The document provides information about the process of obtaining informed consent from participants in clinical trials and research. It discusses key elements of informed consent including understanding the purpose and risks of the research, participation being voluntary, and procedures to ensure comprehension. The summary is as follows:
1. The document outlines the important elements of informed consent such as understanding the nature, risks, and benefits of the research as well as the voluntary nature of participation.
2. It discusses the informed consent process including providing information verbally and in writing, allowing time for questions, and obtaining signatures. Special considerations are given for vulnerable populations.
3. Electronic methods of consent are also discussed as an alternative to traditional paper-based informed consent forms.
inform consent form before participate in clinical trials.for purpose of understanding the nature of research,risk,benefits,and decision about participation
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.
inform consent form before participate in clinical trials.for purpose of understanding the nature of research,risk,benefits,and decision about participation
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.
Before the enrollment of a patient in a clinical trial and beginning of any trial-related procedures, an informed consent is obtained from the potential participants. This informed consent form (ICF) provides the participants with the information related to the clinical trial. TSDP provides regulatory medical writing training on preparation of ICF.
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.
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
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-
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Randomization is the process by which allocation of subjects to treatment groups is done by chance, without the ability to predict who is in what group. It is done in clinical trials. This presentation describes the methods of randmization used in clinical trials.
Before the enrollment of a patient in a clinical trial and beginning of any trial-related procedures, an informed consent is obtained from the potential participants. This informed consent form (ICF) provides the participants with the information related to the clinical trial. TSDP provides regulatory medical writing training on preparation of ICF.
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.
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
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
Randomization is the process by which allocation of subjects to treatment groups is done by chance, without the ability to predict who is in what group. It is done in clinical trials. This presentation describes the methods of randmization used in clinical trials.
inform consent form in clinical research process.defination of inform consent form .documents required for inform consent form
elements required for inform consent form
This is about Informed Consent, in Bio-Ethics, this must be taken from participants before doing any Research, involving Human Participants. And I obtained this information from ICMR's Publication of 2017 about Bio-Ethics.
The Declaration of Helsinki is a set of ethical principles and guidelines for medical research involving human subjects. It was first adopted by the World Medical Association (WMA) in 1964 and has been revised multiple times, with the most recent version released in 2013. The Declaration provides a framework to protect the rights, safety, and well-being of individuals participating in research studies. Here are the key elements of the Declaration of Helsinki:
Respect for Autonomy and Informed Consent: The Declaration emphasizes the importance of respecting the autonomy of individuals and their right to make informed decisions about participating in research. It requires researchers to obtain informed consent from participants or their legally authorized representatives, ensuring they have been adequately informed about the study's purpose, procedures, potential risks and benefits, and their right to withdraw at any time.
Beneficence and Risk Assessment: Researchers have a responsibility to maximize potential benefits and minimize potential harm to research participants. The Declaration states that research protocols should be based on a thorough scientific assessment of risks and benefits and should prioritize the well-being of participants.
Ethical Review and Approval: The Declaration highlights the necessity of independent ethical review of research protocols by an appropriate research ethics committee or institutional review board (IRB). The committee should ensure that the study is scientifically valid, ethically sound, and compliant with relevant regulations and guidelines.
Privacy and Confidentiality: The Declaration emphasizes the importance of protecting the privacy and confidentiality of research participants. Researchers should ensure that participants' personal information is kept confidential, and data should be anonymized or pseudonymized whenever possible to protect participant identities.
Data and Safety Monitoring: The Declaration emphasizes the importance of ongoing data monitoring and safety assessments during the research study. Researchers should have plans in place to detect and manage any adverse events or unanticipated risks that may arise during the study.
Vulnerable Populations: Special protections are outlined for vulnerable populations, such as children, pregnant women, prisoners, and individuals with impaired decision-making capacity. Researchers should take extra precautions to ensure their well-being, and their involvement in research should be justified based on the potential benefits to their own population.
Publication and Dissemination of Results: The Declaration emphasizes the responsibility of researchers to publish and share the results of their research in a timely manner. The results should be accurately reported, and negative or inconclusive results should also be disseminated to prevent publication bias.
