HII logo

Project to harmonize health research guidelines

Bethesda, Maryland (January 25, 2012) – Health Improvement Institute has launched a Project to harmonize health research guidelines. “Much research is of questionable quality. Improving health care and enabling people to maintain their health requires better research,” said Dr. Peter G. Goldschmidt, the Institute’s president. “Guidelines offer one way of increasing the productivity of the research enterprise.” Today, there are conflicts, overlaps, and gaps in needed health research guidelines, according to 35 experts who met in Rockville, Maryland, on November 1, 2011, at the Institute’s invitation, to develop arrangements for a guidelines’ harmonization mechanism. They represented guideline developers, users from industry and academe, and use-facilitators and end-users, including regulators, funders, and providers.


Participants agreed on the need to establish a harmonization mechanism (to foster excellence), to involve stakeholders (to avoid duplication), and to work closely with organizations (to promote adoption). Based on participants’ recommendations, the Institute is planning to:

 “There is an urgent need to develop a ‘meta-guideline’ – a systematic approach to harmonizing guidelines – to realize the full benefits of such efforts. The HII research guidelines Project will facilitate achieving this goal,” commented Dr. Greg Koski, founder of the Alliance for Clinical Research Excellence and Safety (and former director of the U.S. Office for Human Research Protections). He presented this latest work at the Institute’s November meeting and advocated moving beyond local harmonization to global standardization.


“We invite alliances and associations throughout the world that are part of the health research enterprise to participate in the Project to ensure its success,” said Dr. Goldschmidt. “The Project is needed to keep up with the changing science of science, to ensure the utility of research results, to meet the increasing demand for efficiency, and, above all, to maintain public trust”.



The meeting used an interactive format: focused expert presentations to set the scene; followed by workgroup discussions, and plenary presentation of workgroup results. The Institute received input from Clinical Data Interchange Standards Consortium (www.cdisc.org), cooperation from Alliance for Clinical Research Excellence and Safety (www.acresglobal.net), and support from Nuovo Biologics LLC and Digital Infuzion. The meeting report is available at, www.hii.org. For more information about Project/meeting, please contact the Project Coordinator at 301-320-0965 or by email at hii@hii.org.  


Health Improvement Institute (HII), based in Bethesda, MD, is a non-profit, tax exempt, 501(c)3, charitable organization dedicated to improving the quality and productivity of America’s health care. The Institute conducts projects and workshops and sponsors national awards programs to recognize excellence, including the Aesculapius Award (forhealth communications)and Award for Excellence in Human Research Protection.