‘Once the stuff's left my body,it's not me’: service users' views on unlinked anonymous testing of blood for HIV

This paper reports on the qualitative component of a mixed-methods study on unlinked anonymous testing for HIV in genitourinary medicine (GUM) clinics in two English cities. Unlinked anonymous testing is a system of monitoring population prevalence by testing residual blood samples taken for diagnostic purposes after they have been unlinked and anonymised from their source. Little is known about how individuals feel about their blood being tested in this way without their explicit consent, nor is it clear whether the process of unlinking blood affects how people feel about the use of their bodily material for public health surveillance purposes. We report participants' views on these issues, drawing on in-depth interviews with 20 GUM clinic users. The majority thought it preferable for blood samples to be used for population surveillance rather than being discarded. For most, blood and bodily tissue were not seen to represent personal identity even though participants understood that information about them could be gleaned from their analysis. The provision of information, rather than a strict consent process, was advocated as many felt that transactions between health professionals and patients should be as transparent as possible.     

Ethical Issues in Using Social Media to Deliver an HIV Prevention Intervention: Results from the HOPE Peru Study

Social media technologies have become increasingly useful tools for research-based interventions. However, participants and social media users have expressed ethical concerns with these studies, such as risks and benefits of participation, as well as privacy, confidentiality, and informed consent issues. This study was designed to follow up with and assess experiences and perceptions of ethics-related issues among a sample of 211 men who have sex with men who participated in the Harnessing Online Peer Education (HOPE) Peru study, a randomized controlled HIV prevention intervention conducted in Peru. We found that after adjusting for age, highest educational attainment, race, sexual orientation, and prior HIV research experience, participants in the intervention group were more likely than those in the control group to have safe sex (p?=?0.0051) and get tested for HIV regularly (p?=?0.0051). As a result of their participation, those in the intervention group benefited more positively than participants in the control group in improving HIV care (p?=?0.0077) and learning where to receive sexual health services (p?=?0.0021). Participants in the intervention group expressed higher levels of comfort than those in the control group in joining and seeing other people in the Facebook group (p?=?0.039), seeing other people’s posts (p?=?0.038) and having other group members talk to them online (p?=?0.040). We discuss the implications of these results as they relate to social media-based HIV research.     

Health Literacy and Informed Consent Materials: Designed for Documentation,Not Comprehension of Health Research

Minority populations with health disparities are underrepresented in research designed to address those disparities. One way to improve minority representation is to use community-based participatory methods to overcome barriers to research participation, beginning with the informed consent process. Relevant barriers to participation include lack of individual or community awareness or acceptance of research processes and purposes. These barriers are associated with limited health literacy. To inform recommendations for an improved consent process, we examined 97 consent documents and 10 associated Institutional Review Board websites to determine their health literacy demands and degree of adherence to principles of community-based research. We assessed the reading level of consent documents and obtained global measures of their health literacy demand by using the Suitability and Comprehensibility Assessment of Materials instrument. Although these documents were deemed suitable as medical forms, their readability levels were inappropriate, and they were unsuitable for educating potential participants about research purposes. We also assessed consent forms and Institutional Review Board policies for endorsement of community-based participatory principles, finding that very few acknowledged or adhered to such principles. To improve comprehension of consent documents, we recommend restructuring them as educational materials that adhere to current health literacy guidelines.     

Demographic and health surveillance: longitudinal ethical considerations

Longitudinal data gathered from health surveillance, when combined with detailed demographic information, can provide invaluable insight into disease outcomes. Many such surveillance sites exist in the developing world, particularly in Asia and sub-Saharan Africa, and focus on diseases such as HIV/AIDS, cholera, malaria and tuberculosis. The indistinct positions of such surveillance systems, often inhabiting an area between research, treatment and population health monitoring, means that the necessity of and responsibility for ethical oversight is unclear. This regulatory vacuum is further compounded by a lack of attention to longitudinal surveillance systems in ethics literature. In this paper, we explore some key ethical questions that arise during demographic and health surveillance in relation to ethical principles of beneficence, respect for persons and justice: health-care provision, informed consent and study sustainability.     

