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February 27, 2014 | Posted By Aidan B. Ferguson, LCSW and Zubin Master, PhD

Before research involving humans can commence, the ethical aspects of the research study are reviewed by local ethics boards in the United States known as Institutional Review Boards (IRBs). IRBs review many factors surrounding the ethics of research involving humans, including whether the science is valid, there is a favorable benefit-to-risk ratio, participants are recruited fairly and have retained the right to withdraw from research, privacy is protected, and the informed consent process will be performed such that participants are fully informed and understand the nature of the study. IRBs are located within institutions that perform human research such as universities and colleges, research centers, government agencies, and others. IRBs consist of individuals with a diversity of scientific, clinical, ethics, and legal expertise. The advantage of performing ethics review at the local level is that IRB members know their community, including the prevalence of health issues and the average educational level allowing them to be able to effectively communicate with community members and ensure they can access beneficial research. As trust is an essential element to voluntary community participation, an absence of it might lead to decreased enrolment in clinical trials. Knowing that a body of experts has reviewed the ethical aspects of research is likely to promote trust between participants and the research institution.

While local review certainly has its advantages, more research is being performed at multiple institutions, such as large phase 3 and 4 clinical trials that can be performed at dozens of research sites across the country. Currently, this means that researchers will have to submit their protocol to every individual IRB for approval. Several studies surrounding multisite ethics review have been performed and many question whether a more efficient system cannot be developed. Below we discuss some of the issues with multisite ethics review and outline a few reform strategies.

Several studies have shown that individual review of multisite protocols results in variation in comments and feedback from individual IRBs. The variation comes in many forms including asking researchers to make changes to informed consent documents or differences in IRBs’ perception and acceptability of risk. In many situations, some of the changes IRBs request requiring adjusting the protocol for different sites or in its entirety; such changes to methods can introduce biases and differences in research results. Researchers have reported that differences in the interpretation of what is considered “ethical research” by different boards has been unnecessarily burdensome, causing delays in participant recruitment and hiring other researchers leading to delays in commencing research and disseminating results. Delays in the distribution of research can also impact society as potentially effective treatments are delayed in reaching the marketplace. The same protocol being reviewed by multiple ethics boards increases administrative burden and costs, especially if several iterations require review. Many studies report that the changes requested by individual ethics boards are small and insignificant, such as minor word changes, and in no way actually serves to better protect participants. Delays in undertaking research can be especially onerous in the event of a pandemic or natural disaster where ethics review needs to be performed quickly and efficiently so that the research can be done as rapidly as possible. The variation seen in ethics review by independent IRBs may be due to differences in the interpretation of research ethics policy by board members and affected by institutional culture. While we have summarized the issues with multisite ethics review by independent boards, several initiatives have been put forward to streamline processes.

There have been several attempts to restructure the multisite ethics review process. One such process is reciprocal review, which entails an agreement that is made between two or more IRBs to accept a review completed by another board. This is likely to reduce the administrative burden of individual boards and researchers. In turn, reciprocal review can ensure that the research study commences quickly and the results are disseminated in a timely manner. Another alternate review process is centralized review. Centralized review entails two or more institutions entering into an arrangement where one institution assumes responsibility for initial and continued review of a research protocol by becoming the board of record for all other institutions involved in the research endeavor. The board of record is responsible for not only reviewing the protocol, but for disseminating any information or changes concerning the protocol throughout the research process. This review process could also lessen administrative burdens by individual IRBs and researchers, save time and money and helps to ensure there are no lengthy delays in commencing the research.

Several organizations have instituted the use of alternate review processes of multisite research. The Ontario Cancer Research Ethics Board (OCREB) was instituted in 2003-2004 and currently operates as a centralized review committee for many multisite oncology research trials. OCREB currently serves as the board of record for 26 participating centers and averaged only 59 days for approval in 2012. The Harvard Catalyst Institution currently uses reciprocal review for reviewing multi-institutional research. The Harvard Catalyst Institution consists of nine review boards in the Boston area that participate in an arrangement where reciprocal review is only provided if the sites agree to accept the review of another site’s board.

While ethics boards realize that continuing the practice of multisite ethics review in the current manner may be less than ideal for many reasons, there has been little research or development of other review processes, and the few processes that have been developed are seeing little support from research institutions and researchers. Many IRB members mention concerns regarding liability that may be involved when using another ethics board’s review, and there also seems to be confusion over how human participant protections would be handled by an outside review board. Lack of motivation by ethics boards, misunderstanding of alternate review processes, and biases towards local control may play a major role in the acceptance of multisite ethics review reform strategies. Further research needs to better understand the effectiveness of these different strategies, and improved explanations and outreach are required for independent boards to begin considering how to streamline their multisite ethics review processes.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

2 comments | Topics: Research Ethics, Consent

Comments

Dean

Dean wrote on 02/28/14 1:21 PM

Nicely done! very informative.
b. sample

b. sample wrote on 03/02/14 11:56 AM

Insightful article.

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BIOETHICS TODAY is the blog of the Alden March Bioethics Institute, presenting topical and timely commentary on issues, trends, and breaking news in the broad arena of bioethics. BIOETHICS TODAY presents interviews, opinion pieces, and ongoing articles on health care policy, end-of-life decision making, emerging issues in genetics and genomics, procreative liberty and reproductive health, ethics in clinical trials, medicine and the media, distributive justice and health care delivery in developing nations, and the intersection of environmental conservation and bioethics.
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