P11.01
Background: Potential research participants often do not understand information in consent forms (CFs). Long CFs can be a contributing factor, yet empirical evidence is limited on the information that should be included or that could be removed from CFs in HIV-related research and on the barriers to reducing CF length.
Methods: We are exploring these issues from the perspectives of stakeholders affiliated with the HIV Prevention Trials Network (HPTN): participants, investigators and site staff, community and regulatory representatives, institutional officials, and members of institutional review boards. We reviewed data collection approaches that could 1) allow stakeholders to identify CF text as essential or extraneous and 2) identify areas of agreement and divergence across the stakeholder groups. We also explored approaches that could allow stakeholders to learn the perspectives of other stakeholders and to confirm or refute comments attributed to them.
Results: A novel, modified Delphi approach was developed for building stakeholder consensus on how to shorten CFs. The three-step process begins with stakeholders highlighting essential or extraneous sentences of an HPTN CF on a tablet device and describing barriers to reducing CF length during a face-to-face interview. Next, up to three follow-up, on-line surveys will be conducted among a sample of participants from each stakeholder group. During each survey, stakeholders view results from the previous stage; refine their selections of essential information after considering all stakeholder responses, particularly for areas of continued disagreement; and reflect upon the barriers previously identified. The Delphi process concludes with an on-line group interview in which stakeholders will give input on a shorter CF built from the results of the prior steps.
Conclusions: Consensus among key stakeholders about information to keep and remove from HIV-related CFs is critical for reducing CF length. Innovative methods should facilitate this process.
