TY - JOUR
T1 - Principal investigator views of the IRB system
AU - Whitney, Simon N.
AU - Alcser, Kirsten
AU - Schneider, Carl E.
AU - McCullough, Laurence B.
AU - McGuire, Amy L.
AU - Volk, Robert J.
PY - 2008/4/2
Y1 - 2008/4/2
N2 - We undertook a qualitative e-mail survey of federally-funded principal investigators of their views of the US human subjects protection system, intended to identify the range of investigator attitudes. This was an exploratory study with a 14% response rate. Twenty-eight principal investigators responded; their comments were analyzed to show underlying themes, which are here presented along with supporting quotations. There was consensus that it is important to protect human subjects from research abuse, but disagreement over how well the IRB system is functioning. Some researchers felt that the system is effective and serves its purpose well. Of those who support the system, some endorse its methods, purpose, and daily functioning, as they experience it, without reservation. Others, while expressing some frustration, feel that the purpose is important and their local IRB does its best to make a difficult system work well. Those investigators who were more harshly critical commented on multiple flaws in the system, including (1) consent forms that are inappropriate and incomprehensible, (2) an emphasis on minutiae, and (3) concern with protecting the institution more than research subjects. Respondents told us that the IRB system is a particular burden for research in neurology, emergency medical conditions, repositories, and social sciences in general; a more comprehensive study might identify other problematic areas. Significant concern was expressed about the cost, inefficiency, and irrationality of IRB review. The IRB system works well for some researchers, but our results indicate that other investigators feel the costs outweigh the benefits.
AB - We undertook a qualitative e-mail survey of federally-funded principal investigators of their views of the US human subjects protection system, intended to identify the range of investigator attitudes. This was an exploratory study with a 14% response rate. Twenty-eight principal investigators responded; their comments were analyzed to show underlying themes, which are here presented along with supporting quotations. There was consensus that it is important to protect human subjects from research abuse, but disagreement over how well the IRB system is functioning. Some researchers felt that the system is effective and serves its purpose well. Of those who support the system, some endorse its methods, purpose, and daily functioning, as they experience it, without reservation. Others, while expressing some frustration, feel that the purpose is important and their local IRB does its best to make a difficult system work well. Those investigators who were more harshly critical commented on multiple flaws in the system, including (1) consent forms that are inappropriate and incomprehensible, (2) an emphasis on minutiae, and (3) concern with protecting the institution more than research subjects. Respondents told us that the IRB system is a particular burden for research in neurology, emergency medical conditions, repositories, and social sciences in general; a more comprehensive study might identify other problematic areas. Significant concern was expressed about the cost, inefficiency, and irrationality of IRB review. The IRB system works well for some researchers, but our results indicate that other investigators feel the costs outweigh the benefits.
KW - Attitude
KW - Ethics committees
KW - Questionnaires
KW - Research
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UR - http://www.scopus.com/inward/citedby.url?scp=44449105104&partnerID=8YFLogxK
U2 - 10.7150/ijms.5.68
DO - 10.7150/ijms.5.68
M3 - Article
C2 - 18392146
AN - SCOPUS:44449105104
SN - 1449-1907
VL - 5
SP - 68
EP - 72
JO - International journal of medical sciences
JF - International journal of medical sciences
IS - 2
ER -