This document discusses the role and functions of an Institutional Ethics Committee (IEC). The IEC is responsible for ensuring research involving human subjects is conducted ethically and protects participants' rights, safety, and well-being. The IEC reviews research proposals, consent forms, and other documents to evaluate risks and benefits to participants. It can approve research, approve with modifications, require resubmission with more information, or disapprove projects. The IEC also conducts continuing reviews of approved research. It is mandated by guidelines in India to ethically review all biomedical research involving human subjects.
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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ADDRESS-
1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
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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.
The mission of the Clinical Trials Registry-India (CTRI) is to ensure that all clinical trials conducted in India are prospectively registered, i.e. before the enrolment of the first participant. Additionally, post-marketing surveillance studies, BA/BE studies as well as clinical studies as part of PG thesis are also expected to be registered in the CTRI. The vision of the CTRI is to ensure that every clinical trial conducted in the region is prospectively registered with full disclosure of the trial data set items. While this register is meant primarily for trials conducted in India, the CTRI will also accept registration of trials conducted in other countries in the region, which do not have a Primary Registry of its own, provided ethics approval (in English) is available and the study has not begun enrolling. The Clinical Trials Registry- India (CTRI), hosted at the ICMR's National Institute of Medical Statistics (http://icmr-nims.nic.in), is a free and online public record system for registration of clinical trials being conducted in India that was launched on 20th July 2007 (www.ctri.nic.in). Initiated as a voluntary measure, since 15th June 2009, trial registration in the CTRI has been made mandatory by the Drugs Controller General (India) (DCGI) (www.cdsco.nic.in). Moreover, Editors of Biomedical Journals of 11 major journals of India declared that only registered trials would be considered for publication1, 2.
Today, any researcher who plans to conduct a trial involving human participants, of any intervention such as drugs, surgical procedures, preventive measures, lifestyle modifications, devices, educational or behavioral treatment, rehabilitation strategies as well as trials being conducted in the purview of the Department of AYUSH (http://indianmedicine.nic.in/) is expected to register the trial in the CTRI before enrollment of the first participant. Trial registration involves public declaration and identification of trial investigators, sponsors, interventions, patient population etc before the enrollment of the first patient. Submission of Ethics approval and DCGI approval (if applicable) is essential for trial registration in the CTRI. Multi-country trials, where India is a participating country, which have been registered in an international registry, are also expected to be registered in the CTRI. In the CTRI, details of Indian investigators, trial sites, Indian target sample size and date of enrollment are captured. After a trial is registered, trialists are expected to regularly update the trial status or other aspects as the case may be. After a trial is registered, all updates and changes will be recorded and available for public display.
Siro Clinical Research Institute
Post Graduate Diploma in Clinical Research
www.siroinstitute.com
www.siroclinpharm.com
inform consent form before participate in clinical trials.for purpose of understanding the nature of research,risk,benefits,and decision about participation
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
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.
The mission of the Clinical Trials Registry-India (CTRI) is to ensure that all clinical trials conducted in India are prospectively registered, i.e. before the enrolment of the first participant. Additionally, post-marketing surveillance studies, BA/BE studies as well as clinical studies as part of PG thesis are also expected to be registered in the CTRI. The vision of the CTRI is to ensure that every clinical trial conducted in the region is prospectively registered with full disclosure of the trial data set items. While this register is meant primarily for trials conducted in India, the CTRI will also accept registration of trials conducted in other countries in the region, which do not have a Primary Registry of its own, provided ethics approval (in English) is available and the study has not begun enrolling. The Clinical Trials Registry- India (CTRI), hosted at the ICMR's National Institute of Medical Statistics (http://icmr-nims.nic.in), is a free and online public record system for registration of clinical trials being conducted in India that was launched on 20th July 2007 (www.ctri.nic.in). Initiated as a voluntary measure, since 15th June 2009, trial registration in the CTRI has been made mandatory by the Drugs Controller General (India) (DCGI) (www.cdsco.nic.in). Moreover, Editors of Biomedical Journals of 11 major journals of India declared that only registered trials would be considered for publication1, 2.
