DECLARATION OF HELSINKI (UNIT V)

SUBMITTED BY: PRACHI PANDEY, RAHUL PAL

M. PHARM (PHARMACEUTICS), IIIRD SEM, RESEARCH METHEDOLOGY AND BIOSTATISTICS
DEPARTMENT OF PHARMACEUTICS, NIMS INSTITUTE OF PHARMACY, NIMS UNIVERSITY, JAIPUR, RAJASTHAN,
303121, INDIA.
 DECLARATION OF HELSINKI
 It is a set of ethical principles basically for clinical trails followed by medical researchers and given by

World Medical Association.

 As physician’s (investigator) duty in research is to protect the life, health, privacy and dignity of human

participant oversight by Institutional Review Board (IRB); Research Ethical Committee (REC) or Ethical
Review Board (ERB).

 Declaration of Helsinki was followed by Nuremberg code (because of nazii experiments) and

Thalidomide disaster {which was a pharmacovigilance failure; where pregnant women’s morning
sickness was tried to overcome by drug that lead to delivery of babies without limbs (phocomelia)}.

 9 Amendments in 1975, 1983, 1989, 1996, 2000, 2002, 2004, 2008, 2013.

 Regarded as cornerstone documents for human ethics.

 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 Code1948 declaration of Geneva

 Declaration of Geneva (1948) - the WMA binds the physician with the words. "The health of my patient

will be my first consideration".

 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.

GOAL NEW KNOWLEDDE

 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.
 PRINCIPLE

 First Principle – Objective of study is to outweigh risk. If risk is more either modify or stop the study

along with every thing must be monitored, assessed, documented with minimum risk.

 Second Principle – If vulnerable groups (pregnancy, sensitive, children, elderly, psychological issues) are

involved then increase chance additional harm protection must be provided along with consent even with
minors

 Third Principle - Before human study, scientific literature, lab and animal experiments is must to be

read; statements like regarding funding, sponsors, institutional afflation's, potential conflict of interest
must be submitted; research involving humans must confirm to generally accepted scientific principles
and through knowledge of scientific literature and methods; literature review and animal experiments
must be prior to human research.
 PRINCIPLE

 Four Principle (Research Ethical Committee) – Before study, design to conduct the experiment must be

given to the National and International Ethical norms. Research submission about the final report with
study finding and conclusion in end of the study; research protocol must be reviewed by an independent
committee and conduct by medically/ scientifically qualified individuals; main aim is the participant
health, introduction to ethical committee, responsibility to check again and again, increase revolutionary
decision. If not done they have a reason to stop/ declare invalid.

 Five Principle (Privacy and Confidentiality) – Human subject and information must be private. Dignity,

privacy, confidentiality, participant’s physical/ mental integrity and life of participants should be
protected.
 PRINCIPLE
 Six Principle (Informed Consent) – It is a written consent about the experiment that has to be conducted

by the volunteer independently after knowing about research and It must have aim, method, conflict of
interest, function, general outcome of study, voluntary , legally authorative represerntative.

 Seven Principle (Results) – Investigators are obliged to preserve the accuracy of results, negative and

positive results should be publically available.

 Eight Principle (Use of Placebo) – Intervention should be given (+) impact. CARE- avoid abuse of this

option.

 Nine Priciple (Post trail Provision) – Explain human subjects and provide help.

 Ten Principle (Unproven intervention in clinical practice) – Evaluate the efficacy and safety; new

information will be recorded and publically available.

 ADDITIONAL PRINCIPLE
 The physician may combine medical research with medical care, only to the extent that the research is

justified by its potential prophylactic, diagnostic or therapeutic value.

 When medical research is combined with medical care, additional standards apply to protect the patients

who are research subjects.

 The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best

current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo, or no
treatment, in studies where no proven prophylactic, diagnostic or theraptic method exists.

 At the conclusion of the study, every patient entered into the study should be assured of access to the best

proven prophylactic, diagnostic and therapeutic methods identified by the study.

 ADDITIONAL PRINCIPLE

 The physician should fully inform the patient which aspects of the care are related to the research. The

refusal of a patient to participate in a study must never interfere with the patient-physician relationship.

 In the treatment of a patient, where proven prophylactic, diagnostic and therapeutic methods do not exist

or have been ineffective, the physician, with informed consent from the patient, must be free to use
unproven or new prophylactic, diagnostic and therapeutic measures, if in the physician's judgment it
offers hope of saving life, reestablishing health or alleviating suffering. Where possible, these measures
should be made the object of research, designed to evaluate their safety and efficacy. In all cases, new
information should be recorded and, where appropriate, published. The other relevant guidelines of this
Declaration should be followed.