Chesapeake IRB and IRB Services provide independent IRB services for major pharmaceutical companies, universities, individual researchers, academic medical centers, and community hospitals.
The Ethical Responsibilities of Academic Research Instutions and Funder to Safeguard the Integrity of Research Presentation to MedicReS 5th World Congress on October 19,25,2015 in New York by Zubin Master, PhD
David Resnik - MedicReS World Congress 2012MedicReS
Ethical Dilemmas in Scientific Research
David B. Resnik, JD, PhD, NIEHS/NIH
This research is supported by the NIEHS/NIH. It does not represent the views of the NIEHS, NIH, or US government.
Cemal H. Guvercin MedicReS 5th World Congress MedicReS
Ethical Issues in Artifical Intelligence Applied to Medicine Presentation to MedicReS 5th World Congress on October 19,25,2015 in New York by Cemal H. Guvercin, MD, PhD
The Ethical Responsibilities of Academic Research Instutions and Funder to Safeguard the Integrity of Research Presentation to MedicReS 5th World Congress on October 19,25,2015 in New York by Zubin Master, PhD
David Resnik - MedicReS World Congress 2012MedicReS
Ethical Dilemmas in Scientific Research
David B. Resnik, JD, PhD, NIEHS/NIH
This research is supported by the NIEHS/NIH. It does not represent the views of the NIEHS, NIH, or US government.
Cemal H. Guvercin MedicReS 5th World Congress MedicReS
Ethical Issues in Artifical Intelligence Applied to Medicine Presentation to MedicReS 5th World Congress on October 19,25,2015 in New York by Cemal H. Guvercin, MD, PhD
Research Methods: Ethics I (Human Research)Brian Piper
lecture 2 from a college level research methods in psychology course taught in the spring 2012 semester by Brian J. Piper, Ph.D. (psy391@gmail.com) at Linfield College,
Presentation given at the 2012 UNM Jump Start Institute on April 28, 2012.
Research and Academic Integrity
a. Facilitators:
i. William L. Gannon, Ph.D., Director, UNM Responsible and Ethical Conduct of Research, Office of the Vice President for Research (OVPR)
ii. Gary Harrison, Ph.D., Dean, Office of Graduate Studies (OGS).
Research Ethics :-
Ethics are norms of conduct that distinguish between acceptable and unacceptable behavior.
Ethics are the principles and guidelines that help us to uphold things we value.
Meaning :-
Research ethics involves the application of fundamental ethical principles to a variety of topics involving scientific research.
Research ethics educates and monitors a scientist conducting a research to ensure a high ethical standards.
Basic Principles of Research Ethics :-
Honesty
Objectivity
Integrity
Carefulness
Openness
Respect for intellectual property
Confidentiality
Respect for Colleagues
Non discrimination
Social Responsibility
David B. Resnik MedicReS World Congress 2015MedicReS
Protecting Privacy and Confidentiality in the Age of Big Data Presentation to MedicReS 5th World Congress on October 19,25,2015 in New York - David B. Resnik, JD, PhD, Bioethicist, NIH/NIEHS
Research Methods: Ethics I (Human Research)Brian Piper
lecture 2 from a college level research methods in psychology course taught in the spring 2012 semester by Brian J. Piper, Ph.D. (psy391@gmail.com) at Linfield College,
Presentation given at the 2012 UNM Jump Start Institute on April 28, 2012.
Research and Academic Integrity
a. Facilitators:
i. William L. Gannon, Ph.D., Director, UNM Responsible and Ethical Conduct of Research, Office of the Vice President for Research (OVPR)
ii. Gary Harrison, Ph.D., Dean, Office of Graduate Studies (OGS).
Research Ethics :-
Ethics are norms of conduct that distinguish between acceptable and unacceptable behavior.
Ethics are the principles and guidelines that help us to uphold things we value.
Meaning :-
Research ethics involves the application of fundamental ethical principles to a variety of topics involving scientific research.
Research ethics educates and monitors a scientist conducting a research to ensure a high ethical standards.
Basic Principles of Research Ethics :-
Honesty
Objectivity
Integrity
Carefulness
Openness
Respect for intellectual property
Confidentiality
Respect for Colleagues
Non discrimination
Social Responsibility
David B. Resnik MedicReS World Congress 2015MedicReS
Protecting Privacy and Confidentiality in the Age of Big Data Presentation to MedicReS 5th World Congress on October 19,25,2015 in New York - David B. Resnik, JD, PhD, Bioethicist, NIH/NIEHS
Presentation by Rachel Steinacher, on IPA and RCTsTwaweza
A presentation by Rachel Steinacher, Research Manager for IPA-Kenya (Innovations for Poverty Action), on IPA and RCTsThis was presented at the Commission for Science and Technology (COSTECH) in Dar es Salaam, Tanzania, on June 19, 2014, to an audience of researchers.