Informed consent is a process in which a patient or research participant is provided with information about a medical procedure or research study, including its risks and benefits, in order to make an informed decision about whether or not to participate. The informed consent process is a critical component of ethical medical practice and research and is intended to protect the rights and welfare of patients and research participants.
Here are some key elements of the informed consent process:
Information: The patient or research participant must be provided with information about the medical procedure or research study, including its purpose, procedures, risks, benefits, and alternatives.
Capacity: The patient or research participant must have the capacity to understand the information provided and make a decision based on that understanding.
Voluntariness: The decision to participate must be made voluntarily, without coercion or undue influence.
Documentation: The informed consent process must be documented in writing, including the information provided, the decision made, and any questions or concerns raised by the patient or research participant.
Ongoing consent: Informed consent is an ongoing process and must be re-evaluated if there are changes to the procedure or study, or if new information becomes available.
Consent for minors: In the case of minors, informed consent must be obtained from a legal guardian or parent.
The informed consent process is a fundamental aspect of ethical medical practice and research. It ensures that patients and research participants are fully informed about the procedures and risks involved and that they have the opportunity to make an informed decision about whether or not to participate.
ANTIDIARREHAL AGENTS, therapy,ORS, DRUGS used ,
IBD DRUGS, loperamide, probiotics,antisecreatory drugs, antimotility
mechanism of each drugs used in diarrhea
Spontenous adr reporting in india
PASSIVE survillence system, data assement
data aciqsition, data interpretation, what all information required in ADR form, WHEN TO REPORT
BLUE CARD,YELLOW CARD, WHO CODES
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
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.
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
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!
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.
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
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.
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.
3. INTRODUCTION
• Millions of volunteers participate in government and industry sponsored
clinical trial each year.
• Prior to agreeing to participate, every volunteers has right to know and
understand what happen during clinical trial .
• This is called as informed consent and this process that can help to
decide whether or not participating in a trial is right for you .
4. PURPOSE
• Prospective Subject Will ………
Understand nature of research
Be informed of purpose, risks, and benefits, and
alternative therapies.
Make a Voluntary Decision about Participation
5. DEFINING INFORMED CONSENT
Informed consent is defined by the ICH for GCP
“ A process by which a subject voluntarily confirms his or her
willingness to participate in a particular trial, after having been
informed of all aspects of the trial that are relevant to the subject’s
decision to participate”.
Informed consent is documented by means of a written, signed
and dated informed consent form.
6. WHAT IS INFORMED CONSENT FORM
Informed consent is a communication process:
Between the researcher and the participant.
Starts before the research is initiated .
Continues throughout the duration of the study .
Providing all relevant information to the volunteer/ patient.
The patient/ volunteer understanding the information provided
Voluntarily agreeing to participate.
A basic right.
7. INFORMED CONSENT ALLOWS
INDIVIDUALS:
To determine whether participating in research fits with
their values and interests.
To decide whether to contribute to this specific research
project.
To protect themselves from risks.
To decide whether they can fulfill the requirements
necessary for the research.
8. INFORMED CONSENT OF SUBJECT:
Prior to the beginning of the Study
– The Investigator(s) should obtain the Ethics Committee’s approval
for
– The written informed consent form and
– All information being provided to the Subjects and / or their legal
representatives or guardians as well as an impartial witness.
9. The information should be given to
– the Subjects and / or their legal representatives or guardians in a
language and at a level of complexity that is understandable to the
Subject(s) in both written and oral form, whenever possible
Subjects, their legal representatives or guardians should be given
adequate opportunity and time to enquire about the details of the Study
and all questions answered to their satisfaction.
10. The Investigator(s), Sponsor or staff of the Institution should not
pressure or unreasonable influence a potential Subject to participate or to
continue to participate in the Study.
Careful consideration should be given to ensuring the freedom of
consent obtained from members of a group which Classified according
to various structure- such as medical, pharmacy and nursing students,
subordinate hospital and laboratory personnel, employees of the
pharmaceutical industry, and members of the armed forces
11. Persons with
– incurable diseases,
– in custody,
– unemployed or needy,
– in emergency rooms,
– homeless persons,
– wanderers, any ethnic or racial minority groups should be
considered as dangerous population whose mode of consent should
be carefully considered and approved by the Ethics Committee.
