Research - PowerPoint Presentation

Slide1

Research Misconduct: Risks and Best Practices

Allison Moriarty

Vice President, Research Administration and ComplianceSlide2

ResourcesPartners Policies onTrove: http://library.partners.org/PartProd/webserver/custom/trovedemoframeset.asp?HU=http://www.partners.org&P2=1&w=800&h=600&c=16

http://

ori.dhhs.gov

/Slide3

Integrity in ResearchResearch misconduct (as defined by 42 CFR Part 93): Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.

Fabrication

(making up results and reporting them)

Falsification

(manipulating research materials, data, or processes; or manipulating data such that the research is not accurately represented in the record)

Plagiarism

(the appropriation of another person’s ideas, results, or words without giving that person appropriate credit)

An honest difference of opinion or an honest error can result in the occurrence of isolated non-compliance. This is NOT research misconduct.Misconduct requires deliberate or repeated noncomplianceAnd even here, life is not black and white.

Ignorance

Sloppiness

Falsification/Fraud

Unintentional

IntentionalSlide4

Federal regulations on research misconductFirst promulgated in 1990’s – 42 CRF Parts 50 and 93Requires institutions that receive PHS research support to have policies and procedures for reporting and responding to allegations of research misconduct

Have a number of definitive provisions and definitions:

Provisions:

Confidentiality

Protections

Stages of investigation

Definitions:

Complainant

means a person who in good faith makes an allegation of research misconduct. (Emphasis on “good faith.”)Respondent

means the person against whom an allegation of research misconduct is directed or the person who

is the subject of a research misconduct proceeding There can be more than one respondent in any inquiry or investigation.

Both complainant and respondent have rights that must be respected.Any investigation must be timely and fair. Slide5

“Complainant”- Journals- Anonymous

- Proximal to accused (i.e., in lab, collaborator)

- Received from ORI

- Retraction Watch

“

Respondent

”

- Anyone performing, proposing, reporting

- Can be multiple respondents in a given matter- All levels of appointment can and have been respondentsDHHS Office of Research Integrity- Jurisdiction over PHS funded work- Informed when review reaches Investigation- Waits for institutional finding before own review

If sufficient evidence

If sufficient findings

If positive determination

Our process is performed in cooperation with Harvard Medical School if respondent holds a HMS appointment. Slide6

Environmental pressuresGrowing number of investigators vying for limited fundsDecreasing federal research budgetPromotions reliant on robust C.V.Incentives to publish

Prestige

Garner additional funding

In 2002, 5.7 million researchers worldwide competed to produce and publish novel scientific findings or those important enough to advance the

field. By 2011, that

number has ballooned to over

7.1 million

.

Scientific publications on an international scale have seen tremendous growth, from 1.09 million publications in 2002 to 1.94 million in 2010, a

77% increase in published work over less than a

decade

Hicks, 2103 May 14,

The Scientist

http://www.the-scientist.com/?articles.view/articleNo/35543/title/Opinion--Ethics-Training-in-Science/

Source: Royal Society Report, 2011Slide7

Current TrendsFanelli’s 2009 PloS One article: Nearly 2% of scientists admitted to falsifying or fabricating data a minimum of one

time

Nearly

34%

reported engaging in other forms of devious research practices

A

pproximately

14%

of scientists surveyed witnessed colleagues’ manipulation or making up of data. Tavare’s 2012 British Medical Journal article:1 in 7 researchers in U.K. witnessed other investigators falsifying/fabricating data to increase publishing potentialSlide8

Foreign-born Investigators: VulnerabilitiesDavis (2003) found that foreign-born investigators may be more susceptible to distinct pressures levied on non-U.S. researchers to stray from accepted scientific practice. Differing cultural norms (Davis, 2003)Lack of English proficiency

(

Xiguang

& Lei, 1996

) Fear of asking for help (Davis, Riske-Morris and

Diaz, 2007

)

Lack of Responsible Conduct of Research training/oversight in country of origin (Okonta and Rossouw, 2012) Slide9

Inadequate Mentoring62% of mentors had not established procedural standards (Wright et al., 2008) 73% had not reviewed the raw data generated by their trainees (Wright et al., 2008)

“Improvement

in the quality of mentoring in training programs

” is the path to reducing misconduct at any given institution

(Kornfeld, 2012)Slide10

Students and Fellows

Of

8 ORI cases in 2010,

38% of the guilty respondents were

graduate students/undergraduate

students, while 25% were postdocs. Slide11

Data ManagementSchreir and colleagues’ (2006) survey of 96 university officials charged with institutional oversight of research misconduct cases revealed that inquires and investigations were “hampered by inadequate research records.”Martinson

et al. (2005) similarly reported that

27%

of the faculty investigators they interviewed openly confessed to “

inadequate record-keeping related to research projects

.” Schreier

et al. (2006) lament the shortcoming of the present academic research environment, in which formal record-keeping standards are absent or woefully inadequate,

peers rather than superiors teach newcomers record-keeping habits, and foreign investigators often record data in their native languages given insufficient standards dictating the importance of data retention in English. Slide12

Summary of High-Risk AreasSlide13

Recommendations:Standards and TrainingProvide clear guidelines and/or policies on:Research misconductData managementResearch record ownership, access, retention, transfer, and destruction.

Target training

to specific needs of:

New Faculty

Postdocs Junior Faculty

Foreign research personnelSlide14

Recommendations: MentoringMentorship ProgramsEstablish realistic ratios of trainees to mentors Make the

quality

of mentoring a factor in the evaluation of applications for the

funding

of training grants

Make mentors share responsibility for the published work of their trainees

Mentors should*:

Regularly review trainee

raw dataSet and enforce standards in laboratoryPay attention to trainee stress levels*Wright et al, 2008Slide15

Recommendations:Data Management PlansEncourage faculty members to have a strategy/plan (preferably written) for research recordkeeping. Project Description – Project title, funding source, staff working on the project, start and end date of the project, and a short description of the research taking place.

Roles and Responsibilities

– Define the specific role each member of the research group will play in carrying out the DMP.

Form of Data Collected

– Will the data be images, laboratory values, measurements, electronic files, written records, a combination of these? Will the data include patient samples, biological samples, or genetic elements? Describes all the forms of data you will collect.

Special Consideration

– Is the data a limited data set? Will it contain identifiable health information or other confidential information? Did you receive any data from an outside source? Is the data associated with an invention or patent? Slide16

Security – How will you prevent the data from being lost or stolen? What would happen if there was a disaster in the building? Data Sharing – Will you share your data? With Whom? Are there limitations on data sharing such as a Data Use Agreement, Material Transfer Agreement or other contractual arrangement? If the study involves consented subjects, does the informed consent document limit data sharing? Short Term Storage – How will the data be stored during the time the project is active? How many copies of the data will you store? Where will these copies be physically located? Who can access, analyze, or add to the data set?

Long Term Storage

– How long will you store this data after the project has been completed? If the data is electronic what file type will you use for storage? How many copies will you keep and who will have access to these

copies

Recommendations:

Data Management Plans