Do Research Participants Trust Researchers or Their Institution?

Relationships of trust between research participants and researchers are often considered paramount to successful research; however, we know little about participants' perspectives. We examined whom research participants trusted when taking part in research. Using a qualitative approach, we interviewed 36 research participants, including eight Indigenous participants. Thematic analysis was used to analyze the data. This article focuses on findings related to non-Indigenous participants. In contrast to Indigenous participants, non-Indigenous participants placed their trust in research institutions because of their systems of research ethics, their reputation and prestige. Researchers working in non-Indigenous contexts need to be cognizant that the trust that participants place in them is closely connected with the trust that participants have in the institution.

"Doing Trust".

Trust in research is important but not well understood. We examine the ways that researchers understand and practice trust in research. Using a qualitative research design, we interviewed 19 researchers, including eight researchers involved in Australian Indigenous research. The project design focused on sensitive research including research involving vulnerable participants and sensitive research topics. Thematic analysis was used to analyze the data. We found that researchers' understanding of trust integrates both the conceptual and concrete; researchers understand trust in terms of how it relates to other similar concepts and how they practice trust in research. This provides a sound basis to better understand trust in research, as well as identifying mechanisms to regain trust when it is lost in research.

"We're checking them out": Indigenous and non-Indigenous research participants' accounts of deciding to be involved in research.

BACKGROUND: It is important for researchers to understand the motivations and decision-making processes of participants who take part in their research. This enables robust informed consent and promotes research that meets the needs and expectations of the community. It is particularly vital when working with Indigenous communities, where there is a history of exploitative research practices. In this paper, we examine the accounts of Australian Indigenous and non-Indigenous research participants in terms of how and why they agree to take part in research. METHODS: A qualitative research approach was employed to undertake individual interviews with 36 research participants in Victoria, Australia. Eight participants identified as Indigenous and 28 were non-Indigenous. Thematic analysis was used to interpret the data. RESULTS: There were stark differences between Indigenous and non-Indigenous research participants in terms of why and how they decided to participate in research. For Indigenous participants, taking part in research was primarily to benefit their communities rather than for personal interests. Indigenous participants often started from a position of caution, and showed a considered and deliberate process of decision making. In weighing up their decision to participate, some Indigenous participants clearly articulated what was valued in conducting research with Indigenous communities, for example, honesty, reciprocity, and respect; these values were explicitly used to assist their decision whether or not to participate. This was in contrast to non-Indigenous participants who took researchers' claims on face value, and for whom deciding to participate in research was relatively straightforward. The motivations to participate of non-Indigenous participants were due to personal interests, a desire to help others, or trust in the medical practitioner who recruited them for the research project. CONCLUSION: Understanding research participants' motivations about taking part in research is important. This is particularly relevant for Indigenous communities where there is a reported history of research abuse leading to mistrust. This understanding can lead to research practice that is more respectful and responsive to the needs of Indigenous communities and abides by the values of Indigenous communities. Moreover it can lead to more ethical and respectful research practice for all.

Personal growth, grandmother engagement and satisfaction among non-custodial grandmothers.

OBJECTIVES: We investigated grandmothers' personal growth, their engagement with grandchildren, their satisfaction with this role and how personal growth was related to engagement and satisfaction. METHOD: One thousand two hundred and five grandmothers completed a survey containing questions about: personal resources (age, education, whether partnered or not, health); engagement with grandchildren (number of grandchildren, hours spent per week, frequency of activities, satisfaction with being a grandmother); and personal growth (life satisfaction, generativity). RESULTS: Participants had a positive sense of living productive and worthwhile lives with most reporting high scores on life satisfaction and generativity. Most were actively engaged with their grandchildren, participating in a wide range of activities. Active engagement was positively related to grandmother satisfaction. Hierarchical regressions showed that both life satisfaction and generativity were significantly predicted by grandmother resources and grandmother engagement. CONCLUSION: This group of grandmothers did not fit ageist stereotypes of disengagement and loss of function. Our study shows that grandmothering is a rewarding role, and women who engage with it have a positive sense of personal growth.

Human research ethics committees: examining their roles and practices.

Considerable time and resources are invested in the ethics review process. We present qualitative data on how human research ethics committee members and health researchers perceive the role and function of the committee. The findings are based on interviews with 34 Australian ethics committee members and 54 health researchers. Although all participants agreed that the primary role of the ethics committee was to protect participants, there was disagreement regarding the additional roles undertaken by committees. Of particular concern were the perceptions from some ethics committee members and researchers that ethics committees were working to protect the institution's interests, as well as being overprotective toward research participants. This has the potential to lead to poor relations and mistrust between ethics committees and researchers.

