Assessing the impact of a modified informed consent process in a South African HIV/AIDS research trial

Objective

The process of informed consent may be jeopardized in cross-linguistic research trials but little is known about the factors which contribute to this. The present study was designed to assess the impact on the understanding of trial participants of the essential components of a trial, as well as on the perceptions of the participants, through enrollment via a standard versus a modified informed consent protocol.

Methods

Counselors from two HIV trial sites in South Africa were trained to enroll patients for a trial, using a modified informed consent protocol. The standard and modified protocols were compared.

Results

Marked differences were noted in effectiveness of the process after training using the modified protocol, resulting in improved patient understanding. An item analysis suggested those areas of the trial which were most difficult for counselors to communicate effectively and highlighted potential barriers and facilitators to the process.

Conclusions

Cultural and linguistic modifications to the informed consent process can enhance the understanding of components of a research trial and are viewed as largely positive by the participants.

Practice implications

Some implications for future enrollments, for developing policy and for the role of a language specialist on research ethics committees and in trial design are highlighted.     

Randomized,controlled evaluation of a prototype informed consent process for HIV vaccine efficacy trials

Procedures must be developed to ensure that valid informed consent is obtained from participants in HIV vaccine efficacy trials. A prototype informed consent process was evaluated among 4,892 persons at high risk for HIV infection in the HIV Network for Prevention Trials Vaccine Preparedness Study (VPS), a prospective cohort study of HIV seroincidence in eight U.S. metropolitan areas. Twenty percent of VPS participants were selected at random to undergo the prototype informed consent process at VPS month 3. Participants' knowledge of 10 key HIV vaccine trial concepts and willingness to participate in HIV vaccine efficacy trials were assessed and compared at baseline and semiannually thereafter for 18 months. Knowledge of HIV vaccine trial concepts was low at baseline. Participation in the prototype process was associated with substantial and sustained increases in knowledge (relative risks for the 10 items, 1.04-2.26), which were of similar magnitude across HIV risk groups, race/ethnicity, and educational levels. It is recommended that the prototype informed consent process be adopted for future HIV vaccine efficacy trials as well as for clinical trials in other research areas.     

Volunteer experiences and perceptions of the informed consent process: Lessons from two HIV clinical trials in Uganda

Background

Informed consent as stipulated in regulatory human research guidelines requires that a volunteer is well-informed about what will happen to them in a trial. However researchers are faced with a challenge of how to ensure that a volunteer agreeing to take part in a clinical trial is truly informed. We conducted a qualitative study among volunteers taking part in two HIV clinical trials in Uganda to find out how they defined informed consent and their perceptions of the trial procedures, study information and interactions with the research team.

Methods

Between January and December 2012, 23 volunteers who had been in the two trials for over 6 months, consented to be interviewed about their experience in the trial three times over a period of nine months. They also took part in focus group discussions. Themes informed by study research questions and emerging findings were used for content analysis.

Results

Volunteers defined the informed consent process in terms of their individual welfare. Only two of the volunteers reported having referred during the trial to the participant information sheets given at the start of the trial. Volunteers remembered the information they had been given at the start of the trial on procedures that involved drawing blood and urine samples but not information about study design and randomisation. Volunteers said that they had understood the purpose of the trial. They said that signing a consent form showed that they had consented to take part in the trial but they also described it as being done to protect the researcher in case a volunteer later experienced side effects.

Conclusion

Volunteers pay more attention during the consent process to procedures requiring biological tests than to study design issues. Trust built between volunteers and the research team could enhance the successful conduct of clinical trials by allowing for informal discussions to identify and review volunteers’ perceptions. These results point to the need for researchers to view informed consent as a process rather than an event.

