MRI Research Proposals Involving Child Subjects: Concerns Hindering Research Ethics Boards from Approving Them and a Checklist to Help Evaluate Them

2011 ◽  
Vol 20 (1) ◽  
pp. 115-129 ◽  
Author(s):  
J. DEBORAH SHILOFF ◽  
BRYAN MAGWOOD ◽  
KRISZTINA L. MALISZA
Keyword(s):  
United States ◽  
Research Ethics ◽  
Gold Standard ◽  
The United States ◽  
Institutional Review Boards ◽  
Scientific Review ◽  
Initial Development ◽  
Institutional Review ◽  
Research Ethics Boards ◽  
A Current

The process of research is often lengthy and can be extremely arduous. It may take many years to proceed from the initial development of an idea through to the comparison of the new modalities against a current gold-standard practice. Each step along the way involves rigorous scientific review, where protocols are scrutinized by multiple scientists not only in the specific field at hand but related fields as well. In addition to scientific review, most countries require a further review by a panel that will specifically address the ethics of the proposed research. In Canada, those panels are referred to as Research Ethics Boards (REB), with the United States counterparts known as Institutional Review Boards (IRB).

Indigenous Research Ethics Requirements: An Examination of Six Tribal Institutional Review Board Applications and Processes in the United States

2020 ◽  
Vol 15 (4) ◽  
pp. 279-291
Author(s):  
Nicole S. Kuhn ◽  
Myra Parker ◽  
Clarita Lefthand-Begay
Keyword(s):  
United States ◽  
Research Ethics ◽  
Management Practices ◽  
The United States ◽  
Institutional Review Boards ◽  
Indigenous Research ◽  
Cultural Appropriation ◽  
Building Relationships ◽  
Institutional Review ◽  
Indigenous Knowledge Systems

Tribal Institutional Review Boards (TIRBs) in the United States assert their rights within sovereign nations by developing ethical research processes that align with tribal values to protect indigenous knowledge systems and their community from cultural appropriation, exploitation, misuse, and harm. We reviewed six TIRB applications and processes to gain a better understanding about their requirements and research ethics. We located 48 activated and deactivated TIRBs in a database, mapped them in relation to tribal reservation lands, and then conducted in-depth content analysis. Our analysis demonstrates the importance of building relationships, becoming fully acquainted with the TIRB’s operating environment before seeking research approval, and issues related to tribal data management practices.

scholarly journals Structure and Practice of Institutional Review Boards in the United States

1996 ◽  
Vol 3 (8) ◽  
pp. 804-809 ◽  
Author(s):  
Jeffrey S. Jones ◽  
Lynn J. White ◽  
Linda C. Pool ◽  
James M. Dougherty
Keyword(s):  
United States ◽  
The United States ◽  
Institutional Review Boards ◽  
Institutional Review ◽  
Review Boards

scholarly journals “Only Applies to Research Conducted in Sweden…”: Dilemmas in Gaining Ethics Approval in Transnational Qualitative Research

2019 ◽  
Vol 18 ◽  
pp. 160940691986944
Author(s):  
Gabriele Griffin ◽  
Doris Leibetseder
Keyword(s):  
United States ◽  
Decision Making ◽  
Qualitative Research ◽  
Research Ethics ◽  
European Commission ◽  
The United States ◽  
Ethical Conduct ◽  
European Countries ◽  
Health Related ◽  
Research Ethics Boards

Transnational research funders such as the European Commission and NordForsk increasingly require researchers to conduct transnational research. Yet, there is little research on what this means for seeking ethics approval, not least for qualitative researchers. Much work on ethics approval comes from Canada, the United States, and other Anglophone countries, often in a health-related context, and centers on issues between researchers and research ethics boards (REBs), or on inconsistent or inappropriate decision-making by REBs. Ethical conduct within research has, of course, generated a rich literature but not on gaining ethics approval when conducting qualitative transnational research. Rather, the underlying situation usually is that the research is conducted in the same geopolitical space as where the REB is located. Drawing on two cases studies, in which researchers located in one country, Sweden, sought ethics approval to conduct research in other European countries, we explore some of the challenges that we faced in gaining such approval and provide some suggestions how this process might be made both more efficient and more productive for researchers and research funders alike.

scholarly journals Negotiating Responsibility for Navigating Ethical Issues in Qualitative Research: A Review of Miller, Birch, Mauthner, and Jessop’s (2012) Ethics in Qualitative Research, Second Edition

