Misconduct and Other Sins

Stan Korenman

With assistance from Richard Smith Editor, BMJ

NORMS

Norms are general statements implying obligations and/or evaluations

Norms are shared by members of a certain group

A belief held by a single individual alone about the merits of a particular kind of action is not a norm

Norms Of Scientists

Intellectual integrity and objectivity Tolerance for disputes Doubt of certitude Recognition of error Unselfish engagement Communal spirit

» Cournand A. The code of the scientist and its relationship to ethics. Science 1977;198:699-706.

Personal Experiences

Famous case of misconduct

Were shown an unpublished paper

Suspect the work of others

Know an unethical scientist

Personal Experiences

% %

Faculty trainees

Famous case of misconduct 43.5 23.5

Was shown an unpublished paper 65.7 66.0

Suspect work of others 66.0 29.7

Knows an unethical scientist 50.0 26.3

When Norms Beget Regulations

Your university is mandated by the Federal government to:

Manage federal assurance to conduct research ethically.

Ensure that research does not violate rules, (e.g. Unauthorized stem cell research or research using anthrax).

Mandates disclosure and management of financial interests

and conflicts of interest. Handle allegations of misconduct properly

Why Research Misconduct Matters

It’s like child abuse: we didn’t recognise it, now, sadly, we see a lot of it.

Recent evidence shows that most identified cases are deliberate.

It undermines public trust. It corrupts the scientific record and leads to

false conclusions that are sometimes perpetuated for quite a while.

Sins Are Everywhere as are Sinners

Institutional (University) Sins

Fostering a survivalist mentality in researchers.

Favoritism. Coercing students to be research subjects. Failure to firewall financial ties. Poor treatment of whistleblowers Whitewashing misconduct investigations Failure to properly sanction those who

have been convicted and restore those innocent of research misconduct

Research Malfeasance: Unethical but not Illegal

Defective research practices: supervision, record keeping, monitoring, adverse event reporting

Biased analysis: Unfair reporting: guest authors, failure to disclose

conflicts of interest,

Poor scientist interactions: exploitative or negligent mentoring, violations of confidentiality, failure to share, false accusations, unfair allocation of authorship

Biased peer review

Malfeasance: Illegal but Not Research Misconduct

Destruction or theft of research property Misuse or theft of research funds Harassment of personnel Violation of safety rules for;

human subjects, animal subjects, radiation, chemicals, gases, biologicals

Interfering with an inquiry or investigation

Malfeasance in Human Studies

Poor experimental design

Not following protocol scrupulously: – inclusion or exclusion criteria – hidden amendments – not accounting for accidental protocol variances – bias, delay or failure to report serious adverse

events Not maintaining the primacy of the subject

over the research

Institutional Requirements for Reporting in Human Research

The Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) require that institutions have “written procedures for ensuring prompt reporting

to the IRB, appropriate institutional officials, and the department or agency head of any

(i) unanticipated problems involving risks to subjects or

others, or any serious or continuing noncompliance with this policy, or the requirements or determinations of the IRB; and

(ii) any suspension or termination of IRB approval” [45 CFR 46.103(b)(5)]. [21 CFR 56.108(b)].

UCLA IRB Requirements

UCLA personnel, including investigators, research team, faculty, staff, administration or students are responsible for the protection of the rights and welfare of human research subjects. To this end, all parties are responsible for reporting serious or continuing noncompliance with applicable human research regulations or requirements, determinations, or policies of the IRB.

Investigators must report immediately upon discovery and

no later than ten days from the occurrence.

Sec 93.103 Research Misconduct May 2005

Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.

(a) Fabrication is making up data or results and recording or reporting them.

(b) Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.

Sec 93.103 Research Misconduct May 2005

(c) Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit.

(d) Research misconduct does not include honest

error or differences of opinion.

New rules can be found at: http://www.ori.dhhs.gov/documents/FR_Doc_05-

9643.shtml

Sec 93.104 Requirements for findings of research misconduct

There be a significant departure from the norms, the accepted practices of the relevant research community; and

The misconduct be committed intentionally, knowingly, or recklessly; and

The allegation be proven by a preponderance of the evidence.

Burden of proof. The institution or HHS has the burden of proof for making a finding of research misconduct.

Sec 93.106 Evidentiary Standards

The destruction, absence of, or respondent's failure to provide research records adequately documenting the questioned research is evidence of research misconduct.

