Medical Research Pharmacy

Medical Research
Dadasaheb Balpande College of Pharmacy, Besa
Rashtrasant Tukdoji Maharaj University,
Nagpur, Pin No.- 440037
Presented by :
Aparna O. Yadav
M.Pharm III Sem
(Pharmaceutics)
Under Guidance :
Mrs. S .M. Bagde
Assistant Professor,DBCOP
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INDEX
•Introduction
•History
•Values in Medical ethics
•Other Basic Terminologies
•References
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INTRODUCTION
•Medical research involves research in a wide range of fields, such as
biology, chemistry, pharmacology and toxicology with goal of
developing new medicines or medical procedures or improving the
application of those already available.
•It can be viewed as encompassing preclinical research (for example, in
cellular systems and animal models) and clinical research (for example,
clinical trials).
•Medical research, also known as experimental medicine, encompasses a
wide array of research, extending from "basic research", – involving
fundamental scientific principles that may apply to a preclinical
understanding – to clinical research, which involves studies of people who
may be subjects in clinical trials.
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•The evolution of clinical research traverses a long and fascinating journey.
•From the first recorded trial of legumes in biblical times to the first
randomized controlled of trial of streptomycin in 1946, the history of clinical
trial covers a wide variety of challenges - scientific, ethical and regulatory.
• The famous 1747 scurvy trial conducted by James Lind contained most
elements of a controlled trial.
•The UK Medical Research Council's (MRC) trial of patulin for common
cold in 1943 was the first double blind controlled trial. This paved the way
for the first randomized control trial of streptomycin in pulmonary
tuberculosis carried out in 1946 by MRC of the UK.
•This landmark trial was a model of meticulousness in design and
implementation, with systematic enrolment criteria and data collection
compared with the ad hoc nature of other contemporary research.
HISTORY
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VALUES IN MEDICAL ETHICS
•Medical ethics is based on a set of values that professionals can refer to in
the case of any confusion or conflict.
•These values include the respect for autonomy, non-maleficence,
beneficence, and justice.
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•Requires that the patient have autonomy of thought, intention, and action when
making decisions regarding health care procedures. Therefore, the decision-
making process must be free of coercion or coaxing.
•In order for a patient to make a fully informed decision, she/he must understand
all risks and benefits of the procedure and the likelihood of success.
•For example-ARTs are highly technical and may involve high emotions, it is
difficult to expect patients to be operating under fully-informed consent.
AUTONOMY

BENEFICENCE
•Requires that the procedure be provided with the intent of doing good for the
patient involved.
•Demands that health care providers develop and maintain skills and
knowledge, continually update training, consider individual circumstances of
all patients, and strive for net benefit.
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•An example of a nurse demonstrating this ethical principle is by holding a
dying patient's hand.

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NON-MALEFICENCE
•Requires that a procedure does not harm the patient involved or others in society.
•Infertility specialists operate under the assumptions that they are doing no harm
or at least minimizing harm by pursuing the greater good.
•An example of non-maleficence: If an incompetent, or chemically impaired,
health care practitioner is taking care of patients, a nurse should report the
abuse to protect the patient.

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•The idea that the burdens and benefits of new or experimental treatments must
be distributed equally among all groups in society.
•Requires that procedures uphold the spirit of existing laws and are fair to all
players involved.
JUSTICE
•For example-It could be argued that prioritising cancer patients means you're
limiting the ability of other patients to access healthcare.

DOUBLE EFFECT
•It is a set of ethical criteria which Christian philosophers, and some others,
have advocated for evaluating the permissibility of acting when one's
otherwise legitimate act may also cause an effect one would otherwise be
obliged to avoid.
EUTHANASIA
•Euthanasia is the practice of ending the life of a patient to limit the patient’s
suffering.
•The patient in question would typically be terminally ill or experiencing great
pain and suffering.
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•For example-Abortions when the mother's life is in danger.