12. Prior to the Subject’s participation in the Study the written
Informed Consent form should be signed and personally saw by
(i) The Subject or
(ii) If the Subject is incapable of giving an Informed Consent for
example children, unconscious or suffering from severe mental
illness or disability, by the Subject’s legal representative or
guardian or
(iii) If the Subject and his legal representative or guardian is unable
to read / write, An impartial witness who should be present
during the entire informed consent discussion
(iv) The Investigator
13. By signing the consent form the witness certifies that the
information in the consent form and any other written
information was accurately explained to, and apparently
understood by, the Subject or the Subject’s legal representative
or the guardian, and that informed consent was freely given by
the Subject or the Subject’s legal representative or the guardian.
14. HOW DOES INFORMED CONSENT APPLY TO CHILDREN'S??
1. Children do not have the decision-making capacity to provide informed consent.
2. Since Therefore, parents or other surrogate decision-makers may give informed
permission for diagnosis and treatment of a child, preferably with the assent of the child
whenever possible.
3. Other disagreements in care may result in court orders that specify what treatment should
occur (for example, blood transfusions), or in the court-ordered appointment of a
guardian to make medical decisions for the child.
4. Depending on the type of research, the IRB may make provisions for “assent” of
children
Assent
A child’s affirmative agreement to be a participant in research. It is a term used to express willingness to participate
in research by person who are by definition too young to give informed consent but who are old enough to
understand the proposed research in general, its expected risks and possible benefits, and the activities expected of
them as subjects.
15. AGE>/=18
YES NO
Subject and person
obtaining consent sign the
ICD
Parent, guardian, witness, and
person obtaining consent sign the
ICD
1. Child age : 7-12 verbal assent
2. Child age : 13-17 written assent required
16. INFORM CONSENT IN PREGNANT WOMEN
Researchers should obtain informed consent from both
the pregnant woman and the father, consent of the father
is not necessary if…
1. The purpose of the study is to meet the health needs of
the mother.
2. The identity or where about of the father can not be
reasonably ascertained.
17. INFORMED CONSENT FORM IN NON ENGLISH SPEAKING
PERSON
1. Ideal is to use consent translated to participant’s native language
2. A copy of the consent document must be given to each subject.
While a translator may be helpful in facilitating conversation with
a non-English speaking subject, verbal translation of the consent.
3. Document must not be substituted for a written translation.
18. INFORMED CONSENT IN ILLITERATE PERSON
An investigator may enrol individuals, who can speak and
understand English,
The potential subject must be able to place a written mark on the
consent form.
After that the subject must also be able to:
1.Comprehend the concepts of the study and understand the risks
and benefits of the study as it is explained verbally, and
2. Be able to indicate approval or disapproval for study enrollment.
19. BELMONT REPORT
Expanded the definition of Informed consent.
Participants-kept informed throughout the experiment,
Understand risks and benefits.
Protection of vulnerable group.
20. ELEMENTS IN INFORMED CONSENT FORM
1.Protocol number or name of study
2.Purpose of the study.
3.Duration of study and subject involvement
4.A statement that the protocol, and the informed consent were reviewed with the participant, including
the risks and benefits of the study.
5.Alternative treatment options discussed.
6.Confidentiality record
7.No of subjects
8.Compensation for injury
9.Time for questions to be asked and answered.
10.Description of the participant’s decision
11.Contact details
12.Travel reabusment
13.Subject responsibilities
14.Subject satisfaction
15.Use understandable language
16.Copy of consent was given to the participant
17.Sign copy of ICF
21. IN ADDITION, THE FOLLOWING ELEMENTS MAY ALSO BE
REQUIRED, DEPENDING ON THE TYPE OF STUDY:
1.Any alternative procedures or courses of treatment that might be as advantageous
to the participant as the ones to which she/he is going to be subjected.
2.If there is a possibility that the research could lead to any stigmatizing condition,
for example HIV and genetic disorders, provision for pretest- and post-test
counselling.
3.Insurance coverage if any, for research-related or other adverse events.
4.Foreseeable extent of information on possible current and future uses of the
biological material and of the data to be generated from the research.
