SlideShare a Scribd company logo
Informed Consent
5/21/20191 DR. GK SHARMA PHARMD
 Introduction
 Informed consent is a Document or a Process
1. Consent is a continuous process, not a one-time event.
2. Document
 Useful information for subjects
 Names and contact information
 Reminder about study procedures
“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.”
Goal
 “The goal of the informed consent process is to provide people with sufficient information so they
can make informed choices about whether to begin or continue participation in clinical research.”
5/21/20192 DR. GK SHARMA PHARMD
 Need of IC
 Understand nature of research.
 Be informed of purpose, risks, and benefits, and alternative therapies.
 Make a Voluntary Decision about Participation.
Facts
Enrol
do harm
best
alternative
Potential
alternatives
Therapeutic
misconception
5/21/20193 DR. GK SHARMA PHARMD
1. Enroll: Researchers need the person to enroll.
2. Do harm: Research can do harm.
3. Best alternative: Protocols may require specific procedures that may not be the best alternative.
4. Potential alternatives: Researchers may be blinded to potential alternatives.
5. Therapeutic misconception: of research subjects.
PROCEES OF IC
Discussion Review
SignaturesTime
Concerns
Signature
obtained
5/21/20194 DR. GK SHARMA PHARMD
 The process not only includes reviewing and signing the consent document, but may also include the following:
 Recruitment materials
1. Oral instructions or explanations
2. A question and answer period
3. Assessing subject understanding
4. Providing adequate time for the subject to review the form and consider their participation
5. Providing new findings or study updates as appropriate throughout the study
6. Periodic re-affirmation or re-consent as appropriate throughout the study
 In developing the consent process in the protocol, the following should be considered:
1. Setting
2. Timing
3. Minimizing Undue Influence
4. Use additional aids
5. Ask open-ended questions
6. Discuss
Information
provided
Comprehension
monitored and
maintained
Decision madeInformation
understood
5/21/20195 DR. GK SHARMA PHARMD
1. Setting: Generally speaking consent discussions should occur in a private setting where your conversation
won’t be overhead by others.
2. Timing: It may take several meetings/discussions before the potential subject not only understands the study
but, for those recently diagnosed with a new disease or disorder it may also require additional time to
understand the new information and what alternative treatment options may be available.
3. Minimizing Undue Influence: Vulnerable populations such as minors and students are particularly
susceptible to influence from authority. Healthcare providers have tremendous influence over patients within
their clinical practice.
4. Use additional aids: (videos, brochures, etc.) to explain study procedures and supplement the information
provided in the consent document.
5. Ask open-ended questions: to potential subjects to assess their understanding of the study (e.g., “In your
own words, tell me…what the study is about; what will happen to you if you decide to be in the study; what
risks might you experience; what other options do you have.”).
6. Discuss: the study in the presence of “personal advisors” (friends/family members) who may aid in the
subject’s decision making process, with the permission of the potential subject.
5/21/20196 DR. GK SHARMA PHARMD
 Guidelines for Informed Consent
1. The Nuremberg Code, 1947
2. The Declaration of Helsinki, 1964 (2000)
3. The Belmont Report, 1979
4. ICH GCP, 1997
5. ICMR Guidelines, 2000
 The Nuremberg Code What is it?
 Published in 1947
 The voluntary consent of the human subject is absolutely essential
 Person must have legal capacity to consent
 Should have “sufficient knowledge
 Inform the subject of
 The nature, duration and purpose
 The method and means
 All inconveniences and hazards
 Possible effects on health
5/21/20197 DR. GK SHARMA PHARMD
 The Declaration of Helsinki
A statement of ethical principles on research involving humans
 Published by the World Medical Association
 Developed from the Nuremberg Code
 Made by physicians
 First adopted at Helsinki in 1964
 Subjects must be
 Volunteers
 Informed participants
5/21/20198 DR. GK SHARMA PHARMD
 The Belmont Report
 Ethical principles and guidelines for protecting humans in clinical research
 Published in 1979
 Identifies three elements of the process
 Information
 Comprehension
 Voluntariness
 Information
 All information be provided
 Conditions under which information provided also important (rapid/ disorganized manner?)
 Comprehension
 Adapt presentation of information to subject’s capacities
 Investigators must ascertain comprehension
 Special provisions – immaturity, mental disability
 Voluntariness
 There must be no coercion or undue influence
 Understand risks and benefits.
5/21/20199 DR. GK SHARMA PHARMD
 ICMR Guidelines
 Ethical guidelines for research involving humans “Ethical Guidelines for Biomedical Research on Human Subjects”
 Published by the Indian Council of Medical Research in 2000
 Revised version – 2006
1. Nature and purpose: of study stating it as research
2. Duration: of participation with number of participants
3. Procedures: to be followed
4. Investigations, if any, to be performed
5. risks and discomforts adequately described and whether project involves more than minimal risk
6. Compensations in trial related injury
a. Adverse effects of Investigational product(s).
b. Departure from approved protocol, scientific misconduct or negligence by the Investigator.
c. Failure of an Investigational Product to provide attended therapeutic effect.
d. Administration of placebo providing no therapeutic benefits.
e. Compensation for injury to a child in utero because of the participation of parent in Clinical. 5/21/201910 DR. GK SHARMA PHARMD
7. No loss of benefits on withdrawal
8. Benefit sharing in the event of commercialization
9. Contact details of PI or local PI/Co-PI in multicentric studies for asking more information
10. Contact details of Chairman of the IEC for appeal against violation of rights
11. Voluntary participation
12. If test for genetics and HIV is to be done, counseling for consent for testing must be given as per national
guidelines
13. Storage period of biological sample and related data with choice offered to participant regarding future use
of sample, refusal for storage and receipt of its result
5/21/201911 DR. GK SHARMA PHARMD
 Elements of informed consent
Elements of informed consent
Essential Additional
Alternativ
es
Confidentialit
y
Benefi
ts
Risks
Purpo
se
Voluntary
participatio
n
Compensat
ion
Contact
informatio
n
Essential
5/21/201912 DR. GK SHARMA PHARMD
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
5. participant, including the risks and benefits of the study.
6. Alternative treatment options discussed.
7. Confidentiality record
8. No of subjects
9. Compensation for injury
10. Time for questions to be asked and answered.
11. Description of the participant’s decision
12. Contact details
13. Travel reabusment
14. Subject responsibilities
15. Subject satisfaction
16. Use understandable language
17. Copy of consent was given to the participant
18. Sign copy of ICF
5/21/201913 DR. GK SHARMA PHARMD
 Additional
 Additional elements required by federal regulations:
1. Unforeseeable risks: to the subject (or to the embryo or fetus, if the subject is or may become pregnant)
2. Side effects: of a study drug are too severe, the sponsor terminates the study.
3. Additional costs: to the subject to participate (e.g., hospitalization, cost of testing)
4. Consequences of subject withdrawal from the study and procedures for withdrawal: that may be
necessary – include whether any adverse health or welfare effects may be anticipated (e.g., the need to taper
a drug treatment),
5. New toxicities develop: if findings of a data & safety monitoring board raise safety concerns.
 Additional elements required for FDA regulated research:
1. A statement that the test article is “investigational” or “not FDA-approved”
5/21/201914 DR. GK SHARMA PHARMD
 Revisions to Informed Consent
1. Informed consent documents must be revised every time new safety information becomes available or there is
a change in trial procedures, participant compensation or personnel noted on the consent form.
2. Revisions to the informed consent document must be approved by an IRB/IEC prior to its use, and the
informed consent process with the new information and documentation needs to be repeated with every
clinical trial participant.
3. The participant is then required to sign the revised form.
5/21/201915 DR. GK SHARMA PHARMD

