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Ethical Challenges

8. Current Issues Concerning Ethics Committees

Alternate IRB Models

US IRBs were designed as institutional committees that would be familiar with local socio-cultural values.  In many countries, such committees are based in health ministries and are national in scope. Today it is common for research to span many communities and even countries.  Ethics committees from different institutions and/or geographic regions may not agree.  Negotiating acceptable human protections becomes a cumbersome, lengthy and costly process.  To facilitate research and resolve conflicts among local IRBs, central IRBs have been proposed for collaborative multi-site studies. Central IRBs may be ongoing or study specific, composed of members from a sample of the sites involved in research or may be totally independent and free-standing.  The US experience is that many institutions are reluctant to relinquish their autonomy and responsibilities to a central IRB.  Institutions also are concerned about compliance with regulations, local rules and policies and about liability.  In the US, although models such as free-standing for-profit and not-for-profit committees for human research protection in research exist, to date, the institutional ethics review committee is the most prevalent (Association of American Medical Colleges, 2011).

Breadth and competence of ethics committees:

IRB or ethics committee review may vary as a function of the type of research to be reviewed.  Some committees review studies in one or two disciplines while others may review the entire range of human studies carried out in their institution. Ethics Committees should be familiar with the different types of research methods and the ethical issues related to methods and projects they review.  Some types of research commonly have method-specific ethical issues.  For example, when the research demands that full information cannot be disclosed without compromising the research, the informed consent process must be modified if the research is to proceed as designed and plans for debriefing at the conclusion of the study must be assessed.

Some behavioral and social scientists maintain that the Belmont Principles were developed in the context of biomedical research and that they are not readily applicable to behavioral/social research. More specifically, the objection voiced is that many IRBs lack adequate competence to review behavioral/social research. Although behavioral/social research often is minimal risk, the probability and level of risk needs to be assessed.