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ETHICS IN R & D

MANAGEMENT
PRESENTED BY
Navyatha Erukulla
Department Of Pharmaceutical Management
MBA -4th sem
National Institute Of Pharmaceutical Education & Research

Flow of Presentation
9 Pillars of Responsible Conduct
in R & D
Ethics & Research Ethics
Committee
Ethics in Clinical Trials
Plagiarism

NINE PILLARS OF RESPONSIBLE


CONDUCT IN RESEARCH

Data acquisition, management, sharing, and ownership


Mentor/trainee responsibilities
Publication practices and responsible authorship
Peer review
Collaborative science
Research involving animals (Example : NIPER)
Human subjects : CLINICAL TRIALS
Research misconduct
Conflict of interest and commitment

Good Data Management : begins with creating a record of


research that thoroughly, accurately, and clearly documents the
work and evidence that went into creating a scholarly product,
such as a paper, book, patent, computer program, etc
Beyond data collection, good data management also includes
recognizing who owns data, when and how data should be
shared, and when data can be destroyed
Collaborative Research :that involves the cooperation of
researchers, institutions, organizations and/or communities, each
bringing distinct expertise
Peer Review: is the evaluation of creative work or performance
by other people in the same field in order to maintain or enhance
the quality of the work or performance in that field
Data Sharing The federal government requires that data and
unique resources created with its funding be shared and
encourages timely dissemination of results through publication
and presentation in academic venues.

The Role of Mentors &


Trainees
Is important to everyone because research
relies heavily on self monitoring
Is important to the mentors because s/he is
committed to advancing the discipline
Is important to the trainee because
s/he is committed to advancing the discipline
s/he is learning the research milieu through this
experience

Is important to both the mentor and the trainee


because s/he is interested in personal success

Questions that Surround the


Mentor-Trainee Relationship

How much time should the faculty devote to


mentoring?
How much time should the student devote to
research?
Who gets credit for ideas that take shape during
the course of shared research?
Who owns the results?
When does a trainee become an independent
researcher?

The 4 Pillars of a Sound


Mentor-Trainee Relationship
A clear, ongoing understanding of mutual
responsibilities
An ongoing commitment to maintain a
productive and supportive research environment
Proper, ongoing supervision and review, and
An ongoing understanding that the main
purpose of the relationship is to prepare trainees
to become successful researchers

Research Misconduct occurs when a researcher fabricates or


falsifies data, or plagiarizes information or ideas within a
research report. The misconduct must be committed
intentionally, and the allegation must be proven by sufficient
evidence. The definition of misconduct can also extend to
breaches of confidentiality and authorship/publication
violations
A Conflict Of Commitment arises when the external
activities of a faculty member or employee are so demanding
of time, attention, or focus that they interfere with the
individual's responsibilities to the university
Conflict Of Interest may occur when an individuals private
interests influence his or her professional obligations such that
an independent observer might reasonably question whether
the individuals actions or decisions are determined by
considerations of personal gain, financial

Definition of Ethics & Research Ethics Committees


As defined by the Central Office for Research Ethics Committees (COREC) ,
Definition of Ethics usually include reference to morals or the rules or
standards governing the conduct of a person or the members of a
profession
Research Ethics Committees are the Committees which are convened to
provide independent advice to participants, researchers, funders, sponsors,
employers, care organisations and professionals on the extent to which
proposals for research studies comply with recognised ethical standards.
Group of individuals who undertake the ethical review of research
protocols involving humans, applying agreed ethical principles
Research ethics committee (also known as ethical review board (ERB),
ethical review committee (ERC), human research ethics committee
(HREC), institutional review board (IRB)

Purpose of research
ethics committee
The purpose of the REC is to review a proposed
study and to ensure dignity, rights, safety and well
being of all actual or potential research
participants is protected
Why do we need REC?
To protect
To ensure that all work involving the human
participants is conducted in accordance with the
internationally accepted ethical and professional
standards

Objectives of Research
Ethics committee

To preserve the subjects rights, maintain


ethical standards of practice in research
To protect subjects of research and research
workers from harm or exploitation
To provide reassurance to the public that
STANDARDS are followed
To protect research workers from unjustified
criticism