More Related Content

What's hot

INFORMED CONSENT FORM
INFORMED CONSENT FORMINFORMED CONSENT FORM
INFORMED CONSENT FORM
Turacoz Healthcare Solutions
 
Ethical guidelines for biomedical research in human participants
Ethical guidelines for biomedical research  in human participantsEthical guidelines for biomedical research  in human participants
Ethical guidelines for biomedical research in human participants
gangireddysaisneha
 
Informed Consent Form: Purpose, Definition, Rules, Elements, Process, Excepti...
Informed Consent Form: Purpose, Definition, Rules, Elements, Process, Excepti...Informed Consent Form: Purpose, Definition, Rules, Elements, Process, Excepti...
Informed Consent Form: Purpose, Definition, Rules, Elements, Process, Excepti...
Aniket Namdev
 
Informed consent
Informed consentInformed consent
Informed consent
Tamer Hifnawy
 
Origin and principles of international conference on harmonization- Good clin...
Origin and principles of international conference on harmonization- Good clin...Origin and principles of international conference on harmonization- Good clin...
Origin and principles of international conference on harmonization- Good clin...
AbhishekJoshi312
 
Guidelines for the preparation of protocol and documents in clnical trials
Guidelines for the preparation of protocol and documents in clnical trialsGuidelines for the preparation of protocol and documents in clnical trials
Guidelines for the preparation of protocol and documents in clnical trials
Sachin Kumar
 
Clinical trial study team
Clinical trial study teamClinical trial study team
Clinical trial study team
BharatPatil42
 
Guidelines for Preparation of Documents, Clinical Study Report Clinical Trial...
Guidelines for Preparation of Documents, Clinical Study Report Clinical Trial...Guidelines for Preparation of Documents, Clinical Study Report Clinical Trial...
Guidelines for Preparation of Documents, Clinical Study Report Clinical Trial...
Dinesh Gangoda
 
Informed consent process
Informed consent processInformed consent process
Informed consent process
DeveraneniVinay
 
Vulnerable Populations in Clinical Research.pptx
Vulnerable Populations in Clinical Research.pptxVulnerable Populations in Clinical Research.pptx
Vulnerable Populations in Clinical Research.pptx
DrPramod Kumar
 
Documentation clinical trial
Documentation clinical trialDocumentation clinical trial
Documentation clinical trial
ankit sharma
 
Ethics of clinical trials
Ethics of clinical trialsEthics of clinical trials
Ethics of clinical trials
Ssuna Bashir
 
Historical evolution of clinical trial guidelines in the world
Historical evolution of clinical trial guidelines in the worldHistorical evolution of clinical trial guidelines in the world
Historical evolution of clinical trial guidelines in the world
Bhagyashree Srivastava
 
Ethics in clinical research
Ethics in clinical researchEthics in clinical research
Ethics in clinical research
Laxmikant Deshmukh
 
Case Report Form (CRF)
Case Report Form (CRF)Case Report Form (CRF)
Case Report Form (CRF)
Neelam Shinde
 
roles and responsibilities of Investigator[663]
roles and responsibilities of Investigator[663]roles and responsibilities of Investigator[663]
roles and responsibilities of Investigator[663]
Integral university, Lucknow
 
