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THE ETHICS PROJECT
 
 


Progress
 

Introduction

Much has happened in the “land of ethics” since this project formally began. There has been a surge in interest in both the research ethics-review process and the need to collect data that can inform the future direction of change in the area. JERHRE is one of the journals leading the way in presenting this information in ways that can be used by researchers, policy makers, and others to empirically ground the review process.

Although there have been changes over the years, many of the core problems seem to remain.   There are a few new twists and turns, but the road towards reasonable, rational and useful ethics review remains tortuous and often seemingly convoluted. Through projects like this one we have learned about the process in ways that we hope will allow people to travel this road easier. 

We hope that these many new and exciting projects will make positive contributions toward the much need change in this area. Given that there is now a growing awareness that the review system in general is a system that needs more scrutiny to be sure that the process achieves what it is supposed to achieve: to enhance the quality of research and protect the people involved — and does so in an efficient and effective manner that does not negatively affect the research process and its outcomes.

 

Marubra Beach, Sydney, Australia

 

 

Change is needed to be sure that the workload of committees is reasonable and allows these dedicated people to accomplish the work that really needs to be done. Our work suggests that there is an ever growing need to be sure that any changes are guided by a solid evidentiary base and a clear sense of purpose.

Through projects like this one we have learned about the process in ways we hope will allow people to make positive contributions toward the much need change in this area. There is now a growing body of data from this and other projects that can provide the kind of information that can result in informed change.

This project has resulted in the development of an ever growing network of people and organisations that keeps me aware of many of the activities happening in the world of research ethics today. Information from this network often results in such things as additions to the Links page.  More importantly this network allows me to continue to contribute to the field using knowledge gained from my research.

 

Diana, Princess of Wales, water feature, London, UK

 

Overview of the Database with Comments

The body of data to which I refer includes formal interviews/discussions with 214 people from the five primary countries involved: Australia, Canada, New Zealand, the UK and the USA, plus occasional opportunistic interviews with colleagues in other nations, particularly Asian nations, where the substance of the ethics review process has been borrowed and then modified to address local needs. What is happening in the international arena and how it is being affected by processes developed in other contexts now presents a growing area that requires informed direction.

Clearly there are already people looking into this area. The results of our research requires us to support such work and encourage more informed debate about what research ethics review will look like (and should look like) in a global context, even whether it can be considered in a global context.

 

Garden of science museum, San Francisco, California, USA

 

Many colleagues have talked with us to share their “ethics stories” and to ask our advice about some aspect of their review process experience. We have participated in a variety of seminars, workshops, and conferences where we have had the opportunity to share thoughts, ideas, and experiences with others. Then there are the many everyday folk who volunteer their ethics stories and thoughts on research and the review process in all kinds weird and strange of contexts.

More recently people have approached me for assistance in developing research proposals to investigated one or more aspects of the research ethics review process.  I have learned from all the people involved in the research process and this project, and hope they have learned from me and the research I have conducted in collaboration with all these people.

 

Surf on rocks, Sydney, Australia

 

The list below indicates how many people have been formally involved by country. Again, some of these people have been involved on several occasions.

• Australia = 79
• Canada = 52
• New Zealand = 16
• UK = 16
• USA = 51
• Other = 1

We observed 29 committee meetings, more than some members have attended. This includes meetings in the five countries involved.

 

• Australia = 13
• Canada = 2
• New Zealand = 3
• UK = 4
• USA = 7

These meetings include regional and local committees, those devoted primarily to medical research and those focused on behavioural and social science research. Many review a range of types of research.

 

Undergrowth with Sequoias, California, USA

 

The project is now more about sharing our findings with others than it is about learning about the review process from them, although that does continue in a small way.  I now feel more like we are contributing to the process of change rather than just absorbing new information.  On the other hand, the quantity and quality of the new information on the ethics review process is astounding.  There is much for all of us to learn.  I hope this website can aid that learning process.
 
 
 

 

Surfer on beach Northern Beaches, Sydney, Australia

 

There is a real and potential danger that can result from an ineffective and faulty review process: bad research, even the end of research in some areas and the end of using some methodologies. On the other hand, a good review process should not only result in the protection of participants in the research process, but result in enhancements and refinements of the research process itself.

Given the nature of technology in today's global world and the push, particularly in academia, for more and more outside funded research, new ethical issues have arisen and ethics committees are becoming overwhelmed by the workload and the demands such research presents.

 

The Eye

 

Everyone who has been involved in this project wants to be sure that the many people who have assisted with and participated in the project understand how much we appreciate everyone's help and support. So many people have been involved in the project and we are grateful to every one of them.  As a result of this incredible participation, the project database now involves a huge body of data (e.g., more than 1400 single spaced pages of field notes in just one file), to which bits are added all the time.

As the project team worked with the data and tested out emerging ideas with key informants we have developed a sense of confidence in the quality of the data and our analyses. This process, which some call member checking, supports our notion of the quality of the data and our interpretations.

 

 

The people involved in this project represent researchers from a broad range of disciplines who use a vast array of research methods and methodologies, from clinical trials to those more often associated with the social sciences and humanities. We have talked with committee members, including Ethics Officers and Chairs; policy makers; and a representative of the pharmaceutical industry. We have talked to students, including some who have not yet submitted their first ethics application and wanted to share their concerns about entering into the process and to ask for advice on how to proceed given the nature of their particular project. 

 

Kakadu, NT, Australia

 

The people formally involved in our work come from a total of 37 cities or metropolitan areas. As noted in earlier progress reports, the formal interviews/ discussions last from 20 minutes to 4 hours, with most being 1 1/2 to 2 1/2 hours long. Most of these interview/discussions have been face-to-face. Others have been by telephone or email. Many people continue to stay in regular email contact, passing on interesting bits of information, publications, etc.

The opportunity for ongoing contact with people has been so valuable and useful. Not only do these people provide an opportunity for a form of member checking, but they have provided opportunities to try out emerging analyses and interpretations of the data where they happily point out errors that need to be corrected or areas that require refinement. We also deeply indebted to the many generous people who have taken time to read and comment on drafts of papers (writing is being used as an analytical process in the project). They also help us to keep our facts straight (so many are in a constant state of flux) and have added to our understanding of this very human and cultural process. Keeping the “facts” straight is quite a task as there have been so many changes in so many places over the course of the project.

 

Northern Beaches, Sydney, Australia

 

This number represents roughly 66% of the committees formally contacted about participating in the research. An additional 18% agreed to an observation but, for various reasons, we were not able to observe a meeting of these committees. Sixteen percent of the committees formally contacted did not agree to allow us to observe. This turned out to be much better than we thought it would be in the first months of the project when I had concerns about being able to observe enough committees to be sure we had enough data. But, as you can see in some of the papers, we have reached a level of saturation that has often allowed us to predict what would happen in the course of a meeting in general and in some specific contexts. Even I'm amazed sometimes by the level of predictive validity.

Reporting the number of meetings observed does not fully represent the body of information we have on committee meetings. The number is much larger when you include the number of committees represented among our key informants.  We have also learned a lot about committees and the review process through our reviews of committee websites and an increasing familiarity with the process through the rapidly growing body of literature.

 

Kakadu sunset, NT, Australia

 

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