A recruiter sits across from the participant in a quiet screening room to ensure privacy during the consenting process. Typically, only one recruiter is present with one participant, unless particular expertise is needed from additional staff. In this case, and with the participant’s permission, another recruiter may be brought in to assist and offer additional information. The consent process involves conveying study information to a prospective participation and usually requires approximately 30-minutes, but the time can vary depending on the complexity of the study. During the informed consent process, the recruiter gives the prospective participant a copy of the “Experimental Subjects Bill of Rights” to review, which is required by California state law when enrolling in biomedical research that involves medical experimentation. The recruiter explains the HNRP’s privacy practices and data confidentiality procedures, including that participants’ identifying information is stored securely and separately from information collected for the study and only specific research staff have access to that information. Next, the recruiter reviews each paragraph of the IRB approved study consent document with the prospective participant. At the end of each consent section, the recruiter asks if the prospective participant has any questions or concerns. Across studies hosted by the HNRP, the consent documents contain language required by the IRB, standard HNRP practices,indoor vertical farming system and study specific information resulting in documents that range from 4 to 17 pages. Lastly, participant’s knowledge of the study is tested with a validated assessment tool , which is used to evaluate understanding of the study purpose and procedures, including possible risks and benefits.
Two raters independently coded participants’ responses to questions 1, and 2, which were openended prompts where participants could write as much or as little as they wanted. Each rater established their own code book organized by emerging patterns and themes. After initial coding of the responses, the raters and senior author met to review the themes generated. The majority of codes and resulting themes were initially agreed-upon by both raters with discrepant themes discussed with the senior author until reaching inter-rater agreement. Theme labels were determined by group consensus.In research studies, it is the responsibility of the researcher to ensure that the consent process is implemented correctly. While decisional capacity questionnaires are common, particularly in populations with higher risk of impaired decisional capacity, it is not common practice to solicit feedback from participants with regard to the informed consent process. Research participants at the HNRP, a research center with multiple years of working with PWH and dedicated research staff with experience taking potential research participants through the consent process, found the consenting process, on average, to be extremely informative and extremely consistent with what they did during the study. This indicates that the traditional informed consent process involving a face-to-face discussion with a prospective research participant combined with a written consent document can be successful. Additionally, several different themes were endorsed as “most important” and the most common answer for what was “least important” was that everything was important. This would indicate that although some participants do not find all portions of informed consent to be useful, some participants do; including the goals of the study, procedure, risks, and information about protection of confidentiality. This may also suggest the consenting process should be tailored to individual participants, and participants should be able to choose how much additional information they are provided beyond the required information. We did not observe differences in response to any of the questions by HIV status. Unfortunately, there is little research examining what PWH value most from research study participation, the informed consent process in general, or in comparison to HIV-negative persons to compare with our findings.
One review examining barriers to participation in HIV drug trials found societal discrimination and distrust of researchers, among other things , were barriers to participation . Based on this review, as well as historical and ongoing stigma toward PWH, confidentiality may be something PWH highly value in research studies. However, in this study, we did not observe HIV serostatus differences in proportion of participants reporting confidentiality to be “most important.” The majority of PWH participants who filled out the consent questionnaire have been in multiple studies at the center and, on average, have completed more study visits than HIV-negative participants. The center is also actively involved within the community. Therefore, participants prior experience with the center may have had a higher level of trust going into the informed consent process, which may have influenced their responses. Additionally, confidentiality is likely valued by many individuals regardless of HIV status, which also may be why we did not observe any difference by HIV serostatus. While this study adds valuable insights into informed consent literature, there are limitations. First, the center in which this study took place is an established community research facility with highly trained staff experienced both working with this study population and consenting participants. Studies without these resources, trained staff, or established study enrollment practices may have difficulty with establishing the practices described in this study. Second, participants in the study were already willing to come in for the research study, so their responses may not accurately reflect what the general population values from the informed consent process or what aspects of the informed consent process may persuade individuals that are not willing to participate in research. Moreover, we were unable to examine responses by other variables of interest due to sample size restrictions. Future studies should aim to assess participants’ preferences with respect to information presented during the informed consent process and how those preferences differ at the individual level. Lastly, not all participants provided responses to every question, particularly the open-ended response questions, which may be due to participants not having feedback to provide or found the open-ended response questions to be burdensome.