Information about Ethics committee
Information about Ethics committee Information about Ethics committee
Information about Ethics committee
Ankit verma
 
institutional ethics committee
institutional ethics committeeinstitutional ethics committee
institutional ethics committee
Sirisha Annavarapu
 
ICH GCP GUIDELINES FOR CONDUCT OF TRIAL
ICH GCP GUIDELINES FOR CONDUCT OF TRIALICH GCP GUIDELINES FOR CONDUCT OF TRIAL
ICH GCP GUIDELINES FOR CONDUCT OF TRIAL
MOHAMMED FAHEEM KHAN
 
Introduction to clinical research
Introduction to clinical researchIntroduction to clinical research
Introduction to clinical research
Suman Baishnab
 

What's hot (20)

INFORMED CONSENT FORM
INFORMED CONSENT FORMINFORMED CONSENT FORM
INFORMED CONSENT FORM
 
Ethical guidelines for biomedical research in human participants
Ethical guidelines for biomedical research  in human participantsEthical guidelines for biomedical research  in human participants
Ethical guidelines for biomedical research in human participants
 
Informed Consent Form: Purpose, Definition, Rules, Elements, Process, Excepti...
Informed Consent Form: Purpose, Definition, Rules, Elements, Process, Excepti...Informed Consent Form: Purpose, Definition, Rules, Elements, Process, Excepti...
Informed Consent Form: Purpose, Definition, Rules, Elements, Process, Excepti...
 
Informed consent
Informed consentInformed consent
Informed consent
 
Origin and principles of international conference on harmonization- Good clin...
Origin and principles of international conference on harmonization- Good clin...Origin and principles of international conference on harmonization- Good clin...
Origin and principles of international conference on harmonization- Good clin...
 
Guidelines for the preparation of protocol and documents in clnical trials
Guidelines for the preparation of protocol and documents in clnical trialsGuidelines for the preparation of protocol and documents in clnical trials
Guidelines for the preparation of protocol and documents in clnical trials
 
Clinical trial study team
Clinical trial study teamClinical trial study team
Clinical trial study team
 
Guidelines for Preparation of Documents, Clinical Study Report Clinical Trial...
Guidelines for Preparation of Documents, Clinical Study Report Clinical Trial...Guidelines for Preparation of Documents, Clinical Study Report Clinical Trial...
Guidelines for Preparation of Documents, Clinical Study Report Clinical Trial...
 
Informed consent process
Informed consent processInformed consent process
Informed consent process
 
Vulnerable Populations in Clinical Research.pptx
Vulnerable Populations in Clinical Research.pptxVulnerable Populations in Clinical Research.pptx
Vulnerable Populations in Clinical Research.pptx
 
Documentation clinical trial
Documentation clinical trialDocumentation clinical trial
Documentation clinical trial
 
Ethics of clinical trials
Ethics of clinical trialsEthics of clinical trials
Ethics of clinical trials
 
Historical evolution of clinical trial guidelines in the world
Historical evolution of clinical trial guidelines in the worldHistorical evolution of clinical trial guidelines in the world
Historical evolution of clinical trial guidelines in the world
 
Ethics in clinical research
Ethics in clinical researchEthics in clinical research
Ethics in clinical research
 
Case Report Form (CRF)
Case Report Form (CRF)Case Report Form (CRF)
Case Report Form (CRF)
 
roles and responsibilities of Investigator[663]
roles and responsibilities of Investigator[663]roles and responsibilities of Investigator[663]
roles and responsibilities of Investigator[663]
 
Information about Ethics committee
Information about Ethics committee Information about Ethics committee
Information about Ethics committee
 
institutional ethics committee
institutional ethics committeeinstitutional ethics committee
institutional ethics committee
 
ICH GCP GUIDELINES FOR CONDUCT OF TRIAL
ICH GCP GUIDELINES FOR CONDUCT OF TRIALICH GCP GUIDELINES FOR CONDUCT OF TRIAL
ICH GCP GUIDELINES FOR CONDUCT OF TRIAL
 
Introduction to clinical research
Introduction to clinical researchIntroduction to clinical research
Introduction to clinical research
 

Similar to Informed consent

DECLARATION OF HELSINKI
DECLARATION OF HELSINKI DECLARATION OF HELSINKI
DECLARATION OF HELSINKI
ClinosolIndia
 
INFORMED CONSENT-for theory class.pptx, aims , bg nagar
INFORMED CONSENT-for theory class.pptx, aims , bg nagarINFORMED CONSENT-for theory class.pptx, aims , bg nagar
INFORMED CONSENT-for theory class.pptx, aims , bg nagar
RaviMundugaru1
 
Informed consent form
Informed consent form Informed consent form
Informed consent form
rasika walunj
 
Inform consents form
Inform consents form Inform consents form
Inform consents form
rasika walunj
 
Informedconsent lecture
Informedconsent lectureInformedconsent lecture
Informedconsent lecture
Ravi kumar
 
Gcp guidelines
Gcp guidelinesGcp guidelines
Gcp guidelines
Nilesh Siddhawar
 
Declaration of Helsinki
Declaration of HelsinkiDeclaration of Helsinki
Declaration of Helsinki
ClinosolIndia
 
Informed Consent Documents Dr. Prerana.pptx
Informed Consent Documents Dr. Prerana.pptxInformed Consent Documents Dr. Prerana.pptx
Informed Consent Documents Dr. Prerana.pptx
Dr Prerana Kadam
 
Infromed consent
Infromed consentInfromed consent
Infromed consent
SONALPANDE5
 
Helsinki declaration
Helsinki declarationHelsinki declaration
Helsinki declaration
Simran Narang
 
