Research Ethics Workshop - PowerPoint Presentation

Document Sample
Research Ethics Workshop - PowerPoint Presentation Powered By Docstoc
					Research Ethics
  Workshop

“In general terms, responsible conduct in research is simply
       good citizenship applied to professional life”


                   Office of Research Integrity, Introduction to the Responsible Conduct of Research;
                       http://ori.dhhs.gov/education/products/RCRintro/; Accessed October 1, 2010.
            Research Ethics Training
• Federal government requires certain people to have
  certain training, but knowing the “Rules of Research”
  is good for everyone.
• Missouri State University would like to recognize those
  who have achieved certain levels of training.
• Co-curricular transcript “recognition”
• This workshop = 2 hr
• Additional hours this month for:
   – IRB workshop (Tues Nov 9, 4:00 - 5:00, PSU 315) = 1 hr
   – IACUC workshop (Thurs Nov 11, 4:00 - 5:00, PSU 315) = 1 hr
• More details to come on earning this “recognition”
             Presentation Outline
• What is Research Ethics? (aka, Responsible Conduct of
  Research, aka, Research Integrity)
•   Research Misconduct
•   Conflict of Interest
•   Authorship and Publication
•   Intellectual Property
    – Technology Transfer
    – Data Collection & Data Management
    – Data Ownership & Data Sharing
•   Mentor/Trainee Relationship
•   Peer Review
•   Export Control
•   Human and vertebrate research (covered elsewhere)
                     Introduction
A review by Knechtle SJ, published in the PhilosTrans R Soc
Lond B Biol Sci, 2001, May 29;356(1409):681-9, entitled
„Treatment with immunotoxin,‟ cites 4 publications from the
Thomas Laboratory.
Not only were these papers cited, but the reviewer seemed
impressed by the Thomas work.
All 4 papers were later retracted because of false claims.

What does this do to the credibility of other papers from this
research lab?
What does this do to the credibility of Knechtle & his paper?
What does this do to the field of immunotoxicology?
                  Research Ethics
“.. is a kind of applied or practical ethics, meaning that it
attempts to resolve not merely general issues but also
specific problems that arise in the conduct of research. Its
goal is to determine the moral acceptability and
appropriateness of specific conduct and to establish the
actions that moral agents ought to take in particular
situation. Research ethics is therefore not merely
theoretical. It aims to establish practical moral norms and
standards for the conduct of research.”

     Peach, Lucianda (1995) “ An Introduction to Ethical Theory,”
     Research Ethics: Cases and Materials,
  In general terms, “research ethics” is simply good
        citizenship applied to professional life.

Four basic tenants
  – HONESTY — conveying information truthfully and
    honoring commitments,
  – ACCURACY — reporting findings precisely and
    taking care to avoid errors,
  – EFFICIENCY — using resources wisely and avoiding
    waste,
  – OBJECTIVITY — letting the facts speak for
    themselves and avoiding improper bias.
     Ten most important things to
      know about Research Ethics
• Be Honest
• Be Fair
• Do no harm
• Know and Follow the Rules
• Bad rules should be changed, not broken
• Be a good citizen
• When in doubt, ask questions
• Listen to the still small voice of your conscience, especially
  when it’s being overwhelmed by the cacophony of stress
• If you suspect unethical behavior, proceed cautiously
            Your Responsibilities
In order to function effectively and make appropriate ethical
decisions, faculty and administrative staff need to develop
the skills to:

 1. identify when situations present ethical conflicts,
 2. reason among possible courses of action, and
 3. effectively implement their best solution to the problem.

We all function in an environment governed by regulations
and policies, which we must abide by within a core of
ethical principles.
             Research Misconduct
                        Federal Policy
• Research misconduct is defined as fabrication, falsification, or
  plagiarism in proposing, performing, or reviewing research, or in
  reporting research results.

   – Fabrication is making up data or results and recording or reporting
     them.
   – Falsification is 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 is the appropriation of another person’s ideas, processes,
     results, or words without giving appropriate credit.
   – Research misconduct does not include differences of opinion.
      University Policies must . . . .
• Establish definitions of “misconduct”

• Outline procedures for reporting and
  investigation misconduct

• Provide protection for whistle-blowers

• Without these, studies can get out of hand
             Researcher Obligations
 As researchers, there are three sets of obligations, namely:
     o To honor the trust that their colleagues place in them
       (researchers trust their colleagues to have used
       appropriate analytic and statistical techniques in gathering
       of data)
     o To have an obligation to themselves, and
     o To act in ways that serve the public (including the
       university and its stakeholders).
The scientific enterprise is built on a foundation of trust, between
society and researchers and their institution.
    o Researchers HAVE committed misconduct in science
    o Researchers ARE penalized, including research debarment
  Research misconduct has understandably received considerable
  public attention. Researchers who act dishonestly waste public
   funds, harm the research record, distort the research process,
   undermine public trust, and can even adversely impact public
                         health and safety.
Judged on the basis of the number of confirmed cases,
misconduct apparently is not common in research. Over the
last decade, PHS and NSF combined have averaged 20 to 30
misconduct findings a year.
    • < 1 case for every 10,000 researchers.

