Table 1.
Core categories, conceptual categories, frequencies, and coding examples.
| Categories and codes | Frequency | Example(s) | |||
|---|---|---|---|---|---|
| Survey | Interview | Total | |||
| Screening and preparation | |||||
| Barriers | Determining capacity or who has authority to consent | 5 | 1 | 6 | “When working in neurological diseases, it’s difficult to determine if someone is capable of providing consent for themselves or if an LAR is needed.” (34, survey) |
| Insufficient time or resources for consent discussion | 3 | 2 | 5 | “Inadequate time available during visit.” (90, survey) | |
| Participant unprepared for consent discussion | 4 | 0 | 4 | “Potential participants who obviously did not read the consent document.” (42, survey) | |
| Strategies | Encourage participant to review consent in advance | 12 | 6 | 18 | “Giving the ICFs to the subject before the informed consent process so the subject can read it over and come up with their own understanding and questions.” (28, survey) |
| Speak with participant more prior to consent | 5 | 6 | 11 | “I have learned to speak with the patient more prior to the consent … so that I can get a better idea of their cognitive status.” (57, survey) | |
| Plan for ample time and eliminate time constraints | 7 | 3 | 10 | “Adequate time is allotted for the consenting process in case there are issues/so participants are able to consider their options.” (39, survey) | |
| Secure proper space and prepare environment for consent | 4 | 2 | 6 | “Modified environment to accommodate for decline in motor function” (83, survey) | |
| Discuss participant with neurologist prior to consent | 2 | 2 | 4 | “Discussing the participant more in-depth with their neurologist before meeting them” (106, survey) | |
| Conveying study information | |||||
| Barriers | Informed consent is overwhelming | 20 | 7 | 27 | “Explaining everything involved with the study during the consent process seemed to be overwhelming for some participants.” (91, survey) |
| Difficulty simplifying research concepts (e.g. randomization) | 9 | 4 | 13 | “Explaining the studies in a clear, accurate, and unabridged manner is hard to do sometimes in layman language.” (20, survey) | |
| Participants become frustrated, fatigued, or distracted | 9 | 2 | 11 | “Patients with cognitive impairments have difficulty staying focused during a lengthy consent discussion.” (18, survey) | |
| Language barriers | 8 | 2 | 10 | “Language barriers are a big hurdle (we don’t have funding for translators)” (107, survey) | |
| Participant reluctant to go through consent process | 6 | 3 | 9 | “Some subjects want to skim over the consent and sign, they baulk at the detailed requirements needed for the consent process.” (22, survey) | |
| Participants’ questions require specialty knowledge | 2 | 3 | 5 | “One of the main challenges I have experienced is when consenting for studies that involves novel surgically invasive procedures. Potential subjects are apprehensive and want more in-depth clinically informative discussion, which is somewhat beyond regular consenting process.” (11, survey) | |
| Strategies | Use printed, visual, or other educational resources | 9 | 6 | 15 | “Providing additional educational materials” (71, survey) |
| Spend more time with participants | 8 | 4 | 12 | “Really spending time and having a discussion around consent.” (35, survey) | |
| Break down consent form based on cognitive needs | 4 | 6 | 10 | “Explain the document at different levels of understanding, to meet the patient where they were cognitively” (48, survey) | |
| Go through consent process at a slow pace | 5 | 4 | 9 | “Learning to slow down during the consent process to make sure the participant is absorbing all the information.” (91, survey) | |
| Involve PI or physician in discussion | 2 | 4 | 6 | “Make sure yourself as well as the PI is available during the ICF process to field those questions in case they ask some that you don’t know the answers to.” (34, survey) | |
| Orient participant (e.g. explain purpose of consent) | 4 | 2 | 6 | “I often will give a brief overview of the study itself before getting into the consent, so that way a patient goes into the consent with at least a level of understanding of the study.” (19, survey) | |
| Encourage participants to actively engage (e.g. take notes) | 1 | 1 | 2 | “Allowing participants to write on their consent forms/take notes” (37, survey) | |
| Assessing comprehension | |||||
| Barriers | Difficulty assessing comprehension (unclear whether participant understands) | 11 | 2 | 13 | “Ensuring understanding of the information for this population is also difficult at times.” (24, survey) |
| Strategies | Ask participants to repeat back information (“teach-back method”) | 4 | 3 | 7 | “The teach-back method is great with getting participants to understand the consent.” (37, survey) |
| Use a short questionnaire or quiz | 4 | 1 | 5 | “Using a short questionnaire to confirm understanding of the protocol” (15, survey) | |
| Supporting deliberation | |||||
| Barriers | Misconceptions or lack of knowledge about research | 7 | 5 | 12 | “One subject claimed that I was going to try and clone him (he was being serious).” (69, survey) |
| Participant holds unrealistic expectations | 6 | 6 | 12 | “Subjects feel that the treatment will be a magic cure.” (50, survey) | |
| Mistrust in research | 5 | 3 | 8 | “One of the greatest challenges I have incurred is the lack of representation on our study team … I believe this may sometimes lead to further mistrust of the scientific and medical community.” (94, survey) | |
| Participant consents without understanding | 6 | 1 | 7 | “I also encountered patients who did not fully understand the study or the risks due to cognitive decline but signed the consent form anyway.” (17, survey) | |
| Close others disagree or influence decision-making | 5 | 2 | 7 | “There may be challenges when you are consenting a patient who also has a caregiver or friend present … [they] may have different motives and aspirations that can impact a patient’s willingness to enroll.” (40, survey) | |
| Participant doesn’t fully consider risks | 2 | 1 | 3 | “It’s also common that participants will be so eager for relief from some new intervention that they will not properly consider the potential risks or practical downsides to joining a trial.” (20, survey) | |
| Lack of knowledge about/coming to terms with diagnosis | 1 | 1 | 2 | “I feel it’s difficult to present information fairly and concisely when people do not have a good understanding of their disease.” (106, survey) | |
| Strategies | Involve close others to support understanding | 15 | 6 | 21 | “Having a spouse/caregiver present helped to ensure that the study was understood.” (21, survey) |
| Encourage participant to speak with others (e.g. family) | 5 | 4 | 9 | “They are also encouraged to discuss the process prior to consenting with family/friends/caregivers/providers.” (39, survey) | |
| Honesty/transparency | 3 | 2 | 5 | “I find stark honesty works well for participants to recognize the challenges of being in a research trial.” (44, survey) | |
| Encourage participants to join support groups | 1 | 1 | 2 | “For people who have been newly diagnosed or seem to be lacking information about their condition … we encourage subjects and caregivers to join local support groups.” (31, survey) | |
| Existing knowledge about research aids understanding | 0 | 2 | 2 | “Often the populations we are recruiting from found out about the study through patient support groups … so we didn’t have to start from scratch with them.” (90, interview) | |
Shading was used only to create visual contrast to separate barriers and strategies.