Asking a more specific question or interviewing participants about what changes they would suggest for improving the informed consent process may have elicited more responses.This study demonstrates that implementing the informed consent process with trained staff can be successful. Participants reported the experience as both informative and believed what they were told during the consent process was consistent with what they experienced during the study. This is in line with systematic reviews that have found that the most effective way to improve understanding of the informed consent was to have a one-on-one discussion with study participants . This would suggest that IRBs and researchers should be invested in the training of those who implement the informed consent process as well as monitor how the informed consent is presented to research participants. Furthermore, our recommendation to researchers working with PWH is to view the informed consent process as an opportunity to build trust, educate and show a true appreciation for the participants’ time, which will hopefully encourage continued participation in research.There are opportunities to continue to improve the informed consent process, and there have been recent updates to the “Common Rule”, which will influence the presentation of the informed consent moving forward . Often in practice the informed consent falls short of what it aims to accomplish . For example, a recent meta-analysis found that participants’ understanding of portions of the informed consent ranged from 52–76% . Even more discouraging is that Tam et al. found that the proportion of participants who understood the informed consent process has not improved in the past 30years. In hopes of improving informed consent to make it more engaging and understandable, two studies compared a simplified and concise informed consent with a traditional consent form. Both studies reported that participants found the shorter informed consent more engaging, and one study reported that comprehension was equivalent to the standard consent form whereas the other study found improved understanding with the shorter consent form . Another study found that implementing a fact sheet and engaging in a question and answer feedback session improved open-ended questions to assess understanding of the informed consent . Additionally,indoor vertical farming kits in a study that compared ways to assess understanding of the informed consent, found that commonly used forced choice or self-report questionnaires may overestimate the level of understanding of the informed consent as recognition of information does not ensure comprehension of information . Therefore, free-response questions may be a better measure of comprehension indicating that IRBs that review decisional capacity questionnaires and researchers who are trying to improve the informed consent process must be mindful of how understanding of the informed consent is assessed.
As research moves more toward digital studies and trials where the in-person interaction is not feasible, as we are currently facing with the COVID-19 crisis, it will be important to design the consent process that can build upon elements of existing successful consent models. Standards of practice and design features for digital consent, also known as eConsent, are in development. Some groups have begun to create open-source and customizable tools for low-risk, mobile-mediated research , which has been used in patient populations . Digital studies and eConsents are advantageous as they allow for use of multimedia methods , which can be standardized and reviewed by an IRB to ensure that participants are receiving the necessary information. Studies that have examined multimedia methods have shown that they successfully relay information to participants, with some studies reporting that use of video or PowerPoint is related to an increase in engagement and comprehension . Additionally, as more participants want their study results returned to them, digital consent could allow participants to tailor the consent to their personal preferences and select which data they would like access to. However, there are additional considerations when designing eConsent . For example, in a focus group study of patients underrepresented in research, participants overall found eConsent easy to use and interesting; however, minority and rural participants raised concerns about accessibility, trust, and confidentiality . We anticipate our findings demonstrating an engaging informed consent process can be adapted for digital deployment for populations that value privacy and confidentiality such as PWH.Methamphetamine abuse is a significant problem in the United States, particularly in the West and Midwest. Worldwide, amphetamines are second only to cannabis as the most widely abused drugs, with a prevalence of 14 to 57 million, or 0.3 to 1.3%, of all 15-64 year olds. In 2010, an estimated 353,000 people age 12 or older in the United States reported using MA, with 105,000 estimated new users. Women account for a substantial subset of MA users; data from treatment centers in 2003 showed 45% of patients treated for amphetamine abuse were women, increasing to 46% in 2009.Moreover, MA abuse among pregnant women is a persistent problem. The Infant Development, Environment and Lifestyle study found approximately 6% of women reported drug use during pregnancy. Further, the prevalence of MA abuse in pregnant women admitted to federally funded treatment centers in the U.S. rose to 24% in 2006. Similarly, international data from 2004 demonstrates that amphetamines were used by 23% of substance-abusing mothers. The effects of prenatal MA exposure on childhood outcome are not well characterized. MRI data has shown that MA exposure is associated with reductions in striatal and caudate volume, which may be associated with cognitive deficits. Volumetric assessments of MRIs in exposed children have also demonstrated smaller subcortical volumes including the putamen, globus pallidus, and hippocampus, potentially impacting attention and memory. These findings are consistent with behavioral issues described in a small cohort of children exposed to methamphetamine. In this small non-randomized sample, prenatal MA exposure is associated with deficits in executive function and spatial performance, aggressive behavior and problems with peers, as well as delays in math and language. Relatively little is known about the effects of MA during early infancy. In a study of cocaine and MA exposed newborns, there was an increased incidence of intraventricular hemorrhage and white matter densities observed on cranial ultrasound. In another study, prenatal amphetamine exposure has been associated with increased drowsiness in exposed infants in the first few months of life that resolved by twelve months of age. However, these previous findings were retrospective and utilized a small sample size. The Infant Development, Environment and Lifestyle study is a prospective longitudinal investigation of neurobehavioral outcome related to MA exposure in utero.