CONFLICT BETWEEN AUTONOMY & BENEFICENCE/NON-
MALEFICENCE
•The principle of autonomy often comes into conflict with the principle of
beneficence.
•In this situation, intentionally or unintentionally, healthcare professionals use
paternalistic approach while caring for their patients as they consider that
approach as useful for their patient.
•Though the intervention seems useful for the patient, yet it breaches the
autonomy of the patient by disrespecting the right of her decision in the treatment.
•It is important to note that while situations like these require healthcare
professionals to critically analyze the risks and benefits associated with the
choices that they make, in the process of choosing the best option, the entire
situation along with its consequences should be taken into account, well discussed
and planned so that the decision made should promote maximum beneficence and
minimum or no harm with respect to autonomy.
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CONFIDENTIALITY
•Confidentiality involves a set of rules or a promise usually executed
through confidentiality agreements that limits access or places restrictions
on certain types of information.
INFORMED CONSENT FORM
An informed consent document is typically used to provide subjects with the
information they need to make a decision to volunteer for a research study.
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CRITICISMS OF ORTHODOX MEDICAL ETHICS
It has been argued that mainstream medical ethics is biased by the
assumption of a framework in which individuals are not simply free to
contract with one another to provide whatever medical treatment is
demanded, subject to the ability to pay.
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Many so-called “ethical conflicts” in medical ethics are traceable back to a
lack of communication.
The importance of communication in the healthcare industry can help prevent
injuries and death, increase trust between the patient and the caregiver, and
strengthen relationships with other staff members.
CONTROL RESOLUTION
To ensure that appropriate ethical values are being applied within hospitals,
effective hospital accreditation requires that ethical considerations are taken
into account, for example with respect to physician integrity, conflicts of
interest, research ethics and organ transplantation ethics.
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 Here are the various ethical guidelines.
 For example, the Declaration of Helsinki is regarded as authoritative in
human research ethics.
 In the United Kingdom, General Medical Council provides clear overall
modern guidance in the form of its ‘Good Medical Practice’ statement.
 Other organizations, such as the Medical Protection Society and a number
of university departments, are often consulted by British doctors regarding
issues relating to ethics.
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 Often, simple communication is not enough to resolve a conflict, and a
hospital ethics committee must convene to decide a complex matter.
 These bodies are composed primarily of health care professionals, but may
also include philosophers, lay people, and clergy – indeed, in many parts of
the world their presence is considered mandatory in order to provide
balance.
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 Culture differences can create difficult medical ethics problems.
 Some cultures have spirited or magical theories about the origins of disease,
for example, and reconciling these beliefs with the tenets of Western
medicine can be difficult.
 Rule or expectation in any culture that prevents someone, from outside of
that culture, from being included or participating equally.
 Language, behaviour, customs, values and beliefs that a particular culture,
race or country holds.
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 Avoidance of lying, deception, misrepresentation, and non-disclosure in
interactions with patients or relevant to patient care.
ONLINE BUSINESS PRACTICES
 Research which utilizes the internet to collect information through an online
tool and studies about how people use the internet, e.g., through collecting
data and/or examining any online environments; and/or, uses of online
datasets, databases, or repositories.
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 Physicians should not allow a conflict of interest to influence medical
judgment.
 In some cases, conflicts are hard to avoid, and doctors have a responsibility
to avoid entering such situations.
CONFLICTS OF INTEREST
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 For example, doctors who receive income from referring patients for
medical tests have been shown to refer more patients for medical tests.
 This practice is proscribed by the American College of Physicians Ethics
Manual.
 Fee splitting and the payments of commissions to attract referrals of patients
is considered unethical and unacceptable in most parts of the world.
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 Studies show that doctors can be influenced by drug company inducements,
including gifts and food.
 Industry-sponsored Continuing Medical Education (CME) programs
influence prescribing patterns.
 Many patients surveyed in one study agreed that physician gifts from drug
companies influence prescribing practices.
VENDOR RELATIONSHIPS
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 Family therapy or family counseling is a form of treatment that is designed to
address specific issues affecting the health and functioning of a family.
 It can be used to help a family through a difficult period, a major transition, or
mental or behavioral health problems in family members.
FATALITY
A death resulting from an accident or a disaster; "a decrease in the number of
automobile fatalities".
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•https://www.ncbi.nlm.nih.gov/pmc/articles/PMC314940
•https://web.stanford.edu/class/siw198q/websites/reprotech/New%20W
ays%20of%20Making%20Babies/EthicVoc.htm
•https://www.augusta.edu/institutes/ipph/cbhp/documents/primer_5_
3_ethicsdef.pdf
REFERENCES
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