2015 ◽  
Author(s):  
Michelle McCarron
Keyword(s):  
Qualitative Research ◽  
Research Ethics ◽  
Ethical Issues ◽  
Ethics Committees ◽  
Institutional Review Boards ◽  
Research Ethics Committees ◽  
The United Kingdom ◽  
Institutional Review ◽  
Technological Advances ◽  
Research Ethics Boards

Ethics in Qualitative Research (Miller, Birch Mauthner, & Jessop, 2012), now in its second edition, uses a feminist framework to present a variety of issues pertinent to qualitative researchers. Topics include traditional challenges for qualitative researchers (e.g., access to potential participants, informed consent, overlapping roles), as well as those that have garnered more attention in recent years, particularly with regard to uses and consequences of technological advances in research. The book is critical of committees whose function it is to review proposed research and grant research ethics approval (e.g., University Research Ethics Committees [URECs], Research Ethics Boards [REBs], and Institutional Review Boards [IRBs]). The authors of this book are situated within the United Kingdom. The editors take the position that ethics oversight by the researchers themselves is preferable and that such boards and committees are not well equipped to review qualitative research. A rebuttal to this position is presented within this review. Ethics in Qualitative Research provides a good overview of ethical issues that researchers face and is effective in merging theory with practice. It would be strengthened by avoiding the debate over URECs or by offering concrete suggestions for how URECs can improve their reviews of qualitative research.

Maximizing value and minimizing barriers: Patient-centered community consultation for research in emergency settings

2016 ◽  
Vol 14 (1) ◽  
pp. 88-93 ◽  
Author(s):  
Christopher B Fordyce ◽  
Matthew T Roe ◽  
Neal W Dickert
Keyword(s):  
United States ◽  
Informed Consent ◽  
High Risk ◽  
The United States ◽  
Institutional Review Boards ◽  
Community Consultation ◽  
Patient Centered ◽  
Consultation Process ◽  
Institutional Review ◽  
The Impact

Background: Patients with cardiac arrest and other life-threatening emergencies are unable to provide prospective consent for clinical trials. In the United States and other countries, regulations permit an exception from the requirement for informed consent in emergency settings. However, many potential barriers exist, as evidenced by the scarcity of US trials conducted under exception from the requirement for informed consent. One persistent challenge is the requirement that investigators consult communities prior to study approval. Methods: To improve the community consultation process for emergency studies under exception from the requirement for informed consent, we propose that prioritizing engagement of individuals who have experienced the condition under study, or are at high risk for the condition, fulfills regulatory goals and represents the interests of potential enrollees and the community without impeding research. Results: Prioritizing patients engages individuals who are more likely to understand the concerns and experiences of study subjects, to appreciate risks and benefits of the study, and to understand the impact of the disease and intervention on patients’ lives than are members of the general public. Similarly, those explicitly at high risk are more likely to identify as potential participants and may impart some level of accountability on the investigator. Finally, the most logical community of relevance is defined by a combination of condition-related experience and living in the area where a study will be conducted; geographic and condition-related communities should not be treated as distinct. In this sense, patients, their family members, and individuals at high risk within the catchment area represent the appropriate “community.” Conclusion: Exception from the requirement for informed consent regulations have advanced the goal of improving care for emergency conditions, but common interpretations of the community consultation requirement threaten research in the United States. Focusing on the goals of learning from and demonstrating respect for those most directly affected by a study through engaging people most connected to the condition of interest will make community consultation more valuable, better inform institutional review boards, and increase efficiency.

Research with Human Participants in the United States

2021 ◽  
Author(s):  
Carl H. Coleman
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Conflicts Of Interest ◽  
The United States ◽  
Institutional Review Boards ◽  
Federal Regulations ◽  
Institutional Review ◽  
Regulatory Standards ◽  
Human Participants ◽  
Key Aspects

This chapter discusses research with human participants in the United States, most of which has been subject to federal regulations requiring prospective ethical oversight by entities known as institutional review boards (IRBs) since the 1970s. Research that is subject to the federal regulations may not begin until IRB approval has been obtained. The chapter begins by examining key aspects of the federal regulations governing IRB review of research with human participants, including the type of activities that fall under the IRB’s jurisdiction, how IRBs are organized, and some of the key substantive standards that IRBs apply. It then looks at additional regulatory standards that apply to studies involving particular populations, including pregnant women and fetuses, prisoners, and children. Finally, the chapter examines several other bodies of law related to research with human participants, including policies governing the inclusion of women and racial minorities in clinical trials; legal principles governing compensation for injuries to research participants; and requirements for registering clinical trials, reporting trial results, and disclosing research-related conflicts of interest.

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