1

RESEARCH ETHICS IN HUMAN EXPERIMENT

PRESENTED BY:-

Supriya c s

1st M Pharm

Dept….of Pharmacology

2

CONTENT

• History

• General statement

• Statement of general principle

• Ethical review procedures

• Basic responsibilities

• Submission of application

• Selection of special group as research subjects

• References

3

HISTORY

In 1947:- The Court enumerated some rules for "Permissible

Medical Experiments“(Nuremberg code ).

In 1948 :- Universal Declaration of Human Rights expressed

concern about rights of human beings subjected to involuntary

maltreatment.

In 1964:-Based on the preliminary efforts of the Council for

International Organisations of Medical Sciences (CIOMS) at

Helsinki, the World Medical Association formulated general

principles and specific guidelines on use of human subjects in

medical research, known as the Helsinki Declaration, which was

revised from time to time.

4

In 1966:- International Covenant on Civil and Political Rights

specifically stated, ‘No one shall be subjected to torture or to cruel,

inhuman or degrading treatment or punishment.

In 1980:- ICMR released a “Policy Statement on Ethical

Considerations Involved in Research on Human Subjects.”

In 1985 -1990 :- Public Health Service Task Force on Women’s

Health issues report encouraging, for Women’s Health Research

inclusion of women in research.(U.S)

In 1982:-WHO and CIOMS (council for international

organizations of medical sciences) issued the “Proposed

International Guidelines for Biomedical Research involving Human

Subjects.”

5

In 1991:- “International Ethical Guidelines for Ethical Review in

Epidemiological studies” (CIOMS).

In 1993:-

• “International Ethical Guidelines for Biomedical Research

involving Human Subjects” (CIOMS).

• Public exposure of U.S. human radiation experiments

In 1998:- Pediatric Rule passed by Congress, stipulating that newdrugs for children must include specific pediatric labelinginformation

In 2000:- Further publicized ethical abuses promptingestablishment of the Office of Human Research Protections(OHRP)

In 2005 :-“Universal Declaration on Bioethics and Human

Rights”

6

DEFINITION OF HUMAN EXPERIMENTATION

• A subject is defined as an individual who is observed or

experimented with by an investigator; an investigator is a qualified

individual who conducts research.

GENERAL STATEMENT

Medical and related research using human beings as subjects must

necessarily ensure that : -

• The PURPOSE, of such research is that it should be directed

towards the increase of knowledge about the human condition in

relation to its social and natural environment.

7

• Such research is CONDUCTED under condition that no person

or persons become a mere means for the betterment of others

and that human beings who are subject to any medical

research or scientific experimentation are dealt with in a manner

conductive to and consistent with their dignity and well being.

• Such research must be subjected to a regime of EVALUATION at

all stages of the proposal, i.e., research design, and

experimentation, declaration of results and use of the results.

• Each such evaluation shall bear in mind the objects to be achieved,

the means by which they are sought to be achieved , the potential

uses and abuses of the experiment and its results.8

STATEMENT OF GENERAL PRINCIPLES

Principles of essentiality.

Project involving human subjects can be performed only after

if it gets approval from an authorized person, who checks the

essentiality of the project, whether it is useful or harmful for

the society & the person who checks the essentiality should be

an external body of the project.

Principles of voluntariness and community agreement.

Subjects which are going under such projects should be

informed about the project & its benefits & its risk factors.

9

In shortly, volunteer should know everything in briefly about the

project.

o If volunteer feels any risk at any stage of the project he/she can

abstain from further participation & no legal authority can stop

him from doing so.

o Research involving any community or a group of persons as a

research subjects these principles of voluntariness shall apply

to all members of community.

10

Principles of non-exploitation

Research subject are paid for their involvement in the research or

experiment, without seeing his/her economic or social status or

literacy or educational levels.

Subjects should bear the knowledge of all dangers arising in &

out of the research project. If during experiment subject suffers

from any side effects or toxic effects, he or she should be treated

& rehabilitated as soon as possible.

Principles of privacy and confidentiality

The identity of subject keep confidential until & unless it has to be

11

disclosed for any valid scientific & legal reasons & it should havewritten permission from the respective human subject to discloseit.

Principles of precaution and risk minimization

Precaution should be taken at all stages of research & subject

should not get affected by any adverse effects in simple terms,

he/she should bear minimal risks.

