Beruflich Dokumente
Kultur Dokumente
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
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
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
Ethical framework: 7
principles
seven main principles have been described as guiding
the conduct of ethical research:
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
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
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)
http://rpf.health.pitt.edu/rpf/index.cfm
(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:
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