scholarly journals Seeing Beyond the Margins: Challenges to Informed Inclusion of Vulnerable Populations in Research

2018 ◽  
Vol 46 (1) ◽  
pp. 30-43 ◽  
Author(s):  
Sarah Gehlert ◽  
Jessica Mozersky
Keyword(s):  
Informed Consent ◽  
African Americans ◽  
Medical Research ◽  
American Indians ◽  
Vulnerable Populations ◽  
Individual Autonomy ◽  
Foundational Principle ◽  
Structured Groups ◽  
Unstructured Groups ◽  
Participation In Research

Although the importance of including vulnerable populations in medical research is widely accepted, identifying how to achieve such inclusion remains a challenge. Ensuring that the language of informed consent is comprehensible to this group is no less of a challenge. Although a variety of interventions show promise for increasing the comprehensibility of informed consent and increasing a climate of exchange, consensus is lacking on which interventions should be used in which situations and current regulations provide little guidance. We argue that the notion of individual autonomy — a foundational principle of informed consent — may be too narrow for some vulnerable populations by virtue of its failure to acknowledge their unique histories and current circumstances. It has a different meaning for members of structured groups like American Indians than for unstructured groups, such as African Americans, whose complicated histories foster group identity. Ensuring broad participation in research and selecting appropriate methods for obtaining informed consent — namely, methods aligned with the source of vulnerability and level of risk — require new ways of thinking that might produce guidelines for matching informed consent models and processes with subpopulations.

Marie Baldwin, Racism, and the Society of American Indians

2020 ◽  
Vol 44 (1) ◽  
pp. 35-52
Author(s):  
Tadeusz Lewandowski
Keyword(s):  
African Americans ◽  
Conference Proceedings ◽  
American Indians ◽  
Full Account ◽  
Women's Equality ◽  
Indian Affairs ◽  
Indian Rights ◽  
Point Of Departure

The French/Ojibwa lawyer, activist, and Office of Indian Affairs employee, Marie Louise Bottineau Baldwin (1863–1952), often receives mention in scholarly works on the Society of American Indians (SAI). Very few, however, have examined her contributions in detail. Only one article focusing exclusively on Baldwin has ever been published. Cathleen D. Cahill’s flattering portrait depicts Baldwin as a devoted suffragette and leading SAI figure who, in her roles as cofounder and treasurer, promoted the cause of Indian rights and her own Ojibwa values concerning women’s equality. Cahill explains Baldwin’s sudden exit from the SAI as a result of attacks by male, anti-Indian Office “radicals” who condemned her as disloyal for holding a government post, such as Carlos Montezuma (Yavapai) and Philip Gordon (Ojibwa). Closer inspection of the SAI’s conference proceedings and epistolary record reveals a very different story. In providing the first full account of Baldwin’s involvement in intertribal activism, this essay counters Cahill’s inaccurate interpretation of Baldwin’s withdrawal from the society, and, more importantly, examines Baldwin’s underreported, yet openly racist campaign among key SAI members to ban African Americans from the Indian Service. Baldwin’s incendiary statements on race offers a point of departure for further study of how the Society of American Indians viewed African Americans during the Progressive era’s intense segregation and prevailing social Darwinist theories of race.

scholarly journals Ethical, Legal, and Social Issues Related to the Inclusion of Individuals With Intellectual Disabilities in Electronic Health Record Research: Scoping Review (Preprint)

2019 ◽  
Author(s):  
Melissa Raspa ◽  
Rebecca Moultrie ◽  
Laura Wagner ◽  
Anne Edwards ◽  
Sara Andrews ◽  
...  
Keyword(s):  
Informed Consent ◽  
Intellectual Disabilities ◽  
Vulnerable Populations ◽  
Scoping Review ◽  
Social Issues ◽  
Genetic Research ◽  
Return Of Results ◽  
Privacy And Security ◽  
Electronic Health ◽  
Individuals With Intellectual Disabilities

BACKGROUND Data from electronic health records (EHRs) are increasingly used in the field of genetic research to further precision medicine initiatives. However, many of these efforts exclude individuals with intellectual disabilities, which often stem from genetic conditions. To include this important subpopulation in EHR research, important ethical, legal, and social issues should be considered. OBJECTIVE The goal of this study was to review prior research to better understand what ethical, legal, and social issues may need further investigation when considering the research use of EHRs for individuals with genetic conditions that may result in intellectual disability. This information will be valuable in developing methods and best practices for involving this group in research given they are considered a vulnerable population that may need special research protections. METHODS We conducted a scoping review to examine issues related to the use of EHRs for research purposes and those more broadly associated with genetic research. The initial search yielded a total of 460 unique citations. We used an evaluative coding process to determine relevancy for inclusion. RESULTS This approach resulted in 59 articles in the following areas: informed consent, privacy and security, return of results, and vulnerable populations. The review included several models of garnering informed consent in EHR or genetic research, including tiered or categorical, blanket or general, open, and opt-out models. Second, studies reported on patients’ concerns regarding the privacy and security of EHR or genetic data, such as who has access, type of data use in research, identifiability, and risks associated with privacy breach. The literature on return of research results using biospecimens examined the dissension in the field, particularly when sharing individualized genetic results. Finally, work involving vulnerable populations highlighted special considerations when conducting EHR or genetic research. CONCLUSIONS The results frame important questions for researchers to consider when designing EHR studies, which include individuals with intellectual disabilities, including appropriate safeguards and protections.

