Participation In Medical Research Research Articles

Immunisation for medical researchers: an ethical and practical imperative.

we believe it is essential that all researchers who have direct contact with participants are fully immunised. Disciplines Medicine and Health Sciences Publication Details Townsend, M. L., Grenyer, B. F. S., Yeo, W. & Wright, I. (2016). Immunisation for medical researchers: an ethical and practical imperative. Medical Journal of Australia, 204 (7), 263-263. This journal article is available at Research Online: http://ro.uow.edu.au/ihmri/775 Immunisation for medical researchers: an ethical and practical imperative Michelle L Townsend PhD Brin FS Grenyer BA(HONS), MSc, PhD? Wilfred Yeo MB ChB, MD, FRACP Ian Wright FRACP 1 School of Psychology and Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong. 2 Graduate School of Medicine and Illawarra Health and Medical Research Institute University of Wollongong, Wollongong. doi: 10.5694/mja15.01179 Participants in medical research are the most valuable resource within health research, and their wellbeing must be regarded as paramount. Australia’s national statement on ethical conduct in human research1 establishes that the burden is on researchers to safeguard the health, wellbeing and autonomy of their research participants. We argue that additional guidance is required in an area that has not been widely considered in the ethical research literature and policy: immunisation coverage of the research team. It is acknowledged that health care workers with immunisation‐preventable disease infect their patients.2,3 There is no reason to believe that researchers are exempt from transmitting these diseases to their participants. There are national guidelines4 that provide evidence‐based recommendations on immunisation for people at occupational risk, but this guidance does not specifically refer to researchers. We present a case study to illustrate the issue. We undertook a cross‐generational longitudinal study examining environmental, lifestyle and genetic factors influencing health and wellbeing across the lifespan. The study, based at a medical research institute, involved recruiting pregnant women in collaboration with the local health district. University researchers sought honorary appointments for recruitment and data collection in the hospital setting, with the expectation that we would be required to prove immunisation currency according to relevant state health policy.5 When the resultant honorary researcher appointment applications were approved we were not required to demonstrate any immunisation status. There may be several reasons for this: first that individuals classifying risk may interpret the rules differently; and second, employment status in clinical research studies with multiple researchers from different organisations is complex. The study researchers reviewed the university immunisation guidelines and found that those on clinical placements in state health facilities required immunisation coverage, but for all others, including researchers, immunisation was voluntary. After careful consideration, we decided that ensuring the research team was fully immunised was the most ethical way to approach our research. In consultation with an infection control specialist at the local health district, we agreed on several immunisations or evidence of serological immunity. To fulfil our responsibilities as ethical researchers, we believe it is essential that all researchers with direct contact with participants be fully immunised, using national guidelines, against relevant diseases. The prevention of avoidable harm would appear to be an ethical imperative, but we can find no consistent guidance in this area for researchers at a national or international level. We suggest that it is appropriate for the National Health and Medical Research Council to consider guidance on immunisation coverage of researchers with direct contact with participants, rather than leaving it to individual research ethics committees.

Autonomy is a Right, Not a Feat: How Theoretical Misconceptions have Muddled the Debate on Dynamic Consent to Biobank Research.

Should people be involved as active participants in longitudinal medical research, as opposed to remaining passive providers of data and material? We argue in this article that misconceptions of 'autonomy' as a kind of feat rather than a right are to blame for much of the confusion surrounding the debate of dynamic versus broad consent. Keeping in mind two foundational facts of human life, freedom and dignity, we elaborate three moral principles - those of autonomy, integrity and authority - to better see what is at stake. Respect for autonomy is to recognize the other's right to decide in matters that are important to them. Respect for integrity is to meet, in one's relationship with the other, their need to navigate the intersection between private and social life. Respect for authority is to empower the other - to help them to cultivate their responsibility as citizens. On our account, to force information onto someone who does not want it is not to respect that person's autonomy, but to violate integrity in the name of empowerment. Empowerment, not respect for autonomy, is the aim that sets patient-centred initiatives employing a dynamic consent model apart from other consent models. Whether this is ultimately morally justified depends on whether empowerment ought to be a goal of medical research, which is questionable.