Principles of accountability and transparency

The research or experiment should be conducted in fair, honest,

impartial & transparent manner so, that there should not be any

arising of conflicts. Research data should be reserved for a

prescribed period of time

12

Principles of the maximization of the public interest and of

distributive justice

Research should be benefited to all human kind & not just for

people who are socially & economically better.

Principles of institutional arrangements

All persons connected to research should ensure that all

procedure & all institutional arrangements should fully made

in a bonafide & transparent manner.

Principles of public domain

Results emerging from such research or experiments should

bring in to the public domain & its results should generally

13

made known through scientific & other publications.

Principles of compliance

Persons conducting, associated or connected anyhow with this

research project involving human subject should ensure that

these guidelines are carefully observed.

These principles laid down under statement on general

principles are common to all areas of biomedical research

involving human subjects.

14

ETHICAL REVIEW PROCEDURES

It is mandatory that all proposals on biomedical research

involving human subjects should be cleared by an

appropriately constituted Institutional Ethics Committee (IEC),

also referred to as Institutional Review Board (IRB).

The Ethics committees are entrusted not only with the initial

review of the proposed research protocols prior to initiation of

the projects but also have a continuing responsibility of regular

monitoring for the compliance of the ethics of approved

programmes till the same are completed.

15

BASIC RESPONSBILITIES

The basic responsibility of an IEC is to ensure a competent

review of all ethical aspects of the project proposals received.

To protect the dignity, rights and well being of the potential

research participants.

To ensure that universal ethical values and international

scientific standards are expressed in terms of local community

values and customs.

To assist in the development and the education of a research

community responsive to local health care requirements.

16

SUBMISSION OF APPLICATION

The researcher should submit an appropriate application in a

prescribed format along with the study protocol at least

three weeks in advance.

The protocol should include the following: -

Clear research objectives and rationale for undertaking the

investigation in human subjects in the light of existing

knowledge.

Recent curriculum vitae of the Investigators indicating

qualification and experience.

Subject recruitment procedures.

17

Inclusion and exclusion criteria for entry of subjects in the study.

Precise description of methodology of the proposed research,

including intended dosage of drugs; planned duration of treatment

and details of invasive procedures if any.

A description of plans to withdraw or withhold standard therapies in

the course of research.

The plans for statistical analysis of the study.

Safety of proposed intervention and any drug or vaccine to be

tested, including results of relevant laboratory and animal research.

Proposed compensation and reimbursement of incidental expenses.

18

INFORMED CONSENT FOR CLINICAL STUDIES

19

• Name the consent group

• Two parts of consent group

PART I: Information Sheet

• Introduction

• Purpose

• Type of Research Intervention

• Participant selection

• Voluntary Participation

• Information on the Trial Drug [Name of Drug] Procedures and

Protocol

20

• Duration

• Side Effects

• Risks

• Right to Refuse

• PART II: Certificate of Consent

21

SELECTION OF SPECIAL GROUPS AS

RESEARCH SUBJECTS

PREGNANT OR NURSING WOMEN

Pregnant or nursing women should in no circumstances be the

subject of any research unless the research carries no more

than minimal risk to the fetus or nursing infant and the object

of the research is to obtain new knowledge about the fetus,

pregnancy and lactation.

22

CHILDREN

Before undertaking trial in children the investigator must ensure

that-

Children will not be involved in research that could be carried out

equally well with adults;

The purpose of the research is to obtain knowledge relevant to

health needs of children. For the evaluation of a new drug the

study in children should always be carried out after the phase III

clinical trials in adults. It can be studied earlier only if the drug has

a therapeutic value in a primary disease of children.

Research should be conducted in settings in which the child and

parent can obtain adequate medical and psychological support.

23

VULNERABLE GROUPS

Effort may be made to ensure that individuals or communities

invited for research be selected in such a way that the burdens and

benefits of the research are equally distributed.

Research on genetics should not lead to racial inequalities.

Persons who are economically or socially disadvantaged should

not be used to benefit those who are better off than them.

Adequate justification is required for the involvement of subjects

such as prisoners, students, employees, service personnel etc., who

have reduced autonomy as research subjects.

24

REFRENCE

• Ethical guidelines for biomedical research on human

participants(pdf)

• Research in humans (pdf)

• Ethical Principles in Human Subject Research(p pt)

• http://en.wikipedia.org/wiki/Human_subject_research

25

26