Presentation by Prof. George Gray, Director of the Centre for Risk Science and Public Health, George Washington University, at the Workshop on Risk Assessment in Regulatory Policy Analysis (RIA), Session 5, Mexico, 9-11 June 2014. Further information is available at http://www.oecd.org/gov/regulatory-policy/
The Effects of Trauma on Health Care Utilizationandreacamden
This webinar will discuss the effects of childhood trauma on health care utilization and chronic illness. Susan Lax is an Advanced Practice Nurse with a dual degree in psychiatry/mental health nursing and primary care nursing from the Institute of Health Professions at Massachusetts General Hospital. She is certified in Trauma Studies by the Trauma Center at JRI, trained by Bessel van der Kolk and his colleagues. She has completed trainings in Sensorimotor Psychotherapy, a mindfulness approach to treating trauma disorders. In all, she has completed more than 300 hours of training in the treatment of acute and developmental trauma. In 2010 Susan was awarded a leadership in nursing award for her success incorporating a trauma treatment as she worked in acute, residential, and community settings in the Greater Boston Area, including on a PACT team.
Learn how to assess internal (research/project team) and external (patient/public partner) readiness to engage in health research.
CHI's Lunchtime Learning is open to all researchers, decision-makers, clinicians, patients and members of the public who want to learn more about the theory and practice of meaningful, inclusive, and safe patient and public engagement.
Following this session, attendees should be able to:
• Describe the importance of conducting readiness assessments prior to engagement;
• Describe key concepts for assessing internal and external readiness; and
• Conduct readiness assessments in planning patient engagement.
Chapter 2
Study Designs
Learning Objectives
• List and define the components of a good
study design
• Compare and contrast observational and
experimental study designs
• Summarize the advantages and disadvantages
of alternative study designs
Learning Objectives
• Describe the key features of a randomized
controlled trial
• Identify the study designs used in public health
and medical studies
Study Designs
• Observational Studies
– Case-series study
– Cross-sectional (prevalence) survey
– Case-control study
– Cohort study
• Experimental Studies
– Randomized Controlled (Clinical) Trial
Inferences
• Observational studies – inferences limited to descriptions
and associations; with carefully designed analysis can
make stronger inferences (statistical adjustment)
• Experimental studies – cause and effect
In ALL studies – need careful definition of disease
(outcome) and exposure (risk factor)
Which Design is Best
• Depends on the study question
• What is current knowledge on topic
• How common is disease (and risk factors)
• How long would study take, what are costs
• Ethical issues
Case Report/Case Series
• Observational study
• Case report: Detailed report of specific
features of case
• Case series: Systematic review of common
features of a small number of cases
• Advantage: Cost-efficient
• Disadvantages: No comparison group, no
specific research question
Case-Series
• Simplest design – description of interesting
observations in a small number of individuals
• Usually case-series do not involve control patients
(i.e., patients free of disease)
• Usually lead to generation of hypotheses for more
formal testing
• Criticisms: not planned – no research hypotheses
Case-Series
• Gottleib (1981) studied 5 young homosexual
men with rare form of pneumonia and other
unusual infections
• Initial report was followed by more series (26
cases in NY and CA; “cluster” in southern CA;
34 cases among Haitians, etc.)
• Condition termed AIDS in 1982
Cross-Sectional Survey
• Observational study conducted at a point in
time
• Advantages: Cost-efficient, easy to implement,
ethical
• Disadvantages: No temporal information, non-
response bias
Cross-Sectional Survey
• Is there an association between diabetes and
cardiovascular disease (CVD)?
Patients
with
Diabetes
Patients without
Diabetes
Patients with
CVD
Prospective Cohort Study
• Observational study involving a group (cohort)
of individuals who meet inclusion criteria
followed prospectively in time for risk factor
and outcome information
• Advantages: Can assess temporal relationships
• Disadvantages: Need large numbers for rare
outcomes, confounding
Cohort Study
• Is there an association between hypertension and
cardiovascular disease?
CVD
Hypertension
No CVD
Cohort
CVD
No Hypertension
No CVD
Study Start Time
Cohort Studies
• Identify a group of individuals that meet
inclusion crit ...
As patients and families impacted by harm, we imagine progressive approaches in responding to patient safety incidents – focused on restoring health and repairing trust.
We can change how we respond to healthcare harm by shifting the focus away from what happened, towards who has been affected and in what way. This is your opportunity to hear about innovative approaches in Canada, New Zealand, and the United States that appreciate these human impacts.
This interactive webinar is hosted by Patients for Patient Safety Canada, the patient-led program of the Canadian Patient Safety Institute and the Canadian arm of the World Health Organization Patients for Patient Safety Global Network.
Part of the "2016 Annual Conference: Big Data, Health Law, and Bioethics" held at Harvard Law School on May 6, 2016.