Participatory methods in pediatric participatory research: a systematic review

Meaningful child participation in medical research is seen as important. In order to facilitate further development of participatory research, we performed a systematic literature study to describe and assess the available knowledge on participatory methods in pediatric research. A search was executed in five databases: PubMed, CINAHL, PsycINFO, Scopus, and Cochrane. After careful screening of relevant papers, finally 24 documents were included in our analysis. Literature on participatory methods in pediatric research appears generally to be descriptive, whereby high-quality evidence is lacking. Overall, five groups of participatory methods for children could be distinguished: observational, verbal, written, visual, and active methods. The choice for one of these methods should be based on the child's age, on social and demographic characteristics, and on the research objectives. To date, these methods are still solely used for obtaining data, yet they are suitable for conducting meaningful participation. This may result in a successful partnership between children and researchers. Researchers conducting participatory research with children can use this systematic review in order to weigh the current knowledge about the participatory methods presented.

Dying for Science: Historical Perspectives on Research Participants' Deaths.

The continuance of public and institutional support for medical research after the publicized deaths of human research participants in the 1950s contrasts sharply with the disciplining of institutions responsible for two such deaths in recent decades, which suggests that medical research participants are no longer receiving public recognition for their contributions to science.

Medical Research Participation as Citizenship: Modeling Modern Masculinity and Marriage in a Mexican Sexual Health Study

ABSTRACTIn this article, I discuss people's use of medical research participation to perform and model modernity amid societal insecurity. I analyze data from interviews with heterosexual Mexican couples undertaken throughout men's multiyear participation in a human papillomavirus (HPV) study. I argue that through activities like willingly undergoing genital examination and involving wives in husbands’ clinical visits, spouses used the study as a forum for performing ideals of modern gender and health, specifically companionate marriage and non‐macho masculinities emphasizing male self‐care. They also hoped to serve as role models for their children and for society at large. I discuss how specific elements of the Mexican context made fomenting social change through individual research participation seem possible: cultural narratives of the Mexican populace as a bioculturally homogenous whole; longstanding state efforts to modernize the population away from “traditional” gender and health practices; and ongoing failures of the “slippery State” to reliably provide the resources those practices required. In this context, participants framed themselves as a middle‐class vanguard and experienced sexual health research as an act of citizenship through which they hoped to spur national progress despite state failures and the persistence of antimodern gender and health attitudes. [medical research, modernity, Mexico, gender, health]

All in the Blood: A Review of Aboriginal Australians' Cultural Beliefs About Blood and Implications for Biospecimen Research.

Public participation in medical research and biobanking is considered key to advances in scientific discovery and translation to improved health care. Cultural concerns relating to blood have been found to affect the participation of indigenous peoples and minorities in research, but such concerns are rarely specified in the literature. This article presents a review of the role of blood in Australian Aboriginal cultures. We discuss the range of meanings and uses of blood in traditional culture, including their use in ceremonies, healing, and sorcery. We draw on more recent literature on Aboriginal Australians and biomedicine to consider how traditional beliefs may be changing over time. These findings provide an empirical basis for researchers and bioethicists to develop culturally grounded strategies to boost the participation of Aboriginal Australians in biomedical research. They also serve as a model for integrating anthropological literature with bioethical concerns that could be applied to other indigenous and minority groups.

The 'empty choice': A sociological examination of choosing medical research participation in resource-limited Sub-Saharan Africa.