Today, any researcher who plans to conduct a trial involving human participants, of any intervention such as drugs, surgical procedures, preventive measures, lifestyle modifications, devices, educational or behavioral treatment, rehabilitation strategies as well as trials being conducted in the purview of the Department of AYUSH (http://indianmedicine.nic.in/) is expected to register the trial in the CTRI before enrollment of the first participant. Trial registration involves public declaration and identification of trial investigators, sponsors, interventions, patient population etc before the enrollment of the first patient. Submission of Ethics approval and DCGI approval (if applicable) is essential for trial registration in the CTRI. Multi-country trials, where India is a participating country, which have been registered in an international registry, are also expected to be registered in the CTRI. In the CTRI, details of Indian investigators, trial sites, Indian target sample size and date of enrollment are captured. After a trial is registered, trialists are expected to regularly update the trial status or other aspects as the case may be. After a trial is registered, all updates and changes will be recorded and available for public display.
Siro Clinical Research Institute
Post Graduate Diploma in Clinical Research
www.siroinstitute.com
www.siroclinpharm.com
inform consent form before participate in clinical trials.for purpose of understanding the nature of research,risk,benefits,and decision about participation
“CSR is a detailed regulatory document which gives the information about the methods and results (related to efficacy and safety) of a clinical trial. CSRs are created as a part of the process of submitting applications to the Regulatory Authorities for new medical treatments and for its approval. CSRs can be full, abbreviated, synopsis, supplementary, observational etc as per the results and requirements”.
Describes in detail definition, purpose, participants and goal of good clinical practices (GCP). Gives history of GCP staring form Nuremberg code in 1948 to implementation of GCP guidance via WHO handbook in 2005. Also describes Nuremberg's code, declaration of Helsinki and Thirteen principles of GCP.
An informed consent form is a document that is provided to prospective participants in a research study. It is a crucial component of the informed consent process and serves to ensure that participants are fully informed about the study and its potential risks and benefits before they decide to participate. Here are the key elements typically included in an informed consent form
“CSR is a detailed regulatory document which gives the information about the methods and results (related to efficacy and safety) of a clinical trial. CSRs are created as a part of the process of submitting applications to the Regulatory Authorities for new medical treatments and for its approval. CSRs can be full, abbreviated, synopsis, supplementary, observational etc as per the results and requirements”.
Describes in detail definition, purpose, participants and goal of good clinical practices (GCP). Gives history of GCP staring form Nuremberg code in 1948 to implementation of GCP guidance via WHO handbook in 2005. Also describes Nuremberg's code, declaration of Helsinki and Thirteen principles of GCP.
An informed consent form is a document that is provided to prospective participants in a research study. It is a crucial component of the informed consent process and serves to ensure that participants are fully informed about the study and its potential risks and benefits before they decide to participate. Here are the key elements typically included in an informed consent form
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.
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.
Saudi Commission for Health Specialties, Part 1 of the series of lectures I gave for the PEER (Professionalism and Ethics Education for Residents) Project sponsored and organized by the Saudi Commission for Health Specialties (SCHS).
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.
The Thalidomide tragedy is one of the most devastating events in the history of medicine and drug regulation. Thalidomide was a medication that was introduced in the late 1950s and early 1960s as a sedative and treatment for nausea during pregnancy. However, its use led to a widespread public health crisis with severe and tragic consequences.
Here's an overview of the Thalidomide tragedy:
Presentation on theme: "GCP (GOOD CLINICAL PRACTISE)"Nevin Francis
Creating a comprehensive 3000-word essay on Good Clinical Practice (GCP) would be quite extensive and may not fit within the scope of our conversation here. However, I can provide you with a detailed outline and key points that you could expand upon to reach the desired word count.
**Introduction to Good Clinical Practice (GCP)**
- Definition and importance of GCP in clinical research.
- Historical development and international harmonization efforts.
**Ethical Considerations in GCP**
- The role of ethics in clinical trials.
