Abstract
Introduction
While quizzing during informed consent for research to ensure understanding has become commonplace, it is unclear whether the quizzing itself is problematic for potential participants. In this study, we address this issue in a multinational HIV prevention research trial enrolling injection drug users in China and Thailand.
Methods
Enrollment procedures included an informed consent comprehension quiz. An informed consent survey (ICS) followed.
Results
525 participants completed the ICS (Heng County, China=255, Xinjiang, China=229, Chiang Mai, Thailand=41). Mean age was 33 and mean educational level was 8 yrs. While quizzing was felt to be a good way to determine if a person understands the nature of clinical trial participation (97%) and participants did not generally find the quiz to be problematic, minorities of respondents felt pressured (6%); anxious (5%); bored (5%); minded (5%); and did not find the questions easy (13%). ). In multivariate analysis, lower educational level was associated with not minding the quizzing (6–10 yrs versus 0–5 yrs: OR=0.27, p=0.03; more than 11 yrs versus 0–5 yrs: OR=0.18, p=0.03). There were also site differences (Heng County versus Xinjiang) in feeling anxious (OR=0.07; p=<0.01), not minding (OR=0.26; p=0.03), being bored (OR=0.25; p =0.01), and not finding the questions easy (OR=0.10; p=<0.01).
Conclusions
Quizzing during the informed consent process can be problematic for a minority of participants. These problems may be associated with the setting in which research takes place and educational level. Further research is needed to develop, test and implement alternative methods of ensuring comprehension of informed consent.
Trial Registration
clinicaltrials.gov number NCT00270257.
Keywords: informed consent, research ethics, ethics, attitudes
Introduction
Informed consent is a fundamental ethical requirement of clinical research, which is intended to protect the rights and interests of research participants 1–4. Studies on informed consent, however, have consistently shown that study participants often do not fully understand the requirements of the research study in which they are enrolled 5–13. When research poses substantial risk to participants or there may be some question about the capacity of potential participants to provide informed consent, methods to assess potential participants’ comprehension prior to study enrollment, such as quizzes, have been incorporated into the informed consent process. Such methods are now commonplace for certain types of clinical research, such as large, multi-site HIV prevention trials 14–18 and clinical research involving substance users 19. Yet, participant acceptability and cultural appropriateness of these assessment methods have not been well studied, especially in vulnerable populations who may have had limited formal education, engage in illegal or stigmatized activities (e.g., drug use, sex work) or otherwise be unaccustomed to being quizzed.
Our study intended to address this gap in the literature by assessing participants’ opinions about an informed consent comprehension quiz administered as part of a large, multi-site HIV prevention clinical trial and to assess their feelings when completing the quiz.
Methods
Our evaluation was embedded within a phase III randomized controlled trial to evaluate the efficacy of different modalities of drug treatment for the prevention of HIV infection and death among opiate dependent injectors. Additional information about the study is available at: http://www.hptn.org/research_studies/hptn058.asp. Study sites included Xinjiang Uighur Autonomous Region Centers for Disease Control and Prevention in Xinjiang, China; Guangxi Zhuang Autonomous Region Centers for Disease Control and Prevention in Guangxi, China; and the Research Institute for Health Sciences in Chiang Mai University in Chiang Mai, Thailand.
The study was reviewed and approved by the following ethics committees: Chiang Mai University Research Institute for Health Sciences (RIHES), Thailand; Ministry of Public Health Ethical Review Committee for Research in Human Subjects (MOPH), Nonthaburi, Thailand; Guangxi Center for Disease Prevention and Control Institutional Review Board (IRB), China; Xinxiang Uighur Autonomous Region Bureau of Health Disease Control and Treatment IRB, China; The Chinese National Center for AIDS/STD Control and Prevention IRB; and Johns Hopkins Medicine IRB #2, United States. Participants provide their informed consent for the informed consent survey as part of the enrollment consent process for the trial, although they were given the option to decline participation in the survey when it was offered and still participate in the trial. As part of the trial’s informed consent and enrollment process, participants must first pass an informed consent comprehension quiz by answering at least 9 of 12 questions (75%) correctly within three attempts, prior to signing the consent form. Only participants who passed the informed consent comprehension quiz and gave informed consent to participate in the trial were asked to complete the informed consent survey (ICS). Often the ICS was administered immediately following the administration of the comprehension quiz and signing of the consent form, but participants were permitted to complete the ICS at any time during their enrollment study visit. One study staff member administered the informed consent comprehension quiz and a different study staff member administered the ICS to reduce bias associated with socially desirable responses. The ICS was always administered orally.
