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.     

A qualitative study of subject recruitment for familial cancer research

PURPOSE: Familial epidemiological studies of cancer raise familiar ethical issues relating to informed consent and recruitment of participants. When the family is the unit of study, however, additional complexity arises. Educating and recruiting participants must be tailored to the relatives', as well as the proband's needs. An understanding of the prospective participants' concerns will aid the development of strategies for recruitment and will facilitate informed and voluntary consent. In the present study, qualitative methods were used to investigate these issues. METHODS: Focus groups with cancer patients, relatives of cancer patients, and individuals from the general population were separately conducted to identify issues that concern people who are asked to participate in family studies. RESULTS: Many of the issues which arose in the course of the focus group discussions were similar to those in any study. Yet, some of the themes emerging from the discussions were specific to familial research. In particular, participants expressed that the study should be endorsed by a trusted and familiar source; group discussions might facilitate the consent process; the benefit of the research should be clear and personal, as well as benefit the participants' family members; risks of participation should be explicit (e.g., insurance discrimination); and education about the disease and its familial nature would maintain commitment to the study. Finally, participants expressed concerns about being approached by programs to facilitate the identification and recruitment of other family members for research on family health issues. CONCLUSIONS: Findings from this study will aid future familial studies in developing a protocol that both adequately informs potential participants of the nature of familial research and maximize participation.     

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.     

Ethical issues associated with conducting genetic family studies of complex disease

PURPOSE: To examine subjects' recognition of the risks and ethical issues associated with enrollment in genetic family studies (GFS) and explore how this recognition affects their informed and voluntary participation. METHODS: A cross-sectional study design including both quantitative and qualitative data was employed. Structured interviews using the Contextual Assessment Approach Questionnaire (CAA-Q) were conducted with 246 Mexican American (MA) participants. To gain in-depth understanding of questionnaire responses, semi-structured interviews with 30 participants were conducted. All participants were interviewed before their enrollment in the Family Investigation of Nephropathy and Diabetes (FIND). RESULTS: Subjects' average age was 56 years; 62% were females. Seventy-eight percent of participants were not formally educated beyond high school and 72% reported an annual household income of < or =20,000 dollars. Eighty-five percent agreed to provide researchers with information on relatives' ages, gender, and education. Sixty-five percent of participants were willing to provide identifiable information such as names, addresses, and phone numbers of relatives. Sixty-three percent of participants indicated that there were direct benefits (i.e., supporting research) to disclosing relatives' information. Seventy-six percent stated that there were no risks associated with participation in GFS (e.g., discrimination or confidentiality of genetic information) compared with 10% who said that there were such risks. While discussing potential risks, subjects did not consider these to influence their decision to participate. CONCLUSIONS: Subjects enrolled in GFS did not recognize and tended to underestimate the social and cultural risks associated with their participation in GFS. If subjects do not fully comprehend the risks, this raises questions concerning their ability to provide informed consent and to voluntarily participate. We propose a subject-centered approach that views enrollment as an active process in which subjects and recruiters give and receive information on risks and ethical issues related to participation, which enhances protection of the rights and welfare of subjects participating in GFS.     

'Informed consent' in public health activities: based on the universal declaration on bioethics and human rights, UNESCO

OBJECTIVES: The objective of this paper is to discuss the importance of obtaining informed consent for conducting epidemiological studies and public health activities, based on the Report of the UNESCO's Working Group on Informed Consent. METHODS: The Report of the UNESCO's Working Group on Informed Consent was reviewed and discussed in connection with the ethical considerations of public health activities and epidemiological research. RESULTS: It was at the Nuremberg Trial for the German war criminals of the Second World War that the principle of 'consent' was first stated as a consequence of the medical abuses carried out during the War. As a result of the Trial, the Nuremberg Code came out in 1947. Since then, various international declarations or ethical principles on 'informed consent' have been developed and published. These ethical principles on 'informed consent' have mostly to do with the clinical research that involves human subjects, and not with epidemiological studies and public health activities. However, UNESCO recently issued a comprehensive Report on Informed Consent based on the Universal Declaration on Bioethics and Human Rights adopted in 2005, and this included detailed guidelines on informed consent in epidemiological studies and public health activities. CONCLUSIONS: Universal Declaration on Bioethics and Human Rights emphasizes the principle of autonomy to protect the human rights of the human subjects involved in any public health activities and epidemiological research. As a practical guideline, obtaining informed consent is strongly recommended.     