- Informed consent process and protection of participants' rights.
**Designing Clinical Trials under GCP Guidelines**
- Key elements in the design of a clinical trial.
- Considerations for protocol development.
**Conducting Clinical Trials According to GCP**
- Responsibilities of sponsors and investigators.
- Patient recruitment and data management strategies.
**Safety Monitoring and Adverse Event Reporting**
- Monitoring patient safety and reporting adverse events.
- The role of Data Safety Monitoring Boards (DSMBs).
**Quality Assurance in Clinical Trials**
- Audits, inspections, and ensuring compliance with GCP.
- The significance of documentation and record-keeping.
**Statistical Considerations in Clinical Trials**
- Importance of statistical methods in trial design and analysis.
- Interpreting results and determining clinical significance.
**The Future of GCP and Clinical Research**
- Innovations in clinical trial methodology.
- The impact of technology on GCP and patient engagement.
**Conclusion**
- The ongoing importance of GCP for the integrity of clinical research.
- The global impact of GCP on healthcare and medicine.
Each of these sections can be elaborated to create a full essay that discusses the principles and practices of GCP in depth. For the most current and detailed information, you can refer to the ICH E6 (R2) Good Clinical Practice guidelines¹, which are recognized internationally and provide a comprehensive framework for conducting clinical trials that involve human subjects. Additionally, the draft version of the ICH E6 (R3) principles provides updated guidance on ethical trial conduct, participant safety, and reliable results².
Remember, while expanding on these points, it's essential to cite relevant guidelines, regulations, and literature to support your discussion and provide a well-rounded view of GCP.
Source: Conversation with Bing, 19/02/2024
(1) ICH E6 (R2) Good clinical practice - Scientific guideline. https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice-scientific-guideline.
(2) ICH-E6 Good Clinical Practice (GCP). https://database.ich.org/sites/default/files/ICH_E6-R3_GCP-Principles_Draft_2021_0419.pdf.
(3) ICH Guidance Documents | FDA. https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/ich-guidance-documents.
(4) Good Clinical Practice Guidelines (India) - Rajiv Gandhi Centre for .... https://www.rgcb.res.in/documents/Good-Clinical-Practice-Gu
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
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
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.
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.
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
2. SLIDE INDEX
• INTRODUCTION
• DECLARATION OF HELSINKI
• ISTITUTIONAL ETHICS COMMITTEE
• STRUCTURE
• MEMBERS
• FUNCTION OF IEC
• SUBMISSION OF APPLICATION
• REVIEW
• DECISSION
• CONFLICT OF INTEREST
• CONCLUSION
3. INTRODUCTION
The ethical and scientific standards for carrying out biomedical
research on human subjects have been developed and established
in international guidelines, including
Declaration of Helsinki,
CIOMS-International Ethical Guidelines for Biomedical
Research Involving Human Subjects, and
WHO and ICH Guidelines for Good Clinical Practice.
.
4. National Guidelines
ICMR – Ethical guidelines for biomedical research on
human participants.
Indian GCP Guidelines
Principle of precaution and risk minimization states that due
care and caution must be taken at all stages of research to
ensure that research participant and those affected by it
including community are put to minimum risk, suffer from no
known irreversible adverse effects
5. A cardinal principle of research involving human
participants is ‘respect for the dignity of persons’.
All guidelines require the ethical and scientific review of
biomedical research alongside informed consent
6.
7. DECLARATION OF HELSINKI
• The World Medical Association has developed the
Declaration of Helsinki as a statement of ethical
principles to provide guidance to physicians and other
participants in medical research involving human
subjects. Medical research involving human subjects
includes research on identifiable human material or
identifiable data.
• PRINCIPLES:
It is the duty of the physician in medical research to
protect the life, health, privacy, and dignity of the human
subject.
Medical research involving human subjects must
conform to generally accepted scientific principles
8. Appropriate caution must be exercised in the conduct of
research which may affect the environment
The design and performance of each experimental
procedure involving human subjects should be clearly
formulated in an experimental protocol.
