Responsible Conduct in Research

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Responsible Conduct in Research 100a: Proseminar in Research Methods and Scholarly Writin David Penetar, PhD Assistant Professor, Harvard Medical School

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SSCI E-100a: Proseminar in Research Methods and Scholarly Writing. Responsible Conduct in Research. David Penetar, PhD Assistant Professor, Harvard Medical School. Major Ethical Issues in Research. Personal Behavior: - Plagiarism - Falsification - Fraud/Fabrication - PowerPoint PPT Presentation

Transcript of Responsible Conduct in Research

Page 1: Responsible Conduct in Research

Responsible Conduct in Research

SSCI E-100a: Proseminar in Research Methods and Scholarly Writing

David Penetar, PhDAssistant Professor, Harvard Medical School

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Major Ethical Issues in Research

Personal Behavior:

- Plagiarism

- Falsification

- Fraud/Fabrication

- Conflicts of Interest

Collaborative Behavior:

- Authorship

- Conduct of Experiment

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Percentage of scientists who say that they engage in the behavior listed within the previous three years

1. Falsifying or ‘cooking’ research data2. Ignoring major aspects of human-subject requirement3. Not properly disclosing involvement in firms whose products are

based on one’s own research4. Relationships with students, research subjects or clients that may

be interpreted as questionable5. Using another’s ideas without obtaining permission or giving due

credit6. Unauthorized use of confidential information in connection with

one’s own research7. Failing to present data that contradict one’s own previous research8. Circumventing certain minor aspects of human-subject

requirements9. Overlooking others’ use of flawed data or questionable

interpretation of data10. Changing the design, methodology or results of a study in

response to pressure from a funding source

0.3 %0.3 %0.3 %

1.4 %

1.4 %

1.7 %

6.0 %7.6 %

12.5 %

15.5 %

(n = 3,247)

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Major Ethical Issues in Research

What are our obligations when conducting research?

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Major Ethical Issues in Research: Plagiarism

Plagiarism:

Writing with Sources: A Guide for Students, G. Harvey

- Passing off a source’s information, ideas, or words as your own by omitting to acknowledge that source

- An act of

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• Copying text without proper recognition

• Not giving credit for genesis of study

Major Ethical Issues in Research: Plagiarism

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Fraud - serious misconduct with intent to deceive- Must be able to replicate the results- Have confidence in the data/conclusions- Detection is most likely when replication

cannot be confirmed

Causes:

Major Ethical Issues in Research: Fraud

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Sir Cyril Burt’s study of IQ of twins who were reared apart.

Suggested that genetic factors are extremely important in developing intelligence

Other scientists noticed some irregularities in the data and could not locate his two research assistants

Major Ethical Issues in Research: Fraud ?

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Fraud--January 11, 2006

Korean scientist Hwang Woo-Suk resigned after two seminal papers on stem cell research that were published in Science were found to be based on fabricated data.

He claims that he was deceived by younger colleagues at another institute.

Major Ethical Issues in Research: Fraud

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How to deal with it:

Major Ethical Issues in Research: Fraud

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• Identifying “aberrant” data- What defines an “outlying” data point?- When can a data point be removed--if ever?- How should this be described?

Major Ethical Issues in Research: Fraud?

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Authorship • Often is decided before study is conducted, but can change dramatically during study conduct

• Must be decided before paper is written

• First author is main contributor to this particular study (rationale, conduct, analysis and writing)

• Last author is usually lab chief

Major Ethical Issues in Research: Collaborations

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Major Ethical Issues in Research

Conduct of Research- Sound Science

- Risk/Benefit Ratio - Privacy and Confidentiality - Protection of Special Populations

- Stress and Psychological Harm - Deception (& Alternatives to Deception)

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Foundations of Protections of Human Volunteers

Hippocrates (~400 B.C.) physicians should “abstain from whatever is deleterious and mischievous.”

Thomas Percival (1803) “…new methods of …treatment should be devised but … should be … governed by sound reason, .. or well-authenticated facts … previous consultation of the physicians … to the nature of the case.”

William Beaumont (1833): Experimentation is needed; information cannot be otherwise obtained. Investigator must be conscientious and responsible; methodological approach; no random studies. Voluntary consent is necessary. Discontinuation of experiment when it causes distress to the subject or the subject objects or becomes dissatisfied.

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Foundations of Protections of Human Volunteers

Claude Bernard (1865): “Those [experiments] that can only harm are forbidden. Those that are innocent are permissible, and those that may do good are obligatory.”

The Prussian Directive (1900):

- Prompted by Neisser’s studies with immunizations against syphilis

- Prohibited experiments in minors and those not fully competent. Unequivocal consent required after explanation of the experiment and possible adverse consequences. Only certain people were allowed to do the research and they must keep written records.

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Foundations of Protections of Human Volunteers

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The Nuremberg Trials: 1946-1947

23 defendants; 3 non-physicians - 16 found guilty 7 were hanged (4 physicians) 5 sentenced to life in prison 4 sentenced to 10-20 yrs - 7 were acquitted and freed

Separate Trial - 31 “underlings” were also found guilty; 22 of them were hanged

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Foundations of Protections of Human Volunteers

The Nuremberg Code (1947)

• True informed consent prior to experimental procedures; allowed to discontinue at any time

• Research based on prior work with animals

• Truly necessary with benefits justifying risks and no unnecessary physical or mental suffering or injury

• The person performing the task is qualified

• No experiment shall be undertaken where death or injury will likely occur

• Proper preparation and adequate facilities to protect subjects

• Terminate study upon observing the likely risk of injury, disability or death

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Additional Reading

Lopez-Munoz F, et al. (2007)

Psychiatry and political-institutional abuse from the historical perspective: The ethical lessons of the Nuremberg Trial on their 60th anniversary.