The social context of controlled drug use amongst young people in a slum area in Makassar, Indonesia.

BACKGROUND: There are few studies exploring the social context of controlled drug use amongst young people in Indonesia. This qualitative study examines the experience of young people in a slum area (lorong) in Makassar, eastern Indonesia, who use drugs but are not drug dependent and who employ various forms of self regulation to control their use. METHODS: Semi-structured interviews were conducted with eight controlled drug users. RESULTS: The study found that whilst controlled drug users lived in a drug risk environment, they were not deeply embedded in the street culture, risk-taking practises and drug scene within their locality. Their employment, albeit in the informal economy and in low-paid jobs, facilitated their perspective that the status of rewa (a local construct of masculinity) and gaul (being sociable and up-to-date) could and should be accomplished through conventional means such as jobs and halal (legitimate) income. Their employment generated both direct benefit (legitimate income) and indirect benefit, including meaningful activities, structured time, positive identity and wider social networks (bridging social capital). This enabled them to have a stake in mainstream society and provided an incentive to control drug use. All factors which are protective against escalation into problematic drug use. CONCLUSION: The study showed the importance of sociological concepts of direct and indirect benefits of employment and of social capital in understanding the social context of controlled drug use amongst young people in the lorong. Additionally, drug policy should be more cognizant of the social vulnerability in the lorong and of the need to increase access to employment amongst young people in order to potentially decrease the likelihood of problematic drug use.

Unsettled infant behaviour and health service use: a cross-sectional community survey in Melbourne, Australia.

AIMS: To investigate factors associated with health service use by women and their infants in Victoria, Australia. METHODS: Cross-sectional screening survey of 875 women with 4-month-old infants attending immunisation clinics in five local government areas in Melbourne between May 2007 and August 2008. The self-report instrument assessed socio-demographic characteristics, unsettled infant behaviour, maternal mood (Edinburgh Postnatal Depression Scale) and, the outcome, health service use during the first 4 months post-partum. RESULTS: Mothers and their infants used on average 2.8 different health services in the first 4 months post-partum (range 0-8). After adjustment for other factors, high health service use (defined as >3 different services) was more common in mothers whose infants were unsettled with persistent crying, resistance to soothing and poor sleep. A one-point increase on the unsettled infant behaviour measure was associated with an 8% (2-14%) increase in the use of >3 services, 9% (3-16%) in use of emergency departments, 7% (2-13%) in use of telephone helplines and 9% (3-14%) of parenting services. Poorer maternal mental health was also implicated with a one-point increase on the Edinburgh Postnatal Depression Scale associated with a 4% (0.4-8%) increase in the likelihood of using more than three services. CONCLUSIONS: Unsettled infant behaviour is associated with increased use of multiple health services. The high use of emergency departments by families with unsettled infants found in this study suggests that enhancement of primary health-care capacity might be required.

Screening for perinatal common mental disorders in women in the north of Vietnam: a comparison of three psychometric instruments.

BACKGROUND: There is increasing recognition that Perinatal Common Mental Disorders (CMDs) are a major public health problem for women in resource-constrained countries. There is an urgent need for screening tools suitable for use by community based health workers to assist in the identification of people with compromised mental health. The aim of this study was to establish the validity of three widely used psychometric screening instruments in detecting CMDs in women in northern Viet Nam. METHODS: Translated and culturally verified versions of the Edinburgh Postnatal Depression Scale (EPDS), General Health Questionnaire 12 items (GHQ-12), Zung's Self-rated Anxiety Scale (Zung SAS) and a gold-standard diagnostic tool, the Structured Clinical Interview for DSM IV, were administered to a community-based representative cohort of 364 Vietnamese women in the perinatal period. Post-hoc analyses, Cronbach's alpha, and Receiver Operating Characteristic (ROC) analyses were performed to identify the optimal cut-off points and to compare the validity of three scales. RESULTS: The Areas under the ROC Curve were: EPDS 0.77 (95%CI 0.72-0.82); Zung SAS 0.79 (95%CI 0.74-0.84) and GHQ-12 0.72 (95%CI 0.67-0.78). The optimal cut-off point for the EPDS was 3/4 (Se 69.7%; Sp 72.9%). The corresponding value for Zung SAS was 37/38 (Se 67.9%; Sp 75.3%) and for GHQ-12 was 0/1 (Se 77.1%; Sp 56.6%). The internal reliability Cronbach's alpha for EPDS was 0.75, for Zung SAS was 0.76, and for GHQ-12 was 0.64. CONCLUSIONS: These instruments are suitable for use as screening tools for CMDs in women in northern Viet Nam, but probably because of differences in emotional literacy, familiarity with test-taking and the effects of chronic social adversity require much lower cut off scores to detect clinically significant symptoms than in other settings.