The Role of Community Advisory Boards: Involving Communities in the Informed Consent Process

Ethical research involving human subjects mandates that individual informed consent be obtained from research participants or from surrogates when participants are not able to consent for themselves. The existing requirements for informed consent assume that all study participants have personal autonomy; fully comprehend the purpose, risks, and benefits of the research; and volunteer for projects that disclose all relevant information. Yet contemporary examples of lapses in the individual informed consent process have been reported. The authors propose the use of community advisory boards, which can facilitate research by providing advice about the informed consent process and the design and implementation of research protocols. These activities could help reduce the number of individual informed consent lapses, benefiting study participants and the scientific integrity of the research in question.     

The influence of informed consent content on study participants' contraceptive knowledge and concerns

Little is known about how the information presented in the informed consent process influences study outcomes among participants. This study examines the influence of informed consent content on reported baseline contraceptive knowledge and concerns among two groups of HIV-serodiscordant and seroconcordant HIV-positive couples enrolled in research projects at an HIV research center in Lusaka, Zambia. We found significant differences in the reporting of contraceptive knowledge and concerns between couples viewing consent materials that included detailed information about contraception and those viewing consent materials that lacked the detailed information. We conclude that the design of informed consent materials should strike a balance between ensuring that participants give truly informed consent and educating participants in ways that do not compromise the assessment of the impact of behavioral interventions.     

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.     

Prenatal HIV testing in Ontario: knowledge,attitudes and practices of prenatal care providers in a province with low testing rates

OBJECTIVE: To describe the knowledge, attitudes and practices of prenatal care providers in relation to prenatal HIV testing. METHODS: A stratified random sample of 784 family physicians, 200 obstetricians and 103 midwives providing prenatal care in 3 health planning regions in Ontario received a questionnaire. RESULTS: Response was 622/1087 (57%). Almost half of participants (43%) were not aware of Ontario's prenatal HIV testing policy. Eighty-five percent of participants reported that they offered or ordered HIV testing for all pregnant women. Sixty-six percent agreed that women should have a choice about whether to test or not, and midwives were more supportive of having an informed consent process than were physicians. CONCLUSION: Knowledge about the risks and benefits of prenatal HIV testing needs to be improved, and standards for informed consent should be re-evaluated to achieve the most ethical process with the least complexity.     

Beyond "misunderstanding": written information and decisions about taking part in a genetic epidemiology study

Although the need to obtain "informed" consent is institutionalised as a principle of ethical practice in research, there is persistent evidence that the meanings people attribute to research tend to be substantially at variance with what might be deemed "correct". One dominant account in the ethics literature has been to treat apparent "misunderstandings" as a technical problem, to be fixed through improving the written information given to research candidates. We aimed to explore theoretically and empirically the role of written information in "informing" participants in research. We conducted a qualitative study involving semi-structured interviews with 29 unpaid healthy volunteers who took part in a genetic epidemiology study in Leicestershire, UK. Data analysis was based on the constant comparative method. We found that people may make sense of information about research, including the content of written information, in complex and unexpected ways. Many participants were unable to identify precisely the aim of the study in which they had participated, saw their participation as deriving from a moral imperative, and had understandings of issues such as feedback of DNA results that were inconsistent with what had been explained in the written information about the study. They had high levels of confidence in the organisations conducting the research, and consequently had few concerns about their participation. These findings, which suggest that some "misunderstanding" may be a persistent and incorrigible feature of people's participation in research, raise questions about the principle of informed consent and about the role of written information. These questions need to be addressed through engagement and dialogue between the research, research participants, social science, and ethics communities.     