Ethical issues in occupational health research

This is an overview of ethical issues in occupational health research involving human subjects. Research that requires human subjects review must be distinguished from surveillance or public health practice. Confidentiality and privacy concerns are particularly important in an occupational setting because individual participants may be identifiable through job title or other characteristics, and because there may be concerns about employment discrimination associated with participation status or results. Additional issues include notification of individual test results to the study participants, including whether the results have clinical significance and/or provide other potentially relevant information to the study subjects; consent for banking of biological specimens for future research (e.g., uses of the specimens, plans for anonymization, notification of future results); and the higher level of sensitivity of workplace studies involving genetic modifiers of risk. Many occupational studies involve no more than minimal risk. Studies that involve greater than minimal risk require the investigator to document the potential risks and attempt to minimize them.     

Consumer acceptability and validity of m-Health for the detection of adverse events following immunization – The Stimulated Telephone Assisted Rapid Safety Surveillance (STARSS) randomised control trial

IntroductionMonitoring for adverse events following immunisation (AEFI) is critical for vaccine pharmacovigilance. Given the global and expanding availability of mobile phones their utility for consumer-based vaccine safety surveillance is of interest but little is known about consumer acceptability. This study nested within the Stimulated Telephone Assisted Rapid Safety Surveillance (STARSS) randomised control trial sought to evaluate the acceptability of SMS for AEFI surveillance.MethodsThe primary STARSS study was a multi-centre RCT evaluating the efficacy of repeated SMS prompts for AEFI surveillance with participants being adult vaccinees or parents of children receiving any vaccine. This nested study enrolled primary RCT participants who completed a detailed computer assisted telephone interview to determine their attitudes towards SMS-based surveillance and ascertain their knowledge and attitudes toward vaccine safety, efficacy, data privacy and use of electronic health records. Attitudes to surveillance and related behaviour were used as measures of acceptability.Results20% (1200/6555) of the participants were enrolled and 1139 completed the full-length questionnaire. 96% indicated that SMS-based surveillance after immunisation to check the safety of the vaccine “should be done” but 62% of all respondents said it should be done but consent should be sought first. Neither vaccine safety attitudes nor attitudes toward privacy were associated with opposition to SMS-based surveillance. In terms of SMS related behaviour demographic rather than attitudinal factors were associated with non-compliance.ConclusionOverall, the attitude towards SMS-based surveillance was very favourable. Experiencing the SMS surveillance has the effect of reducing opposition to an SMS surveillance system, and at the same time increasing the likelihood of a preference for prior consent. Detection of a vaccine safety signal could be impeded in particular demographic groups who are non-compliant and we should undertake further research to understand why these groups are non-compliant and how this can be improved.     

Adolescent decision making about participation in a hypothetical HIV vaccine trial

PurposeThe purpose of this study was to examine the process of adolescent decision-making about participation in an HIV vaccine clinical trial, comparing it to adult models of informed consent with attention to developmental differences.MethodsAs part of a larger study of preventive misconception in adolescent HIV vaccine trials, we interviewed 33 male and female 16–19-year-olds who have sex with men. Participants underwent a simulated HIV vaccine trial consent process, and then completed a semistructured interview about their decision making process when deciding whether or not to enroll in and HIV vaccine trial. An ethnographic content analysis approach was utilized.ResultsTwelve concepts related to adolescents’ decision-making about participation in an HIV vaccine trial were identified and mapped onto Appelbaum and Grisso's four components of decision making capacity including understanding of vaccines and how they work, the purpose of the study, trial procedures, and perceived trial risks and benefits, an appreciation of their own situation, the discussion and weighing of risks and benefits, discussing the need to consult with others about participation, motivations for participation, and their choice to participate.ConclusionThe results of this study suggest that most adolescents at high risk for HIV demonstrate the key abilities needed to make meaningful decisions about HIV vaccine clinical trial participation.     

Effects of Written Informed Consent Requirements on HIV Testing Rates: Evidence From a Natural Experiment

