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Support for Investigator-Initiated Clinical Research Involving Investigational Drugs or Devices: The Clinical and Translational Science Award Experience

Berro, Marlene MS; Burnett, Bruce K. PhD; Fromell, Gregg J. MD; Hartman, Karen A. MSN; Rubinstein, Eric P. JD, MPH; Schuff, Kathryn G. MD; Speicher, Lisa A. PhDon behalf of the IND/IDE Taskforce of the Clinical and Translational Science Award Consortium

doi: 10.1097/ACM.0b013e3182045059
Clinical Research

Purpose Investigator-initiated research involving investigational drugs and devices is key to improving health. However, this requires the investigator to serve as a “sponsor–investigator,” which can be complex and overwhelming. The Investigational New Drug/Investigational Device Exemption (IND/IDE) Taskforce of the Clinical and Translational Science Award (CTSA) consortium carried out a survey to examine how academic health centers (AHCs) assist sponsor–investigators with regulatory responsibilities.

Method The 24 CTSA centers existing in 2008 were surveyed regarding regulatory oversight and support for sponsor–investigators. Responses were analyzed by descriptive statistics. The evaluation of survey responses yielded three models of institutional support/oversight.

Results Nineteen centers and one affiliate responded. Eleven (55%) reported having an IND/IDE support office, increased from five (25%) prior to their CTSA award. The volume of investigator-initiated IND/IDE research was highly variable (measured by numbers of investigators, IND/IDE applications, and studies). Oversight, if done, was provided by either the IND/IDE office or elsewhere in the institution. Most IND/IDE offices assisted with IND/IDE submissions and preparation for external audits. Half reported advanced training for sponsor–investigators. Almost all reported a goal to increase IND/IDE research. Important issues include the need for robust training of investigator/staff, appropriate determination of IND-exempt research, and sufficient support for preparing IND/IDE applications.

Conclusions Investigator-initiated research involving IND/IDEs is essential, but complex. AHCs should examine how they support sponsor–investigators in meeting the complex requirements. A model of either expert consultation/support or full service will minimize risks to participants and institutions, and regulatory noncompliance.


Ms. Berro is program manager of regulatory support, Clinical and Translational Science Institute, University of California, San Francisco, San Francisco, California.

Dr. Burnett is director of regulatory affairs, Duke Translational Medicine Institute, Duke University School of Medicine, Durham, North Carolina.

Dr. Fromell is executive director, Office of Human Research, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, and Institute for Translational Medicine and Therapeutics, University of Pennsylvania, Philadelphia, Pennsylvania.

Ms. Hartman is operations manager, Office of Research Regulatory Support, Mayo Clinic, Rochester, Minnesota.

Mr. Rubinstein is director, Office of Regulatory Support, Clinical and Translational Science Institute, University of Rochester, Rochester, New York.

Dr. Schuff is director of regulatory support services, Oregon Clinical and Translational Research Institute, Oregon Health & Science University, Portland, Oregon.

Dr. Speicher is director, Clinical Trials Office, Office of Clinical and Translational Research, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.

Please see the end of this article for information about the authors.

Correspondence should be addressed to Dr. Schuff, Division of Endocrinology L-607, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239-3098; telephone: (503) 494-1685; fax: (503) 494-6990; e-mail:

First published online December 16, 2010

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© 2011 Association of American Medical Colleges