BASIC HUMAN RIGHTS

OF RESEARCH SUBJECTS
BASIC HUMAN RIGHTS OF RESEARCH
SUBJECTS
1. Right to Informed Consent
2. Right to Refuse and/or Withdraw
from Participation
3. Right to Privacy
4. Right to Confidentiality or
Anonymity of Data.
5. Right to be Protected from Harm
RIGHT TO INFORMED CONSENT
▪ Self-determination means free
consent is pre-requisite to any
human involvement

Two Components:
a. Recognition of self-determination
b. Thorough comprehension of the
proposed participation
RIGHT TO INFORMED CONSENT
▪ Understand the risks involved,
benefits anticipated, time and
energy requirements, any
anticipated loss of dignity, any
anticipated pain or discomfort,
psychological stress or
embarrassment and the way data
will be handled.
 RIGHT TO REFUSE OR
WITHDRAW FROM PARTICIPATION
▪ No recrimination for the refusal
and withdrawal from participation
▪ Explore the reason for refusing
▪ Careful and honest opinion on
what is to be done should be
given to the subject to minimize
refusal to participate
 RIGHT TO PRIVACY
▪ Inclusive of one’s thoughts,
opinions and physical presence
and privacy of one’s records
▪ Subject has the freedom to
decide the time, the extent and
circumstances the subject will
willingly share one’s thoughts,
beliefs, attitudes and behavior
with others.
RIGHT TO CONFIDENTIALITY
▪ Data about the research subjects shall
be handled confidentiality.
▪ Data shall be available only to
research staff and shall be reported
anonymously.
▪ Data shall be used only for the
purpose for which the subject gave
consent.
▪ Data shall not be made public or
available to others.
RIGHT TO CONFIDENTIALITY
▪ The identity of the agency shall be
protected unless knowledge about the
setting is necessary in the
interpretation of data.
▪ After the report is written, all data by
which individuals can be identified
shall be destroyed by burning or
shredding.
RIGHT TO BE PROTECTED FROM HARM
RISK-BENEFIT RATION:
1. Appropriate balance between
potential benefits of the research and
the risks assumed by the subjects.
2. The benefits outweigh the harm

MINIMAL RISK is defined as exposure to

the possibility of injury beyond everyday
situations. These include physical, legal,
emotional, financial, and social harm.
RIGHT TO BE PROTECTED FROM HARM
▪ The subject may experience undue
anxiety if the instrument evokes
disturbing feelings.
▪ Debriefing is a process of disclosing to
the subject all information that was
previously withheld.
▪ Referral to counselling shall be
included in the study protocol if
necessary.
EXPERIMENTAL SUBJECT’S
BILL OF RIGHTS
An experimental subject has the right to:

1. Be told what that study is trying to

find out,
2. Be told what will happen to
himself/herself and whether the
procedure, drugs, or devices are
different from what are used in
standard practice;
EXPERIMENTAL SUBJECT’S
BILL OF RIGHTS
An experimental subject has the right to:

3. Be told of the frequent or important

risks, side effects or discomforts of
the things that will happen to himself/
herself for research purposes.
4. Be told if he/she can expect any
benefit from participating’ and if so,
what the benefits may be;
EXPERIMENTAL SUBJECT’S
BILL OF RIGHTS
An experimental subject has the right to:
5. Be told the other choices he/she has
and how he/she may become better
or worse than being in the study;

6. Be allowed to ask any question

concerning the study both before
agreeing to be involved and during
the course of the study
EXPERIMENTAL SUBJECT’S
BILL OF RIGHTS
An experimental subject has the right to:
7. Be told what sort of treatment is
available if any complications arise
8. Refuse to participate at all or to
change his/her mind about
participation after the study is started.
This decision will not affect his/her
right to receive the care he/she would
receive if he/ she were not in the
study.
EXPERIMENTAL SUBJECT’S
BILL OF RIGHTS
An experimental subject has the right to:

9. Receive a copy of the signed and

dated consent form

10.Be free from pressure when

considering whether he/ she wishes
to agree to be in the study