Objectives. I evaluated the effects of written informed consent requirements on HIV testing rates in New York State to determine whether such consent creates barriers that discourage HIV testing.Methods. New York streamlined its HIV testing consent procedures on June 1, 2005. If written informed consent creates barriers to HIV testing, then New York''s streamlining exercise should have reduced such barriers and increased HIV testing rates. I used logistic regression to estimate the effects of New York''s policy change.Results. New York''s streamlined consent procedures led to a 31.4% (95% confidence interval [CI] = 20.9%, 41.9%) increase in the state''s HIV testing rate. In absolute terms, 7% of the state''s population had been tested for HIV in the preceding 6 months under the streamlined procedures, whereas only 5.3% would have been tested under the original procedures. These estimates imply that the streamlined consent procedures accounted for approximately 328 000 additional HIV tests in the 6 months after the policy change.Conclusions. Written informed consent requirements are a substantial barrier to HIV testing in the United States.There may be a trade-off between efforts to increase HIV testing rates and efforts to improve patient awareness.In 2006, the Centers for Disease Control and Prevention (CDC) endorsed a shift from targeted HIV testing of high-risk groups to broad-based screening of the general population.¹ The CDC called for opt-out HIV screening of all patients in health care settings and argued that written informed consent procedures that are separate and distinct from general consent to medical treatment procedures should not be required for HIV testing.¹ The CDC recommendations reflect concerns that HIV testing rates are too low in the United States because a large number of people do not learn about their infection until it is too late for treatment to be effective.Opt-out screening has increased testing rates in other settings, including genitourinary clinics in the United Kingdom, and there is little doubt that it would increase HIV testing in the general population.^2,3 The effect of informed consent regulations on HIV testing rates is less clear. The CDC claims that such regulations create administrative and social barriers that discourage HIV testing.¹ There is also some evidence that written informed consent regulations represent a legal impediment to the implementation of opt-out testing.⁴ Such concerns might also explain the CDC''s advocacy of informed consent repeal.Critics of the recommendations argue that separate informed consent promotes important ethical and clinical objectives in public health policy and that removing informed consent regulations could lead to a more coercive HIV testing environment.^5–8 In summarizing the controversy, Bayer and Fairchild argued that the CDC''s informed consent recommendations signal an end to the practice of HIV exceptionalism, which leads the medical establishment to approach HIV/AIDS issues differently than it approaches other health conditions.⁹It is difficult to estimate the effects of informed consent regulations on HIV testing rates because variations in state consent requirements may be correlated with state-level characteristics that themselves predict testing rates; that is, state populations are not randomly assigned to different informed consent policies. Zetola et al. reported the best evidence to date. They found that monthly testing rates increased from 13.5 to 17.9 HIV tests per 1000 patients in a set of institutions in San Francisco after that city''s department of public health eliminated written informed consent requirements.⁵ However, the Zetola et al. study lacked a comparison group, which would have alleviated concerns that the increases observed were associated with underlying trends and changes in HIV testing that occurred in the same time frame as the San Francisco policy change.In addition, Zetola et al. relied on administrative data, for which observations were conditional on patients'' visits to particular institutions. It is possible that HIV testing rates among patients who visited these institutions were different than testing rates in the general population. As a result of such problems, it is difficult to generalize the effects of the San Francisco policy change on HIV testing rates in particular institutions to testing rates in the general population.A careful decision on whether to repeal or maintain written informed consent requirements in HIV testing depends on estimates of the effects of the regulations in terms of both testing rates and the physical and psychological risks to patient well-being. It also requires normative judgments regarding the relative importance of these effects in terms of public welfare.¹⁰ In this study, I investigated the CDC''s claim that informed consent regulations lead to reductions in HIV testing rates. I used data from the Behavioral Risk Factor Surveillance System (BRFSS) to examine HIV testing rates in New York State and a set of comparison states before and after the introduction of streamlined HIV test consent procedures in New York. The policy change in New York generated a natural experiment that helps address many of the challenges associated with evaluating the effects of consent procedures on testing rates.     

Testing for HIV without specific consent: a short review

Abstract: The practice of testing for human immunodeficiency virus (HIV) without the specific knowledge and consent of the patient raises ethical and legal issues. This report argues that diagnostic HIV testing of specific patients, without their consent, is unethical and may also be illegal. Testing for HIV prevalence on an anonymous, unlinked basis, however, is an important aspect of public health surveillance, and the ethics of clinical intervention should not be confused with the ethics of epidemiological research. Specific consent is usually desirable in view of privacy concerns, the importance of patient autonomy, and the potential for conflict of interest. However, where otherwise appropriate, the law should be clarified to permit nonconsensual HIV testing to proceed legally, possibly following scrutiny by an institutional ethics committee.     

