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The Essential Need for Research Misconduct Allegation Audits.

ABSTRACT: Nearly 90 % of allegations of biomedical research misconduct in the United States are dismissed by responsible institutions without any faculty assessment or auditable record. Recently, members of the U.S. Congress have complained that the penalties for those against whom findings of research misconduct are made are too light and that too few grant funds associated with research misconduct have been recovered for use by other researchers and taxpayers. Here we discuss the laws that empower federal agencies that can oversee investigations of biomedical research misconduct: the Office of Research Integrity (ORI) and the Office of the Inspector General (OIG), both located within the Department of Health and Human Services (HHS). Research misconduct investigations pertaining to U.S. physical sciences funded through the National Science Foundation (NSF) are overseen by the NSF's OIG. While OIGs may provide some improvement over the ORI in the handling of research misconduct, we have found that a much more serious flaw exists which undermines an ability to conduct performance audits of the effectiveness by which allegations of research misconduct are handled in the United States. Specifically, sufficient data do not need to be retained by U.S. research institutions funded by HHS or NSF to allow effective audit of why allegations of research misconduct are dismissed before being seen by faculty inquiry or investigative committees. U.S. federal Generally Accepted Government Auditing Standards (GAGAS/Yellow Book), if applied to the research misconduct oversight process, would allow a determination of whether the handling of allegations of biomedical research misconduct actually functions adequately, and if not, how it might be improved. In particular, we propose that independent, external peer review under GAGAS audit standards should be instituted without delay in assessing the performance of ORI, or any other similarly tasked federal agency, in handling allegations of research misconduct.

SUBMITTER: Loikith L

PROVIDER: S-EPMC4996876 | biostudies-other | 2016 Aug

REPOSITORIES: biostudies-other

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The Essential Need for Research Misconduct Allegation Audits.

Loikith Lisa L Bauchwitz Robert R

Science and engineering ethics 20160627 4

Nearly 90 % of allegations of biomedical research misconduct in the United States are dismissed by responsible institutions without any faculty assessment or auditable record. Recently, members of the U.S. Congress have complained that the penalties for those against whom findings of research misconduct are made are too light and that too few grant funds associated with research misconduct have been recovered for use by other researchers and taxpayers. Here we discuss the laws that empower feder ...[more]

PMID: 27349911

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Project description:BackgroundDespite their importance, the number of outcomes research studies conducted in India are lesser than other countries. Information about the distribution of existing outcomes research resources and relevant expertise can benefit researchers and research groups interested in conducting outcomes research studies and policy makers interested in funding outcomes research studies in India. We have reviewed the literature to identify and map resources described in outcomes research studies conducted in India.MethodsWe reviewed the following online biomedical databases: Pubmed, SCIRUS, CINAHL, and Google scholar and selected articles that met the following criteria: published in English, conducted on Indian population, providing information about outcomes research resources (databases/registries/electronic medical records/electronic healthcare records/hospital information systems) in India and articles describing outcomes research studies or epidemiological studies based on outcomes research resources. After shortlisting articles, we abstracted data into three datasets viz. 1. Resource dataset, 2. Bibliometric dataset and 3. Researcher dataset and carried out descriptive analysis.ResultsOf the 126 articles retrieved, 119 articles were selected for inclusion in the study. The tally increased to 133 articles after a secondary search. Based on the information available in the articles, we identified a total of 91 unique research resources. We observed that most of the resources were Registries (62/91) and Databases ( 23/91) and were primarily located in Maharashtra (19/91) followed by Tamil Nadu (11/91), Chandigarh (8/91) and Kerala (7/91) States. These resources primarily collected data on Cancer (44/91), Stroke (5/91) and Diabetes (4/91). Most of these resources were Institutional (38/91) and Regional resources (35/91) located in Government owned and managed Academic Institutes/Hospitals (57/91) or Privately owned and managed non - Academic Institutes/Hospitals (14/91). Data from the Population based Cancer Registry, Mumbai was used in 41 peer reviewed publications followed by Population based Cancer Registry, Chennai (17) and Rural Cancer Registry Barshi (14). Most of the articles were published in International journals (139/193) that had an impact factor of 0-1.99 (43/91) and received an average of 0-20 citations (55/91). We identified 193 researchers who are mainly located in Maharashtra (37/193) and Tamil Nadu (24/193) states and Southern (76/193) and Western zones (47/193). They were mainly affiliated to Government owned & managed Academic Institutes /Hospitals (96/193) or privately owned and managed Academic Institutes/ Hospitals (35/193).ConclusionsGiven the importance of Outcomes research, relevant resources should be supported and encouraged which would help in the generation of important healthcare data that can guide health and research policy. Clarity about the distribution of outcomes research resources can facilitate future resource and funding allocation decisions for policy makers as well as help them measure research performance over time.

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The Essential Need for Research Misconduct Allegation Audits.

Publications

The Essential Need for Research Misconduct Allegation Audits.

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