human Subjects Essential to Medical Progress

“Medical progress is based on research that ultimately must include studies involving human subjects.” This quote from the Declaration of Helsinki (DOH), the World Medical Association (WMA) statement of ethical principles for research involving human subjects makes clear the importance of the DOH as a guide for those doing research.

The truly astounding advances in development of medications and technical devices used to save lives and relieve suffering which we enjoy today and into the future would not be possible without research involving human subjects. Ultimately every drug and device must be tested in human subjects to assure its safety and effectiveness, justifying its use in medical practice. And critical to that testing is adherence to ethical principles of risk assessment and informed consent that protect the patients who are the subjects of the research.

In addition the reality is that absent patient assurance that care is being taken to maximize safety, minimize risks and promote transparency, trust in the process and willingness to participate in research will be damaged. And our ability to achieve advances in medical care will be markedly limited.

It is because of this reality that the DOH, adopted by the WMA in 1964 and recognized the world over, is such an iconic document. Over the past two years the WMA has been involved in a process to evaluate the DOH to determine if changes are needed – not to change core principles, but to determine if additional guidance is needed to deal with an increasingly complex world.

To this end a work group was established by the WMA in 2011. Expert conferences have been held in Rotterdam, Cape Town and Tokyo to seek input from ethics scholars, academicians, government officials and practicing physicians. As has been reported in WMA communications, the WMA Council reviewed the work group’s draft revision of the DOH at it’s meeting in Bali this month and approved its distribution for public comment.

Modifications of the DOH found in the draft document deal with a variety of topics that have become of increased importance over recent years. These include increased protection for vulnerable populations, strengthening of informed consent provisions, making study protocols more clear, issues related to bio banks, post trial access, ethics committees, privacy protections, use of placebos, and unproven interventions.

An additional expert conference will be held in Washington D.C. this August following which the work group will present the final revised DOH to the WMA Council and General Assembly for approval this October in Fortaleza, Brazil.

From my viewpoint, not as an ethicist, but as an internist with decades of experience practicing medicine, the care and thoroughness with which the WMA work group has gone about its work is reassuring. In addition, the transparency of the process encouraging involvement by experts in the field and now the public is a reassuring affirmation that the end product will preserve the DOH as the gold standard for ethical principles in research involving human subjects.

Plans are for celebrations in 2014 to commemorate the fiftieth anniversary of the Declaration of Helsinki, including ceremonies in Helsinki, Finland where the original document was first adopted.