However, two important cautions need to be kept in mind:
1. Underreporting is to be expected, as it is in criminal and
other types of inappropriate behavior.
2. the responsibility to avoid misconduct in research is a
minimum standard for the responsible conduct of research.
Real Cases: NSF Research Misconduct Investigations
In the most serious case of student misconduct NSF has ever investigated,
a graduate student at a Washington university admitted he falsified and
fabricated NSF-funded research data in four manuscripts, three of which
were published. NSF received the allegation following the university‟s
inquiry. During the investigation, the student admitted he falsified and
fabricated the data because of “a combination of lack of motivation, laziness
and a lack of interest in the work (especially experiments).”

The university‟s investigation committee found that a preponderance of the
evidence proved that the subject intentionally fabricated and falsified data.
The university made a finding of research misconduct, dismissed the
student from the university, and revoked his master‟s degree. The university
also encouraged the removal of the publications from the co-authors‟
websites, retraction of the affected publications, and education of the
university community about scientific misconduct. NSF sent the subject a
letter of reprimand; debarred him for 3 years, required both certifications
and assurances for 3 years following debarment, and barred the subject
from serving as an NSF reviewer for 3 years.
Real Cases: NSF Research Misconduct Investigations
A Pennsylvania university notified NSF it was conducting an investigation
into an allegation of data falsification. The investigation focused on a figure
in a paper, whose lead author was a post-doctoral researcher (the subject)
working in an NSF-supported PI‟s laboratory. When the questionable figure
was initially brought to the PI‟s attention, she asked the subject to provide
the raw data for review. The subject provided neither the raw data nor a
suitable explanation. Subsequently, the PI asked the subject to leave her
group and asked another researcher to review the subject‟s lab computer
files related to the figure.
None of the data files on the lab computer supported the data depicted in
the figure. NSF took the following actions: sent a letter of reprimand to the
subject; debarred the subject for 2 years; required certifications from the
subject and his supervisor for 2 years after the debarment that submissions
to NSF are in compliance with NSF‟s research misconduct policy; required
the subject to provide proof of the retraction of the published paper; and
required the subject to attend an ethics class and provide a copy of the
training material.
                 Conflicts of Interest
        “A situation in which an individual has
        one or more significant financial interest
        that have the potential for tainting . . .
        the conduct or reporting of the work
        conducted under a sponsored project.”

                                             Administrator

                                University                   Business



http://orc.missouristate.edu/89845.htm
 Researcher Resigns!
In January of 2009, Dr. Charles Nemeroff, chair of
Psychiatry at Emory resigned after a University
investigation determined he had failed to communicate
with Emory officials about $800,000 in income he had
received from a pharmaceutical company. He now
works at another university.

Questions:
•Why was he obligated to tell his employer?
•Is receiving money a bad thing in this case?
http://www.pn.psychiatryonline.org/content/43/13/1.2.full
              Researcher Conflicts
Researchers’ motivation:
   o Advances knowledge,
   o Leads to discoveries that will benefit individuals and
     society,
   o Furthers professional advancement, and/or
   o Results in personal gain and satisfaction.

Conflicts of Interest cannot and need not be avoided.
However, in three crucial areas, special steps are
needed to assure that conflicts do not interfere with the
responsible conduct of research :
   1. Financial gain
   2. Work commitments
   3. Intellectual and personal matters
                     Federal Policies
These policies require research institutions to establish
administrative procedures for:
    – reporting significant conflicts before any research is undertaken;
    – managing, reducing, or eliminating significant financial conflicts of
      interest;
    – providing subsequent information on how the conflicts were
      handled.

Significant financial conflict is defined as:
    – additional earnings in excess of $10,000 a year, or
    – equity interests in excess of 5 percent in an entity that stands to
      benefit from the research.

