Book 5: Monitoring informed consent and HIV risk-reduction interventions

A plan for monitoring the initial and continuing informed consent process, and for evaluating the quality of risk-reduction interventions, should be agreed upon before the trial commences and be implemented throughout the trial.

15.1 The method and process for monitoring informed consent and risk-reduction interventions should be designed and agreed upon by the partnership of community, host, government, investigator and sponsors.

15.2 Plans to monitor consent, and risk-reduction interventions, should be submitted for approval to local research ethics committees.

15.3 The value of informed consent depends primarily on the ongoing quality of the process by which it is conducted, and not on the structure and content of the informed consent document.

15.3.1 Explicit consideration should be given to mechanisms and personnel for the evaluation of the quality of the informed consent process.

15.3.2 Steps that might be taken include: training counsellors to evaluate the experiences of participants and to provide feedback in order to revise aspects of the informed consent process.

15.3.3 Evaluation and revision should aim to optimise sound decision-making of current and future participants.

15.3.4 All recommended revisions should be within the parameters approved by local research ethics committees.

15.4 Risk-reduction interventions should be evaluated to ensure that quality interventions are provided to participants throughout the trial.

15.4.1 It is recommended that the following components of risk reduction be monitored:

1. Quality of protocols for counselling, STI management, and referral;
2. Cultural, linguistic, gender and age appropriateness of the counselling for target groups;
3. Counsellor skills and the degree to which counsellor training corresponds with policy developed by the National Minimum Standards Committee for the Accreditation and Training of HIV/ AIDS counsellors;
4. Procedures by which risk reduction counsellors are selected, trained and supervised;
5. Availability of adequate supplies of barrier methods and risk-reduction materials; and
6. Risk-reduction interventions should also be evaluated by participant satisfaction, and with regard to their efficacy in reducing high-risk behaviour.

15.5 In order to reduce a real or perceived conflict of interest, evaluation of consent and risk-reduction measures could be done by, or in collaboration with, an independent agency. Consideration should be given to appointing an independent monitor, or expanding the trial monitor's responsibilities, to evaluate consent and risk-reduction measures. This should take into account protection of participants' confidentiality.

15.6 Recommendations to evaluate consent and risk-reduction measures supplement the usual guidelines for monitoring HIV vaccine trials for safety and compliance with scientific and ethical standards and regulatory requirements.