This document discusses medical ethics in view of medical research. It begins by noting conflicts between various stakeholders in medical institutions. It then defines what ethics are and are not, establishing that ethics are based on moral principles of right and wrong. It discusses how medical ethics regulate professional conduct and relationships. The document outlines guidelines from organizations like WHO and ICMR for ethical research involving human subjects. It emphasizes informed consent and the role of institutional ethics committees in reviewing research proposals and ensuring ethical standards are followed. Throughout, it stresses applying ethical values with human perception in medical research.
ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTSjyothibhat21
This presentation highlights the regulations on Ethical requirements for conducting clinical research in India. This is the guiding regulation for the Ethics Committees in India.
The viewers are requested to give their feedback on the utility of the presentation.
A presentation by Niklas Nielsen at the 2017 meeting of the Scandinavian Society of Anaestesiology and Intensive Care Medicine.
All available content from SSAI2017: https://scanfoam.org/ssai2017/
Delivered in collaboration between scanFOAM, SSAI & SFAI.
This presentation describes the procedures and criteria for the assessment of research by the Human Research Ethics Committee (HREC) of the TU Delft (see: http://hrec.tudelft.nl/)
Institutional ethics committee(IEC): A brief insight, by Rxvichu!!RxVichuZ
This is my 26th powerpoint.....its on INSTITUTIONAL ETHICS COMMITTEE(IEC) ...also known as RESEARCH and ETHICAL COMMITTEE(REC). It focusses on the general principles, that ought to be made, while selecting subjects for study.
Brief points, under specific headings, have been included.
Do go through this, and let me know your feedbacks.
Thank you!
Vishnu.
6677 ANMAT Regulation dated November 2010 has recently replaced previous regulations covering studies in clinical pharmacology: Clinical Trial Application Process, ANMAT Inspection Process and ANMAT`s explicit incorporation of GCP guidelines into the regulation.
ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTSjyothibhat21
This presentation highlights the regulations on Ethical requirements for conducting clinical research in India. This is the guiding regulation for the Ethics Committees in India.
The viewers are requested to give their feedback on the utility of the presentation.
A presentation by Niklas Nielsen at the 2017 meeting of the Scandinavian Society of Anaestesiology and Intensive Care Medicine.
All available content from SSAI2017: https://scanfoam.org/ssai2017/
Delivered in collaboration between scanFOAM, SSAI & SFAI.
This presentation describes the procedures and criteria for the assessment of research by the Human Research Ethics Committee (HREC) of the TU Delft (see: http://hrec.tudelft.nl/)
Institutional ethics committee(IEC): A brief insight, by Rxvichu!!RxVichuZ
This is my 26th powerpoint.....its on INSTITUTIONAL ETHICS COMMITTEE(IEC) ...also known as RESEARCH and ETHICAL COMMITTEE(REC). It focusses on the general principles, that ought to be made, while selecting subjects for study.
Brief points, under specific headings, have been included.
Do go through this, and let me know your feedbacks.
Thank you!
Vishnu.
6677 ANMAT Regulation dated November 2010 has recently replaced previous regulations covering studies in clinical pharmacology: Clinical Trial Application Process, ANMAT Inspection Process and ANMAT`s explicit incorporation of GCP guidelines into the regulation.
A well-established hospital is frequently approached by pharmaceutical industry to conduct research on human subjects, for their products and / or for new drug and new formulation.
Even doctors in the hospitals have a keen desire to investigate some of their new ideas by experimenting on the patients.
For all such research involving human subjects in hospital should be routed through an important committee called , 'research and ethics committee' or simply 'independent ethics committee (IEC).
All research involving human subject should be conducted in accordance with ethical principle contained in the current revision of 'declaration of helsinki'.
The declaration is based on three basic considerations namely, justice, respect for persons and to maximize benefits and to minimize harms.
medical ethics is a very important topic when it comes to conducting of clinical trials. this presentation covers the important facts that most of the clinicians should be aware of
Significance and formalities of ethics committees for Clinical ResearchRaktimavaDasSarkar
Clinical research plays a pivotal role in advancing medical knowledge, developing
new treatments, and improving patient care. However, with these advancements
come ethical responsibilities to ensure the safety, dignity, and rights of research
participants are protected.
This is one of the lectures for the POGS Research Forum in Bacolod, mostly based on the chapter on Clinical Practice Guidelines for Ethics Review from the POGS Research Handbook: The Essentials. I hope this can be a guide for residents who are preparing their research proposal for ethical review.