The financial interests of all immediate family members are
included in these figures.
                         Other Policies
Missouri State University:
Researchers must also be aware of our conflict-of-interest policy to find
out when and what they are required to report.
     “The key to handling potential conflicts is to fully disclose significant
      financial interests and, if a conflict of interest is identified, to participate
      in the development and implementation of an appropriate
      management plan ”
     University disciplinary processes
     Federal government sanctions
     Criminal sanctions or civil liability

Professional and journal policies:
A number of professional societies have issued reports or made -
recommendations on appropriate ways to handle conflicts of interest.
         Conflicts of Commitment
Conflicts of commitment arise from situations that place
competing demands on researchers’ time and loyalties. Care
needs to be taken to assure that these commitments do not
inappropriately interfere with one another. These range from:

Allocation of time
Relationships with students
Use of Resources
Disclosure of Affiliations
Representing outside entities
Time allocation
At a minimum, these rules require that researchers:

   o Honor time commitments they have made, such as
     devoting a specified percentage of time to a grant
     or contract;
   o Refrain from charging two sources of funding for
     the same time;
   o Seek advice if they are unsure whether a particular
     commitment of time is allowed under an
     institution’s or the Federal Government’s policies.
Relationship with Students
Academic researchers involved in start-up ventures often
have opportunities to hire students.
As mentors, they have a primary obligation to help students
develop into independent researchers.
Should an individual who is both the researcher’s student and
employee be advised to develop a promising idea that could
lead to an independent career or to work on a more routine
problem that will benefit the start-up company?
Situations such as these create conflicts and should be
avoided or appropriately managed.
 Use of Resources
Equipment and supplies purchased with public funds can
easily be used to advance private research interests.
The equipment can be used for other university work since
this is allowed by the government. But it cannot be used
for a personal project without permission.
In addition, equipment and supplies cannot be used for
research that is explicitly prohibited by the Federal
government, such as stem cell research using lines not
authorized by the government’s policy
Disclosure
It is widely agreed that outside affiliations that create
conflicts of interest should be listed on academic
publications, but should researchers list their academic
affiliations on other publications?
Researchers must be careful to separate their academic
or institutional work from their private work.
They should not inappropriately use their institutional
research affiliation to advance their private interests by
implying, for example, that private work has the support
of their research institution if it does not.
Outside Entities
 The results researchers commercialize in private
 ventures, such as drugs used in a university hospital,
 a software program used in an accounting office, or a
 consultation service for employees, might be used by
 their primary employer

 Each employer in this case presumably wants the
 best deal on the goods and services, whereas the
 researcher is also interested in personal profits,
 creating a conflict of commitment.
    Personal & Intellectual Conflicts
Researchers are also expected to avoid bias in proposing,
conducting, reporting, and reviewing research. They therefore
should be careful to avoid making judgments or presenting
conclusions based solely on personal opinion or affiliations rather
than on scientific evidence.
Researchers generally should not serve as reviewers for grants
and publications submitted by close colleagues and students.
If a researcher holds strong personal views on the importance of a
particular area of research or set of research findings, those views
should be disclosed so that others can take them into
consideration when judging the researcher’s statements.
                         Reporting
If a researcher has a significant conflict of interest, as defined by
Federal, state, institutional, journal, or other policies, it must be
reported and managed or eliminated.

Options for managing conflicts of interest include:
   o requiring full disclosure of all interests so that others are
     aware of potential conflicts and can act accordingly;
   o monitoring the research or checking research results for
     accuracy and objectivity; or
   o removing the person with the conflict from crucial steps in
     the research process, such as the interpretation of data or
     participating in a particular review decision.
http://www.missouristate.edu/internalaudit/Ethics%20Hotline.htm
Case Study: Conflict of Interest
Early in his undergraduate education, Dr. Sam M. decided to
dedicate his studies to finding a cure for a psychological
disorder that seemed to run in his family. As a biology major,
he pursued independent research projects and worked long
hours as a lab assistant. He then enrolled in a
psychopharmacology PhD program in and is now completing a
3-year postdoc in the neurosciences.

During his postdoc, he worked on a promising compound he
first discovered during his graduate years. His work has gone
well and he feels the time is right to explore clinical
applications.
       As Sam weighs the options of an academic versus an
       industry job, he begins to wonder about who owns or will
       own the useful applications of his work, if and when there
       are any. Will it be owned by:



 His graduate institution, where   His postdoc institution,                            Himself, based on his hard     Society, which funded
                                                              His future academic or
he first worked on the promising    where he refined his                                 work and innovative        parts of his education and
                                                               industry employer?
           compound?                       ideas?                                                ideas?               most of his research?




