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.

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.

A Policy in Flux: New York State's Evolving Approach to Human Subjects Research Involving Individuals Who Lack Consent Capacity

2014 ◽  
Vol 42 (3) ◽  
pp. 383-388
Author(s):  
Valerie Gutmann Koch
Keyword(s):  
New York ◽  
Human Subjects ◽  
Institutional Review Board ◽  
Cognitively Impaired ◽  
Conservative Approach ◽  
Important Research ◽  
Human Subjects Research ◽  
Institutional Review ◽  
Voluntary Informed Consent ◽  
Conducting Research

Despite existing federal and state law and regulation, new human subjects research (HSR) scandals involving “vulnerable” populations continue to surface. Although existing oversight mechanisms were enacted to ensure voluntary informed consent for participants and institutional review board (IRB) oversight of HSR, these laws and regulations do not provide any special oversight mechanisms or protections to ensure the ethical and safe inclusion of cognitively impaired adults. The absence of rules to ensure consistently ethical conduct of research involving adults who lack consent capacity may either lead to exploitation of this vulnerable population or the dearth of important research into the broad range of diseases that impair cognition. In other words, while some institutions and investigators are conducting research with this group without guidance, others are taking an extremely conservative approach and are excluding these individuals from research. Without safeguards that are adequate and robust but not overly burdensome, conducting research involving this population is ethically and legally challenging.

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 SoTL and the Institutional Review Board: Considerations before navigating the application process for classroom research in higher education

2014 ◽  
pp. 1-14 ◽  
Author(s):  
Kathryn E. Linder ◽  
E. Deborah Elek ◽  
Lucia Calderon
Keyword(s):  
Teaching And Learning ◽  
Human Subjects ◽  
Institutional Review Board ◽  
Human Subjects Research ◽  
Application Process ◽  
Institutional Review ◽  
History Of ◽  
Research Protections ◽  
Faculty Developer ◽  
Research Compliance

One of the more challenging areas of Scholarship of Teaching and Learning (SoTL) research can be navigating the components of human subjects research protections implemented by the Institutional Review Board (IRB). The authors of this article, a faculty developer and a current and former research compliance coordinator, discuss the history of IRB in relation to SoTL research and explicate some of the foundational components of IRB protocols for SoTL projects. In particular, the authors explore what constitutes “research” for SoTL projects, explain the different IRB types of review, and offer some sample SoTL projects with respect to their IRB implications.

Comment on the Proposed Institutional Review Board Retrospective Review of Research

2020 ◽  
Vol 15 (3) ◽  
pp. 229-231 ◽  
Author(s):  
Min-Fu Tsan
Keyword(s):  
Retrospective Review ◽  
Human Subjects ◽  
Institutional Review Board ◽  
Human Subjects Research ◽  
Common Rule ◽  
Institutional Review ◽  
The Common

Investigators of nonexempt human subjects research conducted without prior institutional review board (IRB) approval often have difficulties in publishing data obtained from such research. Retrospective review and approval of such research has been suggested as a potential pathway for an IRB to help these investigators to publish those data. However, under the Common Rule, an IRB has no authority to retrospectively review and approve human subjects research. Prevention remains the best strategy to ensure that no nonexempt human subjects research is initiated prior to IRB approval.

scholarly journals Social and Behavioral Research with Undocumented Immigrants: Navigating an IRB Committee

2020 ◽  
Vol 42 (1) ◽  
pp. 3-17
Author(s):  
Elizabeth Jach ◽  
Gene Gloeckner ◽  
Colleen Kohashi
Keyword(s):  
Vulnerable Populations ◽  
Human Subjects ◽  
Undocumented Students ◽  
Institutional Review Board ◽  
Federal Regulations ◽  
Political Climate ◽  
Human Subjects Research ◽  
Institutional Review ◽  
The U.S

When conducting human subjects research, social and behavioral researchers seeking to study current issues involving immigrants, refugees, and undocumented students must submit their research to an institutional review board (IRB). Research applications proposing to enroll these populations lie outside the scope of vulnerable populations named in the U.S. Code for Federal Regulations (45 CFR 46). Through a consideration of privacy, confidentiality, flexibility in providing protections, and case study examples, this article examines how researchers and IRBs can negotiate protecting participants who may be undocumented while supporting the advancement of research in the midst of the current, and uncertain, political climate.

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