     

Ten years of dynamic consent in the CHRIS study: informed consent as a dynamic process

The Cooperative Health Research in South Tyrol (CHRIS) is a longitudinal study in Northern Italy, using dynamic consent since its inception in 2011. The CHRIS study collects health data and biosamples for research, and foresees regular follow-ups over time. We describe the experience with the CHRIS study dynamic consent, providing an overview of its conceptualization and implementation, and of the participant-centered strategies used to assess and improve the process, directly linked to participation and communication. In order to comply with high ethical standards and to allow broadness in the areas of research, CHRIS dynamic consent was conceived as an interactive process: based on a strong governance and an ongoing tailored communication with participants, it aims to promote autonomy and to develop a trust-based engaged relationship with participants, also relevant for retention. Built within an online platform, the consent allows granular choices, which can be changed over time. In a process of co-production, participants views have been investigated and kept into account in policy development. Participants showed a high degree of participation, thus enabling the consolidation of the CHRIS resources. Even though a low change rate was reported in the baseline, participants valued the possibility of changing their informed consent choices. Communication (language-tailored, ongoing, multimedia) was important for participants, and for participation and retention. In our experience, dynamic consent was proven to be a flexible consent model, which allowed to meet ethical and legal standards for participation in research, and to accommodate participants’ and researchers’ needs.Subject terms: Ethics, Genetics research     

Teaching the process of obtaining informed consent to medical students.

This paper describes a unit on the informed consent process taught to 119 first-year students at the Michigan State University College of Osteopathic Medicine in 1988-89. The unit consisted of a pretest and a posttest, a lecture, readings, small-group discussions, a model videotaped interview, and the students' videotaped interviews with one of two simulated patients. In the interviews, the students were most successful in establishing rapport and engaging the patients in discussions of treatment alternatives, and were less successful in perceiving the patients as unique individuals and in dealing with situations that involved conflict or confrontation. The authors suggest that curricula can be enhanced by focusing on the importance of patients' participation in the informed consent process.     

Improving the informed consent process in international collaborative rare disease research: effective consent for effective research

The increased international sharing of data in research consortia and the introduction of new technologies for sequencing challenge the informed consent (IC) process, adding complexities that require coordination between research centres worldwide. Rare disease consortia present special challenges since available data and samples may be very limited. Thus, it is especially relevant to ensure the best use of available resources but at the same time protect patients'' right to integrity. To achieve this aim, there is an ethical duty to plan in advance the best possible consent procedure in order to address possible ethical and legal hurdles that could hamper research in the future. Therefore, it is especially important to identify key core elements (CEs) to be addressed in the IC documents for international collaborative research in two different situations: (1) new research collections (biobanks and registries) for which information documents can be created according to current guidelines and (2) established collections obtained without IC or with a previous consent that does not cover all CEs. We propose here a strategy to deal with consent in these situations. The principles have been applied and are in current practice within the RD-Connect consortia – a global research infrastructure funded by the European Commission Seventh Framework program but forward looking in terms of issues addressed. However, the principles established, the lessons learned and the implications for future research are of direct relevance to all internationally collaborative rare-disease projects.     

Spectrum of dermatopathologic lesions associated with HIV/AIDS in India

Histopatholgoical analysis of cutaneous lesions in 195 patients with HIV/AIDS was carried out between 1989 to 1997 at tertiary level public hospital in Mumbai. 104/195 (53%) cases showed infectious diseases which comprised of molluscum contagiosum (28), condyloma accuminata (18), verruca vulgaris (7), varicella zoster (5), syphilis (14), tuberculosis (13), donovanosis (4), leprosy (2), chancroid (2), bacillary angiomatosis (2), lymphogranuloma venercum (1), Norwegian scabies (3), leishmaniasis (2), demodicidosis (1), crytococcosis (1), tinea versicolor (1). In 12 (6%) cases neoplasms were observed which included squamous cell carcinoma (9), basal cell carcinoma (2) and kaposi's sarcoma (1) case. The miscellaneous conditions were observed in 66(33.5%) cases which comprised of psoriasis (21), papular urticaria (13), Reiter's disease (7) and eosinophilic folliculitis (6). The prevalence of cutaneous tuberculosis observed in this study is high as compared with western literature while the prevalence of kaposis's sarcoma is quite low as compared with reports from Africa, USA and United Kingdom.     