   Who has a legitimate interest in Sam‟s work and when do his
   own personal financial interests create conflict of interest?
 Other Questions for Discussion
Should researchers be allowed/encouraged to profit
  personally from their research apart from their
  normal compensation?
What are appropriate mechanisms for managing
 financial conflicts of interest?
What are appropriate mechanisms for protecting
 students from a mentor‟s conflict of commitment?
What are appropriate mechanisms for managing
 intellectual and personal conflicts of interest?
    Authorship and Publication
Researchers share the results of their works with
colleagues and the public in a variety of ways. These range
from:
       • Laboratory meetings,
       • Workshops,
       • In seminars, and
       • At professional meetings.

Whether structured or informal, controlled or free ranging,
responsible publication in research should ideally meet
some minimum standards, such as:
      • a full and fair description of the work undertaken,
      • an accurate report of the results, and
      • an honest and open assessment of the findings.
                   Authorship
The names that appear at the beginning of a paper serve
one important purpose. They let others know who
conducted the research and should get credit for it.
Consequently, the authors listed on papers should fairly and
accurately represent the person or persons responsible for
the work in question.

Contribution
Importance
Corresponding/primary author
                 Contribution
Authorship is generally limited to individuals who make
significant contributions to the work that is reported.
This includes anyone who:
   – Instrumental in obtaining funding for the project
   – was intimately involved in the conception and
      design of the research,
   – assumed responsibility for data collection, analysis,
      and interpretation,
   – participated in drafting the publication, and
   – approved the final version of the publication.
                     Importance
Authors are usually listed in their order of importance, with
the designation first or last author carrying special weight,
although practices again vary by discipline.

Academic institutions usually will not promote researchers to
the rank of tenured faculty until they have been listed as first
or last author on one or more papers.

Some journals have specific rules for listing authors; others
do not, again placing most of the responsibility for this
decision on the authors themselves
  Corresponding/primary author

Many journals now require one author, called the
corresponding or primary author, to assume responsibility
for all aspects of a publication, including:

   – the accuracy of the data,
   – the names listed as authors (all deserve authorship
     and no one has been neglected),
   – approval of the final draft by all authors, and
   – handling all correspondence and responding to
     inquiries.
             Avoid These Practices
Honorary Authorship
- Listing undeserving authors on publications.

Salami publication
- Dividing one significant piece of research into a number of small
experiments, simply to increase the number of publications.

Duplicate publication
- Publishing the same information a second time without
acknowledging the first publication.

Premature public statements
- research results should be made public only after they have
been carefully reviewed and properly prepared for publication.
           Case Study - Methodology
Katherine, a postdoc in Dr. Susan B.‟s laboratory, has just had a manuscript
accepted for publication in a prestigious research journal, conditional on a few
important changes. Most importantly, the editor has requested that she
significantly shorten the methods section to save space. If she makes the
requested changes, other researchers may not be able to replicate her work.
Asked about the situation, Dr. B. recommends that Katherine go ahead with
the changes. After all, if other researchers want more information they can
always get in touch. She remains concerned that an inadequate explanation of
her methods could lead other researchers to waste time and valuable
research dollars attempting to replicate her work.

Should Katherine make the requested changes?
Should she be concerned about providing inadequate information to
colleagues?
How can Katherine get definitive answers to these and other questions
about the responsible conduct of research?
               Intellectual Property
         Data Acquisition, Management, Sharing,
                     and Ownership
University faculty and staff are
engaged in many new media in
their teaching and research,
usually requiring special
resources from the university.
Examples are software for
teaching, web sites, and
databases for reference or
research. Ownership and
licensing issues differ with these
kinds of Intellectual Property
compared with books
Case Study: Intellectual Property
Professor Martha E. teaches a Business class about stock
market dynamics. To help her students learn the material,
she developed a set of software tools that mimic stock
market forces. A student can manipulate the forces, observe
the reactions, and learn the dynamics.
An outside software vendor learns about Martha‟s stock-
market tools and offers to license the rights to market them
commercially.


Question: Is Professor E. legally in a position to pursue the
financial venture without involving the university?
  Ruling
The university owns software created by faculty related to their employment.
There are a few exceptions, like code snippets within printed texts.

Missouri State is reviewing its IP Policy:
     – The new policy clarifies that money provided from competitive, internal MSU
       Faculty Grants would not have to be paid back before gaining royalties, either in
       patents or copyright.
     – The new policy allows that under some circumstances a staff member might be
       the creator and thus inventor or holder of copyright.
     – Includes a larger scope of what is “normal use” or not significant use of University
       resources for the decision of ownership.
         • Includes a science lab as part of “not significant use”
         • Includes kilns and other things of art production.
     – Allows online course development as the property of the creator, but University
       retains ongoing right to use materials.
     – Separates Creation of Intellectual property policy from use of copyrighted Material
       policy.

