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Guidelines for the Conduct of Research in the Intramural Research Program at NIH http://www.nih.gov/campus/irnews/guidelines.htm. Scientific Integrity Mentor-Trainee Relationships Data Acquisition, Management, Sharing, & Ownership Research Involving Human & Animal Subjects

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slide1

Guidelines for the Conduct of Research in the Intramural Research Program at NIH

http://www.nih.gov/campus/irnews/guidelines.htm

slide2

Scientific Integrity

  • Mentor-Trainee Relationships
  • Data Acquisition, Management, Sharing, & Ownership
  • Research Involving Human & Animal Subjects
  • Collaborative Science
  • Conflict of Interest and Commitment
  • Peer Review
  • Publication Practices & Responsible Authorship
slide3

Research Ethics Cases

  • for Discussion by the NIH Community
  • http://www1.od.nih.gov/oir/sourcebook/ResEthicsCases/cases-toc.htm
  • Theme 5 – DataAcquisition, Management, Sharing, & Ownership – 2005
  • Theme 4 – Collaborative Science – 2004
  • Theme 3 – Mentoring - 2003
  • Theme 2 - Authorship - 2002
  • Theme 1 - Scientific Misconduct - 2001
scientific integrity
Scientific Integrity

Intramural scientists at the NIH should be committed to the responsible use of the process known as the scientific method to seek new knowledge. All research staff in the Intramural Research Program should maintain exemplary standards of intellectual honesty in formulating, conducting and presenting research as befits the leadership role of the NIH.

principles of the scientific method
Principles of the Scientific Method
  • Formulation and testing of hypotheses
  • Controlled observations or experiments
  • Analysis and interpretation of data
  • Oral and written presentations of all of these components to scientific colleagues for discussion and further conclusions
why is scientific integrity so important
Why is Scientific Integrity so Important?

The scientific community and the general public rightly expect adherence to exemplary standards of intellectual honesty in the formulation, conduct, and reporting of scientific research.

Without a high standard of Scientific Integrity, the scientific community and general public may become victims of Scientific Misconduct.

what is scientific misconduct
What is Scientific Misconduct?
  • 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
what is scientific misconduct8
What is Scientific Misconduct?
  • Scientific misconduct does not include honest error or difference of opinion
  • Scientific collaborators cannot plagiarize from each other
  • Truth in science is the goal of the discipline - to lie about what one has done is to put a knife in the heart of the profession!
two real life examples of scientific misconduct
Two Real-life Examples of Scientific Misconduct

Breast Cancer Prevention Trial

A data coordinator falsified and fabricated the dates of tests and exams

Nat. Surgical Adjuvant Breast & Bowel Project

A data coordinator falsified and fabricated follow-up data

two real life examples of scientific misconduct10
Two Real-life Examples of Scientific Misconduct

Inaccurate information regarding patient status and date of death could result in an over- or under-estimate of treatment benefits, especially when length of survival and length of disease-free survival are end-points

slide11

Mentor-Trainee Relationship

The goals of a mentor-trainee

relationship are to ensure that

fellows receive the best possible

training in how to conduct research

and how to develop and achieve

career goals.

slide12

Mentoring and being mentored

are life-long essential components

of professional life.

data management
Data Management

Scientific data may be divided into 3 categories…

  • Experimentalprotocols -a detailed plan of a scientific or medical experiment, treatment, or procedure
  • Primary data -includes the following…
    • Instrument set-up and output
    • Raw and processed data
    • Statistical calculations
    • Photographic images
    • Electronic files
  • Procedures of reduction and analysis -the method by which you process the original data into the final format
slide14

Any individual involved in the development and/or execution of an experiment and subsequent data processing is responsible for the accuracy of the scientific data.

  • Principal investigator
  • Post-doctoral fellow
  • Student
  • Research assistant
  • Other support staff

These individuals may include, in addition to the person responsible for executing the experiment:

slide15

Data collected at the NIH, as well as laboratory notebooks and research records, should be retained for a period of time sufficient to allow for:

  • Further analysis of the results
  • Repetition by others of published material

Clinical data should be retained as directed by federal regulations

NIH recommends that all data and laboratory notebooks be retained for 5-7 years

research involving human and animal subjects
Research Involving Human and Animal Subjects

The use of humans and animals in research

is essential to the NIH mission for improving

human health but such research entails

special ethical and legal considerations.

slide17

Peer review can be defined as a critical evaluation, conducted by one or more experts in the relevant field, of either a scientific document- such as a research article submitted for publication, a grant proposal, or a study protocol - or a research program.

slide18

Requisite elements for peer review include:

  • reviewers must be experts in the relevant subject areas
  • evaluation should be thorough and objective, and based solely on the material

under review

  • evaluation should be fair and unprejudiced; real or perceived conflict of interest should be avoided
  • reviews are usually conducted anonymously
slide19

Collaborative Science

Research collaborations facilitate progress

and should be encouraged.

The ground rules for collaborations, including

authorship issues, should be discussed openly

among all participants from the beginning.

According to the Guidelines for the Conduct of

Research, all research data should be made

available to scientific collaborators.

slide20

NIH OFFICE OF THE OMBUDSMAN

Questions for Scientific Collaborators

Although each research project has unique features, certain core issues are common to most of them and can be addressed by collaborators posing the following areas:

Overall Goals

Who Will Do What?