Informed consent form in clinical research.pptx
Informed consent form in clinical research.pptxInformed consent form in clinical research.pptx
Informed consent form in clinical research.pptx
Aneesha0316
 
REGULATORY AFFAIR Involve Informed Concent Process and Procedure.pptx
REGULATORY AFFAIR Involve Informed Concent Process and Procedure.pptxREGULATORY AFFAIR Involve Informed Concent Process and Procedure.pptx
REGULATORY AFFAIR Involve Informed Concent Process and Procedure.pptx
RAHUL PAL
 
REGULATORY AFFAIR (Informed Concent Process and Procedure)).pptx
REGULATORY AFFAIR (Informed Concent Process and Procedure)).pptxREGULATORY AFFAIR (Informed Concent Process and Procedure)).pptx
REGULATORY AFFAIR (Informed Concent Process and Procedure)).pptx
Prachi Pandey
 
ICH GCP by Yogesh Yadav.pptx
ICH GCP by Yogesh Yadav.pptxICH GCP by Yogesh Yadav.pptx
ICH GCP by Yogesh Yadav.pptx
yogesh532361
 
Siobhan gaynor patientclinicalresearchtalkdec15
Siobhan gaynor   patientclinicalresearchtalkdec15Siobhan gaynor   patientclinicalresearchtalkdec15
Siobhan gaynor patientclinicalresearchtalkdec15
ipposi
 
Guidelines on ethical approaches for clinical trials conducted with the pedia...
Guidelines on ethical approaches for clinical trials conducted with the pedia...Guidelines on ethical approaches for clinical trials conducted with the pedia...
Guidelines on ethical approaches for clinical trials conducted with the pedia...
Serkan Kaçar
 
1670327194_887_Research_with_human_participation.pptx
1670327194_887_Research_with_human_participation.pptx1670327194_887_Research_with_human_participation.pptx
1670327194_887_Research_with_human_participation.pptx
VelmaPranayReddy
 
Sept. CTA
Sept. CTASept. CTA
Sept. CTA
Lena Freund
 
Seminar schedule 'y'
Seminar schedule   'y'Seminar schedule   'y'
Seminar schedule 'y'
SameerKhasbage
 
Informed Consent Form
Informed Consent FormInformed Consent Form
Informed Consent Form
ClinosolIndia
 

Similar to Informed consent (20)

DECLARATION OF HELSINKI
DECLARATION OF HELSINKI DECLARATION OF HELSINKI
DECLARATION OF HELSINKI
 
INFORMED CONSENT-for theory class.pptx, aims , bg nagar
INFORMED CONSENT-for theory class.pptx, aims , bg nagarINFORMED CONSENT-for theory class.pptx, aims , bg nagar
INFORMED CONSENT-for theory class.pptx, aims , bg nagar
 
Informed consent form
Informed consent form Informed consent form
Informed consent form
 
Inform consents form
Inform consents form Inform consents form
Inform consents form
 
Informedconsent lecture
Informedconsent lectureInformedconsent lecture
Informedconsent lecture
 
Gcp guidelines
Gcp guidelinesGcp guidelines
Gcp guidelines
 
Declaration of Helsinki
Declaration of HelsinkiDeclaration of Helsinki
Declaration of Helsinki
 
Informed Consent Documents Dr. Prerana.pptx
Informed Consent Documents Dr. Prerana.pptxInformed Consent Documents Dr. Prerana.pptx
Informed Consent Documents Dr. Prerana.pptx
 
Infromed consent
Infromed consentInfromed consent
Infromed consent
 
Helsinki declaration
Helsinki declarationHelsinki declaration
Helsinki declaration
 
Informed consent form in clinical research.pptx
Informed consent form in clinical research.pptxInformed consent form in clinical research.pptx
Informed consent form in clinical research.pptx
 
REGULATORY AFFAIR Involve Informed Concent Process and Procedure.pptx
REGULATORY AFFAIR Involve Informed Concent Process and Procedure.pptxREGULATORY AFFAIR Involve Informed Concent Process and Procedure.pptx
REGULATORY AFFAIR Involve Informed Concent Process and Procedure.pptx
 
REGULATORY AFFAIR (Informed Concent Process and Procedure)).pptx
REGULATORY AFFAIR (Informed Concent Process and Procedure)).pptxREGULATORY AFFAIR (Informed Concent Process and Procedure)).pptx
REGULATORY AFFAIR (Informed Concent Process and Procedure)).pptx
 
ICH GCP by Yogesh Yadav.pptx
ICH GCP by Yogesh Yadav.pptxICH GCP by Yogesh Yadav.pptx
ICH GCP by Yogesh Yadav.pptx
 
Siobhan gaynor patientclinicalresearchtalkdec15
Siobhan gaynor   patientclinicalresearchtalkdec15Siobhan gaynor   patientclinicalresearchtalkdec15
Siobhan gaynor patientclinicalresearchtalkdec15
 
Guidelines on ethical approaches for clinical trials conducted with the pedia...
Guidelines on ethical approaches for clinical trials conducted with the pedia...Guidelines on ethical approaches for clinical trials conducted with the pedia...
Guidelines on ethical approaches for clinical trials conducted with the pedia...
 
