Institutional Review Boards commonly referred to as IRBs plays an important role of protecting the human subjects participating in biomedical research. These are independent ethics committee charged with responsibility of approving, modifying, monitoring and reviewing biomedical and behavioral research involving human beings (Hedgecoe et la, 2006). They are approved by FDA to conduct risk-benefit analysis to determine whether or not the research should be done, with the objective of protecting human subjects from physical and psychological harm. They however face a number of challenges in discharging their duties; these problems include increasing workloads, manipulation by researchers, an attachment to institution and lack of expertise in specific areas (Greene and Geiger, 2006). Although most institutions engaged in human research usually have their own IRBs that oversee researches conducted in the institution, some institutions do not have IRBs and seeks the services of outside IRBs. The country is witnessing slow increase in centralization of IRBs in recent years, albeit many questions and controversies on how they could work and operate still remain unclear (Christian et al, 2002). This is also the scenario in other parts of the world, where Central IRBs or Research Ethics Committees (RECs) as they are called in other countries, are on the increase.
CIRBs can either be private enterprises or government bodies; they vary in terms of their purpose and potential conflict of interest, similarities being that both have been formed as options to apparent limitations of local IRBs. The IRBs have been criticized as being flawed (Menikoff, 2010). This has heightened criticism for IRBs and the calls for CIRB reviews. Some institutions would seek the services of Central IRBs to supplement their often overburdened local boards. Several national agencies are in support of central IRBs, these include the US Food and Drug Administration, the Office of Human Research Protections, the American Society of Clinical Oncology and National Cancer Institute that has established so far established two central IRBs. Central review would be more effective and efficient in protecting human research participants, reduces the burdens on local IRBs, brings expertise not available at local IRBs and eliminates duplication of efforts. The roles of local and central review boards in protecting human subjects are not equivalent, and local IRBs is better than centralized IRBs in protecting human subjects involved in biomedical and behavioral research.
Problems and obstacles
Pro Arguments: In favor of Local IRBs
Local IRBs are perceived to reflect community values. A study by Clitzman (2011) revealed that local IRBS are essential as they reflect differences in community values. Although centralized IRBs system is s good idea, community attitudes and local research context needs to be checked. There is need to acknowledge differences between communities and this could be well reflected in the research using local IRBs. There are also contrasting perceptions on research in rural and urban areas, hence patients in some rural community are more likely to participate in research conducted under local review board, and decline to participate in centralized research (Simek, Zamykalova, and Mesanyova, 2010). This is mainly due to lack of exposure, awareness and understanding on the importance of research among rural communities.
Local IRBs have the local knowledge of the research subjects. They know the culture, the population of patients and standard care guidelines. A local IRB may know some unstated details about a protocol, for instance about the institution that could yield the correct participants for the research. Therefore, the further you move from the actual subjects of study, the harder it becomes for the board to risks and benefits. Local IRBs protect their own subjects in carrying out the research, for instance patients for hospitals and students for training institutions; this reduces risks on the subjects. They develop a particular bond existing between them and their subjects; this is missing in centralized IRBs. The subjects are generally from the community they are committed to serving, most of them their own patients hence the high commitment. It feared that incase IRB becomes centralized and commercialized, it will become de-personalized and commitment might go away (Loh and Meyer, 2004). Therefore for IRBs, a sense of social, professional and geographic closeness appear to heighten moral obligation, this explains increased resistance for central IRBs.
Local knowledge of principle investigator. The reviewers in local IRB are familiar with the working and integrity of the researcher, this is crucial than the research proposal. They know the track record of the researcher and have personal understanding, the feel and flavor required for the review process, these are missing centralized IRBs. Knowing the past experiences of the researcher is useful to review teams in carrying out their mandate (Fleischman, 2005). Curbside Consults with PIs. The idea of establishing local IRBs was to incorporate local inputs into the review if studies in specific communities. In the local IRBs, reviewers can informally interact with PIs, this verbal informal communication allows the PIs to present possible approaches that formal memos impede. This goes a long way in shaping the studies early on, clarifying research approaches that could have been ethically problematic. Local IRBs have local autonomy, authority and comfort which underlines the preference for local review among institutions.
Cons argument: against Local IRBs
- They lack some expertise needed to carry out their mandate and board staffing have failed to keep pace with the demands of services hence slowing down the review process. They are overwhelmed with works due to increased proliferated clinical and IRB workloads since 1990s. Though institutions advocate for local IRBs, the whole system of local IRB is a mess.