22. iii)Right to prevent use of her/his biological sample, such as DNA, cell-line, etc., and
related data at any time during or after the conduct of the research.
iv)Risk of discovery of biologically sensitive information and provisions to safeguard
confidentiality.
v)Post research plan/benefit sharing, if research on biological material and/or data
leads to commercialization.
vi) Publication plan, if any, including photographs and pedigree charts.
Other specifics are as follows:
i)Period of storage of the sample/data and probability of the material being used for
secondary purposes.
ii)Whether material is to be shared with others, this should be clearly mentioned.
23. RESPONSIBILITY OF RESEARCHERS
1.The researcher should only use the EC approved version of the consent form, including
its local translations.
2.Adequate information necessary for informed consent should be communicated in a
language and manner easily understood by prospective participants.
3.In case of differently abled participants, such as individuals with physical, neurological
or mental disabilities, appropriate methods should be used to enhance the participants’
understanding, for example, braille for the visually impaired.
4.There should be no restriction on the participant’s right to ask questions related to the
study or to discuss with family and friends or take time before coming to a decision.
24. 6.The researcher must ensure that the participant is competent and has understood all
aspects of the study and that the consent is given voluntarily. Where the participant
and/or the LAR are illiterate, an impartial literate person, not connected to the research,
should be present throughout the consent process as witness.
7. The researcher should administer a test of understanding whenever possible for
sensitive studies. If need be, the test may be repeated until the participant has really
understood the contents.
5.The researcher should not give any unjustifiable assurances or influence or intimidate a
prospective participant to enroll in the study.
25. 8.When a participant is willing to participate but not willing to sign or give a thumb
impression or cannot do so, then verbal/oral consent may be taken on approval by
the EC, in the presence of an impartial witness who should sign and date the consent
document. This process can be documented through audio or video recording of the
participant.
26. WAIVER OF CONSENT
The researcher can apply to the EC for a waiver of consent if the research involves less
than minimal risk to participants and the waiver will not adversely affect the rights and
welfare of the participants
The EC may grant consent waiver in the following situations:
• Research cannot practically be carried out without the waiver and the waiver is scientifically
justified;
• Retrospective studies, where the participants are de-identified or cannot be contacted;
• Research on anonymized biological samples/data;
• Certain types of public health studies/surveillance programmes/programme evaluation studies;
• Research on data available in the public domain; or
• Research during humanitarian emergencies and disasters, when the participant may not be in a
position to give consent. Attempt should be made to obtain the participant’s consent at the
earliest.
27. PROCESS
A consent form is provided by the sponsor
with the study protocol or created by the
site investigator.
The consent form is personalized by
each site, adding local contact names
and numbers.
The consent from is approved for use by
the institutional review board(IRB)
Investigator or designated study personnel
informs the patient about the study ,purpose,
risks, and potential benefits.
28. The patient is allowed time to read the consent
form, ask questions and consider participation.
Patient or legal representative signs and dates
the consent form. The sponsor and/or IRB may
require additional signatures
The patient given a copy of the consent form
and study treatment and procedures can be
started
29. INFORMATION SHOULD INCLUDE IN INFORMED CONSENT FORM
1.Why the research is being done
2. What the researchers hope to accomplish
3. A description of what will be done during the study and how long you are expected to
participate
4. The risks to you from participation in the study
5. The benefits that you can expect from participation in the study
6. Other treatments that are available if you decide not to participate in the study
7. Verification that you have the right to leave the study at any time, and that standard
medical care will be provided without penalty if you choose to withdraw from the study.
8. Although an informed consent document must be signed before enrollment in a study, it
is important to remember that informed consent is a process that continues throughout the
study.
9. You may ask questions of the health care providers at any time before, during, or after
the study.
30. Informed Consent Worksheet
Date of Consent:__________________ Name of Study: ________________________IRB Study Number:__________________
Patient Name:_____________________ Patient MRN:____________________ Study ID#:________________________
The following has been explained to the potential study subject, and the subject has been offered the opportunity to ask questions regarding the study:
TOPIC COMMENTS
Purpose of the study _________________________________
Qualifications to participate _________________________________
Location and participants _________________________________
What will happen during the study _________________________________
Risk and benefits _________________________________
Study related injury or illness _________________________________
Alternative treatments _________________________________
Confidentiality _________________________________
Study costs _________________________________
Compensation _________________________________
Who to contact with questions _________________________________
Voluntary participation _________________________________
Termination of participation _________________________________
Questions or comments: __________________________________________________________________
__________________________________________________________________
Does the patient state an understanding of the study and procedures and agree to participate?