In promoting these objectives a REC should remember that research benefits


society

Functions of REC
The functions of research ethics committees include:
Identifying and weighing up the risks and potential benefits
of research
Evaluating the process and materials (printed documents
and other tools) that will be used for seeking participants
informed consent
Assessing the recruitment process and any incentives that
will be given to participants
Evaluating risks to participants confidentiality (and the
related risk of discrimination) and the adequacy of
confidentiality protections
Examining any other issues that may affect the ethical
acceptability of the research

Moral problem in clinical


research
The goal of clinical research is generation of
useful knowledge about human health and
illness
Benefit to participants is not the purpose of
research (although it does occur)
People are the means to developing useful
knowledge; and are thus at risk of exploitation

Ethics of Clinical Research


Ethical requirements in clinical research aim to:
minimize the possibility of exploitation;
ensure that the rights and welfare of subjects are respected
while they contribute to the generation of knowledge
Ethical guidelines:
Guidance documents which assist with decisions relating to the
responsibility to adhere to established and relevant standards
of ethical principles and practice

Codes and Guidelines


Nuremberg Code (1949)
Declaration Of Helsinki (1964- 2000)
The Belmont Report (1979)
CIOMS/WHO International Guidelines (1993, 2002)
ICH/GCP-International Conference on
Harmonization- Good Clinical Practice (1996)

Ethical framework: 7
principles
seven main principles have been described as guiding
the conduct of ethical research:

Valuable scientific question


Valid scientific methodology
Fair subject selection
Favorable risk-benefit evaluation
Independent review
Informed consent
Respect for enrolled subjects

Valuable Scientific
Question
A socially, clinically, or scientifically useful
research question that will generate useful new
knowledge about human health

Valid Scientific
Methodology
A study should be designed in a way that will get an
understandable answer to the valuable research question
It includes considering whether the question researchers are
asking is answerable, whether the research methods are valid
and feasible, and whether the study is designed with a clear
scientific objective and using accepted principles, methods,
and reliable practices
It is also important that statistical plans be of sufficient power
to definitively test the objective, and for data analysis
Invalid research is unethical because it is a waste of resources
and exposes people to risk for no purpose

Fair Subject Selection


Justice: Selection of subjects for reasons of science, related to the
purpose of the study, not because they are readily available,
vulnerable, or otherwise easily exploited, or are favored

Consistent with scientific goals:


Select subjects to minimize risks and maximize benefits
Do not exclude subjects without a good reason of science,
vulnerability, or susceptibility to risk or burden
Consider distribution of burdens and benefits of research

Favourable risk-benefit
ratio
Uncertainty about the degree of risks and benefits associated with a drug,
device, or procedure being tested is inherent in clinical research, by
definition, there is more uncertainty about risks and benefits in earlyphase research than in later research
Depending on the particulars of a study, research risks might be trivial or
serious, might cause transient discomfort or long-term changes
Risks can be physical (death, disability, infection), psychological
(depression, anxiety), economic (job loss), or social (for example,
discrimination)
Has everything been done to minimize the risks and inconvenience to
research subjects, to maximize the potential benefits, and to determine
that the potential benefits to individuals and society are proportionate to,
or outweigh, the risks
Research volunteers often receive some health services and benefits in the
course of participating, yet the purpose of clinical research is not to
provide health services

Independent review
To minimize potential conflicts of interest and make sure a
study is ethically acceptable before it even starts, an
independent review panel with no vested interest in the
particular study should review the proposal and ask important
questions, including:
Are those conducting the trial sufficiently free of bias?
Is the study doing all it can to protect research volunteers?
Has the trial been ethically designed and is the riskbenefit
ratio favourable?
In the United States, independent evaluation of research
projects is done through granting agencies, local institutional
review boards (IRBs), and data and safety monitoring boards.
These groups also monitor a study while it is ongoing

Informed consent
For research to be ethical, most agree that individuals
should make their own decision about whether they want
to participate or continue participating in research
This is done through a process of informed consent in
which individuals:
(1) are accurately informed of the purpose, methods,
risks, benefits, and alternatives to the research
(2) understand this information and how it relates to their
own clinical situation or interests
(3) make a voluntary decision about whether to participate