The research protocol should always contain a statement
of the ethical considerations involved and should indicate
that there is compliance with the principles enunciated in
this Declaration.
This independent committee should be in conformity
with the laws and regulations of the country in which the
research experiment is performed. The committee has the
right to monitor ongoing trials
9. Medical research involving human subjects should be
conducted only by scientifically qualified persons and under
the supervision of a clinically competent medical person.
Every medical research project involving human subjects
should be preceded by careful assessment of predictable
risks and burdens in comparison with foreseeable benefits to
the subject or to others
Physicians should cease any investigation if the risks are
found to outweigh the potential benefits or if there is
conclusive proof of positive and beneficial results.
Medical research is only justified if there is a reasonable
likelihood that the populations in which the research is
carried out stand to benefit from the results of the research
10. The subjects must be volunteers and informed
participants in the research project.
Every precaution should be taken to respect the privacy
of the subject, the confidentiality of the patient’s
information and to minimize the impact of the study on
the subject’s physical and mental integrity and on the
personality of the subject.
For a research subject who is legally incompetent,
physically or mentally incapable of giving consent or is a
legally incompetent minor, the investigator must obtain
informed consent from the legally authorized
representative in accordance with applicable law
In publication of the results of research, the investigators
are obliged to preserve the accuracy of the results.
12. INSTITUTIONALETHICS
COMMITTEE (IEC)
Independent body constituted of medical, non-medical,
scientific and non-scientific members whose responsibility is
to ensure the protection of the rights, safety and well-being of
human subjects involved in the trial by, among other things,
reviewing, approving & providing continuing review of trial
protocol & amendments.
13. STRUCTURE OF IEC
Composition:
• Multidisciplinary and multisectorial in composition
• Number of persons- 8-12
Specific members of IECs:
• Chair person should preferably be from outside the
Institution to maintain the independence of the
Committee.
• Member secretary, from same institution should conduct
the business of the Committee
14. MEMBERS OF IEC
Chair person
1-2 basic medical scientists
1-2 clinicians from various institutes
One legal expert or retired judge
One social scientist/representative of NG voluntary
agency
One philosopher/ethicist/theologian
One lay person
Member Secretary
15. ECs should establish standard operating procedures that
state
the functions and duties of the EC,
membership requirements,
the terms of appointment,
the conditions of appointment,
the offices,
internal procedures, and
the quorum requirements
16. FUNCTIONS OF IEC
To provide competent review of all ethical aspects of the
project
Undertake review free from bias and influence
Provide advice to the researchers on all aspects of welfare and
safety of research participants
To protect dignity, rights and well-being of the potential
research participants.
17. To ensure universal ethical values and international
scientific standards in terms of local community values
and customs.
To assist in the development and the education of
research community responsive to local health care
requirements.
18. SUBMISSION OFAPPLICATION OF
RESEARCH TO IEC
• The following documents must be submitted:
- Trial Protocol (in prescribed format)
- Patient Information Sheet and Informed Consent Form and its
translations
- Investigators brochure
- Principal Investigator’s current C.V.
- Insurance policy/ compensation for participation
- Investigators Agreement with the sponsor
19. REVIEW OF PROJECT
• Scientific evaluation should be completed before ethical
evaluation
• Evaluate possible risks to the subjects with proper
justification
• Expected benefits
20. • Adequacy of documentation for ensuring privacy,
confidentiality and justice issues
• The ethical review should be done through formal
meetings and should not resort to decisions through
circulation of proposals
• Decisions are preferably arrived at by consensus
21.
22. The IEC’s member secretary shall screen the proposals
for their completeness and depending on the risk involved
categorize them into:
Expedited review
Full review
Exempted from review
23. FULLREVIEW
All research proposals presenting with more than minimal
risk.
