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.

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.

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.

Symposium on Human Subjects Research: Redux

2002 ◽  
Vol 30 (3) ◽  
pp. 358-360
Author(s):  
Jesse A. Goldner
Keyword(s):  
Quality Improvement ◽  
Human Subjects ◽  
Institutional Review Boards ◽  
Human Subjects Research ◽  
Institutional Review ◽  
New Directions ◽  
Short Run ◽  
Research Protections ◽  
Review Boards

Two years ago, the Journal of Law, Medicine & Ethics published volume 28, number 4, devoted to a symposium entitled Human Subjects Research and the Role of Institutional Review Boards - Conflicts and Challenges. I had the good fortune to be asked to serve as editor of that issue. In her introduction to the symposium, the then editor-in-chief of the journal, Ellen Wright Clayton, observed that the country is currently undergoing a major reexamination of how biomedical research is conducted. While that reexamination has continued in the interim, some very recent events raise questions about the extent to which this will continue, at least in the short run, with equal vigor. The intervening years have witnessed a variety of new directions and events. The federal Office of Human Research Protections (OHRP), directed by Dr. Greg Koski, who wrote a brief commentary for the last symposium,L has taken a new direction, strongly stressing the need for institutions and their institutional review boards ORBS) to engage in extensive educational and quality improvement efforts with both researchers and their own member.

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.

scholarly journals Bone Mineral Density in Gravida: Effect of Pregnancies and Breast-Feeding in Women of Differing Ages and Parity

2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
Ehud Lebel ◽  
Yuri Mishukov ◽  
Liana Babchenko ◽  
Arnon Samueloff ◽  
Ari Zimran ◽  
...  
Keyword(s):  
Bone Mineral Density ◽  
Bone Mineral ◽  
Institutional Review Board ◽  
Mineral Density ◽  
X Ray ◽  
Normal Limits ◽  
Institutional Review Board Approval ◽  
Institutional Review ◽  
History Of ◽  
Breast Fed

Changes of bone during pregnancy and during lactation evaluated by bone mineral density (BMD) may have implications for risk of osteoporosis and fractures. We studied BMD in women of differing ages, parity, and lactation histories immediately postpartum for BMD,T-scores, andZ-scores. Institutional Review Board approval was received. All women while still in hospital postpartum were asked to participate. BMD was performed by dual-energy X-ray absorptiometry (DXA) machine at femoral neck (FN) and lumbar spine (LS) by a single technician. Of 132 participants, 73 (55.3%) were ≤30 years; 27 (20.5%) were primiparous; 36 (27.3%) were grand multiparous; 35 (26.5%) never breast fed. Mean FNT-scores andZ-scores were higher than respective mean LS scores, but all means were within the normal limits. Mean LST-scores andZ-scores were highest in the grand multiparas. There were only 2 (1.5%) outliers with lowZ-scores. We conclude that, in a large cohort of Israeli women with BMD parameters assessed by DXA within two days postpartum, meanT-scores andZ-scores at both the LS and FN were within normal limits regardless of age (20–46 years), parity (1–13 viable births), and history of either no or prolonged months of lactation (up to 11.25 years).

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