DA202Research Ethics

SCIENCE IS A COMMUNITY BASED ON TRUST

“The only ethical principle which has made science

possible is that the truth shall be told all the time…”

C.P. Snow “The Search” C.P. Snow “The Search” 19591959

Quoted in “Honor in Science”Quoted in “Honor in Science”

“Most Americans see a strong science as essential to a successful future. Yet that generous social support is based on the premise that science will be done honestly and that mistakes will be routinely identified and corrected.”

Bruce Alberts, President, National Academy of

Sciences, 1989

Scientific Fraud and Misconduct Frequency Over the Past 10 Years

Ethics A set of principles of right conduct The rules of standards governing

the conduct of a person or the members of a profession

ETHICS IN SCIENCE

Faculty, students, and staff of the University should maintain their professional behavior and conduct research with the highest standards of integrity.

““The right to search for truth The right to search for truth

implies also a duty; implies also a duty;

one must not conceal any partone must not conceal any part

of what one has of what one has

recognized to be true.”recognized to be true.”

- Albert EinsteinAlbert Einstein

Institutional Compliance is: A commitment to obey federal and

state laws and sponsor policies, and follow internal policies and procedures

An ongoing operational program to prevent, detect, and correct wrongdoing

A system of internal control and procedures to evaluate operational practices, minimize legal and business risk and implement corrective action

Expectations of high standards of conduct in science:• Protection of human and animal research

subjects• Proper fiscal management of public funds• Proper use and disposal of hazardous

materials• Adherence to scientific method to

produce valid knowledge

DATA COLLECTION, MANAGEMENT AND RECORD KEEPING

AccountabilityThe laboratory notebook The laboratory notebook

represents the final authority represents the final authority on data collection, on data collection, manipulation, and manipulation, and presentation. It must contain:presentation. It must contain:

1.1. All the information on an All the information on an experiment’s design and experiment’s design and executionexecution

2.2. The original data (preferably The original data (preferably as the raw data output)as the raw data output)

3.3. Calculations and data Calculations and data reductionsreductions

4.4. Conclusions and Conclusions and interpretationsinterpretations

Federal Definition - Research Misconduct:

Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research or in reporting research results. Research misconduct does not include honest error or differences of opinion.

Fabrication: making up data or results and recording or reporting them

Falsification: 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

Plagiarism: the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit

Case Study

Data Falsification- I A student prepares a “scatter-graph”

that demonstrates a time-dependent effect. Unfortunately, several points do not closely follow the relationship.

A peer suggests dropping the lowest points because “the cells were obviously dead” and the highest point because “it is an obvious outlier.”

pp.9

Case Study Data Falsification I, cont.

How should the student go about determining which points to exclude?

What other course(s) of action would you recommend to the student?

Case Study

Data Falsification– II

A student is using an autoanalyzer to test the effects of radioprotective agents on prostaglandin production. Only six of the ten assays demonstrate protection.

Mentor suggests the lack of observed response was due to “equipment failure.”

pp. 11

Case Study Data Falsification II, cont.

Is the mentor’s assessment valid?

How could the interpretation be tested?

If the ambiguity persists, how should the student proceed?

Case Study Data Fabrication

A student believes that the work of a fellow student is forged. The data are too clean, the student isn’t in the lab enough to support the amount of data, and sufficient reagents are not being consumed.

pp. 12

Case Study Data Fabrication, cont.

Is there enough “evidence”?

How should the student proceed?

Case Study Plagiarism

A student prepares a written qualifying examination paper which incorporates entire passages from other works (without attribution). When discovered, she is expelled from the graduate program.

pp. 23

Case Study Plagiarism, cont.

Was this an excusable offense?

Was the punishment to severe?

Research Misconduct

Awardee institutions bear primary responsibility for prevention and detection of research misconduct and for the inquiry and investigation of alleged research misconduct.

Authorship

Authorship on a scientific paper should be limited to those individuals who have contributed directly to the design and execution of the experiments and who have participated in the preparation of the manuscript.

AuthorshipA paper is being prepared concerning the metabolism of sulfites. Which of the following should be included as authors?

–Toxicologist who provided previously published information on animal models

–Wildlife specialist who provided information on breeding mice.

–Technician who helped develop assay and wrote the Methods section.

–Another scientist who helped design experiments and edited the final draft.

pp. 15

Peer review is the process whereby other scientists evaluate grant applicants for funding or scientific papers for publications

Fairness Confidentiality

Case Study Peer Review

An investigator (faculty member and biotech company official) serves on an NIH study section. He reviews a grant which contains information demonstrating that his current work (both academic and corporate) is headed down a blind alley. pp. 19

Case Study Peer Review, cont. How should the investigator

proceed?

