A brief introduction to institutional review boards in the United States

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).

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An audit of US FDA warning letters issued to sponsors, institutional review boards and investigators over a six-year period

Indian Journal of Medical Ethics ◽

10.20529/ijme.2021.094 ◽

2021 ◽

pp. 01-06

Author(s):

Unnati Saxena ◽

Debdipta Bose ◽

Shruti Saha ◽

Nithya J Gogtay ◽

Urmila M Thatte

Keyword(s):

Adverse Drug Events ◽

The United States ◽

Institutional Review Boards ◽

Chi Square ◽

Institutional Review ◽

United States Food ◽

Post Marketing ◽

Chi Square Test ◽

Us Fda ◽

Review Boards

The present audit was carried out with the objective of evaluating warning letters (WLs) issued to trial sponsors, clinical investigators and institutional review boards (IRBs) by the United States Food and Drug Administration during a six-year period and compare it with two similar earlier audits. WLs were reviewed and classified as per stakeholders and further categorised as per predefined violation themes. The chi-square test was performed for trend analysis of WLs. A total of 62 WLs were issued to the three stakeholders. The maximum number of WLs were issued to the clinical investigators (36/62, 58.06%), followed by sponsors (19/62, 30.64%), and least to the IRBs (7/62, 11.29%). Among sponsors, lack of standard operating procedures for the monitoring, receipt, evaluation and reporting of post-marketing adverse drug events was the most common violation theme (8/19, 42.1%). Among clinical investigators, deviation from investigational plan was the most common violation theme (31/36, 86.11%.). For IRBs, inadequate documentation was the most common violation theme (6/7, 85.71%). We saw an overall reduction in the number of WLs issued to the stakeholders. Thus, we identified multiple areas on which each stakeholder should work for improvement.

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

Journal of Empirical Research on Human Research Ethics ◽

10.1177/1556264620912103 ◽

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.

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

Clinical Trials ◽

10.1177/1740774516676084 ◽

2016 ◽

Vol 14 (1) ◽

pp. 88-93 ◽

Cited By ~ 2

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.

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Research with Human Participants in the United States

The Oxford Handbook of Comparative Health Law ◽

10.1093/oxfordhb/9780190846756.013.20 ◽

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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The Suitability of IRB Liability

University of Pittsburgh Law Review ◽

10.5195/lawreview.2005.65 ◽

2005 ◽

Vol 67 (2) ◽

Cited By ~ 2

Author(s):

Sharona Hoffman ◽

Jessica Wilen Berg

Keyword(s):

United States ◽

Biomedical Research ◽

Clinical Studies ◽

Human Subjects ◽

The United States ◽

Institutional Review Boards ◽

Federal Regulations ◽

Institutional Review ◽

Research Oversight ◽

Oversight System

The biomedical research oversight system in the United States delegates most responsibilities to local review entities known as institutional review boards (IRBs). The IRBs are charged with responsibility for safeguarding the welfare of research participants and ensuring that clinical studies involving human subjects comply with federal regulations.

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