Progress in Neuro-Psychopharmacology & Biological Psychiatry, 31: 791-806

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Foundations of Protections of Human Volunteers

Kefauver-Harris Amendments & Declaration of Helsinki

The Belmont Report (1974/9)

Beneficence Justice

Respect for Persons

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Foundations of Protections of Human Volunteers

CFR Title 45 Part 46: Protection of Human Subjects

Referred to as the “Common Rule”

- IRB Review of Research- Requirements for Informed Consent- Institutional Assurances of Compliance

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Foundations of Protections of Human Volunteers

Additional Protections:

- Office for the Protection from Research Risks

- National Bioethics Advisory Commission

- President’s Council on Bioethics

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Major Ethical Issues in Research

Institutional Review Board (IRB)

- Local panel reviewComposition:

- Evaluate study and proposed conduct

- Compares protocol with informed consent

- Insures compliance with all governmental

mandates

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Major Ethical Issues in Research

Criteria for IRB Approval

• Risks to subjects are minimized

• Risks are reasonable in relation

• Selection of subjects is equitable

• Informed consent is sought from

each individual

• Informed consent is appropriately

documented

When appropriate:

• Data collection is monitored to ensure subject safety

• Privacy and confidentiality of subjects is protected

• Additional safeguards are included for vulnerable populations

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Major Ethical Issues in Research

Other IRB Determinations

• Investigator Conflict of Interest

• Serious or Continuing Noncompliance

• Unanticipated Problems

• Multi-site/Collaborative Research

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Major Ethical Issues in Research

Informed Consent

- Providing a participant with all of the details associated with the rationale, methods, expected results and outcome of an experiment

- Allows the subject to decide for him/herself whether they wish to participate

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Major Ethical Issues in Research

Informed Consent

Must fully inform“...acute doses of cocaine have been

associated with fatal or near fatal effects on the heart...”

“...the procedure may result in infection...”“...is not designed to be of benefit to you...”

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Major Ethical Issues in Research

Risk/Benefit Ratio

• The relative weight given to the actual risk experienced by the participant versus the actual,

perceived or potential benefit to the subject or to society as a whole

• Actual benefits to the participants are rare; more commonly, the benefits are for the population as a whole

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Major Ethical Issues in Research

Privacy and Confidentiality- Experimenters must assure privacy and

confidentiality of their participants- Important when studies on sexual behavior, divorce,

family violence, drug abuse, etc. are involved- HIPAA compliance

-Exceptions: - When a participant reveals “danger to self or others”, especially child abuse to a clinician- Reporting of communicable diseases

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Major Ethical Issues in Research

Special Populations

- Ensure voluntary participation because not all populations are equal

- Children, psychiatric patients, elderly and prisoners all need special attention

- Guardians and minor’s assent deal with these limitations

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Major Ethical Issues in Research

Stress and Psychological Harm

- Physical harm— possible whenadminister drugs (experimental)surgical proceduresmedical devices

- Psychological harm--more frequentlydefinition of harm--actual or perceived

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Major Ethical Issues in Research

Deception

- Rationale: participant’s complete knowledge of the study will alter their responses leading to bias and invalid results

- Action: lead a participant to believe something about the study that is untrue

- Expectations: do participants expect to be deceived?

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Major Ethical Issues in Research: Deception

- Advertised as a test of learning and memory- Told it was a study on effects of punishment on learningProcedure:Participant and “learner” who was confederateRequired to learn word pairsWhen error was made, participant instructed to deliver increasing levels of electrical shocks

Milgram’s Obedience Experiment

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Milgram’s Obedience Experiment

- Shock lever labeled from 15 to 450 (XXX) volts

- Used a mock shock machine

- “Learner” pretended to receive shocks and

pleaded to be able to end study

- Experimenter “coerced” learner into remaining in

study

Major Ethical Issues in Research: Deception

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Milgram’s Obedience Experiment

Results:- 65% of participants continued to deliver shocks all the

way up to the highest level!- The study, while controversial, revealed many

insights to beliefs about human’s ability to resist authority

Major Ethical Issues in Research: Deception

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Would People Still Obey Today?

Burger JM (2009) Replicating Milgram, American Psychologist, 64, 1-11.

Conducted a ‘partial replication’ of original experiment

Results:

Table 2

BehaviorBase

ConditionModeled refusal

condition

Milgram's Experiment 5

Stopped at 150 volts or earlier 12 (30.0) 11 (36.7) 7 (17.5)

Continued after 150 volts 28 (70.0) 19 (63.3) 33 (82.5)

Numbers (and Percentages) of Participants WhoStopped and Who Continued

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Ways to Handle Deception: Debriefing

- The traditional solution to the problem of using deception

- Even used when there is no stress

- Explain the tests and results, rationale and subject’s responses; alleviate tension and stress

Major Ethical Issues in Research: Deception

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Foundations of Protections of Human Volunteers

Research Ethics Milestones Decade Trigger Events 1930

The Syphilis Study (begins) 1940 The Nazi Experiments

Human Radiation Experiments (begins) 1950

Nuremberg Code Willowbrook Hepatitis Study 1960 Thalidomide Tragedy

Kefauver-Harris Amendments Milgram’s StudyDeclaration of Helsinki

1970 The Syphilis Study (Exposed)

1980The ‘Common Rule’ 1990OPRR/National Bioethics Advisory

Commission Gene Transfer Subject Death 2000

President’s Council on Bioethics