This conference aimed to: (1) identify the various ways in which law and ethics intersect with the use of big data in health care and health research, particularly in the United States; (2) understand the way U.S. law (and potentially other legal systems) currently promotes or stands as an obstacle to these potential uses; (3) determine what might be learned from the legal and ethical treatment of uses of big data in other sectors and countries; and (4) examine potential solutions (industry best practices, common law, legislative, executive, domestic and international) for better use of big data in health care and health research in the U.S.
The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School 2016 annual conference was organized in collaboration with the Berkman Center for Internet & Society at Harvard University and the Health Ethics and Policy Lab, University of Zurich.
Learn more at http://petrieflom.law.harvard.edu/events/details/2016-annual-conference.
Similar to Chesapeake IRB: Risk and Harm in Research (20)
- 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
CDSCO and Phamacovigilance {Regulatory body in India}NEHA GUPTA
The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. Operating under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, the CDSCO is responsible for approving new drugs, conducting clinical trials, setting standards for drugs, controlling the quality of imported drugs, and coordinating the activities of State Drug Control Organizations by providing expert advice.
Pharmacovigilance, on the other hand, is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. The primary aim of pharmacovigilance is to ensure the safety and efficacy of medicines, thereby protecting public health.
In India, pharmacovigilance activities are monitored by the Pharmacovigilance Programme of India (PvPI), which works closely with CDSCO to collect, analyze, and act upon data regarding adverse drug reactions (ADRs). Together, they play a critical role in ensuring that the benefits of drugs outweigh their risks, maintaining high standards of patient safety, and promoting the rational use of medicines.
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
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.
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
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
Colonic and anorectal physiology with surgical implications
Chesapeake IRB: Risk and Harm in Research
1. Risk and Harm
in Research
Chesapeake IRB
Copyright 2015 Chesapeake IRB
2. Assessment of Risks and Benefits
• An opportunity and a responsibility
For the researcher: a means to examine whether
research is properly designed
For the IRB: a method for determining whether risks to
subjects are justified
For the prospective subjects: assistance in determining
whether or not to participate
Copyright 2015 Chesapeake IRB
3. Important Concepts
• Risk: refers to the probability that some type of
harm will occur
• Harm: refers to some outcome or event that has
a level of magnitude (e.g., mere inconvenience,
serious illness)
• Benefit: refers to something of positive value
related to health or welfare
Copyright 2015 Chesapeake IRB
4. Risk <≠> Benefits
Proper Contrasts :
Harms ó Benefits
Risk of harms ó Probability of benefits
Magnitude of harms ó Magnitude of benefits
Copyright 2015 Chesapeake IRB
5. Types of Benefits
• Gain to society or science through contribution
to the knowledge base
• Gain to the individual
– Through improved well-being, or
– Through empowerment of the individual by giving
him/her a voice
Copyright 2015 Chesapeake IRB
6. Types of Harm
• Mere inconvenience
• Emotional harm: distress, embarrassment, trauma
• Physical harm: from a research procedure or from
from those who would harm the subject for
participating
• Social harm: disclosure leads to stigma, rejection of
subject, persecution, loss of social status
• Economic Harm: Economic costs due to efforts to
avoid or recover from other harms, loss of
employment
Copyright 2015 Chesapeake IRB
7. Sources of Harm
• Participation in research: reaction to materials
or procedures; mere contact
• Breach of Confidentiality: Disclosure of
information from subjects’ participation in
research
• Socioeconomic: The impact of the research
project after its completion
Copyright 2015 Chesapeake IRB
8. “Minimal Risk”
• The probability and magnitude of harm or
discomfort anticipated in the research are not
greater in and of themselves than those
ordinarily encountered in daily life or during the
performance of routine physical or psychological
examinations or tests
Copyright 2015 Chesapeake IRB
9. The “Daily Life” Standard
• Routine physical or psychological tests
– Some discomfort or stress
– Low magnitude
– Transient, short duration
• Daily life encounters
– Hassles, arguments, minor accidents that happen to
most people over a couple of years
Copyright 2015 Chesapeake IRB
10. Interpreting “Risk”
• “Low-risk” refers to research where the worst
harm possible is low-magnitude and transient,
whether or not it is likely to occur
• “Minimal risk” refers to research where the
worst harm likely is not very serious, and if it is,
the probability of a subject experiencing it is
extremely low
• “Greater than minimal risk” is all other research
Copyright 2015 Chesapeake IRB
11. Minimizing Risk
• Alternatives
– Substitute other procedures that are less risky
• Precautions
– Incorporate procedures to decrease the likelihood that
harms will occur
• Safeguards
– Incorporate procedures to deal with harms if they do
occur
Copyright 2015 Chesapeake IRB
12. Chesapeake IRB
Human Connection >>>Technology Driven
Thank you
www.chesapeakeirb.com
www.irbservices.com
www.cirbi.net
Contact Us
Ruth Boulter - 609-731-8786
Ron Di Nofa - 609- 751-6417
Ellen Kelso - 513-218-9699
Copyright 2015 Chesapeake IRB