Questions on the ICS were informed by educational literature on test taking 20–21 and included 6 questions that asked participants to agree or disagree using a 5-point Likert scale (i.e., strongly disagree, disagree, neither disagree or agree, agree, strongly agree) on feelings they experienced when answering the informed consent comprehension quiz, such as being anxious or annoyed. Two additional questions assess participants’ opinions on whether quizzing is an appropriate method to measure comprehension among potential study participants. Several rounds of field-testing were conducted with study staff and members of the community advisory boards in two sites (Chiang Mai and Heng County) to ensure that the all items and response categories were culturally and linguistically appropriate across the sites. The ICS was translated into the local languages and back-translated to confirm questions on the translated versions and the English version all reflect the same meaning. The final items included in the ICS are listed in Table 1 and the ICS instrument is provided in the Appendix. The Chiang Mai site obtained the necessary regulatory approvals to implement this evaluation at a much later date, and enrolled far fewer participants than the sites in China, and hence there were fewer participants available for analysis.
Table 1.
Informed Consent Evaluation Survey Items (English Version)
| Question | Five-point Likert Scale | Three-point Likert Scale | Binary Scale |
|---|---|---|---|
| You were anxious | Strongly Disagree | Disagree | Positive |
| Disagree | |||
| Neither Disagree or Agree | Neutral | ||
|
| |||
| Agree | Agree | Negative | |
| Strongly Agree | |||
|
| |||
| You did not mind | Strongly Disagree | Disagree | Negative |
| Disagree | |||
|
| |||
| Neither Disagree or Agree | Neutral | Positive | |
| Agree | Agree | ||
| Strongly Agree | |||
|
| |||
| You were bored | Strongly Disagree | Disagree | Positive |
| Disagree | |||
| Neither Disagree or Agree | Neutral | ||
|
| |||
| Agree | Agree | Negative | |
| Strongly Agree | |||
|
| |||
| You were irritated | Strongly Disagree | Disagree | Positive |
| Disagree | |||
| Neither Disagree or Agree | Neutral | ||
|
| |||
| Agree | Agree | Negative | |
| Strongly Agree | |||
|
| |||
| You found the questions easy | Strongly Disagree | Disagree | Negative |
| Disagree | |||
|
| |||
| Neither Disagree or Agree | Neutral | Positive | |
| Agree | Agree | ||
| Strongly Agree | |||
|
| |||
| You felt pressured | Strongly Disagree | Disagree | Positive |
| Disagree | |||
| Neither Disagree or Agree | Neutral | ||
|
| |||
| Agree | Agree | Negative | |
| Strongly Agree | |||
|
| |||
| Taking the comprehension quiz made you feel like the researchers really wanted you to understand the clinical trial | Strongly Disagree | Disagree | Negative |
| Disagree | |||
|
| |||
| Neither Disagree or Agree | Neutral | ||
| Agree | Agree | Positive | |
| Strongly Agree | |||
|
| |||
| Testing is a good way to find out if a person really understands the clinical trial | Strongly Disagree | Disagree | Negative |
| Disagree | |||
|
| |||
| Neither Disagree or Agree | Neutral | Positive | |
| Agree | Agree | ||
| Strongly Agree | |||
Data were analyzed using standard descriptive and inferential statistics for ordered and unordered variables. Factor analyses were then conducted.
