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UM Policies & Procedures - HSRO/IRB
1. Preface
2. Background Topics
3. Authorities and Responsibilities
4. Conflict of Interest
5. Institutional Review Boards
6. IRB Meetings
7. General Principles for IRB Reviews
8. Definition of IRB Review Types
9. IRB Review of Initial Studies
10. IRB Review of Continuing Studies
11. Amendments
12. Closing Studies and Final Reports
13. Suspension, Termination and Administrative Closure of IRB Approved Research
14. Unanticipated Problems and Adverse Events
15. Study Violations
16. Compliance Audits
17. Data Safety Monitoring Boards
18. Ancillary Committees
19. External IRB's
20. Policies Specific to Certain Types of Research
21. Informed Consent
22. Participant Recruitment Methods, Advertising Materials and Recruitment-Relevant Payment Arrangements
23. Vulnerable Populations
24. Privacy, Security, Confidentiality and HIPAA
25. Subcontracts/Agreements for UM-Initiated Studies that Engage or Involve non-UM Institutions or Investigators
26. International Research
27. Emergency Use
28. Record Retention
Other Policies
UChart Forms & Guidance
HSRO Forms & Documents
University Fees
Ancillary Committee Information
eProst User Guide
Ethics, Federal Regulations & Guidance
Western IRB (WIRB)
About the HSRO

Basic Folder Information

4.1 General Principles

Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

October 27, 2006

4.1 General Principles

Objectivity is essential to the conduct of scientific research and the basis for public confidence in the integrity of IRB oversight and the research enterprise.  Research must not be led by interests that might undermine scientific integrity and ethical values.  It is recognized that success in research brings rewards including publications, grants, career advancement and the satisfaction of accomplishment.  Research may also bring financial gain through industry sponsorship or through entrepreneurial efforts of investigators and/or the University; and the relationships between government, academia, industry and others are complex and often legitimately include financial relationships. 

Nevertheless, the primary duty of the University, and particularly the IRB, must be to protect the rights and welfare of human subjects while conducting unbiased research. 

The University, the IRB and investigators must consider whether specific financial relationships or other considerations create conflicts of interest in research that may bias judgment and affect the rights and welfare of subjects and, if so, to determine what actions must be taken to protect those subjects.  In such deliberations, it should be noted that a conflict of interest is not intrinsically wrong, that financial interests of IRB members, investigators and the University and affiliated institutions are not in all cases prohibited, and that not all financial interests have the potential to cause conflicts of interest and thereby to bias judgment and affect the rights and welfare of human subjects. 

It is within the discretion of the IRB to decide whether such conflicts of interest are manageable, and if so, to devise a management plan for the protection of human subjects participating in the study.

A conflict of interest creates an ethical problem if a breach of duty or other improper act is caused by the incentive created by the conflict.  The key is that the Belmont principles protecting human subjects should not be compromised by financial relationships or other conflicts of interest.  Rather, these principles should be maintained by openness and honesty in addressing conflicts.  To the extent financial or other conflicts of interest may affect the rights and welfare of human subjects in research, the IRB, institutions and investigators must consider what actions may be necessary to protect those subjects and must ensure the implementation of these actions.

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