1670327194_887_Research_with_human_participation.pptx
1670327194_887_Research_with_human_participation.pptx1670327194_887_Research_with_human_participation.pptx
1670327194_887_Research_with_human_participation.pptx
 
Sept. CTA
Sept. CTASept. CTA
Sept. CTA
 
Seminar schedule 'y'
Seminar schedule   'y'Seminar schedule   'y'
Seminar schedule 'y'
 
Informed Consent Form
Informed Consent FormInformed Consent Form
Informed Consent Form
 

More from Gaurav Sharma

European medicines evaluation agency
European medicines evaluation agencyEuropean medicines evaluation agency
European medicines evaluation agency
Gaurav Sharma
 
Drug development process
Drug development processDrug development process
Drug development process
Gaurav Sharma
 
Clinical trials
Clinical trialsClinical trials
Clinical trials
Gaurav Sharma
 
Clinical trial public access registries [recovered]
Clinical trial public access registries [recovered]Clinical trial public access registries [recovered]
Clinical trial public access registries [recovered]
Gaurav Sharma
 
Approaches of drug discovery
Approaches of drug discoveryApproaches of drug discovery
Approaches of drug discovery
Gaurav Sharma
 
Post marketing surveillance
Post marketing surveillancePost marketing surveillance
Post marketing surveillance
Gaurav Sharma
 
Guidance for industry changes to an approved nda or anda
Guidance for industry changes to an approved nda or andaGuidance for industry changes to an approved nda or anda
Guidance for industry changes to an approved nda or anda
Gaurav Sharma
 
Ma p ps
Ma p psMa p ps
Ma p ps
Gaurav Sharma
 
Inactive ingredients database
Inactive ingredients databaseInactive ingredients database
Inactive ingredients database
Gaurav Sharma
 
Guidance for industry changes to an approved nda or anda
Guidance for industry changes to an approved nda or andaGuidance for industry changes to an approved nda or anda
Guidance for industry changes to an approved nda or anda
Gaurav Sharma
 
Abbreviated new drug application submission
Abbreviated new drug application submissionAbbreviated new drug application submission
Abbreviated new drug application submission
Gaurav Sharma
 
Clinical data management
Clinical data managementClinical data management
Clinical data management
Gaurav Sharma
 
Investigator's brochure
Investigator's brochureInvestigator's brochure
Investigator's brochure
Gaurav Sharma
 

More from Gaurav Sharma (13)

European medicines evaluation agency
European medicines evaluation agencyEuropean medicines evaluation agency
European medicines evaluation agency
 
Drug development process
Drug development processDrug development process
Drug development process
 
Clinical trials
Clinical trialsClinical trials
Clinical trials
 
Clinical trial public access registries [recovered]
Clinical trial public access registries [recovered]Clinical trial public access registries [recovered]
Clinical trial public access registries [recovered]
 
Approaches of drug discovery
Approaches of drug discoveryApproaches of drug discovery
Approaches of drug discovery
 
Post marketing surveillance
Post marketing surveillancePost marketing surveillance
Post marketing surveillance
 
Guidance for industry changes to an approved nda or anda
Guidance for industry changes to an approved nda or andaGuidance for industry changes to an approved nda or anda
Guidance for industry changes to an approved nda or anda
 
Ma p ps
Ma p psMa p ps
Ma p ps
 
Inactive ingredients database
Inactive ingredients databaseInactive ingredients database
Inactive ingredients database
 
Guidance for industry changes to an approved nda or anda
Guidance for industry changes to an approved nda or andaGuidance for industry changes to an approved nda or anda
Guidance for industry changes to an approved nda or anda
 
Abbreviated new drug application submission
Abbreviated new drug application submissionAbbreviated new drug application submission
Abbreviated new drug application submission
 
Clinical data management
Clinical data managementClinical data management
Clinical data management
 
Investigator's brochure
Investigator's brochureInvestigator's brochure
Investigator's brochure
 

Recently uploaded

How to Implement a Real Estate CRM Software
How to Implement a Real Estate CRM SoftwareHow to Implement a Real Estate CRM Software
How to Implement a Real Estate CRM Software
SalesTown
 
Zodiac Signs and Food Preferences_ What Your Sign Says About Your Taste
Zodiac Signs and Food Preferences_ What Your Sign Says About Your TasteZodiac Signs and Food Preferences_ What Your Sign Says About Your Taste
Zodiac Signs and Food Preferences_ What Your Sign Says About Your Taste
my Pandit
 
The 10 Most Influential Leaders Guiding Corporate Evolution, 2024.pdf
The 10 Most Influential Leaders Guiding Corporate Evolution, 2024.pdfThe 10 Most Influential Leaders Guiding Corporate Evolution, 2024.pdf
The 10 Most Influential Leaders Guiding Corporate Evolution, 2024.pdf
thesiliconleaders
 
How MJ Global Leads the Packaging Industry.pdf
How MJ Global Leads the Packaging Industry.pdfHow MJ Global Leads the Packaging Industry.pdf
How MJ Global Leads the Packaging Industry.pdf
MJ Global
 
amptalk_RecruitingDeck_english_2024.06.05
amptalk_RecruitingDeck_english_2024.06.05amptalk_RecruitingDeck_english_2024.06.05
amptalk_RecruitingDeck_english_2024.06.05
marketing317746
 
Understanding User Needs and Satisfying Them
Understanding User Needs and Satisfying ThemUnderstanding User Needs and Satisfying Them
Understanding User Needs and Satisfying Them
Aggregage
 
BeMetals Investor Presentation_June 1, 2024.pdf
BeMetals Investor Presentation_June 1, 2024.pdfBeMetals Investor Presentation_June 1, 2024.pdf
BeMetals Investor Presentation_June 1, 2024.pdf
DerekIwanaka1
 