For each attitude question, the five point Likert scale was collapsed to positive and negative attitudes (Table 1). Logistic regression was used to compute the odds ratios of a negative attitude for each question for site, gender, age, and education. Significant covariates (p-value less than 0.05) were retained in a multivariate logistic regression model.
Factor analysis was used to define combinations of the attitude questions that had commonality across the participants. Specifically, factor analysis with varimax rotation was applied to the eight attitude questions, after mapping the Likert scale using numeric scores of −2, −1, 0, 1 and 2, with positive attitudes mapped to positive scores. A scree plot test was examined to guide the selection of factors capturing most of the variance in attitude. The resulting selected factors combine the original attitude questions using factor loadings, so questions with high (absolute) factor loadings are interpreted as defining a given factor’s characteristics.
Results
587 participants were asked if they were willing to complete the ICS and 525 completed it (255 from Heng County, 229 from Xinjiang, and 41 from Chiang Mai). The response rates for the ICS were 100% in both Chiang Mai (41/41) in Chiang Mai and Heng County (255/255), and 81% (229/282) in Xinjiang. Overall, the mean age was 33; 7% were female; mean educational level was 8 yrs (Table 2). No significant differences in demographic characteristics (age, gender and educational level) were found between those who did and did not complete the ICS in Xinjiang.
Table 2.
Demographic Characteristics of Respondents
| Heng County, China | Xinjiang, China | Chiang Mai, Thailand | |
|---|---|---|---|
| Age | |||
| 18 – 25 | 74/255 (29%) | 31/229 (14%) | 5/41 (12%) |
| 26 – 35 | 122/255 (48%) | 86/229 (38%) | 14/41 (34%) |
| 36 – 45 | 55/255 (22%) | 100/229 (44%) | 14/41 (34%) |
| More than 45 | 4/255 (2%) | 12/229 (5%) | 8/41 (20%) |
| Gender | |||
| Male | 244/255 (96%) | 205/229 (90%) | 40/41 (98%) |
| Female | 11/255 (4%) | 24/229 (10%) | 1/41 (2%) |
| Years of Education | |||
| 0 – 5 | 30/255 (12%) | 20/229 (9%) | 37/41 (90%) |
| 6 – 10 | 216/255 (85%) | 112/229 (49%) | 4/41 (10%) |
| 11 – 12 | 9/255 (4%) | 71/229 (31%) | 0/41 (0%) |
| 13 – 16 | 0/255 (0%) | 25/229 (11%) | 0/41 (0%) |
| 17 – 20 | 0/255 (0%) | 1/229 (<1%) | 0/41 (0%) |
| 21+ | 0/255 (0%) | 0/229 (0%) | 0/41 (0%) |
While quizzing was felt to be a good way to find out if a person understands the clinical trial (97%) and was not problematic for the majority of participants, minorities of respondents felt pressured (6%); anxious (5%); bored (5%); minded being quizzed (5%); and didn’t find the questions easy (13%) (Table 3).
Table 3.
Attitudes about the informed consent questionnaire
| Informed Consent Evaluation Survey | Answers (Bivariate) | ||
|---|---|---|---|
| Questions for Participants | Agree | Neutral | Disagree |
| Were anxious | 28/525 (5%) | 41/525 (8%) | 456/525 (87%) |
| Did not mind | 446/525 (85%) | 55/525 (10%) | 24/525 (5%) |
| Were bored | 28/525 (5%) | 14/525 (3%) | 483/525 (92%) |
| Were irritated | 5/525 (1%) | 7/525 (1%) | 513/525 (98%) |
| Found questions easy | 358/525 (68%) | 98/525 (19%) | 69/525 (13%) |
| Felt pressured | 29/524 (6%) | 72/524 (14%) | 423/524 (81%) |
| Felt that quizzing indicated that the researchers really wanted them to understand the clinical trial | 520/525 (99%) | 4/525 (1%) | 1/525 (<1%) |
| Felt testing is a good way to find out if a person really understands the clinical trial | 511/525 (97%) | 13/525 (2%) | 1/525 (<1%) |
In multivariate analysis, there were site differences (Heng County versus Xinjiang) in feeling anxious (OR=0.07; p=<0.01), not minding the quizzing (OR=0.26; p=0.03), being bored (OR=0.25; p =0.01), and not finding the questions easy (OR=0.10; p=<0.01). Lower educational level was associated with not minding the quizzing (6–10 yrs versus 0–5 yrs: OR=0.27, p=0.03; > 11 yrs versus 0–5 yrs: OR=0.18, p=0.03) (Table 4).