- They are known to duplicate the efforts on some multi-site study and also costly. The costs include installing infrastructure and wastages due to duplication (Wagner et al, 2010). They should also provide unified reviews for multi-site trials, to serve as a single entity reviewing specific research plan for various sites. The unified review eliminates issues that result from multiple IRB reviews.
- Problem of workloads, slow in the review and submission of responses to researchers, this is because the boards have fewer sitting and members are voluntary physicians. On the contrary, centralized IRBs geared towards making quick decisions on research, particularly for commercial sponsors like pharmaceutical firms. They are organized to meet the expectations of commercial sponsors through timely responses. They are widely known in meeting timelines given their efficient hired board members that are regularly available to conduct reviews. This is lacking in to local IRBs whose board members are available on voluntary basis (Loh and Meyer, 2004).
- They are affiliated to institution and give priority to the interest of institutions. Board review teams have attachment to their institutions and take into consideration the concern of financial well being and prestige of the institution in the review process. On the contrary, centralized IRBs provide detached source of expertise, staffed with people with no affiliation to sponsoring institutions (Greene and Geiger, 2006). There are high chances of being manipulated by the researcher since reviewers have collegial relationships with the researcher whose work they review hence the high possibility of sympathizing. There are cases where researchers don’t follow the protocol in doing research hence compromising the review process.
Problems with Centralized IRBs
They are not familiar with actual condition of the research surroundings. Local reviews have the advantage of superior familiarities with the real condition surrounding the conduct of research. The success of centralized IRBs will thus highly depend on being well informed about local sites. This will entail site visits, local contacts, newspaper clipping services and relationships with local IRBs among other means. The advent of centralized commercial IRBs has brought into fore heightened concerns about IRB shopping. Sponsors have the choice of shopping for the IRB that will not fault their research plan without informing them of any prior board determinations. There are concerns about compromising the review for the financial well being of the firm. Board review members are employees of profit making firm and will work to satisfy the corporate equity owners (Loh and Meyer, 2004).
Proposed solutions and methods to overcome obstacles
Local IRBs should be geared towards making quick decisions on research, particularly for commercial sponsors like pharmaceutical firms that value time as money. They also need to be organized to meet the expectations of sponsors and researchers through timely responses. They should employ full time board members to continually review and approve or disapprove research as they come. This will help eliminate the problem of slow responses and heighten the review of research (Greene and Geiger, 2006).
The problem of workloads could be enhanced by hiring efficient and full time board members that are regularly available to conduct reviews contrast to local IRBs whose board members are available on voluntary basis. Recruiting several board members that could work in turns or concurrently could help reduce the workloads (Ahmed and Nicholson, 1996). They should meet more frequently and even on minimal notice. Workloads could also be reduced by hiring the services of centralized IRBs that are known for keeping timelines.
The problem of institutionally attached staff that has the concern of financial well being and prestige of the institutions could be emphasized by the rule of law and professional code of conduct in the review of research. There is need to have external members with no affiliations to the institution to oversee the review process. This will also eliminate the possibility of being compromised by researchers known to the board and even being influenced by the concerns of prestige and financial well being of the institution. They should also provide unified reviews for multi-site trials, to serve as a single entity reviewing specific research plan for various sites. The unified review eliminates issues that result from multiple local IRB reviews (Larson et al, 2004).
Local IRBs have an upper hand compared to the centralized IRBs. However, the country is witnessing a slow growth in centralized IRBs that have the support of national agencies. It is still not clear whether increased centralization will happen, with only limited CIRBs having been instituted in the US for the last fifteen years, and resistance for their establishment have risen considerably (Ahmed and Nicholson, 1996). Despite the growth, many questions remain unclear on how they operate. There is confusion about how central and local IRBs should work together, worries on liability, concerns over administrative hassles among others. The centralized system is faced with resistance from various institutions for fear of losing authority they enjoy at local IRBs. There are many advantages attributed to the use of local IRBs, not to mention the problems of centralized IRBs. The continued use of local review boards is recommended, however centralized IRBs should be established to address the limitations of local IRBs and specific divisions of biomedical research. There is need to carefully evaluate whether the advantages of local IRBs outweigh the problems, and whether there are methods and systems that can be developed to maximize the benefits while at the same time minimizing the limitations of local IRBs.