See http://www.missouristate.edu/provost/intellectualpropertypolicy/
                 Technology Transfer
Technology transfer is the process of Exchange or sharing of
knowledge, skills, processes, or technologies across different
organizations into new products, processes, applications, materials or
services. [Referenced from NSF;
http://www.nsf.gov/statistics/seind06/c4/c4g.htm ; October 6, 2010]

By starting the process at this point, the PI and the office of Sponsored
Research and Programs (OSRP) can access the possible viability of
effectively transferring University technologies to the market so as to
generate benefits for the University, the community, and the general
public.

This process can cover:
    –   Disclosure Facilitation
    –   Patenting and Other Protections
    –   Licensing
    –   Legal Support, and
             Data Management
The central role of proper data management in the realm of
Research Integrity:
   – Maintaining data security, integrity
   – Destruction of Data
   – Sharing Data
   – Mentoring, Data Oversight and Misconduct
   – Presenting data in Research and Grants
   – Ownership of, control of, and access to data
   – Proper recording of research data
         Relationship to Other Issues
            Data/Sharing:
                                          Intellectual Property
      Collaboration/Competition




Export Controls           Research Data                 Mentoring




             Authorship                     Integrity
          Data Management Policies

• Definition of research data
• Distinctions between ownership, control, and access to data
• Standards for keeping laboratory notebooks and research
  journals
• Standards for maintaining data, including perishable data,
  such as biological samples
• Data retention periods and destruction of data
• Standards for mentoring new investigators regarding data
• Standards for sharing data
• Standards for presenting data (including images) in
  publications and grant applications
               Control of Data
• Who are the responsible parties?
     Laboratory Manager
     Principal Investigator
     Department Head
     University

• Responsibilities:
     Authority
     Control
     Safeguard
     Access to data                 Responsibility for Data Control
      Questionable Research Practices
              Involving Data
•   Failure to retain research data;
•   Failure to document agreements over ownership of data;
•   Maintaining inadequate research records;
•   Refusing reasonable access to unique research materials for
    data;
•   Misrepresenting speculations as fact or releasing preliminary
    research results, without sufficient data to allow critical
    review;
•   Inadequate supervision or exploitation of subordinates;
•   Using inappropriate statistics to enhance significance of
    research findings.
      Questionable Research Practices
              Involving Data
• Selecting and reporting data to improve the
  “appearance” of the data or to increase its
  significance
• Failure to disclose or manage conflict of
  interest that may result in biasing the
  interpretation and reporting of data
• Suppression of negative data that may result
  in needless repetition of studies
• Lack of laboratory notebook retention policies
Case Study: Data Ownership
Betty. came to Dr. T‟s lab as a post-doc after completing
her Ph.D. at a leading university. Dr. T accepted her
because of her ability in isolating and manipulating
proteins in complex structures. Dr. T. has some grant
support that will cover much of Betty‟s stipend for three
years. Under Dr. T‟s intellectual leadership they
complete some basic research that promises intellectual
property development. They file a patent application.


     Question: Who has the intellectual ownership?
Ruling

 Both have intellectual ownership, but Dr. T. retains
 primary project management and supervisory role.
 The university has legal ownership based on access
 to and retention of research data.
Case Study: data ownership (part 2)
A major chemical corporation expressed interest in funding further
research. Dr. T. and Betty agree that she is ready to become an
independent investigator and she obtains a job in industry with Dr. T‟s
blessings. They discuss future collaboration. Betty‟s new company is
pushing her to start soon and she begins clearing out her office. Dr. T is
away that day as she removes computer files, biological specimens that
should be left in the lab, even some belonging to others. She dismisses
the other researchers‟ concern, and packs her note books, journals,
computer discs and specimens, and departs. During the time of the
research, the university did not have a university intellectual policy
agreement and no subsidiary agreement signed by Betty.

    Questions: Who has the ownership of data and how
    long should they be retained?
    Can they university sue or file criminal charges?
  Ruling
Because the university did not have a sign subsidiary agreement or
intellectual policy clearly showing who owned the data, it would be
limited in filing federal charges and even criminal charges would be
difficult because of a lack of signed documents.
The most the university can do is to charge here with larceny and
have her pay a fine.