An Extended Model of Reasoned Action to Understand the Influence of Individual- and Network-Level Factors on African Americans’ Participation in HIV Vaccine Research

In the United States, the number and proportion of HIV/AIDS cases among black/African Americans continue to highlight the need for new biomedical prevention interventions, including an HIV vaccine, microbicide, or new antiretroviral (ARV) prevention strategies such as pre-exposure prophylaxis (PrEP) to complement existing condom usage, harm reduction methods, and behavioral change strategies to stem the HIV epidemic. Although black/African Americans are disproportionately impacted by HIV/AIDS, their participation in HIV clinical research continues to have unique challenges. We theorize that interaction among multilevel factors creates ideal alignment for minority participation in HIV clinical studies. Thus, we initially set out to test an extended model of reasoned action with 362 participants to understand the interplay of sociopsychological and network-level considerations influencing minority participation in HIV prevention research efforts. In this study, we linked the intrapersonal dimensions of attitudes, beliefs, and normative concerns to community-level components, appraisal of involvement with the clinical research organization, an entity which operates within a networked structure of community partner agencies, and identification with coalition advocacy aims. Various participatory outcomes were explored including involvement in future HIV vaccine community functions, participation in community promotion of HIV vaccine research, and community mobilization. Three-stage least squares estimates indicated similar findings across three models. Significant effects demonstrate the importance of positive attitudes toward HIV vaccine research, favorable health research beliefs, perceived social support for participation, HIV/AIDS issue engagement, and perceived relevance of the clinical research site’s mission and values. Identification of these nuanced pathway effects provides implications for tailored community program development.     

Informed consent in China: quality of information provided to participants in a research project

AIMS: A study was carried out of informed consent strategies in an epidemiological project approved by the regional research ethics committees in Sweden and China and conducted in three areas south-west of Shanghai. METHODS: All participants in the epidemiological project (EP) were included in the research ethical study (RES), which was conducted as a questionnaire-based interview survey in the three areas. Answers were collected by five field interviewers. RESULTS: All participants included answered the questionnaire. Almost all perceived the information provided as rather good or quite good. However, a majority (on average 76%) had the impression that the EP was part of routine healthcare measures, and not a research project. Almost all participants felt free to abstain from participation although 38% in area II stated that they had not been informed about freedom to abstain from participation. A large proportion of participants did not fully understand the nature of the EP. However, almost all participants stated that they would agree to participate in a similar study in the future. CONCLUSION: Although informed consent procedures are supposed to be internationally applicable our study illustrates that it is not always easy to convey information and obtain consent in the present study setting.     

An approach to addressing ethical issues in a community-based risk assessment for HIV: a case from Chennai, India

Community-based assessment of HIV prevalence and behavioural risk factors is the basis for deciding priorities of prevention and care programmes. Here, upholding the human rights of participants in assessment is of utmost importance. The objective of the paper was to describe the process of implementation of an epidemiological survey to assess HIV-related behavioural and biological factors in Chennai city in South India and to suggest an ethical framework for conducting similar assessment activities in developing-country settings. A survey was conducted with participation from residents (n=1,659) of low-income urban communities (slums) as part of a community-based HIV/STD-prevention trial. Administration of the survey was preceded by extensive community contact and household visits to inform community members about the trial and assessment activities. Formative research further strengthened rapport with community, highlighted community concerns, and identified HIV-related risk behaviours that informed questionnaire design. The process of obtaining informed consent began before assessment activities and provided an opportunity for individuals to discuss participation with their families and friends. Privacy during assessment, comprehensive follow-up care for those who tested positive for HIV/STDs, such as nutritional and prevention counselling, referral services for opportunistic infections, and antenatal-care options for pregnant women increased trust and credibility of the project. The sustained availability of trial staff to facilitate access to resources to address non-HIV/STD-related felt-needs further strengthened participation of the community members. These resources included liaison services with local government to obtain public services, such as water and electricity and resources, to address concerns, such as alcohol abuse and domestic violence. Based on this experience, an ethical framework is suggested for conducting HIV epidemiological risk assessment in developing countries. This framework discusses the role of community participation, transparent and comprehensive informed consent, timely dissemination of results, and access to follow-up care for those living with HIV/STDs.     

Sexual Consent Perceptions of a Fictional Vignette: A Latent Growth Curve Model

Sexual consent can be conceptualized as a process of accumulating cues that build toward and continue throughout a consensual sexual encounter. How people perceive the cues of others during this process is an important aspect of consent. However, previous research has not investigated the trajectories of people’s consent perceptions throughout such a process. Using a novel staggered vignette protocol, we examined participants’ (N?=?1218; 64.4% female) perceptions of fictional targets’ sexual consent at 11 time points. We tested latent growth curve models using multilevel structural equation modeling to examine trajectories in consent perceptions over the course of the vignette. We hypothesized that mean differences and rates of change would be associated with several constructs relevant to sexual consent. We found that initial consent perceptions and trends over the course of the vignette varied by whether the participant was a university student, by an alcohol manipulation in the vignette, by the fictional target’s sex, and by type of sexual behavior. Researchers should examine whether our findings on consent perceptions of a fictional vignette extend to people’s actual sexual encounters, including potential associations between the three primary aspects of sexual consent: perceptions, feelings, and communication.