Innovation Management Frameworks: Your Guide to Creativity & Innovation
Innovation Management Frameworks: Your Guide to Creativity & InnovationInnovation Management Frameworks: Your Guide to Creativity & Innovation
Innovation Management Frameworks: Your Guide to Creativity & Innovation
Operational Excellence Consulting
 
Best practices for project execution and delivery
Best practices for project execution and deliveryBest practices for project execution and delivery
Best practices for project execution and delivery
CLIVE MINCHIN
 
Authentically Social by Corey Perlman - EO Puerto Rico
Authentically Social by Corey Perlman - EO Puerto RicoAuthentically Social by Corey Perlman - EO Puerto Rico
Authentically Social by Corey Perlman - EO Puerto Rico
Corey Perlman, Social Media Speaker and Consultant
 
Brian Fitzsimmons on the Business Strategy and Content Flywheel of Barstool S...
Brian Fitzsimmons on the Business Strategy and Content Flywheel of Barstool S...Brian Fitzsimmons on the Business Strategy and Content Flywheel of Barstool S...
Brian Fitzsimmons on the Business Strategy and Content Flywheel of Barstool S...
Neil Horowitz
 
The Heart of Leadership_ How Emotional Intelligence Drives Business Success B...
The Heart of Leadership_ How Emotional Intelligence Drives Business Success B...The Heart of Leadership_ How Emotional Intelligence Drives Business Success B...
The Heart of Leadership_ How Emotional Intelligence Drives Business Success B...
Stephen Cashman
 
The Genesis of BriansClub.cm Famous Dark WEb Platform
The Genesis of BriansClub.cm Famous Dark WEb PlatformThe Genesis of BriansClub.cm Famous Dark WEb Platform
The Genesis of BriansClub.cm Famous Dark WEb Platform
SabaaSudozai
 
Unveiling the Dynamic Personalities, Key Dates, and Horoscope Insights: Gemin...
Unveiling the Dynamic Personalities, Key Dates, and Horoscope Insights: Gemin...Unveiling the Dynamic Personalities, Key Dates, and Horoscope Insights: Gemin...
Unveiling the Dynamic Personalities, Key Dates, and Horoscope Insights: Gemin...
my Pandit
 
Organizational Change Leadership Agile Tour Geneve 2024
Organizational Change Leadership Agile Tour Geneve 2024Organizational Change Leadership Agile Tour Geneve 2024
Organizational Change Leadership Agile Tour Geneve 2024
Kirill Klimov
 
Lundin Gold Corporate Presentation - June 2024
Lundin Gold Corporate Presentation - June 2024Lundin Gold Corporate Presentation - June 2024
Lundin Gold Corporate Presentation - June 2024
Adnet Communications
 
Event Report - SAP Sapphire 2024 Orlando - lots of innovation and old challenges
Event Report - SAP Sapphire 2024 Orlando - lots of innovation and old challengesEvent Report - SAP Sapphire 2024 Orlando - lots of innovation and old challenges
Event Report - SAP Sapphire 2024 Orlando - lots of innovation and old challenges
Holger Mueller
 
Industrial Tech SW: Category Renewal and Creation
Industrial Tech SW:  Category Renewal and CreationIndustrial Tech SW:  Category Renewal and Creation
Industrial Tech SW: Category Renewal and Creation
Christian Dahlen
 
Part 2 Deep Dive: Navigating the 2024 Slowdown
Part 2 Deep Dive: Navigating the 2024 SlowdownPart 2 Deep Dive: Navigating the 2024 Slowdown
Part 2 Deep Dive: Navigating the 2024 Slowdown
jeffkluth1
 
Observation Lab PowerPoint Assignment for TEM 431
Observation Lab PowerPoint Assignment for TEM 431Observation Lab PowerPoint Assignment for TEM 431
Observation Lab PowerPoint Assignment for TEM 431
ecamare2
 

Recently uploaded (20)

How to Implement a Real Estate CRM Software
How to Implement a Real Estate CRM SoftwareHow to Implement a Real Estate CRM Software
How to Implement a Real Estate CRM Software
 
Zodiac Signs and Food Preferences_ What Your Sign Says About Your Taste
Zodiac Signs and Food Preferences_ What Your Sign Says About Your TasteZodiac Signs and Food Preferences_ What Your Sign Says About Your Taste
Zodiac Signs and Food Preferences_ What Your Sign Says About Your Taste
 
The 10 Most Influential Leaders Guiding Corporate Evolution, 2024.pdf
The 10 Most Influential Leaders Guiding Corporate Evolution, 2024.pdfThe 10 Most Influential Leaders Guiding Corporate Evolution, 2024.pdf
The 10 Most Influential Leaders Guiding Corporate Evolution, 2024.pdf
 
How MJ Global Leads the Packaging Industry.pdf
How MJ Global Leads the Packaging Industry.pdfHow MJ Global Leads the Packaging Industry.pdf
How MJ Global Leads the Packaging Industry.pdf
 
amptalk_RecruitingDeck_english_2024.06.05
amptalk_RecruitingDeck_english_2024.06.05amptalk_RecruitingDeck_english_2024.06.05
amptalk_RecruitingDeck_english_2024.06.05
 
Understanding User Needs and Satisfying Them
Understanding User Needs and Satisfying ThemUnderstanding User Needs and Satisfying Them
Understanding User Needs and Satisfying Them
 
BeMetals Investor Presentation_June 1, 2024.pdf
BeMetals Investor Presentation_June 1, 2024.pdfBeMetals Investor Presentation_June 1, 2024.pdf
BeMetals Investor Presentation_June 1, 2024.pdf
 