Reasons women give for contemplating or undergoing abortion: a qualitative investigation in Victoria, Australia.

OBJECTIVE: To increase understanding of women's perspectives on considering or undergoing elective abortion. DESIGN: Qualitative study. SETTING: A large public women's hospital in the state of Victoria, Australia. SAMPLE: Sixty women who had contacted a public pregnancy advisory service in Victoria, Australia, seeking information, advice, or appointments in relation to an unplanned or unwanted pregnancy. METHODS: Qualitative telephone interviews. The iterative qualitative analysis employed the five stages of a thematic framework approach. MAIN OUTCOME MEASURES: Themes in women's accounts of considering or undergoing elective abortion. RESULTS: Women's accounts emphasized their reasons for considering or seeking abortion. Decisions were made in the context of their lives as a whole; influences were usually contingent and multiple. Reasons related to the woman herself, the potential child, existing children, her partner and other significant relationships, and financial matters. CONCLUSIONS: This research used qualitative methods to produce the only recent study of its kind in Australia. Women's accounts reveal the complex personal and social contexts within which reproductive events must be comprehended and the thoughtfulness with which they make decisions. Results of this research will assist health-care professionals to increase their insights into women's reproductive experiences.

Common perinatal mental disorders in northern Viet Nam: community prevalence and health care use.

OBJECTIVE: To establish the prevalence of common perinatal mental disorders their determinants, and their association with preventive health care use among women in one rural and one urban province in northern Viet Nam. METHODS: We conducted a cross-sectional survey of cohorts of pregnant women and mothers of infants recruited systematically in 10 randomly-selected communes. The women participated in psychiatrist-administered structured clinical interviews and separate structured interviews to assess sociodemographic factors, reproductive health, the intimate partner relationship, family violence and the use of preventive and psychiatric health care. Associations between these variables and perinatal mental disorders were explored through univariate analyses and multivariable logistic regression. FINDINGS: Among women eligible for the study (392), 364 (93%) were recruited. Of these, 29.9% (95% confidence interval, CI: 25.20-34.70) were diagnosed with a common perinatal mental disorder (CPMD). The frequency of such disorders during pregnancy and in the postpartum period was the same. Their prevalence was higher among women in rural provinces (odds ratio, OR: 2.17; 95% CI: 1.19-3.93); exposed to intimate partner violence (OR: 2.11; 95% CI: 1.12-3.96); fearful of other family members (OR: 3.36; 95% CI: 1.05-10.71) or exposed to coincidental life adversity (OR: 4.40; 95% CI: 2.44-7.93). Fewer women with a CPMD used iron supplements than women without a CPMD, but the results were not statistically significant (P = 0.05). None of the women studied had ever received mental health care. CONCLUSION: Perinatal depression and anxiety are prevalent in women in northern Viet Nam. These conditions are predominantly determined by social factors, including rural residence, poverty and exposure to family violence. At present the needs of women with common perinatal mental disorders are unrecognized and not attended to and their participation in essential antenatal preventive care appears to be compromised.

Resources employed by health researchers to ensure ethical research practice.

There is little empirical evidence about what resources health researchers use in order to make decisions about the ethical conduct of human research. Undertaking an empirical examination of how researchers understand research ethics and how they address ethical issues in research practice can lead to a richer understanding of how researchers approach research ethics. Our findings are based on interviews with 54 Australian health researchers. We conclude that, despite the considerable time devoted to ethics review, ethics committees and research guidelines were not seen as valuable resources for researchers undertaking research in the field. Although researchers did not perceive ethics committees as a resource when faced with ethical issues in the field, they nevertheless perceived the process of ethics review as beneficial to them; this allowed them to clarify their research, make decisions about the ethical conduct of the research, as well as offering them a sense of protection when undertaking research. In the actual undertaking of research practice, it was their past professional experience and personal values that researchers considered most useful resources when encountering ethical problems.

Human research ethics in practice: deliberative strategies, processes and perceptions.

