Snyder / Mayes / Smith The Management of Scientific Integrity within Academic Medical Centers

1. Auflage 2015
ISBN: 978-0-12-405929-0
Verlag: Elsevier Science & Techn.
Format: EPUB
Kopierschutz: 6 - ePub Watermark

E-Book, Englisch, 224 Seiten

The Management of Scientific Integrity within Academic Medical Centers discusses the impact scientific misconduct has in eight complex case studies. Authors look at multifaceted mixtures of improper behavior, poor communication, cultural issues, adverse medical/health issues, interpersonal problems and misunderstandings to illustrate the challenge of identifying and managing what went wrong and how current policies have led to the establishment of quasi legal processes within academic institutions. The book reviews the current global regulations and concludes with a section authored by a US federal court judge who provides his perspective on the adequacy of current regulations and policies. - Shows how complex most scientific integrity cases are, and how little is clear cut in the adjunction of each - Discusses how timely and important scientific misconduct is, and its impact on science at large - Reviews the current regulations and policies that guide how we manage scientific integrity - Examines this complexity in 8 anonymous case studies - Concludes with a section authored by an expertly qualified federal court judge

Prof. Peter J. Snyder has served as the Scientific Integrity Officer, as well as the Institutional Official, for the Lifespan Hospital System (Providence, RI) since 2008. He oversees the ethical conduct of research for approximately 350 investigators across a system of five hospitals that form the core teaching campuses for the Alpert Medical School of Brown University. Dr. Snyder is the Chief Research Officer for this academic health system, and he also actively serves as a Professor of Neurology within the medical school. Dr. Snyder has maintained an active research program for more than 20 years, and he has published widely in the fields of clinical neuropsychology, cognitive neuroscience, neuropharmacology and the history of the neurosciences. Dr. Snyder is the Senior Associate Editor for Alzheimer's & Dementia: The Journal of the Alzheimer's Association (published by Elsevier).

Autoren/Hrsg.

Snyder, Peter

Mayes, Linda C.

Smith, William E.

