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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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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

slide3
"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

the fundamental proposition
The 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.

slide6
“The first step in the evolution of ethics is a sense of solidarity with other human beings.”Albert Schweitzer
orcs core areas red federal regulations
ORCS Core Areas(Red = Federal Regulations)
  • Human research protections (IRB)
  • Research misconduct
  • Conflict of interest and commitment
  • Data acquisition, management, sharing, and ownership
  • Mentor/trainee relationships
  • Publication practices and responsible authorship
  • Peer review
  • Collaborative science
slide8

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.

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.
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
robert k merton
Robert K. Merton

Stated that the disinterested pursuit of

truth is the norm of science, expressed as:

  • Universalism
  • Communalism
  • Disinterestedness
  • Organized skepticism
consequences of ambition
Consequences of ambition

Perseverance and success,

but for some increased:

Risk for unintentional bias

Willingness to cut corners

Willingness to commit serious misconduct

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

conflicts of interest
CONFLICTS 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://research.unl.edu/orr/conflict.shtml

key components of regulations
Key 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.
goals of federal regulations
Goals of Federal Regulations
  • Manage
  • Reduce
  • Eliminate
unl conflict of interest policy
UNL 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
slide18

Human Research Protections Program

National Research ActIn July 1974, the passage of the National Research Act established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Researchwhich established IRBs.

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
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).
human research protections program
Human Research Protections Program
  • IRB support
  • Process Overview
  • Training: CITI & In Person
  • AAHRPP
  • Electronic Submission
the essential dilemma

THE ESSENTIAL DILEMMA

Human dignity and social justice in

an economically and politically

unbalanced world

slide24

The major responsibility for insuring ethical decision making in human research rests with the IRBs in terms of empowerment, flexibility and discretion.

irb belmont report
IRBBelmont Report
  • Respect for Persons
  • Beneficence
  • Justice
research
RESEARCH

“Research” means a systematic investigation designed to develop or contribute to generalizeable knowledge. 46.102 (d)

human subject
HUMAN 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)

authority of irb
AUTHORITY 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
criteria for approval of research 45 cfr part 46 111
CRITERIA 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.

criteria for approval of research 45 cfr part 46 1111
CRITERIA 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.

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

slide36

ETHICS IN ETHNOGRAPHIC RESEARCHIn 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

slide37
“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