Shortly after World War II, the World Medical Association (WMA) convened to discuss ethical guidelines for treatment of subjects in clinical research. The first meeting in 1947 convened while memories of the atrocities of World War II remained fresh. By 1964, the WMA had completed the first version of the declaration. Subsequently, it has been revised 10 times.1

The organization of the declaration is as follows:

Preamble

General Principles

Risks, burdens, and benefits

Individual, group, and community vulnerability

Scientific requirements and research protocols

Research ethics committees

Privacy and confidentiality

Frequent informed consent

Use of placebo

Post trial provisions

Research registration and publications and dissemination of results

Unproven interventions in clinical practice.

The longest of these, free and informed consent, consists of paragraphs 25 through 32.

As noted above, the document has been revised in order to maintain high standards in a changing medical and social environment. Bierer notes that “interdigitating themes–vulnerability, impulsivity, and global justice–are particularly salient.”2 Resneck provides an elegant summary of the revisions to the declaration on this 60th anniversary. The original declaration was addressed primarily to physicians. A key component of many of these revisions serves to broaden the audience, urging that the principles enumerated in the declaration should be upheld by all individuals, teams and organizations involved in clinical research. This is echoed in an acknowledgment of the interdisciplinary nature of many research projects.

Distributive and global justice are emphasized. This emphasis is particularly important in the current environment. Patient value is a key component of this premise; clearly social value must be integrated cross culturally. The second component, global justice, entails recognition of protections for vulnerable individuals which is also contextually and culturally dependent.

Groups of “particular vulnerability,” include individuals who are incarcerated, or, who are incapable giving free and informed consent. Additionally, these individuals would be eligible for research only if the investigation could not be carried out with a less vulnerable group or community.3

So why should we be focusing on this declaration 60 years later? So many of its’ recommendations seems self-evident, or at least should. The focus of the declaration continues to be the widespread distribution of equity, fairness, and protection of vulnerable groups. This is framed within the social and cultural context of a changing global village.

I would submit that this is particularly important in the current political and social climate in the United States. Humanitarian efforts, most notably, the Diversity, Equity, and Inclusion (DEI) initiative, are at risk. I would hope that this would serve as a cautionary note to all caregivers, particularly in a group such as NASS, which has always prided itself on ethics and equity.

In this month’s edition, we have some very special features. In the President’s Column, Dr. Kreiner looks back on 40 years of collegiality, one of the many features that make NASS so extraordinary. Drs. Barber and Friedrich penned this issue’s Invited Review on cervicogenic headaches. This is really an outstanding review as it is directly related to the specific expertise recommended for appropriate diagnosis and treatment of these diseases In the Literature Review, Drs. Shi and Grauer examine the correlation of renal dysfunction and outcomes following anterior cervical discectomy and fusion. This certainly is not a topic that is commonly addressed in many spine circles, and for that reason alone is valuable. Osteoporosis and spinal deformity are reviewed in the Section Spotlight by Drs. Bautista et al, and Dr. Blasier provides his usual succinct and extremely relevant Coding update.

In NASS News, Executive Director Eric Muehlbauer offers a 40th Anniversary Message; the 40th anniversary milestones are subsequently reviewed. I would also draw everyone's attention to the In Memoriam article, honoring Shawn Collins. Shawn provided insightful and professional legal counsel to NASS for many years. Having had the opportunity to work with him through various committee assignments, I always found Shawn to be personable, pleasant, and thorough. He also seemed to truly grasp the nuances of our mission. We owe Shawn a debt of gratitude for his service to NASS; he will be missed.