In theory, HREC members should use the ethical guidelines in the National Statement on the Ethical Conduct of Research Involving Humans as the basis for their decisions, and researchers should design their research in accordance with these guidelines. However, very little is known about what researchers and HREC members actually do in practice. In this paper, we report some of the key findings of the study "Human Research Ethics in Practice", a qualitative interview-based study of health researchers and HREC members in Victoria. The findings shed light on how researchers and HREC members conceptualise ethics, how they use the National Statement, and what deliberative strategies they employ to assess the ethical appropriateness of research studies. The findings also reveal differences and similarities between health researchers' and HREC members' perceptions of the roles of HRECs, and point to some sources of misunderstanding and tension. We examine the implications of some of these findings for the ways in which HRECs carry out their task, and research institutions support and promote ethical conduct in research amongst their staff and students. The focus of this study is on health research, but we suggest that the findings are highly relevant to all other research areas where human participants are involved.

Is uptake of genetic testing for colorectal cancer influenced by knowledge of insurance implications?

OBJECTIVE: To assess whether knowledge of insurance implications influenced uptake of genetic testing by participants in a research study of the causes of colorectal cancer. DESIGN, SETTING AND PARTICIPANTS: Analysis of uptake of genetic testing by participants in the population-based Victorian Colorectal Cancer Family Study during two periods: from 1999 to 2003, when participants were not informed of any potential effect of genetic testing conducted during the study on their eligibility for new insurance policies; and from 2003 to 2006, when the protocol was changed to provide participants with information on the potential effect of genetic testing on insurance eligibility. MAIN OUTCOME MEASURE: Uptake of genetic testing for germline mutations in DNA mismatch repair (MMR) genes at a family cancer clinic. RESULTS: The proportion of participants who declined genetic testing among those informed of insurance implications was more than double the proportion among those without this knowledge (29/59 [49%] v 9/47 [19%]; P = 0.002). This difference could not be explained statistically by adjusting for measured putative predictors. CONCLUSION: Identification of people with a mutation in an MMR gene has clinical importance, and such screening may be a cost-effective way to reduce the burden of colorectal cancer in the community. If people are choosing not to obtain genetic information because of how it will affect their eligibility for insurance, reforms to existing insurance practices are indicated.

Reasons women give for abortion: a review of the literature.

The aim was to identify from empirical research that used quantitative or qualitative methods the reasons women give for having an abortion. A search was conducted of peer-reviewed, English language publications indexed in eight computerized databases with publication date 1996-2008, using keywords 'abortion' and 'reason' (Medline: 'induced abortion' OR 'termination of pregnancy' OR 'elective abortion' and 'reason'). Inclusion criteria were empirical research on humans that identified women's reasons for undergoing an abortion, conducted in 'high-income' countries. 19 eligible papers were found. Despite variation in methods of generating, collecting, and analysing reasons, and the inadequacy of methodological detail in some papers, all contributed to a consistent picture of the reasons women give for having an abortion, with three main categories ('Woman-focused', 'Other-focused', and 'Material') identified. Ambivalence was often evident in women's awareness of reasons for continuing the pregnancy, but abortion was chosen because continuing with the pregnancy was assessed as having adverse effects on the life of the woman and significant others. Women's reasons were complex and contingent, taking into account their own needs, a sense of responsibility to existing children and the potential child, and the contribution of significant others, including the genetic father.

Australian clinicians and chemoprevention for women at high familial risk for breast cancer.

OBJECTIVES: Effective chemoprevention strategies exist for women at high risk for breast cancer, yet uptake is low. Physician recommendation is an important determinant of uptake, but little is known about clinicians' attitudes to chemoprevention. METHODS: Focus groups were conducted with clinicians at five Family Cancer Centers in three Australian states. Discussions were recorded, transcribed and analyzed thematically. RESULTS: Twenty three clinicians, including genetic counselors, clinical geneticists, medical oncologists, breast surgeons and gynaecologic oncologists, participated in six focus groups in 2007. The identified barriers to the discussion of the use of tamoxifen and raloxifene for chemoprevention pertained to issues of evidence (evidence for efficacy not strong enough, side-effects outweigh benefits, oophorectomy superior for mutation carriers), practice (drugs not approved for chemoprevention by regulatory authorities and not government subsidized, chemoprevention not endorsed in national guidelines and not many women ask about it), and perception (clinicians not knowledgeable about chemoprevention and women thought to be opposed to hormonal treatments). CONCLUSION: The study demonstrated limited enthusiasm for discussing breast cancer chemoprevention as a management option for women at high familial risk. Several options for increasing the likelihood of clinicians discussing chemoprevention were identified; maintaining up to date national guidelines on management of these women and education of clinicians about the drugs themselves, the legality of "off-label" prescribing, and the actual costs of chemopreventive medications.