Table 4.
Association between attitudes and site, age and education
| Univariate | Multivariate | ||||||
|---|---|---|---|---|---|---|---|
| Questions | Effect | OR | 95% CI | p-Value | OR | 95% CL | p-Value |
| Participants were anxious | |||||||
| Site | Xinjiang | 1.00 | 1.00 | ||||
| Chiang Mai | 1.79 | (0.67, 4.77) | 0.24 | 0.91 | (0.23, 3.64) | 0.90 | |
| Heng County | 0.08 | (0.02, 0.36) | <0.01 | 0.07 | (0.02, 0.32) | <0.01 | |
| Age | 18–35 | 1.00 | 1.00 | ||||
| 36–45 | 1.28 | (0.54, 3.02) | 0.58 | 0.81 | (0.34, 1.96) | 0.65 | |
| >45 | 5.98 | (1.95, 18.34) | <0.01 | 2.70 | (0.81, 9.04) | 0.11 | |
| Education (years) | 0–5 | 1.00 | 1.00 | ||||
| 6–10 | 0.35 | (0.15, 0.86) | 0.02 | 0.70 | (0.20. 2,42) | 0.57 | |
| >11 | 0.52 | (0.18, 1.52) | 0.23 | 0.42 | (0.10, 1.72) | 0.23 | |
| Participants did not mind | |||||||
| Site | Xinjiang | 1.00 | 1.00 | ||||
| Chiang Mai | 5.57 | (2.14, 14.5) | <0.01 | 1.74 | (0.49, 6.15) | 0.39 | |
| Heng County | 0.32 | (0.10, 1.01) | 0.05 | 0.26 | (0.08, 0.87) | 0.03 | |
| Education (years) | 0–5 | 1.00 | 1.00 | ||||
| 6–10 | 0.14 | (0.06, 0.35) | <0.01 | 0.27 | (0.08, 0.87) | 0.03 | |
| >11 | 0.17 | (0.05, 0.60) | 0.01 | 0.18 | (0.04, 0.83) | 0.03 | |
| Participants were bored | |||||||
| Xinjiang | 1.00 | 1.00 | |||||
| Chiang Mai | 2.14 | (0.79, 5.79) | 0.14 | 2.14 | (0.79, 5.79) | 0.14 | |
| Heng County | 0.25 | (0.09, 0.69) | 0.01 | 0.25 | (0.09, 0.69) | 0.01 | |
| Participants were irritated | No Significant Effect | ||||||
| Participants found questions easy | |||||||
| Xinjiang | 1.00 | 1.00 | |||||
| Chiang Mai | 1.25 | (0.59, 2.66) | 0.57 | 0.98 | (0.34, 2.80) | 0.97 | |
| Heng County | 0.08 | (0.03, 0.20) | <0.01 | 0.10 | (0.04, 0.24) | <0.01 | |
| Education (years) | 0–5 | 1.00 | 1.00 | ||||
| 6–10 | 0.35 | (0.18, 0.68) | <0.01 | 0.58 | (0.23, 1.43) | 0.23 | |
| >11 | 1.34 | (0.67, 2.67) | 0.41 | 0.92 | (0.35, 2.39) | 0.86 | |
| Participants felt pressured | |||||||
| Age | 18–25 | 1.00 | 1.00 | ||||
| 26–35 | 1.51 | (0.40, 5.68) | 0.54 | 1.52 | (0.40, 5.73) | 0.54 | |
| 36–45 | 2.99 | (0.83, 10.75) | 0.09 | 2.80 | (0.77, 10.2) | 0.12 | |
| >45 | 7.13 | (1.48, 34.33) | 0.01 | 5.59 | (1.12, 27.9) | 0.04 | |
| Education (years) | 0–5 | 1.00 | 1.00 | ||||
| 6–10 | 0.38 | (0.16, 0.90) | 0.03 | 0.49 | (0.20, 1.21) | 0.12 | |
| >11 | 0.51 | (0.18, 1.50) | 0.22 | 0.57 | (0.19, 1.71) | 0.31 | |
The loadings of the first two factors (Table 5) define a first factor by attitudes related to emotions about quizzing (high loadings on the first four questions), and the second factor related to the content of the quiz (high loadings on the last two questions).