Disclosing the truth: informed participation in the Antemortem Database Project for Survivors of Srebrenica

This article describes a human rights investigation designed to identify bodies exhumed from mass graves in Srebrenica, Bosnia-Herzegovina and the psychological impact of participation on family members, most of whom believed the disappeared could still be alive. A community education intervention, conducted in both group and individual settings, was effective in helping families make an informed decision about participation. For informed participants, the psychological benefits outweighed any deleterious effects. The article concludes that fully disclosing the truth to potential participants, providing culturally and temporally sensitive psychosocial preparation, and securing informed consent are basic ethical and human rights principles that must be upheld at all times. Further studies are necessary to measure the impact of human rights activities of this nature on the survivor participants and implementers alike.     

Comprehension and Recall of Informed Consent among Participating Families in a Birth Cohort Study on Diarrhoeal Disease

Comprehension and recall of informed consent was assessed afterthe study closure in the parents/guardians of a birth cohortof children participating in an intensive three-year diarrhoealsurveillance. A structured questionnaire was administered byfield workers who had not participated in the study's follow-upprotocol. Of 368 respondents, 329 (89.4 per cent) stated thatthe study was adequately explained during enrolment, but only159 (43.2 per cent) could recall that it was on diarrhoea. Nearlyhalf (45.9 per cent) of the respondents stated that they wouldnot have participated if free medical treatment was not provided,although the free medical clinic was not offered at enrolment.Spousal approval (82.9 per cent) was the most important factorin the decision to participate. In the multivariate analysis,maternal education was associated with increased awareness aboutthe disease under study: mothers without any formal educationhad the lowest awareness (OR = 3.47, 95 per cent CI = 1.60–7.51).Despite a high compliance with the study protocol, retentionof understanding about the research study was low over a longperiod of time. Although the local government provides freehealthcare in the study area, respondents cited free healthcareas an important reason for participation, highlighting the needfor true health equity before meaningful informed consent canbe obtained.     

The performance and perception of informed consent in a health-care section of Catalonia

BACKGROUND: Informed consent entails a process which involves more than signing a form to give one's consent. This process involves the mutual exchange of information, understanding, trust and consent between physician and patient. The purpose of this study is that of ascertaining the degree to which those consumers who have gone through the informed consent process in a health care district in Catalonia have filled out and fully understood this form. METHODS: Telephone survey conducted among 314 former surgery patients at hospitals in a given district, ages 18-75, who had undergone surgery within the three months immediately prior to the date on which the survey was conducted for the purpose of ascertaining the opinion of these consumers regarding the consent process. A review of the clinical records of 30% of these individuals was conducted for the purpose of ascertaining the degree of compliance with the consent form process. RESULTS: Sixty-one percent (61%) of the patients surveyed remembered having signed the consent form, 59.2% recalling explanations regarding risks or complications of the surgery they were to undergo. Nine percent (9%) did not understand well enough what was going to be done to them during the surgery, and 36% were of the understanding that the consent form released the health care professionals from liability. A statistically significant relationship was found to exist among the age group, educational level and admissions channel. Seventy-eight percent (78%) of the clinical records reviewed included informed consent forms. The diagnosis was stated on 14.9% of these forms, and 48.9% had been signed by the attending physician. A statistically significant relationship was found between the channels through which patients were admitted to the hospital. CONCLUSIONS: The informed consent process is not being implemented correctly at the two hospitals analyzed. Physicians are not totally involved in the process.     

A model designed to enhance informed consent: experiences from the HIV prevention trials network

HIV prevention research in developing countries has resulted in increased attention to and discussion of ethical issues, particularly the issue of the quality of informed consent. We present a conceptual framework for an enhanced informed consent process, drawing on experiences garnered from domestic and international studies conducted by the HIV Prevention Trials Network, funded by the National Institutes of Health. This framework guides the development of an informed consent process designed to help ensure initial and continued comprehension of research participation, with an emphasis on HIV prevention research. Attention is focused at the individual and community levels and on 3 study phases: preenrollment, enrollment, and postenrollment.     

