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The Responsible Conduct of Research

The Responsible Conduct of Research

Daniel R. Vasgird, PhD, CIP

Research Compliance Services

Office of Research Responsibility

University of Nebraska, Lincoln

(402) 472-1837

dvasgird2@unl.edu

http://research.unl.edu/orr

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"For a scientist, integrity embodies above all the individual's commitment to intellectual honesty and personal responsibility … For an institution, [integrity] is a commitment to creating an environment that promotes responsible conduct by embracing standards of excellence, trustworthiness, and lawfulness…"

-Integrity in Scientific Research, The National Academy of Sciences

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The Fundamental PropositionThe Fundamental Proposition

Rules are just a small part of the picture. The alpha and the omega has to be integrity from

which all else will follow, including compliance.

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“Ethics primarily concerns the effects of our actions on others.”

Randy Cohen

“Ethics primarily concerns the effects of our actions on others.”

Randy Cohen

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“The first step in the evolution of ethics is a sense of solidarity

with other human beings.”

Albert Schweitzer

“The first step in the evolution of ethics is a sense of solidarity

with other human beings.”

Albert Schweitzer

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ORCS Core Areas(Red = Federal Regulations)

ORCS Core Areas(Red = Federal Regulations)

1) Human research protections (IRB)2) Animal research protections (IACUC)3) Data acquisition, management, sharing,

and ownership4) Mentor/trainee relationships5) Publication practices and responsible

authorship6) Peer review7) Collaborative science8) Research misconduct9) Conflict of interest and commitment10) Environmental health and safety liaison (IBC & RSC)11) Export Controls

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ORCS Mission:

Foster a culture of integrity and compliance within the University directed

at ensuring that participants in the University of Nebraska, Lincoln research enterprise internalize and pursue the goal

of self-directed responsible conduct of

research.

ORCS Mission:

Foster a culture of integrity and compliance within the University directed

at ensuring that participants in the University of Nebraska, Lincoln research enterprise internalize and pursue the goal

of self-directed responsible conduct of

research.

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FSGO Compliance Elements(HHS & NSF)

FSGO Compliance Elements(HHS & NSF)

• Implementing written policies and procedures; • Designating a compliance officer and

compliance committee; • Conducting effective training and education; • Developing effective lines of communication; • Conducting internal monitoring and auditing; • Enforcing standards through well-publicized

disciplinary guidelines; and • Responding promptly to detected problems.

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Organization & Governance of Research at UNL

Organization & Governance of Research at UNL

• Academic and research activity is conducted through the faculties and departments, under the direction of the appropriate dean and the Vice Chancellor for Research

• For cases of research misconduct, graduate students involved in research are subject to the same disciplinary procedures as faculty or staff

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Robert K. MertonRobert K. Merton

Stated that the disinterested pursuit of

truth is the norm of science, expressed as:

• Universalism

• Communalism

• Disinterestedness

• Organized skepticism

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Perseverance and success,

but for some increased:

1. Risk for unintentional bias

2. Willingness to cut corners

3. Willingness to commit serious misconduct

Consequences of ambitionConsequences of ambition

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The OSTP Definition of Misconduct

The OSTP Definition of Misconduct

“Research misconduct is defined as 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.”

http://www.unl.edu/research/orr/misconduct.shtml

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CONFLICTS OF INTERESTCONFLICTS OF INTEREST

A conflict of interest is a situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity.

http://www.unl.edu/research/orr/conflict.shtml

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Key Components of RegulationsKey Components of Regulations

The institution, not the federal government or the sponsor, has the primary responsibility to develop its own internal policies and procedures.

The institution is to designate an official to review disclosure of significant financial interest and manage conflicts of interest.

Investigators must disclose any "significant financial interest" to the institution.

The institution must report to the federal funders if it believes an investigator’s significant financial interest could affect the research.

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Goals of Federal RegulationsGoals of Federal Regulations

Manage

Reduce

Eliminate

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UNL Conflict of Interest PolicyUNL Conflict of Interest Policy

• Annual conflict of interest disclosure and reporting by faculty members, officers of research, and officers of administration

• Research-specific conflict of interest disclosure and reporting in sponsored research supported by a business in which key personnel has ANY financial interest or holds executive position

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Human Research Protections Program

National Research Act

In July 1974, the passage of the National Research Act established the National

Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

which established IRBs.

Human Research Protections Program

National Research Act

In July 1974, the passage of the National Research Act established the National

Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

which established IRBs.

