1) Informed consent requires disclosure, understanding, competence, and voluntariness. Patients must understand the nature of the procedure, risks, benefits, and alternatives in order to make an informed decision.
2) There are basic elements that must be included in an informed consent form such as purpose, procedures, risks, benefits, and confirmation that participation is voluntary. Additional elements may also be required depending on the level of risk.
3) Obtaining consent from children requires consideration of their developmental level. For children under age 7, consent is implied. Children ages 7-11 must provide verbal assent. Those 12-17 can provide written assent with parental consent.
In this presentation it has been tried to give a glimpse of different type of consent, how it should be taken, how the patient to be explained, when consent is must and conditions where consent is not required, so as to guide you in your every day practice.
In this presentation it has been tried to give a glimpse of different type of consent, how it should be taken, how the patient to be explained, when consent is must and conditions where consent is not required, so as to guide you in your every day practice.
inform consent form before participate in clinical trials.for purpose of understanding the nature of research,risk,benefits,and decision about participation
Lecture 13 privacy, confidentiality and medical recordsDr Ghaiath Hussein
A lecture on privacy, confidentiality and medical records delivered to Alfarabi Medical College undergraduate medical students in the week starting 27.11.2016
ETHICS COMMITTEE
MEMBERS OF ETHICS COMMITTEE
SOME ETHICS COMMITTEE AROUND THE WORLD
What authority does EC/IRB have?
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FOR ENROLLMENT CALL US ON - 9028839789
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MAIL ID - pristynresearch@gmail.com
FACEBOOK- https://www.facebook.com/pristynsolutions
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TWITTER- https://twitter.com/Pristynresearch
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LINKEDIN- https://www.linkedin.com/in/pristyn-research-191072119/
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4 ,Opposite To Expert Global, Garware Stadium Road , Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
Patient Rights, Patients Bill, ConSumer Protection Act, Nurse and Patient Bill of Rights,
Hospital and Bill of Rights for Patient, Rights of the Pateint, Legal Issues for Patients
inform consent form before participate in clinical trials.for purpose of understanding the nature of research,risk,benefits,and decision about participation
Lecture 13 privacy, confidentiality and medical recordsDr Ghaiath Hussein
A lecture on privacy, confidentiality and medical records delivered to Alfarabi Medical College undergraduate medical students in the week starting 27.11.2016
ETHICS COMMITTEE
MEMBERS OF ETHICS COMMITTEE
SOME ETHICS COMMITTEE AROUND THE WORLD
What authority does EC/IRB have?
.
.
.
FOR ENROLLMENT CALL US ON - 9028839789
https://pristynresearch.com/
MAIL ID - pristynresearch@gmail.com
FACEBOOK- https://www.facebook.com/pristynsolutions
INSTAGRAM- https://www.instagram.com/pristyn_res...
TWITTER- https://twitter.com/Pristynresearch
SLIDESHARE- https://www.slideshare.net/azherkhan5916
LINKEDIN- https://www.linkedin.com/in/pristyn-research-191072119/
ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
2)T-21/4 ,Opposite To Expert Global, Garware Stadium Road , Software Technology Park of India(STPI), MIDC, Aurangabad-431001. Email: info@pristynresearch.com Call us: 09607709586
Patient Rights, Patients Bill, ConSumer Protection Act, Nurse and Patient Bill of Rights,
Hospital and Bill of Rights for Patient, Rights of the Pateint, Legal Issues for Patients
A project with the aim to standardize an RBM approach in clinical trials. It unites four companies and academic organizations, focuses on the evaluation and optimization of Risk-based Monitoring (RbM). For this purpose, PUEKS will use data available from past clinical studies to select substantiated key risk indicators (KRIs). Subsequently, the obtained data-driven KRIs will be tested in an ongoing trial. A comparative evaluation with historical data from past studies will be additionally performed to evaluate the power of the selected KRIs in terms of cost savings, enhanced quality, and risk mitigation. The project is aimed at delivering a robust RbM tool as well as an optimized procedure for the successful implementation of RbM.
This project (HA project no. 448/14-38) is funded in the framework of Hessen ModellProjekte, financed with funds of LOEWE – Landes-Offensive zur Entwicklung Wissenschaftlich-ökonomischer Exzellenz, Förderlinie 3: KMU-Verbundvorhaben (State Offensive for the Development of Scientific and Economic Excellence).
A presentation on INFORMED CONSENT FORM which is easy to understand and easy to explain and in very understandable language. Do give it a heart if you like this presentation and do give your valuable comments on it. I will be reading them all. Do contact me if you want some other presentation related to pharmaceutical science.
Ethical Issues in Obtaining Informed Consent.pptxAhmed Mshari
Medical ethics is a set of moral principles, beliefs and values that guide decisions about patient care.
It is an integral part of good medical practice.
The health care professional uses knowledge, experience, and judgment and considers the ethical principles to make decisions on management recommendations.
What is Informed Consent?
Informed consent is the process by which a patient voluntarily confirms his/her willing participation in an operation after having been informed about all the aspects of the operation that is its benefits, its prognosis, and complications
Informed consent must be in written form and documented with the patients signature and date of consent
Similar to Informed consent: Definition & elements (20)
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
2. What is “Consent?”
Defined as permission, approval, or assent
Touching a person without consent constitutes a
battery, and putting a person in fear of being touched
without consent is assault.
