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Clinical The Importance of Grasping EC/IRB Fundamentals in Clinical Research

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Whether you're a Sponsor, Data Coordinating Center (DCC), Contract Research Organization (CRO), investigational site, or other party involved in a clinical investigation, it's essential to have basic knowledge of EC/IRBs (Ethics Committees/Institutional Review Boards) and their requirements for clinical studies.

If you need help figuring out where to start, we can provide you with the basics.

What is an EC/IRB?

An EC/IRB is a group of individuals responsible for reviewing clinical investigations involving human subjects. They typically consist of a diverse group of at least five individuals that hold positions as healthcare professionals, research experts, community members, etc.

Protecting the rights and welfare of human subjects involved in clinical investigations is the primary function and role of the committee. Without an EC/IRB, it would be difficult to safeguard against unethical research practices, which could result in significant physical and psychological harm to research subjects.

The Belmont Report

EC/IRBs are guided by three major ethical principles derived from the 1976 Belmont Report: Respect for Persons, Beneficence, and Justice.

Respect for Persons

The Belmont Report argues that respect for persons consists of two distinct principles:

  • Individuals should be treated as autonomous.
  • Individuals with diminished autonomy should be entitled to additional protections.

This perspective means that researchers, if possible, should receive informed consent from participants.

The Belmont Report also identifies the three elements of informed consent:

  • Information
  • Comprehension
  • Voluntariness

Respect for Persons implies that participants should be presented with relevant information in a comprehensible format before they can voluntarily agree to participate.

Beneficence

According to the National Institute of Health (NIH), the generic definition of beneficence is an act of charity, mercy, and kindness and doing good to others, invoking a wide array of moral obligations.

Regarding clinical research, beneficence ultimately means keeping the interests of research subjects in mind, minimizing risks, and maximizing all benefits to both research subjects and society.

Beneficence is a principle that requires research professionals and clinicians to provide positive benefits to the best of their ability and prevent (or remove when possible) harmful conditions from research subjects and patients.

Justice

The principle of justice addresses the distribution of all burdens and benefits involved with research. For example, one group in society should refrain from bearing the risks and costs of research while another group receives its benefits.

It is important to consider this principle when performing site selection as a Sponsor and consenting subjects as a research site. Both sites and participants should represent the overall desired patient population. Most of the time, this means selecting sites and patients that are as diverse as possible.

EC/IRB Characteristics

Diversity

An EC/IRB typically has at least five members from diverse backgrounds. It includes community members, scientists, non-scientists, etc., all of different age, race, and gender.

Diversity helps to reduce the amount of bias that might come up and increases the number of perspectives and viewpoints needed during the review process. Decisions made by a diverse EC/IRB allow the committee to consider a wide range of factors (cultural, social, ethical) before drawing conclusions during a review.

Diverse members can increase the number of challenged assumptions that a non-diverse group may not have considered. It also helps increase the amount of trust within the community, especially when the proposed research under review includes vulnerable populations, as this helps to ensure that their perspectives and interests are considered during the review.

Research and Monitoring Expertise

Typically, members of an EC/IRB have some expertise in related areas, such as science, ethics, regulatory compliance, statistics, community perspectives, and others. They also usually have general clinical investigation monitoring expertise, including adverse event reporting.

Independence

EC/IRBs must remain independent from the research they are reviewing. To be considered fully independent, the committee must not have any conflicts of interest that could impact the committee's decision-making process.

Specifically, each member shall not have any financial, professional, or personal relationships with any individuals involved in the clinical investigation (including but not limited to Sponsors, researcher staff, or CROs engaged in the investigation).

Many times, scientific members are also the lead Principal Investigator for a clinical investigation and, therefore, must be absent from the meeting in which their project is being discussed to reduce the chance of bias entering the discussion.

Attention to Detail

EC/IRBs must carefully examine each clinical investigation before committee approval to minimize the risks to research subjects to ensure the protection of their rights, safety, and welfare. Not only does this characteristic assist participants, but this also ensures that the research is reliable and the data generated will likely be of high quality for future submissions or marketing applications.