Authorship, Credit

Contingencies & Communicating

slide21

PUBLICATION PRACTICES & AUTHORSHIP

Publication of results fulfills our responsibility to communicate research findings to the scientific community.

Publication of clinical studies also fulfills our responsibility to have a scientific benefit in return for putting human subjects at risk.

slide22

Why is publication so important for scientists?

  • Publications share findings that benefit society and promote human health
  • Credit for a discovery belongs to the first to publish
  • Publications establish scientific principles
  • Reputations and research funding are based on the number and impact of publications
  • Prestigious positions are gained through reputation and publications
slide23
Other than presentations at scientific meetings, publication in a scientific journal should normally be the mechanism for the first public disclosure of new findings.

[An exception may be appropriate when serious public health or safety issues are involved.]

slide24
Even though each paper should contain sufficient information for the informed reader to assess its validity, the principal method of scientific verification is not review of submitted or published papers, but the ability of others to replicate the results.

Therefore, each paper should contain all the information necessary for other scientists to repeat the work.

slide25

BUT

Timely publication of new and significant results is important for the progress of science

each publication should make a substantial contribution to its field.

Fragmentary publication of the results of a scientific investigation or multiple publications of the same or similar data are not appropriate

- for example, using a tactic termed “salami slicing” or producing lots of “LPU’s” (Least Publishable Units).

slide26

Authorship is:

  • the primary mechanism for determining the allocation of credit for scientific advances and thus the primary basis for assessing a scientist's contributions to developing new knowledge.

As such, it potentially conveys great benefit, as well as responsibility.

slide27

Authorship involves:

  • the listing of names of participants in all communications to scientific colleagues (oral or written) concerning experimental results and their interpretation
  • the fulfillment of our responsibility to communicate research results to the scientific community for external evaluation.
slide28

A significant contribution to the conceptualization, design, execution, and/or interpretation of the research study and

What should justify authorship?

A willingness to assume responsibility for the study.

Individuals who do not meet these criteria, but who have assisted the research by their encouragement and advice or by providing space, financial support, reagents, routine analyses, or patient material should be acknowledged in the text but not be authors.

slide29

When should authorship issues be discussed?

Although there is no universal set of standards

for authorship, each research group should freely discuss and resolve questions of authorship

before and during the course of a study.

Each author should review fully material that is to be presented in a public forum or submitted (originally or in revision) for publication. Each author should indicate willingness to support the general conclusions of the study before its presentation or submission.

slide30

How else is credit established besides authorship ?

Acknowledgments provide recognition of individuals who have assisted the research by their encouragement and advice about the study, editorial assistance, technical support, or provision of space, financial support, reagents, or specimens.

The use of anyone else’s discoveries, words, ideas, data, or analyses must be cited in a way that others can find the reference and see the contribution.

slide31

JAMA Authorship Policy

Authors must describe their specific contributions

Authors must describe the contributions of those

listed in the acknowledgements

Authors must decide who should be an author

and who should be acknowledged by discussions

among themselves

Authors should be listed in order of actual degree

of contribution, to be decided by authors

slide32

Irresponsible Authorship

Honorary authorship

- an author who does not meet the criteria

Ghost authorship

- failure to include as an author someone who

made substantial contributions to the article

Refusal to accept responsibility for an article

despite ready acceptance of credit

Duplicate and redundant publications

from Rennie et al, JAMA 280:222, 1998

slide33

Authorship Analysis

Total Research articles Reviews

Honorary 809 79 (16%) 61 (26%)

Ghost 809 65 (13%) 23 (10%)

Journals: Amer J Cardiology, Amer J Medicine,

Amer J ObGyn, Annals Int Medicine, JAMA, NEJM

from Rennie et al, JAMA 280:222, 1998

slide34

Annals of Internal MedicineAuthorship Criteria

  • Authors should meet all of these criteria:
  • Conceived and planned the work,

or interpreted the evidence it presents, or both

  • Wrote the paper, or reviewed successive

versions and took part in the revision process

  • Approved the final version
slide35

Annals of Internal MedicineAuthorship Criteria

  • The following, by themselves, are not criteria for authorship:
  • holding position of administrative leadership
  • contributing patients or reagents
  • collecting and assembling data
slide36

Dr. Colleen May is a participating neurologist in

a clinical trial to assess the efficacy and toxicity of

a new anticonvulsant medication.

For the duration of the 2-year study, each

neurologist is to meet with each of his/her patients

for an average of 30 minutes per month.

In Dr. May’s case, this amounts to an average of

20 hours per month.

.

slide37

During each visit, the physicians administer a variety of specialized tests, requiring judgments dependent on their experience and training in neurology.

At the completion of the study,the results are to be unblinded and analyzed by the project leaders.

It is anticipated that at least two publications will be prepared for the New England Journal of Medicine.

slide38

Dr. May has just learned that she will be listed in the Acknowledgements, but not as a coauthor of the manuscript.

Dr. May argues that she has provided nearly 500 hours of her expert time, far more than needed to complete a publishable study in her experimental lab.

Does Dr. May have a case for authorship?