This article explores the views of frontline research staff in different Sub-Saharan African contexts on the notion of choice in biomedical research. It argues that the current emphasis on individual choice, in the conduct of biomedical research, ignores significant structural and contextual factors in resource-limited settings. These factors severely constrain individual options and often make biomedical research enrolment the most amenable route to healthcare for the world’s poorest. From the position of frontline research staff, local contextual factors and structural issues narrowly frame the parameters within which many prospective participants are asked to choose, to such an extent that individuals are effectively presented with an ‘empty choice’. The article draws on ethnographic and interview data and insights gained through graphic elucidation techniques. It demonstrates that for frontline research staff, macro-level structural factors and their bearing on everyday realities shape what choice in biomedical research participation means in practice.

Perceptions, barriers, and practices of medical research among students at Taibah College of Medicine, Madinah, Saudi Arabia.

BackgroundResearch is an extremely crucial element in the advancement and improvement of health care services provided to the public.AimTo assess perceptions, barriers, and practices of medical research among students at Taibah College of Medicine, Madinah, Saudi Arabia.MethodsA cross-sectional, self-administered, validated, pretested, and structured questionnaire was completed by 233 medical students (third, fourth, and fifth study year). The questionnaire consisted of demographic data, students’ attitude, practices, and barriers. The collected data were analyzed using appropriate statistical methods including predictive logistic regression models. The level of statistical significance was defined as P#0.05.ResultsThe overall response rate was 64.7% (233/360). The mean age of the studied students was 22.6±1.1 years, of them 50.1% were males and 48.9% were females. The average attitude score was significantly higher among fourth- and fifth-year medical students compared with that of the third-year students. There has been a statistically significant difference between male and female students regarding their practice of medical research where the higher percent of students reported participation in previous medical research was among female students (79%). The most important obstacle predictors implicated in not conducting research among all the studied students were inadequate facility for research, lack of interest by faculty or guide, and unavailability of the samples or patients.ConclusionThe students in the study showed a moderately high positive attitude toward medical research. Addressing and solving perceived students’ barriers by faculty staff and administrators are essential in order to ensure an improvement in research activities among medical students.

Rising to the Challenges of Clinical Trial Improvement in Parkinson's Disease.

Despite an urgent need for new medications, clinical trials in Parkinson's have a relatively low rate of success. Although many reasons have been proposed for this, the opinions of patients and scientists, the two principal stakeholders, have not been widely canvassed. The objective of the present study was to establish the main barriers to clinical trials success in Parkinson's, as perceived by people with Parkinson's and those engaged in conducting clinical trials in Parkinson's. Three hundred and three people (303) with a connection to Parkinson's completed an online four-item questionnaire, directed towards discovering the barriers that interfere with the establishment of effective clinical trials. 87% of respondents were patients and their care partners and 11% were medical professionals involved with clinical research. In the survey, those involved in conducting research cited insufficient financial and administrative support as the biggest obstacles to carrying out effective clinical trials. For responders with Parkinson's, the principal barrier to their participation in medical research was fear of potential adverse consequences and misconceptions regarding the clinical trial system as a whole, issues rooted in a perceived lack of communication of relevant information between the research and patient communities. Areas for future improvement as highlighted by this survey and debated at the Rallying to the Challenge meeting of people with Parkinson's (PwP) at the Van Andel Research Institute that followed included recommendations in the areas of communication, education, funding, recruitment and compliance.

Public Interest in Medical Research Participation: Does It Matter if Patients or Community Members Have Helped Design the Study?

We determined national levels of public participation in medical research study design. We compared public interest in medical research participation (MRP) in studies overall, versus studies explicitly designed with public involvement. Cross-sectional household survey of US population in June 2013. Descriptive statistics estimated participation in medical research study design. Chi-square test compared levels of interest in MRP if respondent knew patients or community members helped design the study. Of 2,048 respondents (participation rate 60%), 5% knew someone who had helped design a medical research study. There was no association between having known someone or personal participation in study design and willingness to engage in MRP. Although the overall proportion of respondents who would consider MRP initially (51%) was similar to the proportion who would consider MRP with community member involvement in study design (49%), the changes in respondents' views across the different scenarios were significantly greater than what would have been expected by chance. We found similar levels of interest in MRP whether or not the public is involved in medical research study design. This finding may indicate that public involvement in study design, like community-based participatory research, may not affect overall rates of MRP.