Affirmative Defense

(2) The respondent has the burden of going forward with and the burden of proving, by a preponderance of the evidence, any and all affirmative defenses raised, as well as any mitigating factors that are relevant to a decision to impose administrative actions following a positive finding of research misconduct.

In determining whether HHS or the institution has carried its burden of proof, the finder of fact shall give due consideration to admissible, credible evidence of honest error or difference of opinion presented by the respondent.

Sec. 93.210 Good faith

Good faith as applied to a complainant or witness, means having a belief in the truth of one's allegation or testimony that a reasonable person in the complainant's or witness's position could have, based on what they knew at the time.

Good faith of a committee member means carrying out the

duties assigned impartially for the purpose of helping an institution meet its responsibilities. A committee member does not act in good faith if his/her acts or omissions on the committee are dishonest or influenced by personal, professional, or financial conflicts of interest with those involved in the research misconduct proceeding.

Sec 93.300 Institutional Responsibilities for Compliance

A) written policies; B) respond competently and objectively. Avoid COIs. C) foster a high integrity research environment. D) protect the reputations of complainants, witnesses and

committee members and protect against retaliation. E) provide confidentiality F) ensure the cooperation of respondents and other institutional

members with research misconduct proceedings G) cooperate with HHS H) assist in administering and enforcing any HHS

administrative actions; And I) have an active assurance of compliance.

Process

Suspicion of wrongdoing Informal communication Formal communication Inquiry Investigation Adjudication Sanctions

Suspicion of Wrongdoing

Informal Communication Lab Chief

Department Chair Ombudsman

Nature of Complaint

Possible Scientific Misconduct

Misunderstanding Disagreement

Breach of Manners, Larceny

Scientific Integrity Officer

Sequester Data

Initiate Formal Inquiry

YES

YES

NO

Mediation or other remedy

Formal Inquiry

Possible Misconduct Not Misconduct

Formal Investigation Expert Committee

Determine nature & extent of misconduct

Quasi-legal procedure

Legal representation

Data sequestered

ORI notified

Mediation

Restore Reputation

Committee Report

NO

Adjudication

Sanctions: Institutional, Governmental

Office of Research Integrity

Institute

YES

Our Response to Whistleblowers

Whistleblowing

Practical issues: Consider it an inquiry rather than an

accusation Talk it over with friends Is there another side to the story? Write it down. Focus on the science and exact

details Try to develop support You shouldn’t illegally examine someone’s data Derived in part from Chris Gunsalus, 1998 Sci. and Eng. Ethics; 4:51-64

Whistleblowing 2

You may not have a right to know what’s going on. Is that okay for you?

What kind of satisfaction do you want from the inquiry?

If it’s your boss, you may have to move. Is that okay for you?

Is there a way to achieve your goals without going to the “authorities”?

Are you prepared for the long haul and for a bad outcome?

ORI : Ten Years of Reporting

3662 Institutions, many sm. businesses 1375 Inst higher learning, res. orgs., Res.

Inst, labs, and foundations. # reporting misconduct 53/ year 55% a single instance, 20% > 5 703 individual cases filed

ORI : Ten Years of Reporting

703 Individual cases filed 602 inquiries 221 investigations 110 findings of misconduct (from 76

institutions)

New Defendants

Now suing everyone including – The university – The teaching hospital – The PI – The sponsor – Top university officials – Individual IRB members – The hospital’s patient advocate (Abiomed)

New Defendants

Grimes v. Kennedy-Krieger Institute of Johns Hopkins - lead exposure study. Controls were allowed to continue to be exposed to lead.

» Maryland’s highest court faulted the judgement of the IRB and determined that its ruling constituted negligence

With many individuals subject to the same conditions - ripe setting for class action suits.

Much more lucrative for the attorneys

Impacts of Litigation

More suits inevitable May tighten up research on humans - a good

thing May make IRBs super-conservative - a bad

thing May make monitoring of research mandatory May create a spate of rule-making.

Why does misconduct happen?

Why not?. It happens in all other human activities. Everyone lies pretty consistently.

Pressure to publish, survivalist mentality. Defective ethical sensitivity (sociopath). Inadequate training. Not taught good practices.

Indeed, sometimes encouraged in the opposite. Does sloppy behaviour spill over to fraud? You can often get away with it. The system works on

trust.

Trust

Research on humans is based on trust: That the truth is told about the study That COIs are revealed That the institution is fulfilling its

responsibilities to the participants. That those conducting the study have the

best interests of the participants at the top of their agenda.