Commentary in 2005

The objective of the multidisciplinary expert Consensus Panel on Research with the Recently Dead (CPRRD) was to craft ethics guidelines for research with the recently dead. The CPRRD recommends that research with the recently dead: (i) receive scientific and ethical review and oversight; (ii) involve the community of potential research subjects; (iii) be coordinated with organ procurement organizations; (iv) not conflict with organ donation or required autopsy; (v) use procedures respectful of the dead; (vi) be restricted to one procedure per day; (vii) preferably be authorized by first-person consent, though both general advance research directives and surrogate consent are acceptable; (viii) protect confidentiality; (ix) not impose costs on subjects' estates or next of kin and not involve payment; (x) clearly explain ultimate disposition of the body.

Traditional boundaries among basic research, clinical research and patient-oriented research are yielding to a single, continuous, bidirectional spectrum commonly termed 'translational research' or 'translational medicine.' These encompass (i) the definition of guidelines for drug development or for the identification and validation of clinically relevant biomarkers; (ii) experimental nonhuman and nonclinical studies conducted with the intent of developing principles for the discovery of new therapeutic strategies; (iii) clinical investigations that provide a biological foundation for the development of improved therapies; (iv) any clinical trial initiated in accordance with the above goals; and (v) basic science studies that define the biological effects of therapeutics in humans. Although these goals are essentially no different from those of traditional academic clinical research, translational research emphasizes strategies to expedite their successful implementation. Unfortunately, several barriers that delay this process need to be surmounted to make translational research more than just an interesting concept.

Preventive vaccines are widely acknowledged as the best hope for protection against infectious pathogens such as avian flu, HIV and SARS. As a result, they have received much recent attention in the media that has exposed some of the challenges involved in optimally using vaccine technology.

The challenges of vaccine development are not limited to identification of suitable antigens, adjuvants and delivery methods, but include regulatory, technical and manufacturing hurdles in translating a vaccine candidate to the clinic. Process development is the technological foundation that underlies the manufacture of new vaccines and is central to successful commercialization.

Infectious diseases are thought to account for nearly 25% of all deaths worldwide, and extract a disproportionate toll in developing countries¹. Moreover, infectious diseases are now appreciated to be major causes of the poverty and economic underdevelopment that characterize the world's poorest countries². Development and deployment of new vaccines to prevent infectious diseases in developing countries have therefore become high priorities in the global health agenda.