Research Misconduct:

Risks and Best Practices

Research Misconduct:

Risks and Best Practices

Allison MoriartyVice President, Research Administration and Compliance

Resources

Partners 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/

Integrity in Research

• Research 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 noncompliance

• And even here, life is not black and white.

Ignorance Sloppiness Falsification/Fraud

Unintentional Intentional

Federal regulations on research misconduct

• First promulgated in 1990’s – 42 CRF Parts 50 and 93• Requires 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.

“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 respondents

DHHS 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.

Environmental pressures

• Growing number of investigators vying for limited funds

• Decreasing federal research budget

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

Source: Royal Society Report, 2011

Current Trends

Fanelli’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

Approximately 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 potential

Foreign-born Investigators: Vulnerabilities

Davis (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)

Inadequate Mentoring

• 62% 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)

Students and Fellows

• Of 8 ORI cases in 2010, 38% of the guilty respondents were graduate students/undergraduate students, while 25% were postdocs.

Data Management

• Schreir 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.

Summary of High-Risk Areas

Recommendations:Standards and Training

• Provide clear guidelines and/or policies on: Research misconduct Data management Research record ownership, access, retention, transfer,

and destruction.

• Target training to specific needs of: New Faculty Postdocs Junior Faculty Foreign research personnel

Recommendations: Mentoring

• Mentorship Programs Establish 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 data Set and enforce standards in laboratory Pay attention to trainee stress levels

*Wright et al, 2008

Recommendations:Data Management Plans

Encourage 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?

• 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