Differing Understandings of Informed Consent Held by Research Institutions, People with Intellectual Disability, and Guardians

2019 ◽  
pp. 27-38
Author(s):  
Britteny M. Howell ◽  
Karrie A. Shogren
Keyword(s):  
Intellectual Disability ◽  
Informed Consent ◽  
Research Participation ◽  
Research Literature ◽  
Self Determination ◽  
Institutional Review Board ◽  
Research Institutions ◽  
Ethical Research ◽  
Institutional Review ◽  
Participation In Research

Increasing participation of people with intellectual disability (ID) is necessary for inclusive, ethical research that reduces persistent disparities in representation. However, many adults with ID have guardians, who must consent to research involvement. Researchers have found that guardians are less likely to provide consent than the person with ID, often resulting in lower participation. Institutional Review Board (IRB) members also have been found to hold very cautious views regarding research participation compared to the views of people with ID or their guardians. This chapter reviews issues that emerge because of differing views of research participation held by IRB members, guardians, and people with ID that may unnecessarily limit the participation of people with ID in research. The research literature on these barriers is summarized along with the authors’ own experiences with alternative participatory strategies that have the potential to increase both self-determination and participation in research for people with ID.

Gatekeepers of Science: Attitudes Toward the Research Participation of Adults With Intellectual Disability

2008 ◽  
Vol 113 (6) ◽  
pp. 466-478 ◽  
Author(s):  
Katherine E. McDonald ◽  
Christopher B. Keys ◽  
David B. Henry
Keyword(s):  
Decision Making ◽  
Intellectual Disability ◽  
Individual Differences ◽  
Research Participation ◽  
Attitude Scale ◽  
Institutional Review Board ◽  
Science Attitudes ◽  
Disability Rights ◽  
Institutional Review ◽  
Participation In Research

Abstract Researchers and Institutional Review Board (IRB) members' attitudes influence scientific knowledge about individuals with intellectual disability. We recruited 260 intellectual disability researchers and IRB members to develop a measure of attitudes toward the research participation of adults with intellectual disability, the Participation in Research Attitude Scale. Findings suggest three conceptual domains: Opportunity and Choice, Help in Decision Making, and Beneficence. We also examined individual differences in attitudes and the relationships between general and specific attitudes. In general, intellectual disability researchers and those with closer relationships to individuals with disabilities had attitudes consistent with disability-rights principles. Some dimensions of global attitudes toward adults with intellectual disability predicted more specific attitudes toward their research participation. Implications are discussed.

scholarly journals What's the Harm? Harms in Research With Adults With Intellectual Disability

2017 ◽  
Vol 122 (1) ◽  
pp. 78-92 ◽  
Author(s):  
Katherine E. McDonald ◽  
Nicole E. Conroy ◽  
Robert S. Olick ◽  
The Project ETHICS Expert Panel
Keyword(s):  
Intellectual Disability ◽  
Service Providers ◽  
Scientific Progress ◽  
Research Participation ◽  
Institutional Review Board ◽  
Board Members ◽  
Ethical Research ◽  
Disability Service Providers ◽  
Participation Decision ◽  
Institutional Review

Abstract Scientific advances can improve the lives of adults with intellectual disability, yet concerns that research participation may impose harm impede scientific progress. What counts as harmful can be subjective and perceptions of harm may vary among stakeholders. We studied perspectives on the harmfulness of research events among adults with intellectual disability, family members and friends, disability service providers, researchers, and Institutional Review Board members. We found considerable variance. For example, adults with intellectual disability see exclusion from research as more harmful, but most psychosocial harms as less significant than others. All stakeholders agree that having someone else make the participation decision is harmful. Findings provide insights into the concept of harm and ethical research with adults with intellectual disability.

The Mindset of Surrogates and Inclusivity Research

2019 ◽  
pp. 225-228
Author(s):  
Deborah R. Barnbaum
Keyword(s):  
Intellectual Disability ◽  
Informed Consent ◽  
Intellectual Disabilities ◽  
Decision Makers ◽  
Research Institutions ◽  
Ethical Research ◽  
Surrogate Decision Makers ◽  
Surrogate Decision

This commentary considers three aspects of Britteny Howell and Karrie Shogren’s chapter “Differing Understandings of Informed Consent Held by Research Institutions, People With Intellectual Disability, and Guardians: Implications for Inclusive, Ethical Research” (Chapter 3). First, strengths of their discussion are considered. Second, a philosophical distinction amongst three justifications for surrogate decisions is elaborated upon, and is used conceptually to ground claims in Howell and Shogren’s chapter. Finally, it is suggested that illustrating this distinction to surrogate decision-makers may bolster the participation of persons with intellectual disabilities in research.

scholarly journals Institutional Review Board (IRB): its role and responsibility in making research ethical

