scholarly journals Costs and Benefits of the National Cancer Institute Central Institutional Review Board

2010 ◽  
Vol 28 (4) ◽  
pp. 662-666 ◽  
Author(s):  
Todd H. Wagner ◽  
Christine Murray ◽  
Jacquelyn Goldberg ◽  
Jeanne M. Adler ◽  
Jeffrey Abrams
Keyword(s):  
Societal Perspective ◽  
National Cancer Institute ◽  
Human Subjects ◽  
Institutional Review Board ◽  
Phase Iii ◽  
Research Staff ◽  
Oncology Research ◽  
Institutional Review ◽  
Definition Of ◽  
Central Institutional Review Board

Purpose In 2001, the National Cancer Institute (NCI) formed the Central Institutional Review Board (CIRB) to conduct a single human subjects review for its multisite phase III oncology trials. The goal of this study was to assess whether NCI's CIRB was associated with lower effort, time, and cost in processing adult phase III oncology trials. Methods We conducted an observational study and compared sites affiliated with the NCI CIRB to unaffiliated sites that used their local IRB for review. Oncology research staff and IRB staff were surveyed to understand effort and timing. Response rates were 60% and 42%, respectively. Analysis of these survey data yielded information on effort, timing, and costs. We combined these data with CIRB operational data to determine the net savings of the CIRB using a societal perspective. Results CIRB affiliation was associated with faster reviews (33.9 calendar days faster on average), and 6.1 fewer hours of research staff effort. CIRB affiliation was associated with a savings of $717 per initial review. The estimated cost of running the CIRB was $161,000 per month. The CIRB yielded a net cost of approximately $55,000 per month from a societal perspective. Whether the CIRB results in higher or lower quality reviews was not assessed because there is no standard definition of review quality. Conclusion The CIRB was associated with decreases in investigator and IRB staff effort and faster protocol reviews, although savings would be higher if institutions used the CIRB as intended.

scholarly journals Institutional Review Board and International Field Research in Conflict Zones

2014 ◽  
Vol 47 (04) ◽  
pp. 840-844 ◽  
Author(s):  
Srobana Bhattacharya
Keyword(s):  
Human Subjects ◽  
Social Science Research ◽  
Field Research ◽  
Science Research ◽  
Political Conflict ◽  
Institutional Review Board ◽  
Biomedical Sciences ◽  
Conflict Zones ◽  
Institutional Review ◽  
The Many

ABSTRACTResearch on political conflict can benefit immensely from fieldwork. However, the Institutional Review Board (IRB) process is elaborate and daunting that discourages rather than encourages this type of research. Existing policies often are insensitive to the many uncertainties related to field research abroad, especially in conflict zones. Three reasons for this are identified in this article. First, the federal regulations to protect human subjects of social science research are most suitable for biomedical sciences. Second, there is huge gap between “procedural ethics” and “ethics in practice.” Third, there is a lack of communication or dialogue between researchers and IRBs. After discussing these reasons, I offer the following suggestions: bridging the gap between the researcher and the IRB; reducing delays in the IRB approval and revision process; encouraging collaboration and dialogue among researchers; and advocating a proactive stance by academic associations.

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.

Ethical issues in phase I oncology research: a comparison of investigators and institutional review board chairpersons.

1992 ◽  
Vol 10 (11) ◽  
pp. 1810-1816 ◽  
Author(s):  
E Kodish ◽  
C Stocking ◽  
M J Ratain ◽  
A Kohrman ◽  
M Siegler
Keyword(s):  
Phase I ◽  
Ethical Issues ◽  
Institutional Review Board ◽  
Phase I Trials ◽  
Conducting Phase ◽  
Institutional Practice ◽  
Oncology Research ◽  
Institutional Review ◽  
Differences Of Opinion ◽  
Board Chairpersons

PURPOSE Phase I research trials assess the safety of agents never before administered to humans. In the field of oncology, this practice raises several important ethical questions. We examined the ethics of these trials by surveying phase I oncology investigators and institutional review board (IRB) chairpersons at major cancer research centers around the country. METHODS Questionnaires were mailed to 78 investigators and 47 chairpersons to obtain their views on the ethical propriety of conducting phase I oncology research, and on institutional practice regarding these trials. The response rate was 68% in each group. RESULTS The majority of each group reported that phase I oncology trials face no more scrutiny or resistance in their institution's IRB process than other research protocols. Nevertheless, IRB chairpersons were more likely than investigators to favor special procedural safeguards to protect subjects in phase I oncology trials. Nearly all respondents agreed that although actual medical benefit was very uncommon, most patients entered for a chance at a therapeutic effect. Investigators were more likely than chairpersons to report that patients obtained psychologic benefit from participation in phase I trials. CONCLUSION Although individual IRB chairpersons and oncology investigators may have important differences of opinion concerning the ethics of phase I trials, these disagreements do not represent a widespread area of ethical conflict in clinical research.

The Role of the Institutional Review Board in Research Involving Human Subjects

1983 ◽  
Vol 17 (11) ◽  
pp. 828-834 ◽  
Author(s):  
John A. Bosso
Keyword(s):  
Experimental Research ◽  
Human Subjects ◽  
Institutional Review Board ◽  
Institutional Review Boards ◽  
Federal Regulations ◽  
Research Subjects ◽  
Basic Composition ◽  
Institutional Review ◽  
Policies And Procedures

Concern with the rights and welfare of human experimental research subjects has given rise to the evolution of institutional review boards. This article describes the basic composition and purposes of these boards, as well as the federal regulations by which they are governed. Since many of these regulations are open to interpretation, the policies and procedures of one such board are included to represent an example of how these regulations are interpreted and applied.

scholarly journals Setting Up Targeted Research Interviews: A Primer for Students and New Interviewers

2014 ◽  
Author(s):  
Darren Noy
Keyword(s):  
Human Subjects ◽  
Warning Signs ◽  
Institutional Review Board ◽  
Institutional Review ◽  
Research Interviews

This article analyzes key strategic considerations for setting up targeted research interviews, including human subjects and Institutional Review Board requirements, approaching respondents, the medium of contact, using technology, cultural conceptions of time and commitment, using networks, wading through bureaucracies, and watching for warning signs. By making these considerations explicit and conscious, we can better specify how to gain interviews for our research and how to ethically approach this task. This analysis will be most useful as a pedagogical explanation for students and for scholars newly approaching interviewing.

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