The document provides an overview of the Declaration of Helsinki, which establishes ethical principles for medical research involving human subjects. It discusses the history and development of the Declaration since 1964. The key principles covered include prioritizing subject well-being and autonomy, minimizing risks and maximizing benefits, obtaining informed consent, ensuring equitable subject selection, and independent review of research protocols.

1. Welcome
DECLARATION OF HELSINKI
K. VAISHALINI
Pharm D
163/082023
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2. Index
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INTRODUCTION
HISTORY
GENERAL STATEMENT
PRINCIPLES
RISK,BURDEN AND BENEFITS
VULNERABLE GROUPS
SCIENTIFIC REQUIREMENTS OF
RESEARCH PROTOCOL
RESEARCH ETHICS COMMITTEES
PRIVACY AND CONFIDENTIALITY
INFORM CONSENT
USE OF PLACEBO
UNPROVEN INTERVENTIONS IN
CLINICAL PRACTICE

3. INTRODUCTION
What is declaration of Helsinki
 Set of ethical principles
 Developed by WMA for medical community –human experimentation
 Followed by Nuremberg code(1947)
 Regarded as cornerstone document of human research ethics
 Included within clinical trial protocols.
 In 1961, public opinion around the world was shocked by the thalidomide
scandal.2,000 children died and 10,000 children were seriously disabled.
 Government authorities were then required to action and make regulatory
arrangements to oversee the testing of new medicines.
 In 1964, the world medical association (MWA) developed and indeed continue
to review and adapt the declaration of Helsinki as a guide for performing research
in human beings.
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4. HISTORY
 Adopted in June 1964
 Amendments- 1975,1983,1989,1996,2000,2002,2004,2008,2013
 First significant effort by medical community to regulate research.
 Prior to 1947 Nuremberg code only specific countries has National policies.(Germany,
Russia)
 Forms basis of most subsequent documents
 1947 declaration of the Nuremberg Code
 1948 declaration of Geneva
 Declarationof Geneva- the WMA binds the physician with the words. “The health of
my patient will be my first consideration”.
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5. GENERAL STATEMENT
Purpose- directed towards the increase of knowledge about the human condition in relation to its social and
natural environment.
Research is for the betterment of all.
Conducted- dignity and well being.
professional fair treatment and transparency
no greater risk
Evaluation- all stages of proposal
(research design, experimentation, deceleration of results, use of results)
benefits and dangers
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NEW KNOWLEDGE
GOAL
But, safeguard, protect
health, rights, respect
humans subjects,
norms (ethical
national/internationals
standards), less harm,
study done by
qualified person,
compensation
treatment(if harm)

6. Risks, Burdens and Benefits
• In medical practice and in medical research, most interventions involve risks and burdens.
Medical research involving human subjects may only be conducted if the importance of the
objective outweighs the risks and burdens to the research subjects.
• Measures to minimize the risks must be implemented. The risks must be continuously monitored,
assessed and documented by the researcher.
• Physicians may not be involved in a research study involving human subjects unless they are
confident that the risks have been adequately assessed and can be satisfactorily managed.
When the risks are found to outweigh the potential benefits or when there is conclusive proof of
definitive outcomes, physicians must assess whether to continue, modify or immediately stop the
study.
RISK>MODIFY/STOP STUDY
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7. Vulnerable Groups and Individuals
• Some groups and individuals are particularly vulnerable and may have an increased likelihood of
being wronged or of incurring additional harm.
All vulnerable groups and individuals should receive specifically considered protection.
• Medical research with a vulnerable group is only justified if the research is responsive to the health
needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. In
addition, this group should stand to benefit from the knowledge, practices or interventions that result
from the research.
Scientific Requirements and Research Protocols
• Before human study-scientific literature, lab and animal experiment
• Statement-regarding funding, sponsors, institutional afflation’s, potential conflict of interest-submitted
• Research involving humans must confirm to generally accepted scientific principles and thorough
knowledge of scientific literature and methods.
• Literature review and animal experiment prior conducting human research provide scientific evidence,
base.
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8. Research Ethics Committees
• The research protocol must be submitted for consideration, comment, guidance and approval to the
concerned research ethics committee before the study begins. This committee must be transparent in
its functioning, must be independent of the researcher, the sponsor and any other undue influence
and must be duly qualified. It must take into consideration the laws and regulations of the country or
countries in which the research is to be performed as well as applicable international norms and
standards but these must not be allowed to reduce or eliminate any of the protections for research
subjects set forth in this Declaration.
• The committee must have the right to monitor ongoing studies. The researcher must provide
monitoring information to the committee, especially information about any serious adverse events.
No amendment to the protocol may be made without consideration and approval by the committee.
After the end of the study, the researchers must submit a final report to the committee containing a
summary of the study’s findings and conclusions.
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9. Privacy and Confidentiality
• Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their
personal information
Informed Consent
• Inform the human subjects of the (Aim/methods/conflicts of interest/function/general outcomes of the
study/voluntary(freely agrees), withdraw consent at any time without reprisal)
• Informed consent in writing and participants should be informed about each intervention.
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10. Elements in Informed Consent Form-
Protocol number or name of the study
Purpose of the study
Duration of the study and subjects involvement
A statement that the protocol, and the informed consent were reviewed with the participant, including
the risks and benefits of the study
Alternative treatment option discussed
Confidentiality record
No of subjects
Compensation for injury
Time for question to be asked and answered
Description of the participants decisions
Contact details
Travel reimbursement
Subject responsibilities
Use understandable language
Copy consent was given to the participants
sign copy of CRF.
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11. Use of Placebo
• The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of
the best proven intervention(s), except in the following circumstances:
• Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or Where
for compelling and scientifically sound methodological reasons the use of any intervention less
effective than the best proven one, the use of placebo, or no intervention is necessary to determine
the efficacy or safety of an intervention and the patients who receive any intervention less effective
than the best proven one, placebo, or no intervention will not be subject to additional risks of serious
or irreversible harm as a result of not receiving the best proven intervention. Extreme care must be
taken to avoid abuse of this option.
Post-Trial Provisions
• In advance of a clinical trial, sponsors, researchers and host country governments should make
provisions for post-trial access for all participants who still need an intervention identified as
beneficial in the trial. This information must also be disclosed to participants during the informed
consent process.
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12. Unproven Interventions in Clinical Practice
• In the treatment of an individual patient, where proven interventions do not exist or other known
interventions have been ineffective, the physician, after seeking expert advice, with informed
consent from the patient or a legally authorized representative, may use an unproven intervention
if in the physician's judgment it offers hope of saving life, re-establishing health or alleviating
suffering. This intervention should subsequently be made the object of research, designed to
evaluate its safety and efficacy. In all cases, new information must be recorded and, where
appropriate, made publicly available.
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13. Thank You!
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