2014 ◽  
Vol 5 (1) ◽  
pp. 5-10 ◽  
Author(s):  
Abu Sadat Mohammad Nurunnabi
Keyword(s):  
Institutional Review Board ◽  
Educational Activity ◽  
Systemic Review ◽  
Ethical Review ◽  
Institutional Research ◽  
Journal Articles ◽  
Research Strategies ◽  
Ethical Research ◽  
Roles And Responsibilities ◽  
Institutional Review

This is a review article prepared as a part of the assignment in the educational activity and training on research ethics titled “Ethical and Regulatory Aspects of Clinical Research” arranged by the Bangladesh Bioethics Society (BBS), Dhaka, Bangladesh, in collaboration with the Department of Bioethics of National Institutes of Health (NIH), Bethesda, Maryland, USA, through video conferencing between September 25 and November 13 of 2013. The search was confined to ‘Google’, ‘HINARI’ and ‘PubMed’ published articles. Besides, some guidelines on roles and responsibilities of Institutional Review Board (IRB) were taken into consideration. Key words used for searching were ‘institutional review board’, ‘ethical review committee’ and ‘ethical research’. A total of 18 journal articles and some guidelines were selected for this writing. The systemic review from the databases revealed some important discussions on research, ethical research, roles and responsibilities of IRB/ERC and its challenges, and national/institutional research strategies. DOI: http://dx.doi.org/10.3329/bioethics.v5i1.18442 Bangladesh Journal of Bioethics 2014 Vol.5(1): 5-10

scholarly journals Suitability of Placental Blood Samples of Newborns for Pre-Transfusion Testing

2021 ◽  
Vol 9 ◽  
Author(s):  
Rana Alissa ◽  
Patty D. Williams ◽  
Erika L. Baker ◽  
Jennifer A. Hipp ◽  
Jinous Saremian ◽  
...  
Keyword(s):  
Informed Consent ◽  
Categorical Data ◽  
Institutional Review Board ◽  
Abo Blood Group ◽  
Blood Samples ◽  
Rhesus Factor ◽  
Institutional Review ◽  
Antiglobulin Test ◽  
Placental Blood ◽  
Antibody Screen

Objective: To show concordance between heel stick and placental blood sample pairs for newborns' pre-transfusion testing and to validate placental blood's tube and gel methodology.Methods: Placental samples were collected for pre-transfusion testing at birth from 78 singleton and twin newborns admitted to our Mother–Baby Unit to compare with the results of heel stick samples taken from same newborns. Gestational age ≥35 weeks, weight ≥2,000 g. The study was approved by the Institutional Review Board (IRB). Informed consent was obtained from newborn parents. ABO blood group, Rhesus factor (Rh), direct antiglobulin test (DAT), and antibody screen were performed. Ortho ProVue Analyzer was used for tube and gel methods. McNemar's test for paired categorical data was performed.Results: One hundred percent concordance in 78 pairs for ABO and Rh. Seventy-four pairs were tested for antibodies, 72 were both negative, 1 was both positive, and 1 gave discordant result. Ninety-nine percent concordance, p = 0.999. Sixty-five pairs were both DAT negative, seven were both DAT positive, and six gave discordant results. Ninety-two percent concordance, p = 0.68. Placental blood gave identical results comparing tube with gel methods.Conclusions: Placental blood is suitable for pre-transfusion testing and can replace heel sticks. Placental blood tube and gel methods are validated.

scholarly journals Is Safety in the Eye of the Beholder? Safeguards in Research With Adults With Intellectual Disability

2016 ◽  
Vol 11 (5) ◽  
pp. 424-438 ◽  
Author(s):  
Katherine E. McDonald ◽  
Nicole E. Conroy ◽  
Carolyn I. Kim ◽  
Emily J. LoBraico ◽  
Ellis M. Prather ◽  
...  
Keyword(s):  
Decision Making ◽  
Intellectual Disability ◽  
Service Providers ◽  
Human Subjects ◽  
Well Being ◽  
Institutional Review Board ◽  
Human Subjects Research ◽  
Disability Service ◽  
Disability Service Providers ◽  
Institutional Review

Human subjects research has a core commitment to participant well-being. This obligation is accentuated for once exploited populations such as adults with intellectual disability. Yet we know little about the public’s views on appropriate safeguards for this population. We surveyed adults with intellectual disability, family members and friends, disability service providers, researchers, and Institutional Review Board (IRB) members to compare views on safeguards. We found many points of convergence of views, particularly for decision-making and participation. One trend is that adults with intellectual disability perceive greater safety in being engaged directly in recruitment, and recruitment by specific individuals. Researchers and IRB members need to consider community views to facilitate the safe and respectful inclusion of adults with intellectual disability.

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