3. What is “INFORMED Consent”?
Consent given by the patient based on
knowledge of the procedure to be performed,
including its risks and benefits, as well as
alternatives to the proposed treatment.
4. Purpose of Consent
Respect Subject’s Will ..
Understand nature of research
Be informed of purpose, risks, and benefits, and
alternative therapies
Make a Voluntary Decision about Participation
5. “Informative” Informed Consent
What you need to know about informed
consent.
What you need to do to create an
“informative” Informed Consent Form.
6. Types of Consent
Expressed consent =either oral or written consent by the
patient to undergo a specific procedure or treatment.
Implied consent =inferred from the circumstances. It is
rarely documented and is relied upon for care or treatment
that is routine and does not involve significant risk.
7. Types of Consent
Expressed consent =either oral or written consent by the
patient to undergo a specific procedure or treatment.
Implied consent =inferred from the circumstances. It is
rarely documented and is relied upon for care or treatment
that is routine and does not involve significant risk.
8. Types of Consent
Expressed consent =either oral or written consent by the
patient to undergo a specific procedure or treatment.
Implied consent =inferred from the circumstances. It is
rarely documented and is relied upon for care or treatment
that is routine and does not involve significant risk.
16. 1 & 4: Competence and Voluntariness
Competence = the ability to perform a certain task.
The task at hand is to make a decision that reflects your values and assessment
of likely outcomes
Values
Assessment
Ability Task
Competence
18. Respecting persons
Autonomy Informed Consent
Autonomy is self-governance
Respecting their right of self-determination
Getting their consent for medical treatment
Protecting their Ability
Competencyinformed
understanding
20. Competence
? Proxy
Voluntary inpatient mental health services
Convulsive treatment
Psychosurgery
Abortion
Neglect of the patient through the omission of care primarily
intended to provide for the comfort of the patient
21. The research presents no greater than
minimal risk to the child
The permission of the child’s
parents or guardians
The assent of the
child
22. Children and Informed Consent
18
17
16
15
14
13
12
11
10
9
8
7
6
5
For children under 7 years of age, it is an
informal process
Children 7 – 11 years of age, assent is
verbally obtained and documented in the
research records
Minors 12 – 17 years of age, should be
given the opportunity to document their
assent on an IRB approved assent form
Assent
Consent
23. General guidelines of what information is required for informed
consent
The nature of the procedure
The risks of the procedure
The alternatives to the procedure
The expected benefits of the procedure
The probable outcome
2 & 3: Disclosure and Understanding
24. No Understanding = No Consent
2 & 3: Disclosure and Understanding
Informed Consent = Shared Decision-Making
29. The 8 Mandatory Elements of Informed Consent
A statement that the study involves research, an
explanation of the purposes of the research
Description
of the
procedures
Identification
of any
procedures
which are
experimental
Duration
30. A description of any reasonably
foreseeable risks or discomforts to the
subject.
Risks
&
Discomforts
The 8 Mandatory Elements of Informed Consent
31. A description of any benefits to the subject or to
others which may reasonably be expected from
the research.
Benefits
Self Other
s
The 8 Mandatory Elements of Informed Consent
32. A disclosure of appropriate alternative
procedures or courses of treatment, if any, that
might be advantageous to the subject.
Alternative
treatments
The 8 Mandatory Elements of Informed Consent
33. A statement describing the extent, if any, to
which confidentiality of records identifying the
subject will be maintained.
Confidentiality
The 8 Mandatory Elements of Informed Consent
34. For research involving more than minimal risk:
•an explanation as to whether any compensation
•and an explanation as to whether any medical treatments are available if injury
occurs and,
•if so, what they consist of, or where further information may be obtained.
Compensation
Including Treatments
The 8 Mandatory Elements of Informed Consent
35. An explanation of whom to contact for answers to
pertinent questions about the research and research
subjects’ rights and whom to contact in the event of a
research-related injury to the subject.
Contacts
The 8 Mandatory Elements of Informed Consent
36. A statement that participation is voluntary, refusal to participate
will involve no penalty or loss of benefits to which the subject is
otherwise entitled, and the subject may discontinue participation at
any time without penalty or loss of benefits to which the subject is
otherwise entitled.
Voluntary
The 8 Mandatory Elements of Informed Consent
38. Additional Elements, When Appropriate
A statement that the particular treatment or
procedure may involve risks to the subject (or
embryo or fetus, if the subject is or may become
pregnant) which are currently unexpected.
Unexpected
Risks
39. Estimated circumstances under which the
subject’s participation may be terminated by the
investigator without regard to the subject’s
consent.
Termination
Additional Elements, When Appropriate
40. Any additional costs to the subject that may result from
participation in the research
Additional
costs
Additional Elements, When Appropriate
41. The consequences of a subject’s decision to withdraw from the
research and procedures for orderly termination of participation by
the subject
Consequences
of withdraw
Additional Elements, When Appropriate
42. A statement that significant new findings developed during the
course of the research which may relate to the subject’s willingness
to continue participation will be provided to the subject.
New findings
Additional Elements, When Appropriate
43. The approximate number of subjects involved in the study.
Number of
subjects
Additional Elements, When Appropriate