Undergraduate Research and the Institutional Review Board: A Mismatch or Happy Marriage?

1996 ◽  
Vol 23 (1) ◽  
pp. 20-25 ◽  
Author(s):  
Carl A. Kallgren ◽  
Robert T. Tauber
Keyword(s):  
Ethical Issues ◽  
Undergraduate Research ◽  
Human Subjects ◽  
Educational Experience ◽  
Psychological Research ◽  
Institutional Review Board ◽  
Research Projects ◽  
Institutional Review ◽  
Happy Marriage ◽  
Student Researchers

Many undergraduate research projects with human subjects are not reviewed by an Institutional Review Board (IRB). Undergraduate research should be reviewed to protect subjects' welfare, ethically and legally protect instructors, enhance the reputation of psychological research, and enrich the educational experience of student researchers. A survey of undergraduate researchers (N = 53), all of whom underwent the IRB process for their research, indicated that they thought they had learned more by going through the IRB process, produced a better product, viewed instructor feedback more positively, saw the instructor as more of an ally, treated their research more seriously, and were sensitized to ethical issues. We recommend the IRB process for all undergraduate research.

scholarly journals Harnessing the Undiscovered Resource of Student Research Projects

2012 ◽  
Vol 7 (6) ◽  
pp. 605-607 ◽  
Author(s):  
Jon E. Grahe ◽  
Alan Reifman ◽  
Anthony D. Hermann ◽  
Marie Walker ◽  
Kathryn C. Oleson ◽  
...  
Keyword(s):  
Undergraduate Research ◽  
Educational Experience ◽  
Research Projects ◽  
Student Research ◽  
Good Test ◽  
Geographic Locations ◽  
Student Researchers ◽  
Hypothetical Question ◽  
Psychological Studies

This article suggests that undergraduate research can help advance the science of psychology. We introduce a hypothetical “question-list paradigm” as a mechanism to do this. Each year, thousands of undergraduate projects are completed as part of the educational experience. Although many of these studies may not contain sufficient contributions for publication, they provide a good test of the replicability of established findings across populations at different institutions and geographic locations. Thus, these projects could meet the needs of recent calls for increased replications of psychological studies while simultaneously benefiting the student researchers, their instructors, and the field in general.

scholarly journals Navigating the Institutional Review Board (IRB) Process for Pharmacy-Related Research

2017 ◽  
Vol 52 (2) ◽  
pp. 105-116 ◽  
Author(s):  
Marjorie Shaw Phillips ◽  
Osama Abdelghany ◽  
Susan Johnston ◽  
Rachel Rarus ◽  
Jennifer Austin-Szwak ◽  
...  
Keyword(s):  
Interdisciplinary Collaboration ◽  
Human Subjects ◽  
Medication Use ◽  
Pharmacy Practice ◽  
Institutional Review Board ◽  
Specialized Training ◽  
Research Projects ◽  
Related Research ◽  
Institutional Review ◽  
Federal Guidelines

Pharmacists' specialized training and knowledge qualify them to lead and engage in research pertaining to optimal medication use. Performing research promotes pharmacy professionalism and fosters interdisciplinary collaboration. To conduct research appropriately, one must have thorough knowledge of when institutional review board (IRB) approval is required and how to successfully navigate IRB processes. The overarching mission of the IRB overseeing research at an organization per federal guidelines is to protect the rights and welfare of human subjects participating in research. This article discusses the following general pharmacy practice–based considerations relating to IRB processes: strategies for developing research projects, key distinctions between quality improvement and research, practical considerations for submitting IRB applications and documentation, different categories of IRB submission, informed consent and conditions for waivers or alterations of consent, and principal investigator obligations for approved research. Pharmacists should also account for organization-specific IRB processes when designing, submitting, and implementing research projects.

scholarly journals Some Questions of Ethics in RCTs

2021 ◽  
Author(s):  
Reetika Khera
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Ethical Issues ◽  
Human Subjects ◽  
Belmont Report ◽  
Institutional Review Boards ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Institutional Review ◽  
Areas Of Concern

Questions of ethics in Randomized Controlled Trials (RCTs) in development economics need greater attention and a wider perspective. RCTs are meant to be governed by the three principles laid out in the Belmont Report, but often violated them, e.g. when local laws are flouted. In other cases, the framework of the Belmont Report itself has proved inadequate: for instance, when there are unintended outcomes or adverse events for which no-one is held accountable. Primarily using RCTs conducted in India, this paper highlights eight areas of concern. RCTs also have a disproportionate influence on shaping research agendas and on policy. Though ethical issues have been raised, there has been little engagement from the RCT community – a manifestation of its power in the profession. As current safeguards (such as oversight by Institutional Review Boards) have failed to protect human subjects, the concluding section discusses possible ways to resolve these issues.

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.

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