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Barriers to conducting clinical research in reproductive medicine around the world
VIEWS AND REVIEWS Barriers to conducting clinical research in reproductive medicine around the world William D. Schlaff, M.D. Department of Obstetrics and Gynecology, Thomas Jefferson Medical College, Philadelphia, Pennsylvania
We asked seven senior and accomplished investigators from around the world to share their experiences conducting research in reproductive medicine. (Fertil Steril 2011;96:801. 2011 by American Society for Reproductive Medicine.)
The topic for the symposium presented in this issue of Fertility and Sterility arose from a discussion of the Editorial Editors of the journal who convened to identify key topics in reproduction that have an impact in the world of reproduction and the membership of the American Society for Reproductive Medicine. The critical importance of clinical research to progress in our field and to many members of our Society was widely emphasized during this discussion, and led us to ask how research in reproduction was perceived, supported, and/or impeded in different areas of the world. We assumed that research experiences would likely be different, and certain common challenges would be more or less relevant in different countries or regions. The Editors thought that it would be both interesting and valuable for our members to learn more about the perceived barriers to clinical research facing their international colleagues based on national or regional culture, availability of economic support, religious/ethical oversight, geographic challenges, and academic organization, among other factors. Our strategy in developing this symposium was to solicit seven senior and accomplished investigators from around the world to share their experiences and impressions. The authors were specifically chosen from different geographical areas—Latin America (Chile), the Middle East (Egypt), Europe (Greece), China, India, Australia, and the United States. We did not think or expect that any one of the authors would ‘‘represent’’ all authors from their region, but nevertheless thought that this mix would provide our readership with perspectives felt more or less compellingly around the planet. Furthermore, in order to ensure that our contributors consistently addressed questions we thought to be particularly relevant, we provided each of them with the same 10 questions, namely: 1. What do you see as the most significant barriers to research? 2. Do institutional review boards/ethics panels present a significant barrier to your research? Alternately, do you feel that the input from such panels has a significant benefit in developing your
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research protocols in any way? In answering this it would be helpful for you to provide a sense of how long it usually takes to compile a submission to institutional review board and to obtain approval for research, and to discuss the impact of institutional review board ongoing overview of research projects. How are research personnel and projects generally funded? How much research is self-initiated as opposed to solicited by industry or pharmaceutical companies? Do the hospitals and medical facilities where you do research represent a barrier to your research (e.g., by charging you for use of facilities), are they neutral, or do they actively support your research efforts? What challenges do you face in recruiting research subjects? Could you describe the informed consent process you generally follow? Is the principal investigator allowed to consent his/her own patient to participate in a trial, and is the principal investigator allowed to treat the patient once enrolled in the trial? What, if any, are the barriers to collaboration in multicenter trials? How are junior investigators trained in doing research? Are investigators required to have specific training by institutional review boards? Are you prohibited from doing some types of research? If you could, what would you change to enhance research opportunities and productivity?
We are very grateful to each of our contributors for their willingness to share their experience and perspectives on clinical research in their countries and regions. Again, we did not ask them to presume to present a unified or homogenous picture for their entire region, but rather a description of their own experience which we hope will be instructive and give our readers some sense of how different regions of the world perceive research challenges. We believe that a number of themes emerged from this symposium, and will leave it to our readers to find relevance in them.
Received August 31, 2011; accepted August 31, 2011. W.D.S. has nothing to disclose. Reprint requests: William D. Schlaff, M.D., University of Colorado School of Medicine, Obstetrics and Gynecology, Academic Office Building 1, 12631 E. 17th Avenue, Aurora, CO 80045 (E-mail: william.schlaff@ ucdenver.edu).
0015-0282/$36.00 doi:10.1016/j.fertnstert.2011.08.048
Fertility and Sterility Vol. 96, No. 4, October 2011 Copyright ª2011 American Society for Reproductive Medicine, Published by Elsevier Inc.
801
We asked seven senior and accomplished investigators from around the world to share their experiences conducting research in reproductive medicine. (Fertil Steril 2011;96:801. 2011 by American Society for Reproductive Medicine.)
The topic for the symposium presented in this issue of Fertility and Sterility arose from a discussion of the Editorial Editors of the journal who convened to identify key topics in reproduction that have an impact in the world of reproduction and the membership of the American Society for Reproductive Medicine. The critical importance of clinical research to progress in our field and to many members of our Society was widely emphasized during this discussion, and led us to ask how research in reproduction was perceived, supported, and/or impeded in different areas of the world. We assumed that research experiences would likely be different, and certain common challenges would be more or less relevant in different countries or regions. The Editors thought that it would be both interesting and valuable for our members to learn more about the perceived barriers to clinical research facing their international colleagues based on national or regional culture, availability of economic support, religious/ethical oversight, geographic challenges, and academic organization, among other factors. Our strategy in developing this symposium was to solicit seven senior and accomplished investigators from around the world to share their experiences and impressions. The authors were specifically chosen from different geographical areas—Latin America (Chile), the Middle East (Egypt), Europe (Greece), China, India, Australia, and the United States. We did not think or expect that any one of the authors would ‘‘represent’’ all authors from their region, but nevertheless thought that this mix would provide our readership with perspectives felt more or less compellingly around the planet. Furthermore, in order to ensure that our contributors consistently addressed questions we thought to be particularly relevant, we provided each of them with the same 10 questions, namely: 1. What do you see as the most significant barriers to research? 2. Do institutional review boards/ethics panels present a significant barrier to your research? Alternately, do you feel that the input from such panels has a significant benefit in developing your
3.
4.
5. 6.
7. 8.
9. 10.
research protocols in any way? In answering this it would be helpful for you to provide a sense of how long it usually takes to compile a submission to institutional review board and to obtain approval for research, and to discuss the impact of institutional review board ongoing overview of research projects. How are research personnel and projects generally funded? How much research is self-initiated as opposed to solicited by industry or pharmaceutical companies? Do the hospitals and medical facilities where you do research represent a barrier to your research (e.g., by charging you for use of facilities), are they neutral, or do they actively support your research efforts? What challenges do you face in recruiting research subjects? Could you describe the informed consent process you generally follow? Is the principal investigator allowed to consent his/her own patient to participate in a trial, and is the principal investigator allowed to treat the patient once enrolled in the trial? What, if any, are the barriers to collaboration in multicenter trials? How are junior investigators trained in doing research? Are investigators required to have specific training by institutional review boards? Are you prohibited from doing some types of research? If you could, what would you change to enhance research opportunities and productivity?
We are very grateful to each of our contributors for their willingness to share their experience and perspectives on clinical research in their countries and regions. Again, we did not ask them to presume to present a unified or homogenous picture for their entire region, but rather a description of their own experience which we hope will be instructive and give our readers some sense of how different regions of the world perceive research challenges. We believe that a number of themes emerged from this symposium, and will leave it to our readers to find relevance in them.
Received August 31, 2011; accepted August 31, 2011. W.D.S. has nothing to disclose. Reprint requests: William D. Schlaff, M.D., University of Colorado School of Medicine, Obstetrics and Gynecology, Academic Office Building 1, 12631 E. 17th Avenue, Aurora, CO 80045 (E-mail: william.schlaff@ ucdenver.edu).
0015-0282/$36.00 doi:10.1016/j.fertnstert.2011.08.048
Fertility and Sterility Vol. 96, No. 4, October 2011 Copyright ª2011 American Society for Reproductive Medicine, Published by Elsevier Inc.
801