Financial records, supporting documents, statistical records, and all
other records pertinent to an award [including research data] shall
be retained for a period of three years from the date of submission
of the final expenditure report or, for awards that are renewed
quarterly or annually, from the date of the submission of the
quarterly or annual report, as authorized by the Federal awarding
agency. (OMB Circular A-110)
Final Thoughts on Intellectual Property
• Technological Advances in scientific instrumentation,
  computing, data storage, makes responsible data
  management more and more complicated.
• Both as a matter of law, federal policy and practical
  necessity, institutions should assert the ownership of
  research data.
  [the institution is the legal party to federal sponsored
  grants and is responsible to safeguard, retain and
  provide access to data.]

OMB Circular A-110
Public Law 105-277 (1998) The Shelby Law
Mentor/Trainee Responsibilities
The term “trainee” is used in this section to refer to anyone
learning to be a researcher under an established
researcher‟s supervision. This includes principally graduate
students and postdoctoral fellows (post-docs), but may also
include undergraduate and high school students working
on research projects or junior research faculty, research
scientists, and research staff.


  ORI: Introduction to Responsible Conduct of Research; Mentor/Trainee Responsibilities,
  Chapter 7, Page 103
Real Cases: NSF Research Misconduct Investigations
A New York university professor plagiarized a substantial amount of text
from multiple sources into a proposal submitted to NSF, and into two
research publications acknowledging NSF support. The professor claimed
that his students and post-doctoral research associate provided the
plagiarized texts to him in their research progress reports. A university
investigation concluded that these individuals did not provide the text, and
determined that the professor had also plagiarized text into a previously
submitted NSF proposal, and into three internal university proposals.

We recommended that NSF make a finding of research misconduct; debar
the subject from receiving federal funds for a period of two years; prohibit
the subject from serving as a reviewer of NSF proposals for the same two-
year period; and require, for a period of two years after the debarment
period, that the subject submit assurances by a responsible official of his
employer that any proposals or reports submitted by the subject to NSF do
not contain plagiarized material. We also recommended that NSF require
the professor to complete an ethics training course.
        Mentor-Trainee relationship
The essential elements of a productive mentor-trainee
relationship are difficult to codify into rules or guidelines,
leaving most of the decisions about responsible mentoring
to the individuals involved.
Common sense suggests that good mentoring should
begin with:
   – A clear understanding of mutual responsibilities,
   – A commitment to maintain a productive and supportive research
     environment,
   – Proper supervision and review, and
   – An understanding that the main purpose of the relationship is to
     prepare trainees to become successful researchers.
                       Sample Agreement
To: New & Used Graduate Students in the Laboratory of Last Resorts
From: Director Major Dread
Subject: General Rules

Welcome to our laboratory. As you know, research in this laboratory is funded by
grants from NIH, NSF, DoD, ED, and other agencies. The projects so funded have
specific aims and a detailed research plan stated in the grant applications. Departure
from these aims and plans requires re-application for the grant funds. We would do
this only if the original ideas prove early to be without merit.

Therefore, students in the laboratory are not free to pursue ideas and activities of
their own design, unless these fit the aims and research plan of the project that
supports them. In accepting this fact you are surrendering a significant amount of
intellectual freedom. It is important that you understand what you will gain here and
what you will give up. Please be certain that the mutual agreement stated below is
acceptable to you.
I agree to provide . . .
 1). Your tuition and a stipend to live on.
 3). Excellent laboratory facilities, including all necessary computers,
 instruments, equipment, tools, supplies, and desk space.
 4). Superior research training.
 5). Thesis idea and guidance.
 6). A long-term commitment to your career goals.
. . . you agree that I may
1). Set your daily work schedule.
2). Determine your research.
3). Personally present your work whenever and wherever I deem appropriate.
4). Decide what and when to publish.
5). Decide the authorship and order of names on all publications.
6). Determine your readiness for PhD qualifying, preliminary, and final
 examinations.
7). Approve your committee membership.
8). Have exclusive ownership of your data -- before and after you leave the
 laboratory.
9). Restrict your lunches to the usual banana and an occasional tuna
 sandwich.
           Mutual Expectations
Mentors need to know (a written agreement is
preferred) that a trainee will:

   Do assigned work in a conscientious way,
   Respect the authority of others working in the
    research setting,
   Follow research regulations and research
    protocols,
   Live by agreements established for
    authorship and ownership.
    Trainees need to know . . . .
 How much time they will be expected to spend on
  their mentor‟s research;
 The criteria that will be used for judging
  performance and form the basis of letters of
  recommendation;
 How responsibilities are shared or divided in the
  research setting;
 Standard operating procedures, such as the way
  data are recorded and interpreted;
 How credit is assigned, that is, how authorship
  and ownership are established.
Common Mentor/Trainee Ethical Problems
The mentor is too focused on his/her own research agenda to consider
whether trainees are having appropriate educational experiences;

