Participant's Bill of Rights

SOUTH AFRICAN PREVENTIVE HIV/AIDS VACCINE TRIAL PARTICIPANT CHARTER OF RIGHTS

Final draft – 11 March 2004

Preamble
We, the subscribers to this bill of rights – volunteers, trial participants, affected families and communities, sponsors, principal investigators, researchers, and other relevant trial site staff

We therefore, subscribe to this Trial Participant Charter of Rights, so as to –

SECTION 1: INFORMED CONSENT TO PARTICIPATE IN TRIALS

1.1 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:

1. information about the nature, scope, duration, research methodologies (including whether placebos are involved), the objectives and the relative importance of objectives of the trial;
2. information about the nature, duration, and extent of the medical intervention;
3. information on the actual and foreseeable risks and information on the possibility of as yet unknown risk;
4. information on the role of the principal investigator, trial organisers, and trial administration and information on who and how to contact them in appropriate circumstances;
5. information on actual and expected benefits to participants and society;
6. information on possible resources or referral points to assist in dealing with social harm and trial related stigma and discrimination; and
7. information about the need to submit to regular HIV tests for the duration of the trial.
8. 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 a document.

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:

1. 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 becomes available;
2. 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
3. all relevant information about the risks, if any, associated with leaving the trial.

SECTION 2: NON-DISCRIMINATION AND HUMAN DIGNITY

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:

1. appropriate counselling and other assistance aimed at empowering participants to deal with trial related social harm, such as stigma and discrimination;
2. 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 CARE SERVICES

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 counselling.

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 medically required.

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 trial.

4.2 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 confidentiality.

4.3 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.

RESPONSIBILITIES OF TRIAL PARTICIPANTS
Every trial participant has a duty to:

1. inform trial site staff as soon as possible about any negative consequences to oneself, ones family or community, resulting from association with the trial.
2. not to attempt to donate blood during the trial.
3. 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 the study.
4. treat trial organisers and trial site staff with respect and dignity.
5. keep confidential others’ participation in the study should one get access to this information.
6. comply with trial study requirements to the best of one’s ability and provide complete and accurate information.
7. inform trial site staff as soon as possible if one is unable to continue or decides to discontinue one’s study participation.

SAAVI is supported by

SA Medical
Research Council