IRB Submission of Drugs
Medical research, especially in the field of drug discovery, does not stop at laboratory experiments. Newly synthesized drugs need to be tested on volunteers – actual people – before they can be mass-produced and sold as products to the market. The conduct of human-based research is very sensitive, which is why such studies are subject to stringent ethical and federal regulations.
The Institutional Review Board, or IRB, is the first barrier to study approval that medical researchers must overcome. So, if you are considering participation in clinical research, whether as a principal investigator or a team member, this article is meant for you. The following paragraphs will introduce you to the duties of the IRB, and the documents you must submit to receive its approval.
The Institutional Review Board Mandate
In the United States, IRBs are under the jurisdiction of the Office for Human Research Protection (OHRP). However, they also work closely with other organizations such as the Food and Drug Administration (FDA). Governments of other countries may put IRBs under a different purview, but their impetus and function remains the same.
IRBs and Human Subjects Research
So, what are IRBs intended for? Generally speaking, IRBs are tasked with protection of human subjects involved in biomedical research. The board performs reviews of clinical trials and monitors it regularly. IRBs are involved from the moment when the project is initially proposed and are present throughout the final phases of the study.
Despite being tied to regulatory functions, an IRB review does much more than just make sure that the trial is being conducted properly. The board also checks whether the study upholds the highest ethical standards for the human subjects. If the board members determine that a proposed study entails an unreasonable risk to the wellbeing of a participant, the IRB may require that the investigators submit a revised proposal.
The Structure of an IRB
An IRB is required to have at least five members, all from different disciplines. At least one of the members should have scientific credentials in line with the research up for review, and at least one should be a community layperson.
The IRB also requires one of the board members to be from a non-affiliated party – someone who is not connected to the principal investigator nor the study sponsors; having such a member helps keep conflict of interest to a minimum.
How to Prepare Your IRB Submission
Seeking the approval of an IRB for a research project starts with submitting the required documents. There are different types of IRB reviews, and it is imperative to first know which one best suits your research.
Types of IRB review
There are three common types of IRB review, each based on different criteria: Full Board, Expedited, and Exempt. The level of risk, and the involvement of vulnerable populations, determine the type of IRB review you need to complete.
A Full Board review is usually requested whne the research involves more than minimal risk to human subjects, does not meet the criteria for one of the categories of expedited review, or has been referred to the committee by an expedited reviewer or the Chair. Some of the examples include research which involves genetic testing, unethical behaviors, vulnerable persons (e.g., prisoners), and other experiments where participants are subject to an elevated risk. This type is the most difficult to get approved because of the many review forms and materials that need to be submitted. On the other hand, an expedited review is conducted for studies involving minimal risk. The OHRP has a list of clinical study categories tagged as amenable to being expedited.
Lastly, the revised Common Rule has a research project roster that lists which studies can be exempt from an IRB review. Examples of exempt studies include surveys and interviews, benign behavioral interventions, and secondary research.
Required Documents
Regardless of the type of IRB review that fits your research, the documents needed are essentially the same. The primary requirement is the application form which lists important details about the study to be conducted.
Supporting documents are also required for the approval of your report. These documents give the board an aggrandized understanding of your study. Examples of supporting documents are informed consent forms, data collection instruments (e.g., questionnaires and survey forms), and grant proposals, just to name a few.
It is essential to note that the specific format and submission protocol of said documents depends on which IRB will process the approval of your proposal. Search the site of your institution’s IRB to check for submission deadlines and other important details.
After Your IRB Documents Are Submitted
Once the submission of IRB review forms is completed, the waiting game begins. Processing time varies between the different types of IRB reviews. Exempt or expedited reviews may take two to three weeks to process, while full board reviews take longer.
Once the board has convened, it will release their determinations at once. Studies that meet the federal regulations and ethical standards, stipulated by the IRB, are granted an approved status. Otherwise, a research proposal is qualified as disapproved. Investigators of disapproved studies may raise queries to the IRB, either in person or in writing, to have the ruling overturned.
There are also cases wherein the IRB cannot give a final determination because of inadequate data. Such studies are considered as action deferred, and the board will require the proponents to submit additional materials or make changes to the research protocol or consent form.
Who Will Prepare IRB Submissions?
It is without a doubt that preparing the documents for the IRB application is a grueling task. Many documents must be filled out, which can take weeks or even months. This requires a significant time commitment from the principal investigator. The IRB approval process is hard to navigate, and in some cases requires multiple submission attempts before a successful response is issued.
The good news is that there are professional services available to help researchers compile and prepare IRB review requirements. Cromos Pharma is a US-Based CRO, which can help with this laborious and confusing task.
Despite having its roots in the United States, the medical professionals at Cromos Pharma are also adept in the workings of regulatory agencies and ethics committees in Central and Eastern Europe. Our services will be beneficial in your journey toward getting your study approved by the IRB.
Interested? Message Cromos Pharma now to get your medical research off the ground.
About Cromos Pharma
Cromos Pharma is a US-based, international contract research organization delivering fully integrated clinical research solutions, in all trial phases, across a wide range of therapeutic indications. Our expert team, comprised of 95% MDs, has extensive expertise in study design, medical writing, regulatory affairs, site management, patient recruitment and data management.
Cromos Pharma has experience in delivering success in a wide range of trial types, from biosimilars and generics, to successfully managing trials of novel therapeutics in a wide range of clinical indications. Our team provides full-service solutions to international pharma and biotech companies in high-recruiting regions, assuring exceptional data quality. Cromos Pharma combines global expertise with in-depth experience and knowledge in the US, Central and Eastern Europe, Central Asia, Republic of Georgia, and Türkiye to offer exceptional patient recruitment. Our team has met or reduced enrollment timelines in 95% of conducted trials.
We provide accelerated study start-up timelines in our regions of operation. Regulatory inspections by FDA and EMA and site audits attest to the highest quality of our clinical data.
Established in 2004, Cromos Pharma has strong regional experience that is supported by a global network of offices. Its international HQ is located in Portland, Oregon, USA and its European HQ is in Dublin, Ireland.