Indian Council of Medical Research (ICMR).pptxSamikshaHamane
Introduction
Objective
Organisation structure
Roles & responsibilities of ICMR
Intramural research & Extramural research
General principles
Ethical Review Procedures
Composition
Training & regulation
At the end of this lecture , all participants will be able to know …
What is Ethics
Brief History of ethics
Ethical Principles
Types Of Ethics
Research Ethical Codes and Policies
Importance Of Ethical Norms in Research
Nematodes” are Round worms
Most nematodes are free living in fresh water, sea water and soil.
Are elongated bilaterally symmetrical, Non-segmented cylindrical worms, tapering at both the ends.
Sexes are separate (diecious), male is smaller than female & its posterior end is curved ventrally.
Females are either Viviparous (produces larvae/ embryo), Oviparous (lay egg) or ovo-viviparous (lays eggs which hatches immediately)
Lives in intestinal tract or tissues.
The name is derived from Greek word,
Trypano means (borer)
Soma means (body)
They are unicellular flagellate protozoa.
Have corkscrew like motion.
Oftenly transmitted by a vector.
Pneumococci are normal commensals of the upper respiratory tract
Important pathogen of pneumonia & otitis media
Reclassified as Streptococcus pneumoniae
Differ from Streptococci in morphology, bile solubility, optochin sensitivity & capsule
Oldest disease known to mankind
First described in ancient Indian
texts as “Kustha roga” attributed ]
to curse from God
Leper : Greek “scaly”
Hansen’s Disease – 1873 Norwegian Armauer Hansen discovered that leprosy is caused by bacterium - Mycobacterium leprae
Albert Neisser (1879) – stained the organism with fuchsin & gentian violet ( AFB )
The Paramyxoviridae is a family of single-stranded RNA viruses known to cause different types of infections in vertebrates. Examples of these infections in humans include the measles virus, mumps virus, parainfluenza virus, and respiratory syncytial virus (RSV).
Largest viruses that infect vertebrates
Can be seen under light microscope
Poxvirus diseases are characterized by skin lesions – localized or generalized
Important diseases caused by poxviruses are-
Smallpox
Monkeypox
Cowpox
Tanapox
Molluscum contagiosum
bacterial Growth curve and nutrition of bacteria.pptNCRIMS, Meerut
The bacterial cell contains water (80% of total weight), proteins, polysaccharides, lipids, nucleic acids, mucopeptides and low molecular weight compounds. For growth and nutrition of bacteria, the minimum nutritional requirements are water, a source of carbon, a source of nitrogen and some inorganic salts.
A type of virus that causes herpes infections and has DNA as its genetic material. There are two types of human herpesviruses. Infections with type 1 viruses cause cold sores on the lips or nostrils. Infections with type 2 viruses cause sores on the genitals (external and internal sex organs and glands).
HPV can cause cervical and other cancers, including cancer of the vulva, vagina, penis, or anus. It can also cause cancer in the back of the throat (called oropharyngeal cancer). This can include the base of the tongue and tonsils. Cancer often takes years, even decades, to develop after a person gets HPV.
polio virus lecture for MBBS
The picornaviruses are small (22 to 30 nm) nonenveloped, single-stranded RNA viruses with cubic symmetry. The virus capsid is composed of 60 protein subunits, each consisting of four poly-peptides VP1–VP4. Because they contain no essential lipids, they are ether resistant. They replicate in the cytoplasm.
Prokaryote cells grow by increasing in cell number (as opposed to increasing in size).
Replication is by BINARY FISSION, the splitting of one cell into two
Therefore, bacterial populations increase by a factor of two (double) every generation time
The time required to for a population to double (doubling time) in number.
Ex. Escherichia coli (E. coli) double every 20 minutes
Ex. Mycobacterium tuberculosis double every 12 to 24 hours
In 1900, Jules Bordet along with Octave Gengou observed a small ovoid bacterium in the sputum of a 5 month old child suffering from pertussis, or whooping cough.
The bacterium was similar to Haemophilus influenza but showed distinct morphological characterstic which led Bordet and Gengou to consider it as a separate species.
The organism was unable to be isolated and cultivated on ordinary blood agar plates.
Six years later, Bordet and Gengou suceed in making a selective media called Bordet and Gengou (BG) medium, which helped in isolating this fastidous bacteria.
this ppt well describes the principle, procedure, modification, usage and limitations of gram's staining.
it is a differential staining method used in bacteriology laboratory
The genus Shigella exclusively infects human intestine.
Shigella dysenteriae is the causative agent of bacillary dysentery or shigellosis in humans.
It is a diarrheal illness which is characterized by frequent passage of blood stained mucopurulent stools.