     

Conducting research in developing countries: experiences of the informed consent process from community studies in Peru

This article discusses the process for obtaining genuine informed consent for the participation of human subjects in research in developing countries. We discuss the consent process in the light of recently published guidelines, the experience of nutrition and health research projects, and the ethics review process of the Instituto de Investigacion Nutricional with peri-urban and rural populations in Peru. We discuss the cultural context in relation to (i) who should be involved in the decision for participation, especially for research in children and in community settings; (ii) when to use written or verbal consent; (iii) the format and presentation of the consent form to ensure understanding by the target population; and (iv) the process of how and by whom information is given and consent is obtained. Common concerns of participants with regard to their involvement in research studies are presented, as well as aspects that participants find difficult to understand. Some specific concerns of conducting research with Indigenous Peoples are discussed. We recommend future research to further understand and implement informed consent processes to assure genuine and voluntary consent in different developing country contexts.     

Proposing modesty for informed consent

The extension of informed consent into social science research has met with considerable opposition. The history and concept of informed consent, however, is based on a substantive ethical notion of the research relationship as informed and voluntary that is appropriate for social science research relationships. Yet social science research might sometimes be different from health research in ways that justify a different approach to informed consent and research relationships. Social science research tends to have a lower magnitude of risk, usually does not need to disrupt the therapeutic assumption common in health research contexts or when researchers are health professionals, and recruitment is sometimes incremental and reflects a building of trust and development of the research participant's role. These differences may sometimes justify novel approaches to the research relationship and require case-by-case evaluation to determine their relevance to establishing the informed and voluntary nature of the relationship through the use of informed consent procedures. Ultimately, respect for research participants requires social research into practices that can support or replace informed consent. The institutional role of informed consent and the goal of informed and voluntary research participation serve modest but important roles in health and social research. Their proper role in health and social research requires flexibility and experimentation, but does not justify abdication of informed consent or the notion of informed and voluntary participation.     

"Research participants want to feel they are better off than they were before research was introduced to them": Engaging Cameroonian Rural Plantation Populations in HIV Research

ABSTRACT: BACKGROUND: During a period of evolving international consensus on how to engage communities in research, facilitators and barriers to participation in HIV prevention research were explored in a rural plantation community in the coastal region of Cameroon. METHODS: A formative rapid assessment using structured observations, focus group discussions (FGD), and key informant interviews (KIIs) was conducted with a purposive non-probabilistic sample of plantation workers and their household members. Eligibility criteria included living or working >1 year within the plantation community and age >18 years. Both rapid and indepth techniques were used to complete thematic analysis. RESULTS: Sixty-five persons participated in the study (6 FGDs and 12 KIIs). Participants viewed malaria and gastrointestinal conditions as more common health concerns than HIV. They identified three factors as contributing to HIV risk: concurrent sexual relationships, sex work, and infrequent condom use. Interviewees perceived that the community would participate in HIV research if it is designed to: (1) improve community welfare, (2) provide comprehensive health services and treatment for illnesses, (3) protect the personal information of participants, especially those who test positive for HIV, (4) provide participant incentives, (5) incorporate community input, and (6) minimize disruptions to "everyday life". Barriers to participation included: (1) fear of HIV testing, (2) mistrust of researchers given possible disrespect or intolerance of plantation community life and lack of concern for communication, (3) time commitment demands, (3) medical care and treatment that would be difficult or costly to access, and (4) life disruptions along with potential requirements for changes in behaviour (i.e., engage in or abstain from alcohol use and sex activities). CONCLUSIONS: Consistent with UNAIDS guidelines for good participatory practice in HIV prevention research, study participants placed a high premium on researchers' politeness, trust, respect, communication, tolerance and empathy towards their community. Plantation community members viewed provision of comprehensive health services as an important community benefit likely to enhance HIV research participation.     