Free informed consent: the experience of Brazilian researchers in the area of fertility regulation

This study aimed to evaluate the experience of Brazilian researchers in relation to: assessment of the research protocol by a research ethics committee with the elaboration of a free informed term of consent (FITC) and the process of obtaining consent, as well as to verify whether the content and wording of the term of consent complies with Federal Ruling 196/96. Thirty-four researchers filled out a questionnaire and returned it by electronic mail. The vast majority of the respondents (91%) reported that the respective study protocol had been evaluated by a research ethics committee. More than half reported that they had received a previously prepared FITC; that consent from potential study subjects had been obtained by the researcher in charge; and that the subjects had received a copy of their signed FITC. Approximately one half of participants stated that the form of reimbursement of subjects was specified in the FITC, and 44% reported the same in relation to occasional damages resulting from the study. According to participants, in general the provisions of Ruling 196/96 had been met.     

Adapting patients' oncological treatment through remote participation of general practitioners in multi-disciplinary consultation meetings: A feasibility study

BackgroundThe general practitioner (GP) is central to managing patients with cancer, whose numbers are increasing worldwide. The GP’s involvement requires better coordination between involved partners, in particular oncologists and GPs.ObjectivesTo conduct a feasibility study of remote participation of GPs in multi-disciplinary consultation meetings (MCMs). We analysed participation, participants’ satisfaction, and their impact on therapeutic decisions.MethodsWe conducted a feasibility study in the regional cancer centre of Toulouse, France. All patient cases discussed in the MCMs for myelodysplasia from 1 January to 31 March 2016 were included. Cases of patients aged over 18 years, with a diagnosis of myelodysplasia and registered with a GP were included if patients gave informed consent. One investigator collected the data provided by GPs during three telephone or video calls: before, during, and after the MCM, respectively.ResultsOf 86 patient cases discussed during three months of MCMs, 44 were eligible for GP participation; 27 GPs participated in discussions of 27 patient cases. The GP’s participation in the MCM led to a change in management in five cases, with four times treatment intensifications and once de-intensification. Medical, social, family-related, and psychological domains were discussed with input from the GPs. Overall, all participants were satisfied with the MCMs.ConclusionRemote participation of GPs in MCMs is feasible and may result in adapting oncological and haematological management for patients. This patient-centred approach requires a specific organisation that, when implemented, satisfies the needs of all participants.     

Confusions in the equipoise concept and the alternative of fully informed overlapping rational decisions

Despite its several variations, the central position of equipoise is that subjects in clinical experiments should not be randomized to conditions when others believe that better alternatives exist. This position has been challenged over issues of which group in the medical or research community is authorized to make that determination, and it has been argued that informed consent provides sufficient ethical protection for participants independent of equipoise. In this paper I frame ethical participation in clinical research as a two-party decision process involving offering and accepting participation under informed consent. Nine conditions are identified in which it is possible that potential participants and researchers or care professionals can rationally choose divergent actions based on identical understandings of the situation. Under such circumstances, researchers or care professionals cannot ethically substitute their understanding of equipoise in the situation for the patients’ choices, or vice versa.     

Informed consent in clinical trials

A review is provided in this paper on the empirical literature on informed consent from 1979 to 1995 referring to information disclosure and trial participation in clinical trials. Articles being reviewed focus upon information disclosure, reactions to disclosure and recall, features of consent and perceptions of informed consent, both in hypothetical and in real life situations. It is concluded that further research is needed to study the process of informed consent in clinical trials, to obtain a better insight into the myth and reality of informed consent in daily practice. Future studies should come forward on the limitations of previous empirical research on informed consent. Additional research should focus on the perspectives of patients who accept or decline trial participation.