PURPOSE: Research Governance has been introduced to regulate research involving National Health Service (NHS) patients and staff but the process is lengthy and bureaucratic and has improved little since its introduction. The paper seeks to investigate changes over time. DESIGN/METHODOLOGY/APPROACH: A comparison between two studies, one in 2003-2004 and the second in 2004-2005, provided the opportunity of observing the process of Research Governance as it was developing. Both studies included postal questionnaire surveys and interviews with study participants. FINDINGS: In order to achieve Research Governance approval, application forms have to be completed, reviews undertaken, sponsors and indemnity information identified and honorary contracts from individual PCTs applied for. Honorary contracts can require references and health and Criminal Records Bureau checks. The process reduces the time available for research and employs large numbers of people, yet is still inefficient. Some of the requirements reduce the quality of the research and researchers' rights are marginalised. RESEARCH LIMITATIONS/IMPLICATIONS: The studies took place in a rapidly changing research environment. Further studies should continue to assess the situation and report any progress in making Research Governance less onerous for researchers. PRACTICAL IMPLICATIONS: There is an urgent requirement to investigate how procedures can be simplified and made less bureaucratic and costly, and to protect the rights of researchers. Without this, primary care research will be seriously disadvantaged and may become impossible to pursue. ORIGINALITY/VALUE: The study compares process over time and shows that achieving Research Governance approval is seriously limiting research in primary care.
PURPOSE: Research Governance has been introduced to regulate research involving National Health Service (NHS) patients and staff but the process is lengthy and bureaucratic and has improved little since its introduction. The paper seeks to investigate changes over time. DESIGN/METHODOLOGY/APPROACH: A comparison between two studies, one in 2003-2004 and the second in 2004-2005, provided the opportunity of observing the process of Research Governance as it was developing. Both studies included postal questionnaire surveys and interviews with study participants. FINDINGS: In order to achieve Research Governance approval, application forms have to be completed, reviews undertaken, sponsors and indemnity information identified and honorary contracts from individual PCTs applied for. Honorary contracts can require references and health and Criminal Records Bureau checks. The process reduces the time available for research and employs large numbers of people, yet is still inefficient. Some of the requirements reduce the quality of the research and researchers' rights are marginalised. RESEARCH LIMITATIONS/IMPLICATIONS: The studies took place in a rapidly changing research environment. Further studies should continue to assess the situation and report any progress in making Research Governance less onerous for researchers. PRACTICAL IMPLICATIONS: There is an urgent requirement to investigate how procedures can be simplified and made less bureaucratic and costly, and to protect the rights of researchers. Without this, primary care research will be seriously disadvantaged and may become impossible to pursue. ORIGINALITY/VALUE: The study compares process over time and shows that achieving Research Governance approval is seriously limiting research in primary care.