Inhaltsverzeichnis

1;Front Cover;1
2;The Management of Scientific Integrity within Academic Medical Centers;4
3;Copyright;5
4;DEDICATIONS;6
5;CONTENTS;8
6;FOREWORD;12
7;ABOUT THE AUTHORS;14
8;ACKNOWLEDGMENTS;16
9;Chapter 1 - Introduction: Research Misconduct in Biomedical Research Institutions;18
9.1;REFERENCES;28
10;Chapter 2 - Research Integrity: The Legal and Regulatory Landscape;30
10.1;1. INTRODUCTION;30
10.2;2. THE INSTITUTIONAL AND AGENCY PROCESS;30
10.3;3. OTHER LEGAL CONSEQUENCES FOR RESEARCHERS ENGAGING IN RESEARCH MISCONDUCT;36
10.4;4. PROCESS-BASED CHALLENGES;41
10.5;5. OTHER TYPES OF CLAIMS ARISING OUT OF INSTITUTIONAL PROCEEDINGS;45
10.6;6. LITIGATION OVER RECORDS;50
10.7;END NOTES;54
11;Part I - CASE STUDIES;62
11.1;A NOTE ON THE PRESENTATION OF NINE RESEARCH INTEGRITY CASE STUDIES;62
11.2;Chapter 3 - Question of Data Manipulation in Failure to Replicate Findings in Published Manuscript;64
11.2.1;1. PRESENTING COMPLAINT;64
11.2.2;2. BACKGROUND AND HISTORY;64
11.2.3;3. RELEVANT EVIDENCE;66
11.2.4;4. CASE MANAGEMENT AND ADJUDICATION;67
11.2.5;5. SYNTHESIS AND FORMULATION;68
11.2.6;6. RESOLUTION;68
11.2.7;7. COMMENTARY;69
11.2.8;QUESTIONS FOR DISCUSSION;70
11.2.9;REFERENCES;71
11.3;Chapter 4 - Violation of Institutional and Public Health Service Policies Governing the Care and Use of Animals in Research: Cultural Barriers in the Academic Workplace;72
11.3.1;1. PRESENTING COMPLAINT;72
11.3.2;2. BACKGROUND AND HISTORY;73
11.3.3;3. RELEVANT EVIDENCE;74
11.3.4;4. CASE MANAGEMENT AND ADJUDICATION;75
11.3.5;5. SYNTHESIS AND FORMULATION;83
11.3.6;6. RESOLUTION;85
11.3.7;7. COMMENTARY;86
11.3.8;QUESTIONS FOR DISCUSSION;90
11.3.9;REFERENCE;91
11.4;Chapter 5 - Research Assistants Coming Forward with Concerns about Perceived Behavior of Principal Investigator;92
11.4.1;1. PRESENTING COMPLAINT;92
11.4.2;2. BACKGROUND AND HISTORY;93
11.4.3;3. RELEVANT EVIDENCE;94
11.4.4;4. CASE MANAGEMENT AND ADJUDICATION;94
11.4.5;5. SYNTHESIS AND FORMULATION;97
11.4.6;6. RESOLUTION;98
11.4.7;7. COMMENTARY;98
11.4.8;QUESTIONS FOR DISCUSSION;100
11.4.9;REFERENCES;101
11.5;Chapter 6 - Questionable Mentorship and Oversight of Federal Grant Funding;102
11.5.1;1. PRESENTING COMPLAINT;102
11.5.2;2. BACKGROUND AND HISTORY;102
11.5.3;3. RELEVANT EVIDENCE;103
11.5.4;4. CASE MANAGEMENT AND ADJUDICATION;104
11.5.5;5. SYNTHESIS AND FORMULATION;106
11.5.6;6. RESOLUTION;106
11.5.7;7. COMMENTARY;107
11.5.8;QUESTIONS FOR DISCUSSION;108
11.5.9;REFERENCE;108
11.6;Chapter 7 - Submission of Fraudulent Data to a Peer-Review Journal: What Is the Role of the Lab Head/Mentor?;110
11.6.1;1. PRESENTING COMPLAINT;110
11.6.2;2. BACKGROUND AND HISTORY;112
11.6.3;3. RELEVANT EVIDENCE;113
11.6.4;4. CASE MANAGEMENT AND ADJUDICATION;114
11.6.5;5. INTERVIEW WITH DR ALATAS;115
11.6.6;6. INTERVIEW WITH DR PERKASA;117
11.6.7;7. SYNTHESIS AND FORMULATION;119