The four important species of the genus Shigella are:
Shigella dysenteriae
Shigella flexneri
Shigella sonnei
Shigella boydii.
A virus is an obligate intracellular parasite containing genetic material surrounded by protein
Virus particles can only be observed by an electron microscope
Most viruses range in sizes from 20 – 250 nanometers
Protozoa of this group possess one or more whip like flagella as their organs of locomotion
Classification
According to their habitat
Lumen dwelling flagellates
Alimentary canal – Intestinal flagellates
Urogenital tract – Genital flagellattes
2.Hemoflagellates - flagellates found in blood and tissues
Pathogenic:
Intestinal flagellates - Giardia lamblia Duodenum, Jejunum -Diarrhoea.
Genital flagellates - Trichomonas vaginalis Vagina, Urethra -Vaginitis , Urethritis
Non pathogenic:
Trichomonas tenax ( Mouth)
Trichomonas hominis ( Caecum).
Enteromonas hominis ( Colon)
Dientamoeba fragilis( Colon)
Viruses that infect and parsitized bacteria is known as bacteriophage.
It was discovered by Frederick.W.Twort in Great Britian (1915) and Felix d’ Herelle in France(1917).
D’ Herelle coined the term bacteriophage meaning ‘bacterial eater’ to describe the agent’s bacteriocidal activity. He observed lysis of a broth culture of a dysentry bacillus.
Antibiotic Stewardship by Anushri Srivastava.pptxAnushriSrivastav
Stewardship is the act of taking good care of something.
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
WHO launched the Global Antimicrobial Resistance and Use Surveillance System (GLASS) in 2015 to fill knowledge gaps and inform strategies at all levels.
ACCORDING TO apic.org,
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
ACCORDING TO pewtrusts.org,
Antibiotic stewardship refers to efforts in doctors’ offices, hospitals, long term care facilities, and other health care settings to ensure that antibiotics are used only when necessary and appropriate
According to WHO,
Antimicrobial stewardship is a systematic approach to educate and support health care professionals to follow evidence-based guidelines for prescribing and administering antimicrobials
In 1996, John McGowan and Dale Gerding first applied the term antimicrobial stewardship, where they suggested a causal association between antimicrobial agent use and resistance. They also focused on the urgency of large-scale controlled trials of antimicrobial-use regulation employing sophisticated epidemiologic methods, molecular typing, and precise resistance mechanism analysis.
Antimicrobial Stewardship(AMS) refers to the optimal selection, dosing, and duration of antimicrobial treatment resulting in the best clinical outcome with minimal side effects to the patients and minimal impact on subsequent resistance.
According to the 2019 report, in the US, more than 2.8 million antibiotic-resistant infections occur each year, and more than 35000 people die. In addition to this, it also mentioned that 223,900 cases of Clostridoides difficile occurred in 2017, of which 12800 people died. The report did not include viruses or parasites
VISION
Being proactive
Supporting optimal animal and human health
Exploring ways to reduce overall use of antimicrobials
Using the drugs that prevent and treat disease by killing microscopic organisms in a responsible way
GOAL
to prevent the generation and spread of antimicrobial resistance (AMR). Doing so will preserve the effectiveness of these drugs in animals and humans for years to come.
being to preserve human and animal health and the effectiveness of antimicrobial medications.
to implement a multidisciplinary approach in assembling a stewardship team to include an infectious disease physician, a clinical pharmacist with infectious diseases training, infection preventionist, and a close collaboration with the staff in the clinical microbiology laboratory
to prevent antimicrobial overuse, misuse and abuse.
to minimize the developme
Struggling with intense fears that disrupt your life? At Renew Life Hypnosis, we offer specialized hypnosis to overcome fear. Phobias are exaggerated fears, often stemming from past traumas or learned behaviors. Hypnotherapy addresses these deep-seated fears by accessing the subconscious mind, helping you change your reactions to phobic triggers. Our expert therapists guide you into a state of deep relaxation, allowing you to transform your responses and reduce anxiety. Experience increased confidence and freedom from phobias with our personalized approach. Ready to live a fear-free life? Visit us at Renew Life Hypnosis..
Medical Technology Tackles New Health Care Demand - Research Report - March 2...pchutichetpong
M Capital Group (“MCG”) predicts that with, against, despite, and even without the global pandemic, the medical technology (MedTech) industry shows signs of continuous healthy growth, driven by smaller, faster, and cheaper devices, growing demand for home-based applications, technological innovation, strategic acquisitions, investments, and SPAC listings. MCG predicts that this should reflects itself in annual growth of over 6%, well beyond 2028.