Research problems seem to be distributed in an unfair or arbitrary manner
within the research group;

Ground rules are not articulated for communicating and sharing data;

Policies are not clear for the assignment of credit and authorship;

Mentor fails to follow funder, institutional or professional expectations or
otherwise acts in ethically prohibited or ethically questionable ways in
carrying out the work;

Mentor and trainee disagree regarding the ownership of data, the timing of
presentation or publication, or about the accuracy or interpretation of what
is to be reported.
   Trainee Supervision and Review
Proper supervision of a trainee takes time. In
one way or another, a mentor needs to:

  o Assure proper instruction in research methods,
  o Foster the intellectual development of the
    trainee,
  o Impart an understanding of responsible
    research practices,
  o Routinely check to make sure the trainee
    develops into a responsible researcher.
Mentors should review work done under their
supervision carefully enough to assure that it’s
well done and accurate. This can be
accomplished by:
  o Reviewing laboratory notebooks and other
    compilations of data;
  o Reading manuscripts prepared by trainees
    carefully to assure that they are accurate, well-
    reasoned, and give proper credit to others;
  o Meeting with trainees on a regular basis to keep in
  Case Study: Mentoring Ethics
Dr. Elizabeth Sterling has a federal grant to develop an enzymatic method
of isolating the epithelial cells that line the pancreatic duct. She‟s been
working on this project for about a year and must submit a progress report
on the study. With the assistance of Jim Wong, a Ph.D. candidate in her
lab, she is poring over photographs of isolated epithelial cells that she
might include in the report. To Jim‟s eye, the photographs are of
approximately equal contrast and quality, but some suggest more than
others a greater yield of cells. Readouts from the automated cell counter,
however, indicate that the yields have been fairly consistent.

Dr. Sterling instructs Jim to gather up four specific photos out of the ten
that they have produced. These four photos will be included in the report,
which Jim will help prepare. The photos, which Dr. Sterling says she has
selected for their aesthetic quality, also happen to be the most supportive
of the cell counter results. In the report, the photos will serve to illustrate
the effectiveness and yield of Dr. Sterling‟s technique.
 Case Study Questions
1. What are some appropriate criteria for selecting
   photographic material to illustrate research results?
   What criteria might be inappropriate?
2. How do Dr. Sterling‟s responsibilities change when
   she involves a trainee in this project?
3. In aiding Dr. Sterling in the manner described above,
   to what extent is Jim responsible for the integrity and
   content of the annual report?
4. If Jim is uncomfortable with Dr. Sterling‟s request,
   how might he respond?
Peer Review       Hmm.. You know?
                 This procedure would
                   sure speed up my
“evaluation by         inquiries….

  colleagues
  with similar
knowledge and
 experience”
        Evaluation by Colleagues
Many important decisions about research
depend on advice from peers, including:
  o Which projects to fund (grant reviews),
  o Which research findings to publish (manuscript
    reviews),
  o Which scholars to hire and promote (personnel
    reviews), and
  o Which research is reliable (literature reviews and
    expert testimony).
Case Study: Publication & Peer Review
 Mary, a computer science professor, is asked by a journal
 editor to review and comment on a manuscript submitted
 by John, a faculty member at another institution. Upon
 reading the paper, Mary is struck by how useful the novel
 technique described by John would be in speeding up the
 data processing stage in her own computer simulation
 study. Incorporating John‟s technique would allow Mary to
 complete her research project in just two weeks, rather
 than the 12 weeks projected. Mary decided to go ahead
 and use the author‟s technique

Question: What harm will that do? After all, the technique is
quite useful and the paper will be published soon anyway.
Ruling
Even though the reviewer, Mary, did not or will not claim
the author‟s technique as her own, by writing it in a paper
or presenting it at a conference, she nevertheless
appropriated to herself someone else‟s intellectual
property and used it to her own advantage without the
permission of the true owner.

Mary abused one of the important tenets of the review
process, namely that reviewers will keep the contents of
the manuscripts confidential and will not use that
information to give them an unfair advantage.

      Question 2: What should Mary have done?
Solution
 It is reasonable for Mary to continue using the older
 techniques until the new one is published. However, if
 the results of Mary‟s research holds out the promise of
 significant benefits to society, Mary may have some
 moral obligation to seek permission to use the new
 technique.

 Normally this is not a proper option, as reviews are
 generally confidential and under the supervision of the
 editor.