EC/IRBs also monitor clinical investigation data frequently (often more than once per year) to review the overall progress and any adverse events that may have occurred during its course. Overall, EC/IRBs are thorough in their initial review and after investigation activation to protect participants and ensure the research staff operates with ethics and responsibility.

Punctuality

The timeliness of an EC/IRB’s approval is essential to the overall success of a clinical investigation. The research staff must promptly provide all critical and required documents to the EC/IRB, allowing the committee to plan its full review accordingly.

Once a proposal has been submitted, the research staff must wait for the EC/IRB to review and provide feedback on the submission, which usually takes from 2 weeks to 1 month. After receiving initial feedback, the EC/IRB and research staff must coordinate and communicate frequently until a proposal is approved.

Delays in the approval process can be frustrating and costly for the research staff. Therefore, selecting an EC/IRB with a reputation for prompt review turnaround time is crucial.

International Research versus US Research and EC/IRBs

Each country has different cultures and values. Therefore, it is imperative to understand your
documentation's local context on the desired region for your clinical investigation before an
EC/IRB submission.

Below are a few points to consider:

  • Reviewing all legal and regulatory requirements, committee expertise, language and communication barriers, cultural sensitivity, and the cost of having your clinical investigation approved in a specific country is a must.
  • Most countries have a regulatory body that must approve the research before (or sometimes in parallel) an EC/IRB submission. For example, in the US, we have the US Food & Drug Administration (FDA), which must approve a proposal before (sometimes in parallel to) EC/IRB submission for a "significant risk" investigation.
  • Countries such as Panama and Paraguay have a Ministry of Health (MOH) that approves research. However, these countries differ in their overall approval process.
    • In Panama, the Ministry of Health can approve documents parallel to Panama's EC/IRB to expedite the approval process (2-4 month turnaround).
    • In Paraguay, the Ministry of Health (MOH) also takes on the responsibilities of the EC/IRB, which can make the approval process quicker than the Panama region (2-4 week turnaround for overall approval).

By carefully reviewing and understanding the local context of your documentation as well as understanding the unique differences in approval processes across countries, such as the varying roles of the Ministry of Health (MOH) in Panama and Paraguay, you can select the most appropriate EC/IRB and expedite your approval process.

Diversity

EC/IRB Assistance and the Biotex CRO

The Biotex CRO provides expertise and guidance on the regulatory requirements required for EC/IRB submissions for US and Outside US (OUS) investigations. Additionally, we provide support in developing the required documentation for submission, such as the Clinical Investigation Plan (CIP)/protocol, Informed Consent Form (ICF), HIPAA Authorization Form, Investigator’s Brochure (IB), etc.

  • We assist with coordinating EC/IRB submissions and communication between sites and the EC/IRB committee members to ensure that all documentation is submitted promptly and reviewed thoroughly before the EC/IRB submission.
  • We work to establish relationships with US and OUS EC/IRBs, which fosters a seamless review and approval process.
  • We provide ongoing support throughout the clinical investigation as EC/IRBs conduct routine monitoring reviews of the data generated from each site.

The Biotex Advantage

The Biotex CRO can significantly assist throughout the EC/IRB submission and approval process for your US and OUS clinical investigations. Our comprehensive services and experienced team of Clinical Research Associates (CRAs) are well-known for providing valuable and ongoing support throughout the entire lifecycle of a clinical investigation.

Ultimately, Biotex will ensure a smooth and efficient process for your clinical investigation, saving you significant time and resources.

About the author:

Britnee Ochabski is a Senior Clinical Research Associate (CRA) with an ACRP certification for CCRA and CP who developed the clinical program at Biotex and currently manages the Biotex CRO+. Since 2015, Britnee has managed several clinical investigations involving devices and drugs at various institutions and sites inside and outside the U.S., involving national and international travel. She is a reliable CRA with knowledge in all research areas, including clinical and regulatory requirements for a seamless U.S. or OUS EC/IRB approval. She is known for her strong ethics and commitment to quality patient care.

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RESPECT FOR PERSONS BENEFICENCE JUSTICE
DIVERSITY RESEARCH & MONITORING INDEPENDENCE ATTENTION TO DETAIL PUNCTUALITY