According to Chris Mouchabhani, Managing Partner at M Capital Group, “Despite all economic scenarios that one may consider, beyond overall economic shocks, medical technology should remain one of the most promising and robust sectors over the short to medium term and well beyond 2028.”
There is a movement towards home-based care for the elderly, next generation scanning and MRI devices, wearable technology, artificial intelligence incorporation, and online connectivity. Experts also see a focus on predictive, preventive, personalized, participatory, and precision medicine, with rising levels of integration of home care and technological innovation.
The average cost of treatment has been rising across the board, creating additional financial burdens to governments, healthcare providers and insurance companies. According to MCG, cost-per-inpatient-stay in the United States alone rose on average annually by over 13% between 2014 to 2021, leading MedTech to focus research efforts on optimized medical equipment at lower price points, whilst emphasizing portability and ease of use. Namely, 46% of the 1,008 medical technology companies in the 2021 MedTech Innovator (“MTI”) database are focusing on prevention, wellness, detection, or diagnosis, signaling a clear push for preventive care to also tackle costs.
In addition, there has also been a lasting impact on consumer and medical demand for home care, supported by the pandemic. Lockdowns, closure of care facilities, and healthcare systems subjected to capacity pressure, accelerated demand away from traditional inpatient care. Now, outpatient care solutions are driving industry production, with nearly 70% of recent diagnostics start-up companies producing products in areas such as ambulatory clinics, at-home care, and self-administered diagnostics.
India Clinical Trials Market: Industry Size and Growth Trends [2030] Analyzed...Kumar Satyam
According to TechSci Research report, "India Clinical Trials Market- By Region, Competition, Forecast & Opportunities, 2030F," the India Clinical Trials Market was valued at USD 2.05 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 8.64% through 2030. The market is driven by a variety of factors, making India an attractive destination for pharmaceutical companies and researchers. India's vast and diverse patient population, cost-effective operational environment, and a large pool of skilled medical professionals contribute significantly to the market's growth. Additionally, increasing government support in streamlining regulations and the growing prevalence of lifestyle diseases further propel the clinical trials market.
Growing Prevalence of Lifestyle Diseases
The rising incidence of lifestyle diseases such as diabetes, cardiovascular diseases, and cancer is a major trend driving the clinical trials market in India. These conditions necessitate the development and testing of new treatment methods, creating a robust demand for clinical trials. The increasing burden of these diseases highlights the need for innovative therapies and underscores the importance of India as a key player in global clinical research.
CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
Telehealth Psychology Building Trust with Clients.pptxThe Harvest Clinic
Telehealth psychology is a digital approach that offers psychological services and mental health care to clients remotely, using technologies like video conferencing, phone calls, text messaging, and mobile apps for communication.
Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
As we watch Dr. Greene's continued efforts and research in Arizona, it's clear that stem cell therapy holds a promising key to unlocking new doors in the treatment of kidney disease. With each study and trial, we step closer to a world where kidney disease is no longer a life sentence but a treatable condition, thanks to pioneers like Dr. David Greene.
One of the most developed cities of India, the city of Chennai is the capital of Tamilnadu and many people from different parts of India come here to earn their bread and butter. Being a metropolitan, the city is filled with towering building and beaches but the sad part as with almost every Indian city
1. Medical Ethics in view of
Medical Research
Dr. Anil Kumar
Associate Professor
Microbiology Department
2. • Nowadays, conflicts of interests between the
government & medical institutions, between medical
institutions and medical personnel, between physicians
and patients are getting more and more serious and
complex.
3. Ethics are not …
• Ethics is not the same as feelings
• Ethics is not religion
• Ethics is not following the law
• Ethics is not following culturally
accepted norms
• Ethics is not science
4. Ethics are …
• Moral Principles
• What is good and bad
• What is right and wrong
• Based on value system
• Ethical norms are not
universal – depends on the sub
culture of the society
5. Medical Ethics are …
• the rules of etiquette
adopted by the medical
profession to regulate
professional conduct with
each other, also towards
their individual patients
and towards society, and
includes considerations of
the motives behind that
conduct.
6. Research Ethics and Integrity
• Research, in all domains, is
an important activity of
every human society
• Represents a major
commitment on the part of
the various people
involved, whether in the
public or private sector.
• So, it is essential that the
research itself be
conducted with integrity, in
a responsible manner and
in accordance with high
ethical standards.