What issues of confidentiality and conflict of interest are involved?

How might this situation have been avoided?

Video – “Only a Bridge”

Case Study Data Ownership

A graduate student has just defended his dissertation and is leaving for a post doctoral position.

While packing up his office he is informed by his mentor that he may not remove the laboratory notebooks.

pp. 27

Case Study Data Ownership, cont.

Who do you think owns the research data?

Should the student have been allowed to take the results of his labors?

What if the student had been going to a competitor’s laboratory?

Case Study

Effort Reporting Physician Scientist has 2 NIH

grants (@ 25% effort), 3 days/week in clinic, directs Infectious Diseases block in 2nd year medical curriculum, lectures in that block, and is on the institutional promotions and tenure committee.

Case Study

Effort Reporting Is there a problem with this

investigator’s time commitment? How might he manage this?

WhistleblowersInstitutions must: Protect “to the maximum extent

possible” the privacy of those who in good faith report apparent misconduct

Undertake “diligent efforts to protect the positions and reputations of those persons, who, in good faith make allegations”

Whistleblowers

A good faith allegation is made with the honest belief that research misconduct may have occurred. An allegation is not in good faith if it is made with reckless disregard for or willful ignorance of facts that would disprove the allegation

Qui Tam provisions of the False Claims Act Allows private parties to sue entities

and individuals that have submitted false claims to the federal government

Can receive a portion of the settlement if the government receives a monetary agreement with the defendant

Recent settlementsRevealed via Qui Tam (Whistleblower): University 1- $5.5 M (Feb, 2003) University 2 - $2.6 M (Feb, 2004) University 3- $3.4 M (Apr, 2005) University 4- $4.4 M (Jun, 2005)Revealed via voluntary disclosure: University 5- $2.4 M (June 2004)

All involved overstatement of effort on NIH grants

Competing Interests (Conflicts?)

Competing interests are unavoidable- it is how they are managed• Conflicts of conscience

Sometimes good, but not always

• Conflicts of commitmentAssigned duties vs. free-lancing

• Conflicts of interestAn expanding universe

Conflicts of Interest Professional

(reviewing friends/competitors grants and/or manuscripts)

Financial(vested interest in experimental outcome)

Conflicts of Interest

Primary responsibilities and professional judgment (e.g., patient’s welfare, research validity)• vs

Secondary interests (e.g., financial gain)

Conflicts of Interest The public (i.e., taxpayers) expect that

University research is objective• Protect research subjects and personnel• Preserve public trust• Promote scientific progress

Bioethicists are concerned• Financial gain may cloud scientific integrity• Experiments may be pushed that might not

be safe

Conflicts of Interest

Pressures Desire for:

– Faculty advancement– Success in grant funding– Acquisition of limited resources (space,

staff support, tenure-track position)– Prestigious national reputation– Cure disease, alleviate pain and

suffering

Conflicts of Interest

It’s About Public Trust

“Is the situation likely to interfere or appear to interfere with the independent judgment one is supposed to show as a professional performing official duties?

Conflicts of Interest

Financial Ties between Researchersand Industry Grants and Contracts Consultants Advisory Boards Speaker’s Bureaus Patent/Royalty

Arrangements Expensive Gifts/Trips Equity Interest

Conflicts of Interest

PHS and NSF Definition – Significant Financial Interest Anything of monetary value, including

but not limited to, salary or other payments for services; equity interests; and intellectual property right

> $10,000 or > 5% ownership interest for any one enterprise or equity

Conflicts of Interest

Individual Conflict of Interest Situations where financial considerations

may compromise, or have the appearance of compromising, an employee’s professional judgment in designing, conducting, evaluating, or reporting research

DISCLOSURE is key

Conflicts of Interest

Significant Financial Interest University concerns regarding

significant financial interests:• Are students adequately protected? • Are publications resulting from research?• Are inventions reported to University?• Are laboratory personnel aware of PI’s

significant financial interest?• If clinical research, are research participants

made aware of PI’s significant financial interest?

Case Study

Conflict of Interest case study

Research Ethics

Conclusions Science is a community of trust. When

this trust is violated, it tends to be on the front page of the paper.

You cannot teach ethics, but you can watch for it

Conflicts of interest and commitment are natural. They cannot be eliminated, but they can (and should) be managed.