Considering abortion: a 12-month audit of records of women contacting a Pregnancy Advisory Service.

OBJECTIVE: To characterise the demographic and psychosocial circumstances of women contacting Victoria's largest public pregnancy advisory service (PAS). DESIGN AND SETTING: Audit of PAS electronic records for the 12 months from 1 October 2006 to 30 September 2007. De-identified data were extracted from a comprehensive electronic database used for recording consultations. MAIN OUTCOME MEASURES: Summary statistics and measures of association. RESULTS: During the 12 months, 5462 women contacted PAS; records were created for 3827 women, and data were available in more than 80% of records for 77% (13/17) of items. Over half of the women receiving pregnancy support from PAS (60%) were 18-29 years old; 12% lived outside the metropolitan area; 51% held a health care card, and smaller percentages faced housing, financial, or drug and alcohol problems; 16% reported violence, but 71% described partners as involved and supportive. Most (79%) made contact within 2 weeks of discovering pregnancy, and 72% were referred by a general practitioner. Later gestation at contact was associated with younger age (P < 0.001), having a health care card (P < 0.001), and living outside the metropolitan area (P < 0.001). The most common reasons for seeking abortion were the desire to delay pregnancy (23%) and family completion (18%); 42% already had at least one child. Twenty-three women reported that the pregnancy was the result of rape. Ten per cent had mental health problems, and smaller numbers faced access barriers and had special needs. CONCLUSIONS: This PAS responds to demand from women with diverse social and personal circumstances. Findings provide evidence for policy, prevention and service development.

Physically violent mothers are a reason for young people's leaving home.

In a qualitative study, 302 homeless young people (aged 12 to 20 years) were asked to discuss their reasons for leaving home. Some 103 youth cited physical violence by a parent or stepparent, and of these, 39 cited their mother's or stepmother's violence as the reason for leaving home. Females were more likely than males to report being the target of violence by their mother; however, the converse was true for stepmothers. Several discrete reasons for maternal violence were identified, including maternal personal characteristics and behaviors, issues associated with blended families, or young people's own behavior. In some cases, young people reported violence by both parents. Their attributions of maternal violence centered on a single dimension of the mother/stepmother or her relationship with a partner. They rarely discussed the contribution that they had made to the conflict or acknowledged the social context that may have been a catalyst for violence.

The social context of initiation into injecting drugs in the slums of Makassar, Indonesia.

BACKGROUND: The association between socio-economic marginalisation in urban poor neighbourhoods and the prevalence of violence, crime, drug use and drug dealing has been well documented. However few studies have explored the social context of the transition to, initiation and maintenance of drug injection career in slum areas in developing countries. This study examines the lived experience of young men in initiating and maintaining drug injection in slum areas, commonly named lorong, in the city of Makassar, Indonesia. METHOD: In-depth interviews were conducted with 18 male injecting drug users who attended a drop-in centre for drug users in the city. RESULTS: The interviews revealed that the pharmacological effects of putaw (street grade heroin) and the economics of injection were factors in initiating and maintaining injection. Importantly, the intersection of socio-economic deprivation with pursuing the status of rewa (local concept of masculinity) and the dynamics of gang participation led many members of the lorong into a drug injection career, making them vulnerable for HIV and other blood-borne viral infections. CONCLUSION: To be more effective, the existing harm reduction programmes in Makassar that focus on individualistic behavioural changes need to be complemented with community-based programmes that take into consideration the social and structural context of risk-taking practices amongst young people in the lorong.

Adolescents Exiting Homelessness Over Two Years: The Risk Amplification and Abatement Model.

The Risk Amplification and Abatement Model (RAAM), demonstrates that negative contact with socializing agents amplify risk, while positive contact abates risk for homeless adolescents. To test this model, the likelihood of exiting homelessness and returning to familial housing at 2 years and stably exiting over time are examined with longitudinal data collected from 183 newly homeless adolescents followed over 2 years in Los Angeles, CA. In support of RAAM, unadjusted odds of exiting at 2 years and stably exiting over2 years revealed that engagement with pro-social peers, maternal social support, and continued school attendance all promoted exiting behaviors. Simultaneously, exposure to family violence and reliance on shelter services discouraged stably exiting behaviors. Implications for family-based interventions are proposed.