Table 5.
Factor Analysis
| Score | After Rotation | |||
|---|---|---|---|---|
| Question | Mean | STD | Factor 1 Loading | Factor 2 Loading |
| Were anxious | 0.90 | 0.64 | 0.75 | −0.07 |
| Were bored | 0.99 | 0.62 | 0.81 | 0.02 |
| Were irritated | 1.17 | 0.51 | 0.76 | 0.02 |
| Felt pressured | 0.81 | 0.63 | 0.57 | 0.24 |
| Did not mind | 0.83 | 0.63 | 0.12 | 0.32 |
| Found questions easy | 0.59 | 0.75 | 0.18 | 0.35 |
| Felt researchers really wanted them to understand | 1.09 | 0.33 | −0.02 | 0.86 |
| Felt testing is a good way to find out if a person really understands | 1.06 | 0.34 | −0.08 | 0.89 |
| Variance Explained by Each Factor (%) | 27.14 | 22.86 | ||
Discussion
While quizzing during the informed consent process is aimed at helping to ensure that potential research participants have adequate understanding of the proposed research, and participants in general believe that quizzing is a good way to assess understanding, it can be problematic for some participants.
In a multivariate analysis, those with more education were more likely to mind being quizzed. Perhaps, those with more education view quizzing in such a situation to be excessive or insulting. Alternatively, they might associate quizzing with stressful experiences in school.
In addition, in this study the extent to which quizzing is problematic relates at least in part to the setting in which the research takes place. In multivariate analyses, there were significant differences among the two sites in China (which each have substantially more respondents than the site in Thailand). Participants in Heng County compared to those in Xinjiang were more likely to report that they minded answering the quiz and not finding the questions easy; yet they were less likely to be bored or anxious due to quizzing. It is conceivable that these findings are related to a variety of factors such as culture, ethnicity, and the urban (Xinjiang) versus rural (Heng County) location of the sites.
Of course, these findings should be interpreted with several limitations in mind. First, respondents’ reports about quizzing during the informed consent process may be subject to a social response bias, in which respondents are inclined to report that the quizzing was not problematic. Such bias would be understandable since the participants have just given informed consent to participate in the parent trial and may want to please the research team by not ‘complaining.’ In order to minimize the likelihood of such a bias, in this study separate study staff members administered the informed consent survey from those who did the quizzing itself. Related, those participants who completed the informed consent survey all passed the quiz, which may have influenced their evaluation of it. Also, the small number of participants in Chiang Mai limits our power to detect anything other than very substantial site differences in attitudes in Thailand compared to the China sites. While the response rate was high in Chiang Mai and Heng county, as many as 20% refused to participate in the ICS in Xinjiang, raising the potential for non-response bias in this site, although no differences were observed in the demographic characteristics among responders and non-responders. Despite these possibilities, this analysis indicates variability in attitudes towards quizzing, suggesting that the instrument was able to overcome these limitations. In addition, although we have data from a large number of participants and the response rate was high, it is important to remember that our data derive from a single parent study taking place in 3 sites in 2 countries that includes quizzing about the particularities of that trial. Therefore, it would not be surprising if findings from a similar evaluation would differ if it were to be conducted in other geographic regions and cultures or for another trial. While it is conceivable that quizzing during the informed consent process may be more or less problematic in other instances, such variability alone would be an interesting finding. Moreover, it would be arguably important to identify trials and sites where quizzing would be especially problematic so that alternative means of assessing comprehension might be used.
