4.0 CONCLUSION
The objective of this review was to examine every step in the current process of applying for, receiving, monitoring and reporting on industry-sponsored research, and to recommend changes in these process steps, where needed, to improve and enhance the ability of faculty to market their research and service capabilities.
Our findings indicate that any plan to aid faculty in being more competitive in attracting industry-sponsored research must include the seamless coordination of all institutional and regulatory policies and procedures and approvals that affect corporate research. The plan must also include more responsive administrative, oversight, approval, and compliance monitoring services throughout the AHC.
We have recommended changes to the current process steps, and that a research service support office be developed to support investigators in navigating the new and improved process. There is little disagreement about the need for change on some scale. There is evidence from within and outside of the institution that real, meaningful improvements in our research management and compliance processes are essential.
It is clear that some within the AHC and the institution recognize the need for meaningful change. The questions now are: whose interests does the institution need to most protect? Can the interests of the institution be adequately supported and protected without supporting and protecting its constituent parts? Can the institution go beyond its inclination to consider "who" often sacrificing "what" and "how"? Implementing the changes recommended will require direct, strong, committed leadership. The AHC has leaders who can effect the meaningful change needed.
5.0 APPENDICES
5.2 Academic/Research Misconduct
5.4 Protection of Animal Subjects
5.5 ORTTA
5.6 Department of Environmental Health and Safety
5.7 General Clinical Research Center
Cancer Center
5.8 General Appendices
5.1 Conflict of Interest
5.1.1 Federal Register: September 22, 1994
Federal Register: (http://law.house.gov/7.htm)
Docket No. 93N-0445: Financial Disclosure by Clinical Investigators; Proposed Rule Department of Health and Human Services
5.1.2 Federal Register: July 11, 1995 (Volume 60, Number 132)
Objectivity in Research; Investigatory Financial Disclosure Policy; Final Rule and Notice
5.1.3 Federal Register: July 11, 1995 (Volume 60, Number 132)
Investigator Financial Disclosure Policy (NSF technical changes to investigator financial disclosure policy)
5.1.4 Federal Register: March 5, 1996 (Volume 61, Number 44) Proposed Rules
Docket No. 93N-0445: Financial Disclosure by Clinical Investigators; Reopening of Comment Period and Notice of Meeting
5.1.5 Federal Register: July 3, 1996 (Volume 61, Number 129) Frequently Asked Questions Concerning the Department of Health and Human Services Objectivity in Research Regulations and the National Science Foundation Investigator Financial Disclosure Policy
5.1.6 University of Minnesota Board of Regents' Policy: Consulting and Outside Affiliations - Conflict of Interest (http://www.fpd.finop.umn.edu)
5.1.7 University of Minnesota Board of Regents' Policy: Outside Consulting, Service Activities, and Other Work (http://www.ortta.umn.edu/policy/respolcy.htm)
5.1.8 Current Academic Health Center Conflict Review Committee Application5.2.1 Office of Research Integrity Advisory Document: Model Policy and Procedures for Responding to Allegations of Scientific Misconduct - April 1995 (http://www.os.dhhs.gov/phs/ori/policy/policy.htm)
5.3 Protection of Human Subjects
5.2.2 University of Minnesota Board of Regents' Policy: Academic Misconduct (http://www.ortta.umn.edu/policy/respolcy.htm)
5.2.3 Integrity and Misconduct in Research (Report of the Commission on Research Integrity) (http://os.dhhs.gov/phs/ori/policy/policy.htm)
5.3.1 FDA Information Sheets (http://www.fda.gov/oc/oha/toc.html)
5.3.2 FDA Code of Federal Regulations (21 CFR Part...) (http://law.house.gov/cfr.htm)
50: Protection of Human Subjects/Informed Consent
56: Institutional Review Boards
5.3.3 Federal Register: October 2, 1996 (Volume 61, Number 192) Protection of Human Subjects; Informed Consent and Waiver of Informed Consent Requirements in Certain Emergency Research; Final Rules
5.3.4 University of Minnesota Subjects Protection Program Committee Membership Lists
5.3.5 OPRR Protecting Human Research Subjects Guidebook (http://www.nih.gov/grants/oprr/oprr.htm)
5.3.6 UM Research Subjects Protection Programs (http://www.ortta.umn.edu/subjects/subjects.htm)
5.3.7 Current IRB Application Form, Continuing Review Form
5.4.1 FDA Code of Federal Regulations (21 CFR Part...)
(http://law.house.gov/cfr.htm)
511: New Animal Drugs for Investigational Use
514: New Animal Drug Applications
5.4.2 OPRR Animal Care Guidebook (http://www.nih.gov.80/grants/oprr/library_animal.htm)
5.4.3 Animal Research Application Form B.A. 22
5.4.4 IACUC Executive Committee & Committee Panel Membership5.5.1 GEMS and IDEA Grants Management Information (http://www.ortta.umn.edu/gems.htm)
5.5.2 Current University of Minnesota Standard Contract/Agreement (http://www.ortta.umn.edu)
5.5.3 ORTTA Policies and BA 23 (http://www.ortta.umn.edu)
5.5.4 Patents Technology Marketing Policy Manual (http://www.ortta.umn.edu/policy/respolcy.htm)
5.5.5 Roles and Responsibilitities Document
(http://test.finop.umn.edu/research/roles.html)
5.6.1 Local, State, Federal Biohazard Regulations
5.6.2 UM Policies, Application Forms - Environmental Health and Safety
5.6.3 Regents' Policy on Research Involving Recombinant DNA and Hazardous Biological Materials
(http://www.fpd.finop.umn.edu)
5.7.1 General Clinical Research Center Application and Committee Membership
5.7.2 NIH Policy for GCRCs
(http://www.ncrr.nih.gov/ncrr.prog/clcenter.htm)
5.7.3 Cancer Center Protocol Review Process
(http://www.cancer.umn.edu/)
5.8.1 FDA Code of Federal Regulations (21 CFR Part...)
(http://law.house.gov/cfr.htm)
312: Investigational New Drug Application (IND)
361: Prescription Drugs for Human Use Generally Recognized as Safe and Effective and not Misbranded: Drugs Used in Research
571: Food Additive Petitions
812: Investigational Device Exemptions
813: Investigational Exemptions for Intraocular Lenses
5.8.2 FDA Form 1572
5.8.3 University of Minnesota Laboratory Certification and License Documents
5.8.4 Federal Register: October 7, 1996 (Volume 61, Number 195) Medical Devices; Current Good Manufacturing Practice (GCMP) Final Rule; Quality System Regulation (http://law.house.gov/7.htm)
5.8.5 Articles Related to Patents and Technology Marketing
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