Innovation Management Frameworks: Your Guide to Creativity & Innovation
Innovation Management Frameworks: Your Guide to Creativity & InnovationInnovation Management Frameworks: Your Guide to Creativity & Innovation
Innovation Management Frameworks: Your Guide to Creativity & Innovation
 
Best practices for project execution and delivery
Best practices for project execution and deliveryBest practices for project execution and delivery
Best practices for project execution and delivery
 
Authentically Social by Corey Perlman - EO Puerto Rico
Authentically Social by Corey Perlman - EO Puerto RicoAuthentically Social by Corey Perlman - EO Puerto Rico
Authentically Social by Corey Perlman - EO Puerto Rico
 
Brian Fitzsimmons on the Business Strategy and Content Flywheel of Barstool S...
Brian Fitzsimmons on the Business Strategy and Content Flywheel of Barstool S...Brian Fitzsimmons on the Business Strategy and Content Flywheel of Barstool S...
Brian Fitzsimmons on the Business Strategy and Content Flywheel of Barstool S...
 
The Heart of Leadership_ How Emotional Intelligence Drives Business Success B...
The Heart of Leadership_ How Emotional Intelligence Drives Business Success B...The Heart of Leadership_ How Emotional Intelligence Drives Business Success B...
The Heart of Leadership_ How Emotional Intelligence Drives Business Success B...
 
The Genesis of BriansClub.cm Famous Dark WEb Platform
The Genesis of BriansClub.cm Famous Dark WEb PlatformThe Genesis of BriansClub.cm Famous Dark WEb Platform
The Genesis of BriansClub.cm Famous Dark WEb Platform
 
Unveiling the Dynamic Personalities, Key Dates, and Horoscope Insights: Gemin...
Unveiling the Dynamic Personalities, Key Dates, and Horoscope Insights: Gemin...Unveiling the Dynamic Personalities, Key Dates, and Horoscope Insights: Gemin...
Unveiling the Dynamic Personalities, Key Dates, and Horoscope Insights: Gemin...
 
Organizational Change Leadership Agile Tour Geneve 2024
Organizational Change Leadership Agile Tour Geneve 2024Organizational Change Leadership Agile Tour Geneve 2024
Organizational Change Leadership Agile Tour Geneve 2024
 
Lundin Gold Corporate Presentation - June 2024
Lundin Gold Corporate Presentation - June 2024Lundin Gold Corporate Presentation - June 2024
Lundin Gold Corporate Presentation - June 2024
 
Event Report - SAP Sapphire 2024 Orlando - lots of innovation and old challenges
Event Report - SAP Sapphire 2024 Orlando - lots of innovation and old challengesEvent Report - SAP Sapphire 2024 Orlando - lots of innovation and old challenges
Event Report - SAP Sapphire 2024 Orlando - lots of innovation and old challenges
 
Industrial Tech SW: Category Renewal and Creation
Industrial Tech SW:  Category Renewal and CreationIndustrial Tech SW:  Category Renewal and Creation
Industrial Tech SW: Category Renewal and Creation
 
Part 2 Deep Dive: Navigating the 2024 Slowdown
Part 2 Deep Dive: Navigating the 2024 SlowdownPart 2 Deep Dive: Navigating the 2024 Slowdown
Part 2 Deep Dive: Navigating the 2024 Slowdown
 
Observation Lab PowerPoint Assignment for TEM 431
Observation Lab PowerPoint Assignment for TEM 431Observation Lab PowerPoint Assignment for TEM 431
Observation Lab PowerPoint Assignment for TEM 431
 