Optimizing treatment for African Americans and Latinos with HIV/AIDS

HIV/AIDS is a disease that has a disproportionate negative impact on the African-American and Latino communities when compared with the general population. African Americans account for more than 50% of new AIDS cases, though they comprise only 12% of the general population. More than one-third of AIDS-related deaths in the United States have been among African Americans. Many factors contribute to the HIV/AIDS healthcare disparities seen in the African-American and Latino communities. These factors include medical issues (such as resistance to antiretroviral therapy, toxicities of medications and hepatitis-C coinfection) and social factors (such as a lack of faith in the healthcare system, cultural circumstances and poor access to healthcare services). Healthcare providers can take steps to improve HIV care for African Americans and Latinos. Distrust of the medical establishment can be addressed by increasing the number of culturally sensitive healthcare providers. Communication is the first step toward establishing the trust of patients and minimizing the devastating effects of perceived institutional bias that may lead many HIV patients to be diagnosed late in the course of the disease. Medical and cultural issues faced by African Americans and Latinos should also be addressed in treatment guidelines. When healthcare providers take steps to overcome the medical and cultural issues facing African Americans and Latinos, HIV patients will have access to more effective disease management.     

A stakeholder-driven approach to improve the informed consent process for palliative chemotherapy

ObjectivePatients often anticipate cure from palliative chemotherapy. Better resources are needed to convey its risks and benefits. We describe the stakeholder-driven development and acceptability testing of a prototype video and companion booklet supporting informed consent (IC) for a common palliative chemotherapy regimen.MethodsOur multidisciplinary team (researchers, advocates, clinicians) employed a multistep process of content development, production, critical evaluation, and iterative revisions. Patient/clinician stakeholders were engaged throughout using stakeholder advisory panels, featuring their voices within the intervention, conducting surveys and qualitative interviews. A national panel of 57 patient advocates, and 25 oncologists from nine US practices critiqued the intervention and rated its clarity, accuracy, balance, tone, and utility. Participants also reported satisfaction with existing chemotherapy IC materials.ResultsFew oncologists (5/25, 20%) or advocates (10/22, 45%) were satisfied with existing IC materials. In contrast, most rated our intervention highly, with 89–96% agreeing it would be useful and promote informed decisions. Patient voices were considered a key strength. Every oncologist indicated they would use the intervention regularly.ConclusionOur intervention was acceptable to advocates and oncologists. A randomized trial is evaluating its impact on the chemotherapy IC process.Practice implicationsStakeholder-driven methods can be valuable for developing patient educational interventions.     

Evaluating the benefits of a patient information video during the informed consent process

The study objective was to evaluate the effect of a patient information video during the informed consent process of a perinatal trial. Ninety women, between 19 and 33 weeks gestation, were randomised to receive written information about this perinatal trial and watch an information video or to receive written information only. Participants completed a questionnaire immediately after entry and 2–4 weeks later assessing knowledge of; feelings about the worth of; and willingness for future participation in the perinatal trial. When initially asked, more women who watched the video thought they would consent to the study (χ² =6.3; DF = 1; P = 0.01). No differences in knowledge about the perinatal trial were found initially, but 2–4 weeks later more knowledge had been retained by women who had watched the video (χ² = 6.7; DF = 1; P = 0.01). These results suggest that a patient information video combined with an information sheet may result in greater participation in a research trial and may increase women's knowledge of a specific health problem and related research trial.     

Understanding and retention of the informed consent process among parents in rural northern Ghana

Background

In Nigeria, as in other developing countries, access to training in research ethics is limited, due to weak social, economic, and health infrastructure. The project described in this article was designed to develop the capacity of academic staff of the College of Medicine, University of Ibadan, Nigeria to conduct ethically acceptable research involving human participants.

