IRBs for Pharmaceutical Companies

At AmPharm Statistics, we are familiar with Institutional Review Board (IRB) requirements and expectations, especially with regard to clinical trial protocols, study designs, and protocol statistical sections.

What are IRBs?

An institutional review board (IRB) is an independent review committee that oversees human research.  IRB’s are part of the research process across the United States and throughout the world.  IRB’s are formally designated to approve, monitor, review and sometimes stop biomedical and behavioral research. IRBs are commonly referred to under other names such as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB).  Broadly, for each protocol and informed consent form(s) submitted, IRBs conduct a thorough risk-benefit analysis and may make recommendations for protocol or consent modifications, to protect study participants, and establish an acceptable risk-benefit ratio per the committee’s group decision.

The current U.S. system of protection for human research subjects has its foundation in the Belmont Report, written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The three guiding principles of the Belmont Report, and therefore IRB’s, include: respect of persons, beneficence and justice.

A second foundational document for IRBs is the US Policy for the Protection of Human Subjects or the “Common Rule”, which was first published in 1991 and codified in separate regulations by 15 federal departments.  The Common Rule outlines the basic provisions for IRBs, informed consent, and Assurances of Compliance.  Specific federal IRB regulations may be found in the Code of Federal Regulations, TITLE 45, PUBLIC WELFARE, DEPARTMENT OF HEALTH AND HUMAN SERVICES, PART 46, PROTECTION OF HUMAN SUBJECTS.

Statistics and IRBs

It is common, but not mandatory, for an IRB to have a member that is a credentialed statistician, although at a minimum the committee should have access to a consultant statistician.

The IRB Statistician has several tasks, including review of all protocols submitted to the committee, serving as a resource especially to non-statistician committee members, and focusing on the following aspects of the protocol: Methodology, Study Design, Data Analysis/Statistical Methods, and Sample Size Considerations.  This supports the IRB committee’s role in assessing the risk:benefit ratio.  This is done by the statistician together with all other committee members considering the risk to subjects versus the potential benefit of the protocol to science and society.  Reasonability, a study subject should have the right to avoid risks that have little chance of benefiting science or society, or themselves, in some manner.  It is impossible to do a complete risk/benefit analysis without a review of the study design and analysis plan.  A study that is poorly designed or has an incomplete data analysis plan provides no benefit to society, and may in fact be detrimental to science and society.

AmPharm and IRB Protocol Review

At AmPharm Statistics, we know the IRB statistician reviewer (along with others) will focus on the following aspects of protocol design.

Study Design:

  • General study design
  • Primary and secondary outcomes
  • Correlation among outcomes
  • Bias
  • Controls
  • Blinding
  • Randomization
  • Interim monitoring plans and analysis
  • Sample size review
  • Data management, data security, privacy of personal health information (PHI)

We can assist with protocol writing, study modeling, and simulations, all of which will prepare your protocols for a thorough and thoughtful IRB review.

Why Choose AmPharm Statistics for IRBs?

At AmPharm Statistics, our company was founded in 1994. We are a service-oriented organization that is dedicated to excellence in science, statistics, and the protection of human research participants. We are also committed to providing efficient customer-oriented services to both research CROs and sponsors.

With more than two decades of experience in the field, you can rest assured that our dedicated teams understand the unique needs of each research project.

If you are getting your protocols ready for IRB review, do not hesitate to call us at 844-674-3377 or email us at to schedule an initial consultation.