Bill of Rights
AFRICAN PREVENTIVE HIV/AIDS VACCINE TRIAL
CHARTER OF RIGHTS
draft – 11 March
the subscribers to this bill of rights – volunteers,
trial participants, affected families and communities,
sponsors, principal investigators, researchers,
and other relevant trial site staff
- Believe that appropriate medical research
is of value to society and that we need an affordable,
effective, and relevant HIV/AIDS vaccine.
the fact that individuals in our society
are willing to participate in clinical
trials – even
where no protective benefit from the
test vaccine is guaranteed.
- Recognise that medical and/or scientific
experimentations have on occasion in the past
resulted in exploitation of individuals.
- Recognise, further, that medical and/or
scientific experimentation in South Africa must
comply not only with the highest attainable standards
of ethics, but also with the provisions of the
South African Bill of Rights.
- Recognise, further, that the South African
Bill of Rights places legal obligations on the
state and, where applicable, on private institutions
- Therefore, require that prior approval for
clinical trials be obtained through independent
scientific and ethical review, and any other
approval required by law.
- Undertake to minimise risks and reduce harm
to trial participants.
therefore, subscribe to this Trial Participant
Charter of Rights, so as to –
- Demonstrate our commitment and adherence
to the values of equality, freedom and dignity
underlying the South African Constitution during
the conduct of trials
SECTION 1: INFORMED CONSENT TO PARTICIPATE
Every volunteer/trial participant in an HIV/AIDS
preventive vaccine trial has the right not to be
subjected to medical or scientific experimentation
without his or her (or, where appropriate, his
or her parent’s or guardian’s)
independent and informed consent.
1.2 In the case of a minor volunteer/trial participant,
both the parent or guardian and the minor must provide
informed consent unless the minor is incapable of
understanding what he or she is consenting to.
1.3 Informed consent can only be given if a volunteer/trial
participant is provided with a full disclosure of
all relevant information relating to the trial. This
information includes but is not limited to:
- information about the nature, scope, duration,
research methodologies (including whether placebos
are involved), the objectives and the relative
importance of objectives of the trial;
- information about the nature, duration, and extent
of the medical intervention;
- information on the actual and foreseeable risks
and information on the possibility of as yet
- information on the role of the principal investigator,
trial organisers, and trial administration and
information on who and how to contact them in appropriate
- information on actual and expected benefits to
participants and society;
- information on possible resources or referral points
to assist in dealing with social harm and trial
related stigma and discrimination; and
- information about the need to submit to regular
HIV tests for the duration of the trial.
- information about the voluntary nature of participation,
no guarantee of protective benefit, and the right
of the participant not to take part in the trials
after being provided with the information above.
1.4 Every volunteer/trial participant has the right
to be presented with all relevant information in
a way that he or she will be able to understand.
This includes access to trained staff capable of
explaining the information in a manner and in a language
that a volunteer/trial participant can understand.
1.5 After being provided with all the relevant
information, every volunteer/trial participant has
the right to choose or to refuse to take part in
the trial and to choose whether to involve family,
friends, partners, or others in such a decision.
1.6 Every volunteer/trial participant has the right
to be presented with a comprehensive written informed
consent document and, if he/she decides not to take
part in the trial, the right to refuse to sign such
1.7 Every volunteer/trial participant has a right
not to be pressured or unduly influenced to provide
informed consent. In particular, every volunteer/trial
participant has the right to consider all relevant
information for a reasonable time before deciding
to provide informed consent.
1.8 Every trial participant has a right to leave
the trial at any time without losing any of the rights
set out in this Charter of Rights. In order to enable
participants to exercise this right in a responsible
and independent manner, every trial participant has
a right to be provided with:
all relevant new information about the nature and
scope of the trial and the nature and scope of
the risks associated with the trial as this information
- all relevant information about the progress of
the trial as well as information about when the
results may become available and how these results
could be accessed; and
- all relevant information about the risks, if any,
associated with leaving the trial.
SECTION 2: NON-DISCRIMINATION AND HUMAN
2.1 Every trial participant has the right to be
treated with dignity and respect.
2.2 Every trial participant has the right not to
be subjected to unfair discrimination on any ground,
including race, sex, gender, pregnancy, marital status,
ethnic or social origin, colour, sexual orientation,
age, disability religion, conscience, belief, culture,
language, birth, HIV status and economic status.
2.3 In order to prevent unfair discrimination against
trial participants from all vulnerable groups, including
women, children and sex workers, trial organizers/administrators
has a duty, where appropriate, to take special measures
to ensure their full and equal enjoyment of the rights
set out in this Charter.
2.3 In order to protect every trial participant
against unfair discrimination, trial participants
have the right to:
appropriate counselling and other assistance aimed
at empowering participants to deal with trial related
social harm, such as stigma and discrimination;
- re-imbursement for agreed-upon expenses incurred
as a result of participating in the trial.
2.4 All trial participants maintain their legal
rights and do not waive any of their legal rights
by consenting to take part in the trial.
SECTION 3: THE RIGHT OF ACCESS TO HEALTH
3.1 Every trial participant has the right to have
continued free access throughout the trial to the
optimal standard of preventive counselling about
the risks of HIV infection available in the country.
3.2 Every trial participant has the right to have
access to free and accurate testing for HIV infection
throughout the trial. This right includes a right
to have access to voluntary pre-testing and post-testing
3.3 Every trial participant has the right to have
access to free follow-up testing after completion
of the trial in the event of a antibody positive
HIV-test until the test shows a negative result.
3.4 Every trial participant has the right to free
access to treatment for any injury or illness caused
by the study vaccine or trial related procedure.
3.5 Every trial participant who becomes infected
with HIV during the trial at a minimum has the right
to free access to the highest standard of health
care available in the public health sector, or such
higher standard negotiated at a national level.
3.6 In order to safeguard the continued health
of trial participants, every trial participant has
the right to be informed whether they have received
a placebo or a vaccine when the study ends or when
3.7 Ever trial site participant who had received
a placebo has a right to free access to any effective
vaccine tested during the trial.
3.8 The rights in this section can be enforced
against the state and/or relevant state institutions
and/or trial sponsors in accordance with pre-trial
agreements concluded between the state, state institutions
and trial sponsors.
SECTION 4: THE RIGHT TO PRIVACY
4.1 Every participant has the right to privacy
and confidentiality which includes:
a. the right of every individual participant to
have all information about his or her participation
in the trial kept confidential; and
b. the right not to have any data gathered about
an individual which is not directly related to the
Despite the right to confidentiality guaranteed
in 4.1, an trial participant’s name and record
may be released to institutions or bodies evaluating
the study, or for emergency health reasons. Individuals
may also explicitly waive their general right to
Every trial participant has the right to be offered
study identification, confirming participation
in the study. This optional identification will
include a phone number, and/or address, or the
name of a person who can provide additional information
about trial participation in general but not confidential
information about a participant’s personal
participation, without his or her informed consent.
OF TRIAL PARTICIPANTS
trial participant has a duty to:
inform trial site staff as soon as possible about
any negative consequences to oneself, ones family
or community, resulting from association with the
- not to attempt to donate blood during the trial.
- not to attempt to determine whether one has received
the vaccine or the placebo by getting and HIV test
done outside of the study site before the end of
- treat trial organisers and trial site staff with
respect and dignity.
- keep confidential others’ participation
in the study should one get access to this information.
- comply with trial study requirements to the
best of one’s
ability and provide complete and accurate information.
- inform trial site staff as soon as possible
if one is unable to continue or decides to discontinue
is supported by