Informed consent

  • 2.  Introduction  Informed consent is a Document or a Process 1. Consent is a continuous process, not a one-time event. 2. Document  Useful information for subjects  Names and contact information  Reminder about study procedures “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.” Goal  “The goal of the informed consent process is to provide people with sufficient information so they can make informed choices about whether to begin or continue participation in clinical research.” 5/21/20192 DR. GK SHARMA PHARMD
  • 3.  Need of IC  Understand nature of research.  Be informed of purpose, risks, and benefits, and alternative therapies.  Make a Voluntary Decision about Participation. Facts Enrol do harm best alternative Potential alternatives Therapeutic misconception 5/21/20193 DR. GK SHARMA PHARMD
  • 4. 1. Enroll: Researchers need the person to enroll. 2. Do harm: Research can do harm. 3. Best alternative: Protocols may require specific procedures that may not be the best alternative. 4. Potential alternatives: Researchers may be blinded to potential alternatives. 5. Therapeutic misconception: of research subjects. PROCEES OF IC Discussion Review SignaturesTime Concerns Signature obtained 5/21/20194 DR. GK SHARMA PHARMD
  • 5.  The process not only includes reviewing and signing the consent document, but may also include the following:  Recruitment materials 1. Oral instructions or explanations 2. A question and answer period 3. Assessing subject understanding 4. Providing adequate time for the subject to review the form and consider their participation 5. Providing new findings or study updates as appropriate throughout the study 6. Periodic re-affirmation or re-consent as appropriate throughout the study  In developing the consent process in the protocol, the following should be considered: 1. Setting 2. Timing 3. Minimizing Undue Influence 4. Use additional aids 5. Ask open-ended questions 6. Discuss Information provided Comprehension monitored and maintained Decision madeInformation understood 5/21/20195 DR. GK SHARMA PHARMD
  • 6. 1. Setting: Generally speaking consent discussions should occur in a private setting where your conversation won’t be overhead by others. 2. Timing: It may take several meetings/discussions before the potential subject not only understands the study but, for those recently diagnosed with a new disease or disorder it may also require additional time to understand the new information and what alternative treatment options may be available. 3. Minimizing Undue Influence: Vulnerable populations such as minors and students are particularly susceptible to influence from authority. Healthcare providers have tremendous influence over patients within their clinical practice. 4. Use additional aids: (videos, brochures, etc.) to explain study procedures and supplement the information provided in the consent document. 5. Ask open-ended questions: to potential subjects to assess their understanding of the study (e.g., “In your own words, tell me…what the study is about; what will happen to you if you decide to be in the study; what risks might you experience; what other options do you have.”). 6. Discuss: the study in the presence of “personal advisors” (friends/family members) who may aid in the subject’s decision making process, with the permission of the potential subject. 5/21/20196 DR. GK SHARMA PHARMD
  • 7.  Guidelines for Informed Consent 1. The Nuremberg Code, 1947 2. The Declaration of Helsinki, 1964 (2000) 3. The Belmont Report, 1979 4. ICH GCP, 1997 5. ICMR Guidelines, 2000  The Nuremberg Code What is it?  Published in 1947  The voluntary consent of the human subject is absolutely essential  Person must have legal capacity to consent  Should have “sufficient knowledge  Inform the subject of  The nature, duration and purpose  The method and means  All inconveniences and hazards  Possible effects on health 5/21/20197 DR. GK SHARMA PHARMD
  • 8.  The Declaration of Helsinki A statement of ethical principles on research involving humans  Published by the World Medical Association  Developed from the Nuremberg Code  Made by physicians  First adopted at Helsinki in 1964  Subjects must be  Volunteers  Informed participants 5/21/20198 DR. GK SHARMA PHARMD
  • 9.  The Belmont Report  Ethical principles and guidelines for protecting humans in clinical research  Published in 1979  Identifies three elements of the process  Information  Comprehension  Voluntariness  Information  All information be provided  Conditions under which information provided also important (rapid/ disorganized manner?)  Comprehension  Adapt presentation of information to subject’s capacities  Investigators must ascertain comprehension  Special provisions – immaturity, mental disability  Voluntariness  There must be no coercion or undue influence  Understand risks and benefits. 5/21/20199 DR. GK SHARMA PHARMD
  • 10.  ICMR Guidelines  Ethical guidelines for research involving humans “Ethical Guidelines for Biomedical Research on Human Subjects”  Published by the Indian Council of Medical Research in 2000  Revised version – 2006 1. Nature and purpose: of study stating it as research 2. Duration: of participation with number of participants 3. Procedures: to be followed 4. Investigations, if any, to be performed 5. risks and discomforts adequately described and whether project involves more than minimal risk 6. Compensations in trial related injury a. Adverse effects of Investigational product(s). b. Departure from approved protocol, scientific misconduct or negligence by the Investigator. c. Failure of an Investigational Product to provide attended therapeutic effect. d. Administration of placebo providing no therapeutic benefits. e. Compensation for injury to a child in utero because of the participation of parent in Clinical. 5/21/201910 DR. GK SHARMA PHARMD
  • 11. 7. No loss of benefits on withdrawal 8. Benefit sharing in the event of commercialization 9. Contact details of PI or local PI/Co-PI in multicentric studies for asking more information 10. Contact details of Chairman of the IEC for appeal against violation of rights 11. Voluntary participation 12. If test for genetics and HIV is to be done, counseling for consent for testing must be given as per national guidelines 13. Storage period of biological sample and related data with choice offered to participant regarding future use of sample, refusal for storage and receipt of its result 5/21/201911 DR. GK SHARMA PHARMD
  • 12.  Elements of informed consent Elements of informed consent Essential Additional Alternativ es Confidentialit y Benefi ts Risks Purpo se Voluntary participatio n Compensat ion Contact informatio n Essential 5/21/201912 DR. GK SHARMA PHARMD
  • 13. 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 5. participant, including the risks and benefits of the study. 6. Alternative treatment options discussed. 7. Confidentiality record 8. No of subjects 9. Compensation for injury 10. Time for questions to be asked and answered. 11. Description of the participant’s decision 12. Contact details 13. Travel reabusment 14. Subject responsibilities 15. Subject satisfaction 16. Use understandable language 17. Copy of consent was given to the participant 18. Sign copy of ICF 5/21/201913 DR. GK SHARMA PHARMD
  • 14.  Additional  Additional elements required by federal regulations: 1. Unforeseeable risks: to the subject (or to the embryo or fetus, if the subject is or may become pregnant) 2. Side effects: of a study drug are too severe, the sponsor terminates the study. 3. Additional costs: to the subject to participate (e.g., hospitalization, cost of testing) 4. Consequences of subject withdrawal from the study and procedures for withdrawal: that may be necessary – include whether any adverse health or welfare effects may be anticipated (e.g., the need to taper a drug treatment), 5. New toxicities develop: if findings of a data & safety monitoring board raise safety concerns.  Additional elements required for FDA regulated research: 1. A statement that the test article is “investigational” or “not FDA-approved” 5/21/201914 DR. GK SHARMA PHARMD
  • 15.  Revisions to Informed Consent 1. Informed consent documents must be revised every time new safety information becomes available or there is a change in trial procedures, participant compensation or personnel noted on the consent form. 2. Revisions to the informed consent document must be approved by an IRB/IEC prior to its use, and the informed consent process with the new information and documentation needs to be repeated with every clinical trial participant. 3. The participant is then required to sign the revised form. 5/21/201915 DR. GK SHARMA PHARMD