What patients really got and what they wanted in surgical informed consent: a cross-sectional survey in China

2019 ◽  
Author(s):  
Jing Wu ◽  
Jiajia Yu ◽  
Xuchun Ye ◽  
Qing Wu ◽  
Chenling Luo
Keyword(s):  
Decision Making ◽  
Informed Consent ◽  
Clinical Medicine ◽  
Focal Point ◽  
Final Analysis ◽  
Individual Autonomy ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Potential Risks ◽  
Perceptions And Expectations

Abstract Background Informed consent (IC) is a fundamental element of modern clinical medicine based on the spirit of individual autonomy. Patients’ comprehension of the key elements of clinical IC is often poor. Aims and Objectives This study aimed to explore patients’ perceptions and expectations of IC process in invasive and surgical procedures. Design A cross-sectional descriptive study was carried out in Shanghai, China. Methods A self-administered structured questionnaire was developed to evaluate patients’ perceptions and expectations of the IC process. In total, 317 individuals were included in the final analysis. Results Majority (73.8%) of the process was undertaken one day prior to the procedure and nearly half (47.6%) lasted less than 15 minutes. Most (96.8%) patients were given verbal explanation information by healthcare professionals. The nature of illness, potential risks and complications (74.1%) and the necessity of the procedure (69.4%) were mostly memorized while alternative treatments rarely (13.6%). Patients expected their family members involved in the decision making and could be provided more time to read the IC document and prepare for the decision-making. What the patients got was significantly different from what they expected in the following aspects, such as who participated in IC, where and when it took place, how long it lasted and main contents that should be discussed in IC (P <0.05). Statistically significant relationship was found in expectations of IC patients and their income and payment type of medical expenses (P <0.05). Discussion This study explored patients’ expectation and perception of IC process regarding invasive procedures. Patients wanted to be more involved in IC process. To promote patient participation, more time should be given to the patients to comprehend and understand the IC document. In addition, information related with long-term issues should be discussed as a focal point. There is a need to re-consider IC process and to develop methods to promote the patients’ satisfaction in achieving autonomy.

Autism, Autonomy, and Research

2019 ◽  
pp. 53-64 ◽  
Author(s):  
Kenneth A. Richman
Keyword(s):  
Informed Consent ◽  
Ethical Issues ◽  
Ethical Concerns ◽  
Autistic People ◽  
Participation In Research

This chapter addresses ethical issues for informed consent when recruiting autistic participants for research. The process of informed consent for participation in research involves some abilities, such as dialogue and understanding the intentions of the researchers, that can be especially challenging when autistic individuals are being asked to participate. This chapter reviews these abilities, and suggests ways to provide meaningful support to promote autonomy and help researchers meet their responsibilities. Beyond these more general challenges, it explores Hans Jonas’s suggestion that true informed consent for research requires that participants identify with the goals of the researchers. Given the plurality of perspectives on how to respond to autism, Jonas’s ideas point to additional ethical concerns that can arise when autistic people are recruited for research on autism.

Fulfilling the Underlying Purpose of Informed Consent to Research

2001 ◽  
Author(s):  
Jessica W. Berg ◽  
Paul S. Appelbaum ◽  
Charles W. Lidz ◽  
Lisa S. Parker
Keyword(s):  
Informed Consent ◽  
Best Interests ◽  
Research Subjects ◽  
Bodily Integrity ◽  
Traditional Concept ◽  
Treatment Situation ◽  
Consent To Treatment ◽  
History Of ◽  
Participation In Research ◽  
Treatment Settings

To a great extent the underlying purposes of informed consent in research settings resemble those in the treatment situation. Informed consent promotes individuals’ autonomy by allowing subjects to make meaningful decisions about participation in research projects. Informed consent is also a means of reducing inequalities of knowledge and power in the researcher-subject relationship and thus increases the cooperation and compliance of subjects. Increased knowledge also enhances patients’ abilities to make decisions that will protect them from unwanted and undesirable intrusions on bodily integrity, perhaps of even greater importance here than in treatment settings, because of the sorry history of abuses inflicted on research subjects. As great as the similarities are between consent to treatment and consent to research, the differences are equally great. In treatment settings, as already noted, clinicians and patients are presumed to share the same goal: promoting patients’ health. They may disagree over the means, but a general coincidence of interests is ordinarily the rule. Charles Fried calls this confluence of interests the principle of personal care. “The traditional concept of the physician’s relation to his patient is one of unqualified fidelity to that patient’s health. He may certainly not do anything that would impair the patient’s health and he must do everything in his ability to further it”. The essence of this principle is that physicians will not allow any other considerations to impinge on their decisions as to what measures are in their patients’ best interests. Since the goal of scientific investigation is the production of generalizable knowledge, not primarily the promotion of individual health, the interests of subjects and researchers are not identical. Clinician-researchers who are providing treatment to subjects in their research studies may feel this clash of interests most acutely as steps taken to protect the generalizability of the data may conflict with the maximization of benefit to individual subjects (2). The need to take this conflict into account in the decisionmaking process is largely responsible for the differences between consent to research and consent to treatment.

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