Centralized Institutional Review Boards

Ethical review of human trials is paramount to modern research.  In the 1970s, federal policy required every institution performing human research to establish an Institutional Review Board (IRB) also known as Ethical Review Boards or Committees.   The primary mission of the IRB is to safeguard the rights and welfare of human research subjects.  The impartial panel has the authority to approve, require modification, or disapprove study protocols, the informed consent, and/or the investigator.   These local IRBs are required as a mechanism for each institution to protect patient rights within their academic medical center (AMC).  However, local IRBs limited access of research trials to patients who were treated at an AMC, which excluded most community oncologist.  The good intentions of local IRBs were further hampered as they became another redundant, costly and time-consuming mechanism for trials to be opened at other AMCs.  For example, for a nationwide multi-institutional phase III trial, as many as 100 AMCs, each with their own local IRBs would perform the same mechanism charging hundreds of dollars for the same review process.  On a logistical basis, this required any small change to the protocol or informed consent to be amended, and re-reviewed by all 100 local IRBs again -- often while the trial remained halted for many months.  Since most local IRBs meet monthly, this became a significant administrative hindrance, adding costs while delaying access to new research trials.  The average delay for a local IRB at an AMC to approve a trial ranges from 2-9 months.   At some large academic medical centers, delays greater than 12 months are common due to multiple layers of protocol and scientific review committees, local IRBs, legal, budget and contract review committees.   Pharmaceutical industry and federally funded trials waste millions of research dollars due to redundancies of local IRB administrative trial delays.  While these delays add real costs to the trials, the far greater consequence is that they become a disincentive for investigators or industry to design and author trials, which results in fewer trials for patients and ultimately, slows cancer advancements.

Fortunately, the field has responded with a way to meet the IRB requirements while minimizing delays and disincentives.  “Centralized IRBs” was originally developed to expand outpatient access to clinical trials beyond the campus of AMC’s.  Centralized IRBs are able to meet twice weekly for faster review leading to trial approvals within days.  Additionally, centralized IRBs have the advantage of specialized sub-committees focused on aspects of trials unique to a certain discipline, such as oncology, pediatrics, or genetics.  The Western Institutional Review Board (WIRB) is the oldest independent central IRB in the U.S. Founded in 1968 in Washington State, the WIRB is focused on ethical principle, regulatory compliance, and expediting the review process.  It has greatly improved the efficiency of protocol review, allowing faster and wider access to research trials by patients nationwide.  WIRB has innovated new ways to streamline the independent ethical review process, including online submission forms, informed consent templates to aid investigators, video teleconferencing and translation services for international research trials.   WIRB also sponsors valuable investigator training workshops to aid in the ethical design of clinical research trials. In May 2003, WIRB became the first independent IRB to achieve national accreditation by the recently created Association for the Accreditation of Human Research Protection Programs (AAHRPP).

The independent ethical review landscape is changing, as some cancer centers are outsourcing ethical review to centralized IRBs via local IRB waiver of jurisdiction.  The leading cancer organizations such as ASCO, and the Office for Human Research Protections (OHRP) and the FDA have recognized the need for increased efficiency in ethical review boards.  A multi-agency task force is examining the potential of local IRBs relinquishing their authority to centalized IRBs.  If sanctioned by the FDA and OHRP, it would allow cancer centers nationwide to rapidly implement new trials.  Until that happens, small outpatient research clinics will continue to outpace the inefficiencies of large academic institutions.