The ABC's of clinical drug trials, including misperceptions.
www.cancerandcareers.org
Nonprofit, institutional review board that provides contract services for the regulatory review of clinical trials.
www.biomedirb.com
A committee designated by an institution to review, to approve the initiation of, and to conduct periodic review of research involving human subjects, at the University of Maryland.
www.bsos.umd.edu
Research firm providing Institutional Review Board (IRB) services as well as consulting in clinical trials development.
www.chesapeakeirb.com
Independent Review Board meets weekly for the thorough ethical review of clinical research studies. The IRB staff strives to process resulting documents within 72 hours of each meeting.
www.copernicusgroup.com
Center for Drug Evaluation and Research, information on IRB's and their roles.
www.fda.gov
Guidance on reporting adverse events to Institutional Review Boards for NIH-supported multi-center clinical trials.
grants.nih.gov
IRB for the University of Utah for research with human subjects.
www.utah.edu
Companies involved in clinical drug trials should have clinical drug trial review boards. These boards, also known as Institutional Review Boards (IRB's), consist of various professionals and members of the community. The board serves as a type of gatekeeper, protecting the rights of individuals who participate in human research under the guise of a institution or company with which the board is affiliated.
All companies or institutions conducting research on human subjects should establish a competent institutional review board. Drug trials research, just like other research, is specific and requires a competent and professional IRB. Before establishing your IRB consider some of the issues surrounding review boards including:
1. Federal guidelines require that clinical drug trials institutional review boards have a minimum of five members.
2. There is an emerging trend to use independent IRB's for clinical drug trial board review.
3. IRB software simplifies communication between researchers and the clinical drug trial review boards.
4. Companies and institutions must be on guard for possible conflicts of interest on their clinical drug trials review boards.
Action Steps
The best contacts and resources to help you get it done
Identify potential members for your clinical drug trials review board
Members of your institutional review board should come from a variety of backgrounds. Members must demonstrate the professional competency to evaluate proposals. There should be racial, ethnic and gender diversity. One member of the board shouldn't be affiliated with your institution or company.
I recommend: For detailed information about IRB membership, review the Federal Drug Administration information sheet guidance for Institutional Review Boards, Clinical Investigators and Sponsors. Another good source is the Department of Health and Human Services' IRB Guidebook.
Contract with an independent IRB to conduct your clinical drug trial institutional review
Recently, the use of independent IRB's has grown. There are advantages to using an independent IRB, such as timely reviews, reduced chances for conflicts of interest and cohesive reviews for multiple-sites. One disadvantage is the fact that such boards are not local review bodies; therefore, they lack some familiarity with the institution itself. In addition, there's concern about the financial conflict of interest that comes with paying an independent IRB for services. Finally, the potential for 'IRB shopping' worries some professionals.
I recommend: Review the history of independent IRB's at the Consortium of Independent Review Boards. Here you'll find a list of members who offer independent IRB services. Look for companies that have AAHRPP accreditation, such as New England IRB. This company, which has passed audits by the Food and Drug Administration, offers institutional review for multiple sites and independent investigators. Their boards review all phases of FDA-regulated trials ranging from phase 0 to phase IV. They also review drug, device and biologic studies.
Purchase software to streamline the clinical drug trial board review
Companies that use in house IRB's should consider purchasing software to facilitate communication between the IRB and researchers.
I recommend: ProIRB Plus offers IRB software that is used by large corporations and academic institutions. This company also offers a newer IRB management tool known as CyberIRB, which has features, such as electronic submission of protocols and online review. iMedRIS Data offers its clients the IRB Assistant, which uses an online interface for submitting research applications and other forms to your institution’s IRB. The software also allows board members to communicate directly with researchers using an internal/external mail feature.
Tips & Tactics
Helpful advice for making the most of this Guide
- • Watch for conflicts of interest, which may occur on the individual or institutional level during clinical drug trials board review. Conflicts of interest may involve personal and financial goals of IRB members and researchers.