The ethics of feedback of HIV test results in population-based surveys of HIV infection

Population-based disease prevalence surveys raise ethical questions, including whether participants should be routinely told their test results. Ethical guidelines call for informing survey participants of any clinically relevant finding to enable appropriate management. However, in anonymous surveys of human immunodeficiency virus (HIV) infection, participants can “opt out” of being given their test results or are offered the chance to undergo voluntary HIV testing in local counselling and testing services. This is aimed at minimizing survey participation bias. Those who opt out of being given their HIV test results and who do not seek their results miss the opportunity to receive life-saving antiretroviral therapy.The justification for HIV surveys without routine feedback of results to participants is based on a public health utility argument: that the benefits of more rigorous survey methods – reduced participation bias – outweigh the benefits to individuals of knowing their HIV status. However, people with HIV infection have a strong immediate interest in knowing their HIV status. In consideration of the ethical value of showing respect for people and thereby alleviating suffering, an argument based on public health utility is not an appropriate justification. In anonymous HIV surveys as well as other prevalence surveys of treatable conditions in any setting, participation should be on the basis of routine individual feedback of results as an integral part of fully informed participation. Ensuring that surveys are ethically sound may stimulate participation, increase a broader uptake of HIV testing and reduce stigmatization of people who are HIV-positive.     

Conducting Virtual,Synchronous Focus Groups Among Black Sexual Minority Men: Qualitative Study

BackgroundFocus groups are useful to support HIV prevention research among US subpopulations, such as Black gay, Black bisexual, and other Black sexual minority men (BSMM). Virtual synchronous focus groups provide an electronic means to obtain qualitative data and are convenient to implement; however, the protocols and acceptability for conducting virtual synchronous focus groups in HIV prevention research among BSMM are lacking.ObjectiveThis paper describes the protocols and acceptability of conducting virtual synchronous focus groups in HIV prevention research among BSMMMethodsData for this study came from 8 virtual synchronous focus groups examined in 2 studies of HIV-negative BSMM in US cities, stratified by age (N=39): 2 groups of BSMM ages 18-24 years, 5 groups of BSMM ages 25-34 years, and 1 group of BSMM 35 years and older. Virtual synchronous focus groups were conducted via Zoom, and participants were asked to complete an electronic satisfaction survey distributed to their email via Qualtrics.ResultsThe age of participants ranged from 18 to 44 years (mean 28.3, SD 6.0). All participants “strongly agreed” or “agreed” that they were satisfied participating in an online focus group. Only 17% (5/30) preferred providing written informed consent versus oral consent. Regarding privacy, most (30/30,100%) reported “strongly agree” or “agree” that their information was safe to share with other participants in the group. Additionally, 97% (29/30) reported being satisfied with the incentive.ConclusionsConducting virtual synchronous focus groups in HIV prevention research among BSMM is feasible. However, thorough oral informed consent with multiple opportunities for questions, culturally relevant facilitation procedures, and appropriate incentives are needed for optimal focus group participation.     

Views of US researchers about informed consent in international collaborative research

Informed consent poses challenges in all settings. Challenges may be particularly great in international collaborative research, where cultural perspectives may differ, and where education levels and language may be barriers to participant understanding. We conducted a written survey and focus groups with US health researchers doing research in developing countries, asking about informed consent and other ethical issues in their research. We present here both qualitative and quantitative data relevant to informed consent. Qualitative data revealed that researchers' experiences and beliefs about informed consent fell into three paradigms: regulatory, community, and individual. The regulatory paradigm refers to researchers' views and practices relating to informed consent requirements of institutional review boards and other oversight bodies. The community paradigm refers to researchers' approach to the content and methodology of informed consent in the context of long-term relationships between research teams and study communities. Researchers emphasized the importance of these relationships for creating and maintaining communication fundamental to the informed consent process. Finally, the individual paradigm refers to researchers' views about individual participants' understanding and decision-making process regarding research. Researchers described community-level influences on participants' decision-making, but stressed the need for individual comprehension and voluntary participation. While these paradigms are distinct, they also are intertwined. Quantitative data supported the existence of these three paradigms in respondents' characterization of informed consent. Researchers frequently stated that legal language on the consent forms was meaningless (52%). Forty-four percent of researchers had consulted with community leaders, and 23% believed the consent process focuses too much on the individual, rather than on family or community. Most researchers (82%) reported that the consent process was an important means of educating participants about the study. Fifty-four percent of researchers believed participants did not understand placebos. Further research is needed to understand how culture and relationships affect research participation, and to provide information and dialogue among researchers, oversight bodies and community representatives about appropriate ways to approach informed consent in international research.