Accordingly, further research is needed to assess satisfaction with quizzing during the informed consent process in other studies and in different geographic regions. Fortunately, as we have demonstrated in this study, evaluating attitudes towards quizzing during the informed consent process can be relatively easily implemented in actual clinical trials using standard clinical trial procedures. Others wishing to evaluate the process could elect to use the informed consent survey we developed, perhaps eliminating those items which did not add information based on the factor analysis described above. Regardless, careful attention should be paid to ensure that the items translate and back-translate properly.
These pending issues notwithstanding, concerted effort should be directed at ensuring comprehension during the informed consent process. While at first glance quizzing seems to provide a relatively easy means of appearing to fulfill this objective, there remains a surprisingly difficult set of questions which remain regarding quizzing; these include what constitutes adequate understanding, what aspects of the study are important to understand, and what effects will this quizzing have on potential participants, including not only their attitudes, but also on their willingness to participate, trust, and adherence to study requirements. These issues warrant rigorous attention, both conceptually and empirically. In the meantime, formative research should be conducted in settings in which quizzing is being proposed to evaluate comprehension during the informed consent process so that alternative means for ensuring comprehension might be developed and implemented in settings where quizzing may be problematic.
Supplementary Material
Footnotes
Contributors
Lara Siree Johnson, Research Institute for Health Sciences, Chiang Mai, Thailand, for testing and translation.
Ms. Kanungnit Nugate, MSc (RIHES), Chiang Mai, Thailand, for administration of the survey.
Louise Walshe, BSN, MPH, Johns Hopkins University, Baltimore, Maryland, USA, for pilot testing the survey Shuaifeng Liu, QA/RA Coordinator, Guangxi Center for Disease Prevention and Control, Guangxi, China, made suggestions during survey development, translated the survey into Chinese, and trained counselors to use the survey.
Jianhua Huang, Site Coordinator, Guangxi Center for Disease Prevention and Control, Guangxi, China, made suggestions during survey development, pilot tested the survey, and trained counselors to use the survey.
Rongjian Li, Outreach Coordinator, Guangxi Center for Disease Prevention and Control, Guangxi, China, made suggestions during survey development and pilot tested the survey.
Quiying Zhu, Data Manager, Guangxi Center for Disease Prevention and Control, Guangxi, China, made suggestions during survey development.
Maria Au, DrPH student, Johns Hopkins School of Public Health, assisted with survey development.
Jun Ma, Xinjiang Center for Disease Control and Prevention, Urumqi, China, for administration of the survey.
Hong Zhu, Chinese Center for Disease Control and Prevention, Beijing, China, for recruitment and managing the cohort.
Yunxia Wang, Urumqi municipal Center for Disease Control and Prevention, Urumqi, China for recruitment and managing the cohort.
Funding, Disclaimer, and Competing Interests:
JS, AC, SR, BD, DD, TYL, DC, BJ, AA, LW, YS, FL, BR, and DM had full access to all of the data and have support from the HIV Prevention Trials Network (HPTN) under award numbers U01 AI068619 and U01 AI 069482 from the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute on Drug Abuse (NIDA) and the National Institute of Mental Health (NIMH) for the submitted work. The study funders were not involved in the study design, analysis, or writing of this manuscript. JS, AC, SR, BD, DD, TYL, DC, BJ, AA, LW, YS, FL, BR and DM have no specified relationships with Reckitt Benckiser that might have an interest in the submitted work in the previous 3 years; their spouses, partners, or children have no specified financial relationships that may be relevant to the submitted work. JS, AC, SR, BD, DD, TYL, DC, BJ, AA, LW, YS, FL, BR, and DM have no specified non-financial interests that may be relevant to the submitted work. The content is solely the responsibility of the authors and does not necessarily represent the official views of the HPTN, NIAID, or NIMH.
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