Responsible Conduct of Research

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New ORI Training Video Allows Role Play in Misconduct Case

The National Office of Research Integrity has a "video simulation on research integrity" that applies to all institutions with Public Health Service-funded research. "In the simulation, research misconduct causes a noted lab to lose funding, creates bad publicity to the university, and eventually causes the withdrawal of a multi-million dollar endowment," ORI announced. "Viewers [will] have the opportunity to undo the damage by assuming the roles of a graduate student, post doc, principal investigator, and a research integrity officer and make decisions to prevent misconduct from occurring unnoticed." A trailer of the video is posted on the ORI website.

Link: http://ori.hhs.gov/TheLab  

RESPONSIBLE CONDUCT OF RESEARCH

I. INTRODUCTION

Western Kentucky University has a strong commitment to the responsible conduct of research. The Responsible Conduct of Research (RCR) Program is designed increase the knowledge of and coordinates the practice of responsible and ethical research to the Western Kentucky University researchers. This program encompasses the following nine elements that have been outlined as core instructional areas by the Public Health Services:

1. Data acquisition, management, sharing and ownership

2. Conflict of interest and commitment

3. Human subjects

4. Animal welfare

5. Research misconduct

6. Publication practices and responsible authorship

7. Mentor/trainee responsibilities

8. Peer review

9. Collaborative science

II. DATA ACQUISITION, MANAGEMENT, SHARING AND OWNERSHIP

Many issues that directly and indirectly affect the acquisition, ownership, management, and the federal government regulates sharing of data. Regulations may apply to all research, regardless of sponsorship, and may be issued at an agency or government-wide level.

Each federal agency publishes detailed guidelines for conducting research supported by the agency. The National Science Foundation, National Institutes of Health, U.S. Department of Education are only a few federal agencies that sponsor university research that have guidelines governing the acquisition, management, sharing, and ownership of data. These guidelines are often codified in the Code of Federal Regulations.

Also, the federal government has developed government-wide regulations and policies that apply to all research that must be followed by all government supported agencies. These policies include:

* 45 CFR Part 46: Protection of Human Subjects

* The Animal Welfare Act

Both of these policies contain mandates that must be followed when data is collected, managed, and presented when humans or invertebrate animals are the subjects of the research.

In addition, there are governmental created policies that directly apply to the ownership and transfer of data from federally funded research. These include:

* The Bayh-Dole Act of 1980 governs the ownership and transfer of technology developed under Federally supported grants and encourages the commercialization of new technologies.

* Section 36 of the Office of Management and Budget (OMB) Circular A-110, Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and other Nonprofit Organizations regulates the use, ownership, and sharing of data and other intellectual property developed under federal grants, including the rights of the public to gain access to research information under the Freedom of Information Act.

The Office research Integrity of the U.S. Department of Health and Human Services has developed and implemented a policy that governs how allegations of misconduct in research, are handled.

Currently, this policy applies only to grants funded under the Public Health Service Act, but has been revised and its scope expanded to apply to research funded by all federal agencies.

* The Office of Research Integrity Policy on handling Research Misconduct (42 CFR Part 50).

University and Governmental Regulations and Policies

Like with federal policies and regulations, the conditions under which data is acquired, managed, and shared are regulated by various University and governmental policies.

WKU’s Research Policies WKU Policies

NSF RCR Training Policy/Requirement  NSF guidelines

NIH RCR Training Policy/Requirement  NIH RCR Training Policy

NIH Data Sharing Policy   NIH Data Sharing Policy