IRB Approval Process

The IRB Approval Process

Biomonitoring Tool Kit
IRB Approval Process
Laboratories List
Chemicals
Case Studies

Q: What is an IRB?

A: An Internal Review Board is generally a panel of experts authorized by an academic or medical facility to grant approval for a human participant research project. Because some studies using human subjects in the past have caused great harm to study participants, federal and state law now requires that any federally or state-funded research study must request approval for human research study. The approval process ensures that the basic human rights of study participants are upheld and the standards of medical ethics are maintained.

Companies also exist that offer an independent service for a fee when no other IRB process is readily available. For example, Independent Review Consulting, Inc. info@irb-irc.com.

Q: Who needs IRB approval?
A: Any study that is federal- or state-funded is required to get IRB approval. In addition, researchers (medical professionals or scientists) who are affiliated with an institution are usually required by their institution to go through an IRB approval process, even if the study is being done outside the programmatic research of that institution, or if the study is privately funded.

Q: What does IRB require? 
A: The IRB approval requires documented assurance that the basic human rights of study participants are recognized and upheld. The IRB needs to know that no study participant is being subjected to unreasonable risk, that continual monitoring ensures agreements between researchers and participants are upheld, and that benefits from the study are commensurate with any accepted risk. IRB approval requires that each study participant be informed of all risk, however minimal, and that each participant agrees to accept such risk by signing appropriate forms. The privacy of study participants needs to be assured throughout the study, and a process for maintaining confidentiality of the data needs to be determined. Any special vulnerabilities of possible study participants needs to be considered and respected. A study participant rights form and consent form are pasted below.

Q: Do privately funded biomonitoring projects need IRB approval? 
A: Legally, no, as long as the scientists and health professionals who are engaged in the study are also working independently from any institutional contractual agreement that would require them to submit an application for such an approval. But the IRB approval process is important and useful. It will help you make sure that your study design is fair and respectful. Industry biomonitoring studies typically don’t apply for IRB approval and as a consequence, no one knows how participants were recruited, how or whether they were informed about any risks of the study, whether these risks were considered and approved by a group of independent health professionals, whether participants were informed about their right to confidentiality, privacy and their right to withdraw from the study, and whether participants were compensated in any way, unless this information is made public.

Internal Review Boards are charged primarily with protecting human rights, but they also want to know that good science is being done. This is your opportunity to work with a cluster of professionals to make sure your study is solid, defensible, and is going to be worth all the time and resources of those involved. Even though the process can be lengthy, it may well be worth your time and can help you avoid some unpleasant surprises during the course of your project.

Q: How long does an IRB approval process take?
A: Depending on how well you have filled out some fairly technical forms, the IRB process can take up to nine months, or more. If your study involves little risk (urine analysis) you may be able to apply for an expedited approval, but the IRB itself decides whether an expedited approval process is acceptable.

Q: How does the process begin? 
A: The researchers or medical professionals you are working with will be familiar with the IRB steps. Generally, they will direct you to the appropriate institution’s website, which will have down-loadable forms. For a sense of what a typical application looks like, and expedited application is included below.

SAMPLE FORMS

  1. Project Consent Form
  2. Patient Rights Form