Australia’s best practice guidelines for information access in the informed consent process for people with vision impairment: A scoping review using the AACTT framework

Background Providing accessible information during informed consent practice helps people make important decisions about research participation. The aim of this review is to critically appraise the current Australian clinical research guidelines to assess their guidance on delivering accessible informed consent processes for people with vision impairment. Methods An archival search of the Overton database was conducted for policy documents and guidelines pertaining to informed consent practice in Australia. This was cross checked with the Australian Research Council’s online catalogue of national codes and guidelines. Content analysis was performed using an implementation science framework to code the actors, actions, context, target and time (AACTT) elements of informed consent practice. The AACTT framework enables a detailed specification of the behaviours targeted for championing or change. Results Ten policy documents specific to conducting consent procedures for clinical research or healthcare participation in Australia were identified and included in this review. Five of the 10 guidelines provided sufficient detail for researchers to know what actions to perform to enable inclusive consent practice and mutual engagement with people with vision impairment. However, they varied in their content describing how and when to perform them. Two of the key reference documents for clinical research conduct in Australia entirely lacked recommendations for accessible informed consent practice. Conclusions Australian research policy and practice documents offer some direction in helping researchers to deliver accessible informed consent practice. However, guidelines produced by peak disability bodies and patient advocacy groups offer more direction on how to engage people with vision impairment and offer useful templates for producing accessible print materials.