Beliefs and Preferences for Medical Research Among African-Americans.

Numerous factors contribute to underrepresentation of African-Americans in medical research, including beliefs, historical events, structural, and health access obstacles. This study examined beliefs about medical research and the types of study methods preferred among potential African-American research participants. A sample of 304 African-American participants from the Washington, DC Metropolitan area, completed a survey evaluating beliefs about medical research and preferred research study methods. Multiple Regression analyses were performed to examine how age, gender, and education may influence these beliefs and preferences for research study methods. The beliefs and preferences surveyed did not differ by age, gender, or educational attainment. There was an overwhelmingly favorable belief (90%) that medical research was necessary and assists in finding a cure for a disease. Most respondents preferred participating in research related to issues with which they were familiar (e.g., diabetes, hypertension) or working with researchers of a similar ethnic background to themselves. Interestingly, though nonsignificant, those with higher levels of educational trended toward the belief that participation in research was risky. The findings of this study indicate that certain beliefs about medical research participation and preferred study methodologies reported by African-Americans did not differ by age, gender, or level of education. This information about African-American's beliefs and preferences regarding medical research should lead to an awareness of potential gains in African-American participation through the development of culturally sensitive medical research studies and methodologies.

Disclosure and Consent to Medical Research Participation

Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The standard view of the conditions for valid consent therefore implies that these people have failed to give valid consent to research participation. In this paper we argue that the standard view is false. The primary function of the requirement that researchers disclose information about a study is the avoidance of illegitimate control over someone’s consent decision, which is a form of fraud.We derive the content and manner of appropriate disclosure by analysing the ways in which the manipulation of information can invalidate consent. Our analysis shows that the informational requirements for valid consent are conceptually distinct and thus unlikely to have identical contents. This implies that consent can be valid when not everything that ought to be disclosed by the person asking for consent is understood by the person who proffers it.

Are Children Always Vulnerable Research Participants?

International guidelines stipulate that in order for children to participate in research, consent must be obtained from their parents or guardians. This is because researchers and ethics committee members have historically viewed children as vulnerable subjects. We, the authors of this article, think that in terms of decision-making for participation in medical research, children are not always vulnerable. Vulnerability is context- and study-specific. In this article, we argue that the blanket categorisation of children as vulnerable research subjects is ethically problematic. Significant numbers of mature minors, particularly in low-income settings, are currently being ruled out of research participation because their parents are unavailable or refuse to provide consent, despite the possibility that they might wish to do so and that such research has the potential to be of real benefit. Consequently, older children are under-represented in all types of clinical research. We here have illustrated our arguments using two case studies. In cases where research is important; meets international scientific and ethical standards and has been approved by relevant ethics committees; where the research team is trained to take consent; and where the information is presented in a way that is accessible to children, then children should sometimes be allowed to consent for themselves, rather than always being dependent on an adult. If children are able to provide valid consent to medical research in their own right, they should be allowed to do so, regardless of their age. The requirements for valid consent that we propose are competence, voluntariness, maturity, independence and contextual appropriateness.

Stopped hearts, amputated toes and NASA: contemporary legends among healthy volunteers in US phase I clinical trials.

The first stage of testing new pharmaceuticals in humans is referred to as a phase I clinical trial. The purpose of these studies is to test the safety of the drugs and to establish appropriate doses that can later be given to patients. Most of these studies are conducted under controlled, in-patient conditions using healthy volunteers who are paid for their participation. To explore healthy volunteers' experiences in clinical trials, an ethnographic study was conducted at six in-patient phase I clinics in the USA. In addition to the observation of clinic activities (from informed consent procedures to dosing to blood draws), 268 semi-structured interviews were conducted, 33 with clinic staff and 235 with healthy volunteers. Drawing on this dataset, this article explores healthy volunteers' exchange of contemporary legends about phase I clinical trials. In addition to potentially scaring the listener and communicating distrust in the medical community, these incredible stories help participants cope with perceived stigma and establish a gradient of risk of trial participation, creating potential boundaries to their participation in medical research. The article argues that contemporary legends play a productive role in society, shaping how people view themselves and others and influencing their decisions about risky activities.