6
7. Purpose of Research …..
• The PURPOSE, of research is that it should
be directed towards the increase of
knowledge about the human condition in
relation to its social and natural
environment
• Mindful, that the human species is one of
the many species in a planet in which the
no less from the human species as any
other, and that such research is for the
betterment of all, especially the least
advantaged.
8. Proposed guidelines by WHO
•In 1982,the World Health Organisation (WHO) and the
The Council for International Organizations of Medical
Sciences (CIOMS) issued the ‘Proposed International
Guidelines for Biomedical Research involving Human
Subjects.’
•‘International Guidelines for Ethical Review in
Epidemiological studies’
•‘International Ethical Guidelines for
Biomedical research involving human subjects’.
1
0
9. ICMR FORMULATES ITS OWN
GUIDLINES
• In February 1980, the Indian
Council of Medical Research
released a ‘Policy Statement
on Ethical Considerations
involved in Research on
Human Subjects’
• for the benefit of all those
involved in clinical research
in India.
10. ICMR GUIDELINES BECOMES SOP’S
• "Ethical guidelines for
biomedical research on
human participants"
prepared by the Indian
Council of Medical
Research in 2006 came
as a welcome step in the
process of regulation of
research on human
subjects, since clear cut
Indian guidelines were
absent earlier
11. ICMR GUIDELINES ACCEPTED AS SOP’S
The guidelines have
been accepted as
the standard
operating manual by
Institutional Ethics
Committees (IEC) in
India
12. Institutional Ethics Committees
• The IECs should be
multidisciplinary and multi-
sectorial in composition. Found in
most health care facility’s
• Usually Ten to Twelve members
1. Chairperson
2. One -two persons from basic medical
science area
3. One -two clinicians from various Institutes
4. One legal expert or retired judge
5. One social scientist/ representative of
non-governmental voluntary agency
6. One philosopher/ ethicist/ theologian
7. One lay person from the community
8. Member Secretary
13.
14.
15. BASIC RESPONSIBILITIES OF ETHICAL COMMITTEE
• The basic responsibility of an Institutional
Ethics Committee (IEC) is to ensure a
competent review of all ethical aspects of the
project proposals received by it in an objective
manner.
• IECs should provide advice to the researchers
on all aspects of the welfare and safety of the
research participants after ensuring the
scientific soundness of the proposed research
through appropriate Scientific Review
Committee
16. SUBMISSION OF APPLICATION
• The researcher should submit an application in
a prescribed format along with the study
protocol as prescribed in SOP of IEC
concerned. The protocol should include the
following : -
1. The title with signature of Principal
Investigator (PI) and Co- investigators as
attestation for conducting the study.
2. Clear research aims and objectives
17. SUBMISSION OF APPLICATION
• Recent curriculum vitae of the Investigators
indicating qualification and experience.
• Inclusion and exclusion criteria.
• Precise description of methodology of the
proposed research, including sample size (with
justification), type of study design
(observational, experimental, pilot,
randomized, blinded etc.), intended
intervention, dosages of drugs, route of
administration, duration of treatment and
details of invasive procedures if any.
18. SUBMISSION OF APPLICATION
• Plan for statistical analysis of the study.
-- Informed consent .
-- informed consent forms in English and local
languages.
-- sample of patient information sheet .
19. SUBMISSION OF APPLICATION
• 14. Plans for publication of results - positive or
negative - while maintaining
• the privacy and confidentiality of the study participants.
All other relevant documents related to the study
protocol like investigator's brochure for trial on
drugs/ devices/ vaccines/ laboratory results
should be documented
20. All participants to be educated
and oriented on Ethics
before Starting the Research
Work
21. Informed Consent means
• Informed consent is a process
for getting permission before
conducting a healthcare study.
• Researcher may ask a research
participant/patient before
enrolling that person into a
clinical trial.
• Informed consent is collected
according to guidelines from
the fields of medical ethics and
research ethics.
22. Simple Signature do not End the
matters when thing go wrong
From a clinical ethics
perspective, informed
consent is a
communication
process, and should
not simply be treated
as a required form for
the patient’s signature
or Thumb Impression.
23. Informed choice linked with State
of Mind of the Patient
Similarly, the legal
concept of informed
consent refers to a
state of mind, i.e.,
understanding the
information provided
to make an informed
choice
24. Right of Participants to withdraw
from the Research assessments
• The right of participants in
research to decline to
participate, or withdraw, or
abstain from further
participation, has been
repeatedly emphasised by the
ICMR guidelines. It has been
clearly stated that the
patients can “withdraw
without penalty or loss of
benefits which the
participant would otherwise
be entitled to.”
25. Consent Forms to be Simple
and Understandable in local
language and familiar to
the participants