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HUMAN RESEARCH GONE AWRY HUMAN RESEARCH GONE AWRY

• Nazi Experiments (Nuremberg Code)• Milgram Obedience Experiments• Radiation Experiments • Wichita Jury Taping Study • Jewish Chronic Disease Cancer Study• Thalidomide Tragedy• Syphilis Experiment (PHS, Tuskegee)

Led to NRA (IRBs & Informed Consent)• Jesse Gelsinger

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MAIN FUNCTION OF IRB REVIEW TO ASSURE THAT:

MAIN FUNCTION OF IRB REVIEW TO ASSURE THAT:

• RISKS ARE MINIMIZED AND REASONABLE IN RELATION TO ANTICIPATED BENEFITS.

• THERE IS INFORMED CONSENT.

• RIGHTS AND WELFARE OF SUBJECTS ARE MAINTAINED (i.e., Continuous).

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DRAMATURGICAL FUNCTION

To become the subject as much as possible

DRAMATURGICAL FUNCTION

To become the subject as much as possible

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Human Research Protections Program

Human Research Protections Program

• IRB support

• Process Overview

• Training: CITI & In Person

• AAHRPP

• Electronic Submission

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THE ESSENTIAL DILEMMATHE ESSENTIAL DILEMMA

Human dignity and social justice in

an economically and politically

unbalanced world

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The major responsibility for insuring ethical decision making in human

research rests with the IRBs in terms of empowerment, flexibility and

discretion.

The major responsibility for insuring ethical decision making in human

research rests with the IRBs in terms of empowerment, flexibility and

discretion.

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IRBs have ethical responsibility and legal

authority.

IRBs have ethical responsibility and legal

authority.

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IRBBelmont Report

IRBBelmont Report

•Respect for Persons

•Beneficence

•Justice

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The research protection system fundamentally

revolves around mutual trust.

The research protection system fundamentally

revolves around mutual trust.

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RESEARCHRESEARCH

“RESEARCH” MEANS A SYSTEMATIC INVESTIGATION DESIGNED TO DEVELOP OR CONTRIBUTE TO GENERALIZEABLE KNOWLEDGE. 46.102 (d)

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HUMAN SUBJECTHUMAN SUBJECT

• “Human subject” means a living individual about whom an investigator…conducting research obtains

(1) data through intervention or interaction with the individual, or (2) identifiable private information. 46.102(f)

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Reasonable ExpectationsReasonable Expectations

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AUTHORITY OF IRBAUTHORITY OF IRB

• Requirement of review• Approve, disapprove or modify• Conduct continuing review

• At any time and in person if desired• Must be done at least once per year

• Observe/verify changes • Suspend or terminate approval

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CRITERIA FOR APPROVAL OF RESEARCH 45 CFR PART 46.111CRITERIA FOR APPROVAL OF RESEARCH 45 CFR PART 46.111

To approve research, an IRB should determine that all of the following conditions exist: 1. Risks to subjects are minimized. 2. Risks are reasonable in relation to anticipated benefits, if any, to subjects and to advancement of knowledge.3. Selection of subjects is equitable.4. Informed consent will be sought.5. Informed consent will be documented.

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CRITERIA FOR APPROVAL OF RESEARCH 45 CFR PART 46.111CRITERIA FOR APPROVAL OF RESEARCH 45 CFR PART 46.111

6. Where appropriate, research plan makes adequate provision for monitoring the data collected to insure safety of subjects. 7.

There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.8. Where any of the subjects are likely to be vulnerable to coercion or undue influence, additional safeguards have been included in the study to protect subjects.

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Ensure that language and readability are appropriate to

the subject.

Ensure that language and readability are appropriate to

the subject.

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46.116 Consent - the Process 46.116 Consent - the Process

• Process of information exchange which should include: - written materials (CF, letters,

debriefs) - verbal instructions

- questions & answers after reading ICF with subject

- setting/timing (family/friends consultation)

- agreement/documentation - reaffirmation/re-consent

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ETHICS IN ETHNOGRAPHIC RESEARCH

In a nutshell, researchers must make their research goals clear to the members of the community where they undertake their research and gain the informed

consent of their consultants to the research beforehand. It is also important to learn whether the group would prefer to be named in the written report of the research or given a pseudonym and to offer the results of the research if informants would like to read

it. Most of all, researchers must be sure that the research does not harm or exploit those among whom

the research is done.

http://www.aaanet.org/committees/ethics/ethics.htm

ETHICS IN ETHNOGRAPHIC RESEARCH

In a nutshell, researchers must make their research goals clear to the members of the community where they undertake their research and gain the informed

consent of their consultants to the research beforehand. It is also important to learn whether the group would prefer to be named in the written report of the research or given a pseudonym and to offer the results of the research if informants would like to read

it. Most of all, researchers must be sure that the research does not harm or exploit those among whom

the research is done.

http://www.aaanet.org/committees/ethics/ethics.htm

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“One is apt to think of moral failure as due to weakness of

character: more often it is due to an inadequate ideal.”

Richard Livingstone

“One is apt to think of moral failure as due to weakness of

character: more often it is due to an inadequate ideal.”

Richard Livingstone