Table 6.

Themes Identified Relevant to the Informed Consent Process^*

Participants’ Themes Extent of satisfaction with the process Time spent reading information Adequacy or clarity of information or signing process Individual approach to obtaining consent (style) Extent to which characterization of risks is clear Length of the process and repetition of content Indifference to content of informed consent document Instilling fear of study participation Undue pressure to enroll Adaptation of information to the individual Use of video media Degree to which process was engaging

Research Professionals’ Views of Aspects of the Informed Consent Process Likely to be Important to Participants* Individual approach to obtaining consent (style) Appropriate pace for the process (i.e., not rushed) Length of the consent form Clarity of the description of the risks Use of techniques that confirm participant understanding Level and clarity of language Adequate time allowed between the consent discussion and start of the protocol Absence of undue pressure Trust Clarity about freedom for participants to withdraw at any time

^*Listed in order of the frequency with which each issue was identified.