Participation in medical research as a resource-seeking strategy in socio-economically vulnerable communities: call for research and action.

The freedom to consent to participate in medical research is a complex subject, particularly in socio-economically vulnerable communities, where numerous factors may limit the efficacy of the informed consent process. Informal consultation among members of the Switching the Poles Clinical Research Network coming from various sub-Saharan African countries, that is Burkina Faso, The Gambia, Rwanda, Ethiopia, the Democratic Republic of Congo (DRC) and Benin, seems to support the hypothesis that in socio-economical vulnerable communities with inadequate access to health care, the decision to participate in research is often taken irrespectively of the contents of the informed consent interview, and it is largely driven by the opportunity to access free or better quality care and other indirect benefits. Populations' vulnerability due to poverty and/or social exclusion should obviously not lead to exclusion from medical research, which is most often crucially needed to address their health problems. Nonetheless, to reduce the possibility of exploitation, there is the need to further investigate the complex links between socio-economical vulnerability, access to health care and individual freedom to decide on participation in medical research. This needs bringing together clinical researchers, social scientists and bioethicists in transdisciplinary collaborative research efforts that require the collective input from researchers, research sponsors and funders.

Barriers to Medical Research Participation as Perceived by Clinical Trial Investigators: Communicating with Rural and African American Communities

Clinical trials help advance public health and medical research on prevention, diagnosis, screening, treatment, and quality of life. Despite the need for access to quality care in medically underserved areas, clinical trial participation remains low among individuals in rural and African American communities. This study assessed clinical trial research in South Carolina's five main academic medical centers, focusing specifically on clinical trial investigators' perceived barriers to recruitment in the general population and in rural and African American communities. Online survey responses (N = 119) revealed that it was most difficult for investigators to recruit from rural areas and that rural residents were least likely to be represented in medical research, behind both the general public and African Americans. Barriers focusing on communication or awareness proved to be the biggest hurdles to finding potential participants in both the general public and rural communities. Psychological barriers to recruitment were perceived to be most prevalent in African American communities. Study findings provide important insights from the perspective of the clinical trial investigator that will aid in the development of effective communication and education strategies for reaching rural and African American residents with information about clinical trials.

African American women's perceptions and attitudes regarding participation in medical research: the Mayo Clinic/The Links, Incorporated partnership.

To examine perceptions and attitudes toward health-related research participation among professional African American women. Participants were members of an African American women's service organization, The Links, Incorporated. Data were collected via self-administered questionnaires at The Links, Incorporated 2012 National Assembly. Sociodemographics, prior research experience, intention to participate (ITP), willingness to participate (WTP) in a variety of research studies and attitudes about research participation were measured. A total of 381 surveys were analyzed. A majority of respondents were married (66%), employed (69%), and college educated (96%). Median age was 59; 38% reported prior research participation. Overall, 78% agreed with the statement, "Participation in research will mean better care," 24% agreed "Participation in research is risky" and 3% agreed "Scientists cannot be trusted." Fifty-two percent agreed with the statement, "Research conducted in the U.S. is ethical." Mean ITP in research was 4.9±1.7 on a rating scale of 1 ("definitely no") to 7 ("definitely yes"). WTP was highest for an interview study and providing a blood sample, and lowest for clinical trial and medical record review. Attitudes toward research participation were generally favorable among professional African American women; many expressed WTP in a variety of research study types.

Medical education research: is participation fair?