 She could ask the editor to contact the author to seek
 for permission.
          Ethics of Peer Review

• For peer review to work, it must be:

  o Timely (even though uncompensated and with
    short deadlines),
  o Thorough (appropriate? important? flawed?)
  o Constructive,
  o Free from personal bias,
  o Respectful of the need for confidentiality.
         Thorough Assessment
• Assessing whether the research methods are
  appropriate;
• Checking calculations and/or confirming the
  logic of important arguments;
• Making sure the conclusions are supported by
  the evidence presented;
• Confirming that the relevant literature has been
  consulted and cited;
• Assessing whether the researcher has the tools
  to complete the study.
         Judging Importance
• Assuming a researcher could carry out a
  proposed research project, is it important
  to conduct this project?
• Are these research results important
  enough to publish?
• Has a researcher made important
  contributions to a field of study?
• Is this evidence important enough to be
  used in setting policy?
       Assist in Finding Problems
• Careless mistakes made in reporting data and/or
  listing citations;
• The deliberate fabrication and falsification of data;
• Improper use of material by others (plagiarism);
• Inaccurate reporting of conflicts of interest,
  contributors/authors; and
• The failure to mention important prior work, either by
  others or by the researcher submitting a paper for
  publication.
               Confidentiality
It is not acceptable to do any of the following
without getting permission:
  o Ask students or anyone else to conduct a review you
    were asked to do;
  o Use an idea or information contained in a grant
    proposal or unpublished manuscript before it
    becomes publicly available;
  o Discuss grant proposals or manuscripts you are
    reviewing with colleagues in your department or at a
    professional meeting;
  o Retain a copy of the reviewed material (generally
    manuscripts and grant proposals should be shredded
    or returned after the review is complete); and
  o Discuss personnel and hiring decisions with
         Questions for discussion
1.   What should researchers or students do if a colleague or
     mentor asks them to take a look at a manuscript they have
     not been authorized to review?
2.   What information contained in a manuscript or proposal
     should reviewers be expected to check?
3.   Should peer review be anonymous?
4.   How can researchers who sit on committees that advise on
     research directions separate their own interests from the
     best interests of the field they are helping shape?
5.   What would happen if the public lost confidence in peer
     review and looked for other mechanisms to judge the
     quality and importance of research?
                        Export Control
 Export controls are based on:
   (a) the nature of the item or activity,
   (b) the country involved in the transaction,
   (c) the person receiving or ultimately using the item or service
   (d) the end-use to which the item or service will be put.

 U.S. export controls serve the following purposes:
    (a) to control any potential military application;
    (b) to protect U.S. trade/economic interests;
    (c) to control the exposure of controlled technologies, materials
    and information to foreign nationals and foreign countries; and
    (d) to prevent the proliferation of weapons of mass destruction.


http://orc.missouristate.edu/84657.htm
                                        Sources
•   University of Michigan; http://my.research.umich.edu/peerrs
•   Office of Research Integrity, (ORI); http://ori.dhhs.gov/education/products/rcr_general.shtml
    http://ori.dhhs.gov/assurance/electronic_submission.shtml
    http://ori.dhhs.gov/education/products/rcr_general.shtml
•   Indiana University, Poynter Center for the Study of Ethics and American Institutions;
    http://mypage.iu.edu/~pimple/
•   National Institutes of Health, (NIH);
    http://grants.nih.gov/grants/guide/notice-files/not-od-10-019.html



                             Other Resources
•   http://ori.dhhs.gov/education/products/unh_round1/www.unh.edu/rcr/index-2.html
•   http://ori.dhhs.gov/education/products/rcr_general.shtml
•   http://www.missouristate.edu/internalaudit/Ethics%20Hotline.htm
•   http://ori.dhhs.gov/education/products/rcradmin/index.html
•   http://ori.dhhs.gov/education/products/RCRintro/index.html
•   http://ori.dhhs.gov/education/products/montana_round1/issues.html
•   http://poynter.indiana.edu/tre/resources.shtml
•   http://www.research.umn.edu/ethics/materials/
Missouri State University Office of Research Compliance
  The Office of Research Compliance (ORC) assists Missouri
   State University faculty, staff, and students to assure proper
   conduct of research.
  These regulations [that we follow] protect research subjects,
   researchers, and the research conducted at the university.
  The ORC provides coordination, oversight, and education in
   the areas of animal care and use, biosafety, conflict of
   interest, export control, human subjects research, intellectual
   property, radiation safety, responsible conduct of research,
   and technology transfer.

       ORC homepage: http://orc.missouristate.edu/default.htm
Responsible Conduct of Research: http://orc.missouristate.edu/90478.htm

				
DOCUMENT INFO