Cont
Documentation given to potential subjects should be
comprehensible
Consent should normally be in writing and records kept
Potential subjects are free to withdraw without implication
All subjects should be volunteers, decisions not to
participate should not prejudice the subject in any way
If any potential participants are under the age of 18 or are
people over 18 ( Example: Adults with learning disabilities)
who are unable to reach informed decision about
participation, additional, separate consent forms are needed
from parents/guardians, alongside informed agreement from
the child, where applicable

Respect for potential and


enrolled subjects
Individuals should be treated with respect from the time they
are approached for possible participation , throughout their
participation and after their participation ends. This includes:
Respecting their privacy and keeping their private information
confidential
Respecting their right to change their mind, to decide that the
research does not match their interests, and to withdraw
without penalty
Informing them of new information that might emerge in the
course of research, which might change their assessment of the
risks and benefits of participating

Cont
Monitoring their welfare and, if they experience adverse
reactions, untoward events, or changes in clinical status,
ensuring appropriate treatment and, when necessary, removal
from the study
Informing them about what was learned from the research.
Most researchers do a good job of monitoring the volunteers
welfare and making sure they are okay. They are not always so
good about distributing the study results

Standards of care
International debate about standard of care that
should be provided to control group in
research:
Universal (the best treatment available anywhere
in the world)
Non-universal (the treatment available in a
defined region)

Wherever appropriate, a universal standard of


care should be offered to the control group
Where this is not appropriate, the minimum is
the best treatment provided by the national
public health system

Some Important Web Resources


Research Administrators Council
http://www.cmu.edu/rac/

Associate Provost for Research & Academic Administra


tion
http://www.cmu.edu/provost/sponres/compliance/compliance.htm

Research Administrators Certification Council


http://www.cra-cert.org/Default.htm

Education & Certification Program in Research & Pract


ice Fundamentals
(Pitt)

http://rpf.health.pitt.edu/rpf/index.cfm

Bioethics Resources on the Web


http://www.nih.gov/sigs/bioethics/IRB.html

Conflicts of Interest Resources

(UCSD)

http://ethics.ucsd.edu/courses/ethics/resources/conflicts.htm#reg
ulations

Human Subljects
http://ethics.ucsd.edu/courses/ethics/resources/human.htm

PLAGIARISM
Plagiarism is taking the writings or literary ideas of
another and selling and/or publishing them as one's own
writing
Brief quotes or use of cited sources do not constitute
plagiarism
The original author can bring a lawsuit for appropriation
of his/her work against the plagiarist and recover the
profits, a person who plagiarizes is subject to being sued
for fraud or copyright infringement if prior creation can
be proved
Penalties vary depending on jurisdiction, the charges
brought, and are determined on a case by case basis

Forms of Plagiarism
There are four common forms of plagiarism:
The duplication of an author's words without
quotation marks and accurate references
The duplication of author's words or phrases
with footnotes or accurate references, but
without quotation marks
The use of an author's ideas in paraphrase
without accurate references
Submitting a paper in which exact words are
merely rearranged even though footnoted

Detection services

These services variously test for appropriation from web resources, compare text
against a database of papers from an essay mill or check for collusion (students
copying from each other or from a previous year's assignments). They compare
vocabulary and phrasing, e.g. identical sentences and paragraphs or keywords
They include:

Essay Verification Engine (EVE2) - a US product aimed at teachers;


users download the software onto their machine/network and use it to
compare student texts submitted electronically
CopyCatch - UK "forensic automated collusion and plagiarism"
software that compares networked essays within educational
institutions
Plagiarism.com (Glatt Plagiarism Services) - is a commercial body,
independent of plagiarism.org and plagiarized.org, that offers
detection software and training programs

Cont.
Cite master is a US commercial service, has been promoted
as using "supercomputer processing power" to compare
student essays with a proprietary database of books, journals
and essays
My Drop Box claims to have searched some 4.3 billion web
pages and have a database with 345,000 term-papers in
internal database that's parsed by an "innovative artificial
intelligence module that actually comprehends the content of
each processed document
Measure of Software Similarity (MOSS) is a tool that has
been used to detect plagiarism in software development (e.g.
identifying similarities in C++, Java and Pascal programs)

Thank
You

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