Medical researchers and ethicists emphasise the importance of equity, fairness and justice in general medical research participation. No individual or group should be over-represented or under-represented in research—there should be fair participation. Thus far little thought has been given to fair participation in medical education research. There is no evidence based answer as to whether vulnerable groups are ever exploited in medical education research, or whether other individuals or groups are overlooked. However the heavy reliance on undergraduate learners as subjects for medical education research creates two key threats to the fairness of that research. First, there is a risk that undergraduate learners, as a potentially vulnerable population, may be exploited in research settings. Often the faculty carrying out medical education research will be the same faculty that are responsible for delivering medical education and assessing medical students’ competencies. It is possible as a result that medical students might feel pressured to participate in research. Second, there is a risk that other important groups of learners may be inadequately represented. Much medical education research is carried out on undergraduates and relatively little on those who have been doing CPD for many years. Thus much of our research concentrates on only a small proportion of medical learning. The relatively small amount of research carried out on those doing continuing professional development (CPD) is probably because of the difficulties of recruiting and retaining this group of learners in research programmes. Both risks threaten the integrity and usefulness of the resulting research product. Unfair participation in medical education research programmes could have serious repercussions for learners at all levels.

Consent and assent in paediatric research in low-income settings

BackgroundIn order to involve children in the decision-making process about participation in medical research it is widely recommended that the child’s assent be sought in addition to parental consent. However, the concept of assent is fraught with difficulties, resulting in confusion among researchers and ethics committees alike.DiscussionIn this paper, we outline the current international debate surrounding pediatric consent and assent, and its unique challenges arising in low-income settings. We go on to propose some key requirements for a fit-for-purpose assent model in these difficult settings. The paper recommends that children who are competent, that is, children who are judged to be able to understand and retain relevant information, weigh this information in making a mature judgment, come to a decision and communicate the decision, should be able to consent for themselves. Our proposal is that where the decision about whether to participate in a study is of comparable complexity to the decisions the child is used to making in other aspects of his or her life, it should be made by the child him or herself. The relevant level of complexity should be judged by local standards rather than standards of the developed world. In the paper we explore some of the practical challenges and counter arguments of implementing this proposal. As in high-income settings, we argue that in the case of children who are judged to lack this level of competence both parental consent and assent from the child should be sought and go on to define assent as involving the child to the extent compatible to his or her maturity and with cultural norms and not as obtaining the child’s permission to proceed.SummaryThe concept of assent in the current guidelines is confusing. There is an urgent need for clearer guidelines that can be adapted for all types of paediatric research wherever it is to be carried out and an evidence-base concerning good assent/consent practice. This paper argues that a context specific approach should be adopted when assessing whether consent or assent should be sought from children in low-income settings.

Public Interest in Medical Research Participation: Differences by Volunteer Status and Study Type

We assessed national levels of public interest in medical research participation (MRP) and factors associated with interest as a healthy volunteer; as a diagnosed volunteer; and in seven study types. Cross-sectional, Web-based survey of the US population in June 2012. Descriptive statistics estimated interest in MRP and multivariable logistic regression determined associations between respondent-level predictors and interest in MRP. Of 2,668 respondents (response rate = 61%), 41% were interested in MRP as healthy volunteers and 60% as diagnosed volunteers. Respondents with some college (OR = 1.54, 1.09-2.19) or higher education (OR = 1.86, 1.29-2.70) had higher adjusted odds of interest as healthy volunteers. Non-Hispanic black race (OR = 0.56, 0.37-0.86) and education below high school (OR = 0.57, 0.35-0.92) were associated with lower adjusted odds of interest as diagnosed volunteers. Non-Hispanic black race was associated with lower odds of interest in medication trials as diagnosed volunteers (OR = 0.61, 0.40-0.93). We found high levels of interest in MRP that contrast with low levels of prior research participation. Interest is higher in medical research involving noninvasive designs. Comparatively lower levels of interest in MRP among non-Hispanic blacks and those with less education raise concerns about disparities in future study enrollment.