11.6.8;8. RESOLUTION;121
11.6.9;9. COMMENTARY;123
11.6.10;QUESTIONS FOR DISCUSSION;126
11.6.11;REFERENCES;127
11.7;Chapter 8 - Plagiarism versus Data Shared between Junior and Senior Investigators;128
11.7.1;1. PRESENTING COMPLAINT;128
11.7.2;2. BACKGROUND AND HISTORY;128
11.7.3;3. RELEVANT EVIDENCE;130
11.7.4;4. CASE MANAGEMENT AND ADJUDICATION;130
11.7.5;5. SYNTHESIS AND FORMULATION;133
11.7.6;6. RESOLUTION;134
11.7.7;7. COMMENTARY;134
11.7.8;QUESTIONS FOR DISCUSSION;136
11.7.9;REFERENCES;137
11.8;Chapter 9 - Misappropriation and Use of Data from a Multisite and Multi-investigator Study;138
11.8.1;1. PRESENTING COMPLAINT;138
11.8.2;2. BACKGROUND AND HISTORY;138
11.8.3;3. RELEVANT EVIDENCE;139
11.8.4;4. CASE MANAGEMENT AND ADJUDICATION;140
11.8.5;5. SYNTHESIS AND FORMULATION;140
11.8.6;6. RESOLUTION;141
11.8.7;7. COMMENTARY;142
11.8.8;QUESTIONS FOR DISCUSSION;145
11.8.9;REFERENCES;145
11.9;Chapter 10 - Determining the Extent of Data Fabrication Following an Apparent Single Incident;146
11.9.1;1. PRESENTING COMPLAINT;146
11.9.2;2. BACKGROUND AND HISTORY;146
11.9.3;3. RELEVANT EVIDENCE;148
11.9.4;4. CASE MANAGEMENT AND ADJUDICATION;148
11.9.5;5. SYNTHESIS AND FORMULATION;150
11.9.6;6. RESOLUTION;151
11.9.7;7. COMMENTARY;151
11.9.8;QUESTIONS FOR DISCUSSION;154
11.9.9;REFERENCES;154
11.10;Chapter 11 - Anonymous Allegations of Scientific Misconduct;156
11.10.1;1. PRESENTING COMPLAINT;156
11.10.2;2. BACKGROUND AND HISTORY;156
11.10.3;3. RELEVANT EVIDENCE;157
11.10.4;4. CASE MANAGEMENT AND ADJUDICATION;157
11.10.5;5. SYNTHESIS AND FORMULATION;158
11.10.6;6. RESOLUTION;159
11.10.7;7. COMMENTARY;159
11.10.8;QUESTIONS FOR DISCUSSION;162
11.10.9;REFERENCES;163
11.11;Chapter 12 - Management of Research Integrity within Academic Medical Centers: A Summary and Suggested “Best Practices”;164
11.11.1;1. THEMES ILLUSTRATED IN THE CASE MATERIAL;166
11.11.2;2. RECOMMENDATIONS AND BEST PRACTICES;170
11.11.3;3. CONCLUSION;185
11.11.4;REFERENCES;187
12;APPENDIX 1 - FEDERAL POLICY ON RESEARCH MISCONDUCT1;188
12.1;I. RESEARCH2 MISCONDUCT DEFINED;188
12.2;II. FINDINGS OF RESEARCH MISCONDUCT;188
12.3;III. RESPONSIBILITIES OF FEDERAL AGENCIES ANDRESEARCH INSTITUTIONS4;189
12.4;IV. GUIDELINES FOR FAIR AND TIMELY PROCEDURES;191
13;APPENDIX 2 - LIFESPAN SYSTEM-WIDE POLICY;194
13.1;PURPOSE;194
13.2;1. INTRODUCTION;194
13.3;2. DEFINITIONS;196
13.4;3. GENERAL POLICIES AND PRINCIPLES;197
13.5;4. PROCESS FOR HANDLING ALLEGATIONS OF RESEARCHMISCONDUCT;201
13.6;5. CONSEQUENCES OF INVESTIGATION;207
13.7;6. OTHER CONSIDERATIONS;208
13.8;7. RECORD RETENTION;209
13.9;8. CONCLUSION;209
13.10;9. PROCEDURE;209
14;APPENDIX 3 - POLICIES AND PROCEDURES FOR DEALING WITH ALLEGATIONS OF ACADEMIC MISCONDUCT AT YALE UNIVERSITY;212
14.1;1. INITIATION OF ALLEGATION;213
14.2;2. INQUIRY;215
14.3;3. INVESTIGATION;217
14.4;4. REPORT OF INVESTIGATION;219
14.5;5. APPEAL;220
15;INDEX;222