Projects that involve vulnerable population (children,
psychiatric patients etc.,)
Full review is carried out in cases involving
(a) collection of blood samples
(b) Prospective collection of biological specimens eg. Skin
appendages, excreta saliva, placenta, amniotic fluid, sputum
etc
24. EXPEDITED REVIEW
• Those with no more than minimal risk to research
participants may be subjected to this review
Ex: clinical studies of drugs and medical devices
the research involves already approved drugs
when a adverse event or unexpected adverse reaction is
reported
25. EXEMPTED FROM REVIEW
Proposals with less than minimal risk
Ex: research on educational practice,
• instructional technics, curricula,
• classroom management methods
26. Following are consideredfor ethical review
Scientific design and conduct of study
Recruitment of Research Participants
Care and Protection of Research Participants
Protection of research participant confidentiality
Informed Consent Process
27. SCIENTIFIC DESIGNAND CONDUCT
OF STUDY
Appropriateness of study design
Statistical methodology including sample size calculation
Risk vs anticipated benefits for research participants.
Justification for Controls used
Withdrawal criteria of participants
Criteria for termination of trial
Adequacy of monitoring and auditing the conduct of
research.
Site facilities for handling emergencies.
Reporting and Publication issues
28. RECRUITMENT OF RESEARCH
PARTICIPANTS
• Study population – demographic characteristics
• Means by which participants are contacted and recruited.
• Means by which full information is conveyed to research
participants or their representatives
• Criteria for recruitment
Inclusion criteria
Exclusion criteria
29. CAREAND PROTECTION OF
RESEARCH PARTICIPANTS
• Suitability of investigator qualifications and experience for
proposed study.
• Medical care to be provided to participants during and after
research.
• Adequacy of medical supervision
• Steps taken if participants voluntarily withdraw from study
• Informed consent
• Insurance and indemnity arrangements
30. PROTECTION OF RESEARCH
PARTICIPANT CONFIDENTIALITY
• Description of persons who will have access to personal
data of research participants, including medical records
and biological samples.
• Measures taken to ensure the confidentiality and security
of personal information concerning research participants.
31. INFORMED CONSENT PROCESS
Adequacy, completeness and understandability of written and
oral information given to participants or their legal
representatives
Clear justification for intention to include research
individuals who cannot consent
Assurance that participants will receive any new information
that becomes available
Contact details of persons whom the participants need to
contact for any complaints or queries.
32. DECISION
Out right approval (at most, only very minor changes are
suggested. The application contained all necessary
information.)
Approval with modifications (there is enough information
to judge the study, but clarification or changes are
needed)
Resubmit with more information (there is not enough
information to judge the application appropriately
Outright disapproval (there is no way the researcher can
ethically do study)
33. RECORDS
Constitution & composition of IEC.
CV of all members & records of training
SOPs of the IEC
National & International guidelines
Copies of protocol submitted for review
All correspondence with IEC members and
Investigators regarding application, decision and follow
up.
34. Agenda of all IEC meetings and Minutes signed by
chairperson
Copies of decisions communicated to applicants
Notifications issued for premature termination of study
Final report of the study
All records must be safely maintained after
completion/termination of study for 3 years.
35. REVIEW
Periodic Review:
Ongoing research may be reviewed at regular intervals of six
months to one year
Continuing Review:
The IEC has the responsibility to continue reviewing approved
projects for continuation, new information, adverse event
monitoring, follow up.
Interim Review:
Interim Review – decide special circumstances for review by
sub-committee – re-examination of proposal already examined
by IEC.
36. CONFLICT OF INTEREST
• A conflict of interest is a set of conditions in which
professional judgment concerning a primary interest (such as
a patient’s welfare or the validity of the research) tends to be
unduly influenced by a secondary interest (such as financial
gain)
37. CONCLUSION
• An Institutional Ethics Committee is a mandatory
requirement as per the ICMR which is the over –seeing
body of medical research in India
• It is an Independent body constituted of medical, non-
medical, scientific and non-scientific members whose
responsibility is to ensure the protection of the rights,
safety and well-being of human subjects involved in the
trial
Minimum risk would be defined as one which may be anticipated as harm or discomfort not greater than that encountered in routine daily life activities or during performance of routine examinations or tests.