Ethical Issues in CR

8/4/2019 Ethical Issues in CR

1/23

Ethical Issues inClinical Research

Vijeta (Roll no.36)


2/23

Ethics is notdefinable, it is notimplementable,because it is not

conscious, itinvolves not onlyour thinking, butalso our feeling.


3/23

Ethics - Greek ethos: tradition, habit... the philosophical study of the principles at the basis of morale

Morale - Latin mores: custom, habit... indicates the distinction between what is good and what is evil in the

everyday life

Both ethics and morale are the resultof the society's evolution towards"standard" behaviors.


4/23

Medical progress is based on research experimentation that involves human

subjects.

In research on man, the interest of science and society should never take

precedence over considerations related to the well-being of the subject .

By bringing ethical issues into sharp focus we will be able to improve the

research quality of our research.


5/23

Autonomy: Respect for Persons, Informed consent; confidentiality

Beneficence: Improve wellbeing while doing no harm (weighing risksversus benefits of research)

Non-malfeasance:Dont inflict harm and dont refuse aid

Justice: Fairly distribute the burdens and benefits of research


6/23

Human participants in research:

People are the means to developing useful knowledge; and are thus atrisk of exploitation.

Vulnerable Populations: It considers people who are HIV infected,Disabled Persons, Mentally Retarded, Women, Children, The Elderly,Prisoners,Refugees, Students, Patients, and Economically andEducationally disadvantaged persons.

Rural Populations.


7/23

Research on animals: ethical debate

Avoidance of experiments on larger animals like cats, dogs,

monkeys, when such can be done on smaller animals like guinea

pigs, rabbits, frogs, rats, mice.

As far as possible, experiments should not be performed merely for

the purpose of acquiring manual skills .

Animals intended for performance of experiments should be looked

afterboth before and after the experiments.


8/23

Writing research proposals: process, guidelines.

State the specific contribution and responsibilities of each author (and

make acknowledgments specific and detailed)

Publishing of research papers

Copyright Issues


9/23

Institutional Ethics Committee

(IEC) /Institutional

Review Board (IRB)

Informed ConsentETHICAL RESEARCH
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10/23


11/23

Institutional Review Board

means any board, or committee, or any other group formally designated

by an institution to review biomedical research involving humans as

subjects, to approve the initiation of and conduct periodic review of such

research.
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12/23

I.C.M.R. GUIDELINES STIPULATE:

No. of members recommended minimum : 57 ; maximum : 12

15

Quorum necessary for meeting - 5 members

Chairman preferably from outside not the head of the institute

Member secretary from the institute to conduct the business

Other members are medical, nonmedical, scientific and

nonscientific, legal expert / retired judge, philosopher including lay

public
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13/23

Competent review of ethical aspects of proposals received

Regular monitoring for compliance of ethics as per the guidelines

Protect dignity, rights and well being of the participants

Protect universal ethical values and international scientific standards and localcommunity values and customs.

Development and education of research community responsive to health care

Review by I.E.C. should be complete and adequate

written documentation of all meetings and records to be maintained

premature termination of study if noncompliance is observed
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15/23

A process by which a subject voluntarily confirms his or her willingness toparticipate in a particular trial, after having been informed of all aspects of thetrial 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.

Synonyms: Subject Information Sheet Patient Information Leaflet

Informed Consent Form
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Sponsor

EthicsCommittee Investigator
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Subject / Trial SubjectAn individual who participates in a clinical trial, either as a recipient of the

investigational product(s) or as a control.

Legally Acceptable Representative (LAR)

An individual or juridical or other body authorized under applicable law

to consent, on behalf of a prospective subject, to the

subject's participation in the clinical trial.
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Impartial WitnessA person, who is independent of the trial, who cannot be unfairly influenced

by people involved with the trial, who attends the informed consent process if

the subject or the subjects LAR cannot read, and who reads the informed

consent form and any other written information supplied to the subject

Vulnerable Subjects

Individuals whose willingness to volunteer in a clinical trial may be unduly

influenced.
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It is conducted, strictly adhering to the trial related guidelines, so that it can

protect the individuals freedom of choice and respect for individuals

autonomyand the subjects rights

All the trial related Essential Information and the identity of the ICF

conducting team with address and phone numbers;has to be given to the

subject before taking his consent

There should be no coercion / undue influence on the

subject

Ample time and opportunity to discuss the procedure hasto be given to the subject for his/her decision
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20/23

Subject

if subject unable to give consent (minor , dementia etc.) then the consent isgiven by the

Subjects legally acceptable representativesubject should be informed to the extent compatible with his/herunderstanding and consent sought and documented.

In case ofChildren2 consents: one from parents / legally acceptable representative and one fromthe child.

ICF is Signed and dated by

Subject / Subjects LAR

Person conducting the IC process

If subject / subjects LAR is illiterate, then

an impartial witness
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21/23

Incomplete informed consent forms

Overstated benefits of the study

Implemented substantive changes to the study without obtaining IRB

approval.

Failure to adhere to the protocol

E.g.: Directly ship study vaccine to some subjects homes for self-administration

As Regulators are very sensitive to ICFs, Inadequate/ Poor consents may

lead to:

Possible Investigator disqualificationfor further trials (FDA warning

letters) and/or Possible Rejection of sponsor data.
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22/23

. . . is not a piece of paper.. . . is not a signature.

. . . It is aProcess by which we

Documents

Ethical Issues in CR