Leseproben

Chapter 2 Research Integrity
The Legal and Regulatory Landscape
Abstract
Regulation of research integrity is, in the first instance, largely left to research institutions themselves. This institutional process is, however, constrained by a confluence of legal requirements. A federal agency, the Office of Research Integrity (within the National Institutes of Health), possesses broad oversight responsibility. Moreover, even when the government is not directly involved, individuals accused of research misconduct at the institutional level, or even those who bring the accusations may raise a variety of legal challenges to the process afforded by the institution. While these challenges have proven largely unsuccessful, the possibility of litigation should be considered by Research Integrity Officers and other institutional officials who are tasked with investigating suspected research misconduct. Keywords
federal regulations; law; legal issues; legal system; Office of Research Integrity; research integrity 1. Introduction
The integrity of institutional research is policed under a comprehensive set of self-effectuating regulations known as the Public Health Service Policies on Research Misconduct. These regulations create a multilayered approach to individual and institutional misconduct investigations in scientific research. The regulatory scheme is layered in the sense that it imposes first-line investigation and reporting obligations on the institution in which the alleged misconduct occurs with secondary proceedings occurring, if at all, within the regulatory agency, the United States Department of Health and Human Services (HHS). HHS has delegated the lion’s share of its responsibility for addressing research misconduct to the Office of Research Integrity (ORI),1 created by Congress in the National Institutes of Health Revitalization Act of 1993.2 This chapter will review in some detail how the regulations work: the obligations they impose and the procedures they employ. Following a general overview, and a sketch of the institutional/ORI process, we will examine various kinds of legal challenges that have been brought against the regulatory scheme itself, as well as specific challenges to actions taken by institutions pursuant to the regulations, and some of the lessons these cases teach; finally, we will attempt to summarize the legal mosaic that this combination of statutory, regulatory, and common law (or case-law) has created. 2. The Institutional and Agency Process
We begin with the regulatory scheme created by Congress and HHS. HHS regulations3 place the initial responsibility for responding to research misconduct with “institutions,”4 which include “colleges and universities” as well as certain “research laboratories” and “research and development centers.”5 Institutions that apply for or receive support from the Public Health Service (PHS), a unit within HHS,6 are required to, among other things, put in place “written policies and procedures for addressing research misconduct.”7 These policies must include protection of the parties’ confidentiality, protocols for handling the research record and evidence, institutional actions in response to findings of research misconduct, efforts to protect the reputations of individuals involved in the proceedings, and full cooperation with ORI.8 The regulations define “research misconduct” as “fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.”9 The definition “does not include honest error or differences of opinion,”10 and it requires that the misconduct be “committed intentionally, knowingly, or recklessly.”11 Research misconduct must also involve “a significant departure from accepted practices of the relevant research community.”12 It is important to note, however, that institutions are free to adopt standards for research misconduct broader than those prescribed by the regulations,13 and in fact, some institutions have done this. Both Yale University and the University of Medicine and Dentistry of New Jersey (now known as Rutgers Biomedical and Health Sciences), as two examples, arguably exceeded the scope of federal regulations by prohibiting “duplicative publication,” or redundant publication of research that has already been reported in a published article.14 Similarly, the University of Maryland, Baltimore, defines misconduct to include “[i]mproper experimental manipulation,” “[i]mproper assignment of credit,” “[a]buse of confidentiality,” and “[m]isappropriation of funds or resources.”15 As of September 2000, an ORI study of 156 institutional policies found that slightly more than half those policies contained a definition of research misconduct broader than that used by the agency.16 When a Research Integrity Officer (RIO) receives an allegation of research misconduct, he or she must conduct a preliminary assessment of the allegation to determine whether an inquiry is warranted.17 In making this determination, the RIO should consider the credibility and specificity of the allegation, whether it involves PHS support, and whether it falls within the definition of research misconduct.18 There is no particular formula for assessing threshold credibility, but, as a practical matter, an RIO should keep in mind that he/she is not a rubber stamp for allegations of misconduct; the RIO should make a serious assessment as to whether the allegation seems well-grounded or merely speculative or vindictive. Moreover, the threshold burden is not a high one—but, in practical terms, must pass the “smell test.” In other words, the allegation needs to appear credible on its face, to make sense and stand up to a common-sense assessment of credibility. Some institutions (e.g., Yale University) have in place a procedural step to help RIO’s make this determination. For example, an initial step may be to seek consultation of members of the institutional staff or faculty with sufficient expertise in the science to review the allegations and/or materials as received and render an opinion to a hypothetical question: Were these allegations true, would they constitute academic misconduct? While the threshold for moving forward is not high with such a hypothetical, such a consultative step necessarily insures some consideration of the merit and substance of the allegation and provides the RIO with an initial consideration of the possible questions to guide a formally convened review committee. If the RIO’s preliminary assessment (with or without consultation from others) finds the allegation is credible, he or she must initiate an “inquiry,” which involves “an initial review of the evidence.”19 Typically, the inquiry will be conducted by a committee appointed by the RIO.20 At or before the beginning of an inquiry, the RIO must make a good faith effort to notify the accused (called the “respondent” in the regulations) and take all reasonable and practical steps to obtain custody of research records and evidence.21 (These records, as well as additional materials generated during the institutional proceedings, generally must be retained for 7 years.22) After interviewing key witnesses and examining relevant evidence, the committee, in consultation with the RIO, will decide whether an investigation is warranted.23 The inquiry must culminate in a written report,24 and it is highly recommended that institutional counsel review the report for legal sufficiency.25 The regulations require that the respondent be notified of the inquiry’s outcome26 and be given an opportunity to review and comment on the inquiry report.27 If the conclusion is that the allegation has merit, then an “investigation” is called for. The institution should conduct an investigation if it appears that the allegation falls within the definition of research misconduct, involves PHS support, and may have substance.28 If the institution determines that an investigation is warranted, then notice to ORI is required.29 Once an internal proceeding has moved to the investigation stage, the institution must examine all research records and relevant evidence, conduct interviews, and pursue all leads.30 The investigation, much like the inquiry that preceded it, will generally be conducted by a committee appointed by the RIO.31 At or before the beginning of an investigation, the RIO must provide notice to the respondent and ORI, as well as take all reasonable steps to obtain custody of research records and evidence that were not previously sequestered during the inquiry.32 At the outset, the RIO should meet with the committee to review the charge as well as the applicable procedures and standards.33 On (somewhat rare) occasions the accused may seek representation by counsel during the investigation. This, of course, is his right. If counsel is engaged, he or she should be afforded all the courtesies one would expect, but should not be allowed to obstruct the process. The respondent is expected to cooperate in the investigation, and if he does not cooperate an adverse inference may be appropriate. After completing its investigation, the institution must provide the respondent with a draft of the investigation report and allow him or her an opportunity to comment on it.34 Before submitting the report to the respondent, institutional counsel should...