Methods

Three in-depth interviews and one focus group discussion were conducted to assess the training needs of participants. A research ethics training workshop was then conducted with College of Medicine faculty. A 23-item questionnaire that assessed knowledge of research ethics, application of principles of ethics, operations of the Institutional Review Board (IRB) and ethics reasoning was developed to be a pre-post test evaluation of the training workshop. Ninety-seven workshop participants completed the questionnaire before and after the workshop; 59 of them completed a second post-test questionnaire one month after the workshop.

Results

The trainees came from a multi-disciplinary background including medicine, nursing, pharmacy, social science and laboratory science. The mean scores for knowledge of the principles of research ethics rose from 0.67 out of 3 points at pre-test to 2.25 at post-test (p < 0.05). Also, 42% correctly mentioned one international guideline or regulation at pretest, with most of those knowing of the Declaration of Helsinki. Trainees' knowledge of the operations of an IRB increased from 6.05 at pre-test to 6.29 at post test out of 7 points. Overall, participants retained much of the knowledge acquired from the workshop one month after its completion.

Conclusion

The training improved participants' knowledge of principles of research ethics, international guidelines and regulations and operations of IRBs. It thus provided an opportunity for research ethics capacity development among academic staff in a developing country institution.     

The use of an educational video during informed consent in an HIV clinical trial in Haiti

BACKGROUND: Research volunteers from developing countries who enroll in HIV clinical trials may be illiterate and unfamiliar with the conduct of medical research. Educating volunteers about the contents of the consent form is essential but can be difficult and time consuming. We evaluated the feasibility and effectiveness of an educational video during the informed consent process for an HIV clinical trial conducted in Port-au-Prince, Haiti. METHODS: HIV-seronegative volunteers were recruited into a longitudinal cohort to study rates of high-risk sexual behavior and incidence of HIV-1 infection. Before enrollment, all volunteers received information about the consent form during 2 educational sessions. In the first session, groups of 5 to 10 volunteers viewed an educational video on the essential elements of the consent form. In the second, the volunteers met one-on-one with a social worker. Volunteers' comprehension was then evaluated orally by 16 true-false questions and 4 open-ended questions. Volunteers who failed the first evaluation received additional education and had a second evaluation. RESULTS: Two hundred fifty volunteers received education, and 186 (74%) passed the first evaluation. Higher formal education was a significant predictor of passing the first evaluation (odds ratio, 1.60; 95% confidence interval, 1.05-2.44). Of the 64 who failed, 47 returned for a repeat one-on-one education session and a second evaluation. Among these 47, 39 (83%) passed, and 8 (7%) failed the second evaluation. In total, 225 (90%) of 250 individuals passed either the first or second evaluation and were eligible to enroll in the study. CONCLUSIONS: Informed consent using an educational video ensured good comprehension in most of the volunteers. Additional educational sessions may be necessary for some participants with lower educational level.     

艾滋病与咨询

1　艾滋病流行概况艾滋病 (ＡＩＤＳ)是人类免疫缺陷病毒 (ＨＩＶ )引起的、通过性、血液和围产期母婴三种途径传播的传染病。根据联合国艾滋病规划署 (ＵＮＡＩＤＳ)和世界卫生组织 (ＷＨＯ) 1999年 12月公布的数据 ,自艾滋病流行以来 ,全世界累计已有 1880万人死于艾滋病 ,目前存活的艾滋病毒感染者和艾滋病人估计为 3430万[1] 。艾滋病已成为世界上仅次于心脏病、脑卒中和急性下呼吸道感染的第四个主要死因 ,是造成死亡最多的传染病 ,它已成为发展中国家主要的疾病负担[2 ] 。艾滋病流行对社会、经济和人口方面的毁灭性冲击是独一无二的[…