___yes ___no
_____________________________________ __________________________
Person administering consent Date / Time
Signed copy given to patient? ___yes ___no Copy in patients chart? ___yes ___no
31. CONSENT FORM
INFORMATION SHEET
•1. Introduction
• 2. Purpose of
research
• 3. Type of
research
intervention
• 4.
Participation
selection
• 5. Voluntary
participation
•6. Procedure
CONSENT
CERTIFICATE
32. INTRODUCTION
Briefly state who you are and explain that you are inviting them to participate
in the research you are doing.
Inform them that they may talk to anyone they feel comfortable talking with
about the research and that they can take time to reflect on whether they want
to participate or not.
Assure the participant that if they do not understand some of the words or
concepts, that you will take time to explain them as you go along and that they
can ask questions now or later.
33. PURPOSE OF RESEARCH
Explain in lay terms why you are doing the research.
The language used should clarify rather than confuse. Use local and
simplified terms for a disease, e.g. local name of disease instead of
malaria, mosquito instead of anopheles, “mosquitoes help in
spreading the disease” rather than “mosquitoes are the vectors”.
Avoid using terms like pathogenesis, indicators, determinants,
equitable etc.
There are guides on the internet to help you find substitutes for
words which are overly scientific or are professional jargon.
34. TYPE OF RESEARCH INTERVENTIONS
Briefly state the type of intervention that will be undertaken.
This will be expanded upon in the procedures section but it may
be helpful and less confusing to the participant if they know from
the very beginning whether, for example, the research involves a
vaccine, an interview, a biopsy or a series of finger pricks.
35. PARTICIPATE SELECTION
State why this participant has been chosen for this research. People often wonder
why they have been chosen to participate and may be fearful, confused or
concerned.
Voluntary participations.
36. PROCEDURES AND PROTOCOL
A. Unfamiliar Procedures
This section should be included if there may be procedures which are not familiar to the
participant.
If the protocol is for a clinical trial:
1) involving randomization or blinding, the participants should be told what that means and
what chance they have of getting which drug (i.e. one in four chances of getting the test
drug).
2) involving an inactive drug or placebo, it is important to ensure that the participants
understand what is meant by a placebo or inactive drug.
3)which may necessitate a rescue medicine, then provide information about the rescue
medicine or treatment such as what it is and the criterion for its use.
37. If the protocol is for clinical research:
Firstly, explain that there are standards/guidelines that will be followed for the treatment
of their condition. Secondly, if as part of the research a biopsy will be taken, then explain
whether it will be under local anesthesia, sedation or general anesthesia, and what sort of
symptoms and side effects the participant should expect under each category.
For any clinical study (if relevant):
If blood samples are to be taken explain how many times and how much in a language
that the person understands.
38. B. Description of the Process
Describe to the participant what will happen on a step-by-step basis. It may be
helpful to the participant if you use drawings or props to better illustrate the
procedures. A small vial or container with a little water in it is one way of showing
how much blood will be withdrawn.
Duration
Side effects
Risks
Benefits
Reimbursements
Confidentiality
Right to refuse or withdraw
Alternative to participation
Who to contact
39. ELECTRONIC CONSENT
These are electronic processes that use various, and possibly multiple, electronic formats such as
text, graphics, audio, video, podcasts or interactive websites to explain information related to a
study and to document informed assent/consent from a participant or LAR.
The process, electronic materials, method of documentation (including electronic/ digital
signatures), methods used to maintain privacy of participants, confidentiality, and security of the
information as well as data use policies at the research site must be reviewed and approved by the
EC
In addition to electronic consent, if required a paper/soft copy of the document is needed for
archiving and a paper/soft copy is also given to the participant.
Interactive formats, if used, should be simple to navigate.
Electronic methods should not be used if participants, for any reason, indicate a lack of
comfort with electronic media.