Do Private Companies Need IRB Approval?
IRB approval is a regulatory requirement for research involving human subjects. If your study involves collecting data from or about individuals, you may need IRB approval before proceeding.
In this article, we'll explore the role of IRBs, the types of research that require approval, and the steps private companies can take to ensure compliance with ethical and regulatory standards.
Key Takeaways
Private companies conducting research involving human subjects (e.g., clinical trials, surveys, or use of medical data) generally need Institutional Review Board (IRB) approval.
The IRB ensures the protection of participants' rights and welfare by reviewing research protocols, informed consent forms, and study procedures.
Failing to obtain IRB approval can lead to serious consequences such as regulatory penalties, legal actions, reputational damage, and difficulties in publishing or securing funding for research.
IRB approval demonstrates ethical research practices, protects participants' rights, enhances the credibility of research findings, and ensures compliance with regulatory requirements.
The Role of IRBS
The purpose of IRB review is to protect participants' rights and welfare. IRBs are responsible for evaluating research protocols, informed consent documents, and other study materials to assess the risks and benefits of the research.
IRBs are typically affiliated with academic institutions, hospitals, or other research organizations. However, private companies conducting research may also need to obtain IRB approval, either by partnering with an institution that has an IRB or by using an independent IRB service.
The IRB review process involves submitting a detailed protocol describing the study's objectives, methods, and procedures for protecting participants. The IRB reviews the protocol and may approve the study, recommend modifications, or disapprove the research if it does not meet ethical or regulatory standards.
In many cases, obtaining IRB approval is not only a legal requirement but also demonstrates a commitment to ethical research practices. Submitting to IRB review enhances the credibility of your findings and protects your company from potential legal and reputational risk.
Types of Research That Require IRB Approval
Private companies need IRB approval for research that meets the regulatory definitions of "research" and "human subjects." This includes studies that:
Are designed to develop or contribute to generalizable knowledge
Involve living individuals
Collect data through intervention or interaction with participants
Obtain, use, study, analyze, or generate identifiable private information or biospecimens
Examples of research activities that typically require IRB review include:
Clinical trials testing the safety or efficacy of drugs, devices, or other interventions
Studies collecting personal data through surveys, interviews, or focus groups
Research using identifiable medical records, biological specimens, or other private information
It's important to note that even if your research does not initially involve human subjects, you may still need IRB approval if you plan to use the data for future research purposes. This is known as the "secondary use" of data and requires IRB oversight to protect participants' rights and welfare.
Consequences of Not Obtaining IRB Approval
Failing to obtain IRB approval when required can seriously affect private companies in many ways, including:
Regulatory penalties and fines
Legal action by study participants or their representatives
Reputational damage and loss of public trust
Inability to publish or present research findings
Difficulty securing funding or partnerships for future studies
To avoid these risks, private companies must carefully assess whether their research requires IRB review and seek approval.
Benefits of Obtaining IRB Approval
IRB approval offers several benefits for private companies conducting research with human subjects. These include:
Ensures Ethical Conduct
IRB review helps maintain high ethical standards in research. The IRB assesses the study design, procedures, and materials to ensure they are ethically sound and minimize risks to participants. This oversight helps prevent exploitation, coercion, or undue influence in the research process.
Protects Participants' Rights
The IRB process safeguards participants' autonomy, privacy, and well-being. IRBs review informed consent documents to ensure participants are fully informed about the study's purpose, procedures, risks, and benefits. They also assess data protection measures to maintain confidentiality and prevent unauthorized access to personal information.
Enhance Research Credibility
IRB approval demonstrates a company's adherence to regulatory requirements and ethical principles. This can enhance the credibility of its research findings and increase trust among stakeholders, including participants, funders, and the scientific community.
IRB oversight also helps ensure the integrity and reproducibility of research, which is essential for generating reliable and meaningful results.
Facilitating Publication and Dissemination
Many scientific journals and conferences require evidence of IRB approval before accepting research for publication. By obtaining IRB approval, you increase the likelihood of successfully disseminating your findings to a wider audience, which can advance scientific knowledge and support product development and marketing efforts.
Mitigating Legal and Reputational Risks
IRB approval helps mitigate legal and reputational risks associated with human subjects research. IRB review ensures compliance with relevant regulations, such as FDA requirements for clinical trials or HIPAA regulations for handling protected health information.
This can help prevent costly legal challenges, regulatory penalties, or negative publicity that could harm a company's reputation and bottom line.
Attracting Funding and Partnerships
IRB approval can make a company more attractive to potential funders and partners. Many grant agencies and sponsors require IRB approval as a condition for funding, and collaborators may be more willing to work with companies that demonstrate a commitment to ethical research practices.
IRB oversight can also streamline the establishment of research partnerships with academic institutions or other organizations with their own IRB requirements.
How Does the IRB Review Process Work?
When submitting a research proposal to an IRB, you must provide a detailed study protocol, informed consent documents, and other relevant materials. The IRB then reviews these documents to assess the study's risks, benefits, and procedures for protecting participants.
During the review process, the IRB evaluates several aspects of the study, including:
The study's objectives and scientific merit
The qualifications of the research team
The selection and recruitment of participants
The informed consent process and documentation
The procedures for minimizing risks and ensuring participant safety
The plans for data collection, storage, and confidentiality
The provisions for participant compensation and medical care, if applicable
After reviewing the submission, the IRB may take one of three actions:
Approve the study as submitted, allowing you to proceed with the research
Recommend modifications to the protocol or informed consent documents before granting approval
Disapprove the study if it does not meet ethical or regulatory standards
If the IRB recommends modifications, you must address the concerns and resubmit the revised materials for further review. This process may involve several revisions and resubmissions until the IRB confirms that the study meets the requirements.
Once a study receives IRB approval, you can conduct the research per the approved protocol and submit any proposed changes or amendments to the IRB for review and approval. You also need to provide the IRB with regular progress reports and promptly report any adverse events or unanticipated problems during the study.
To streamline the IRB review process, consider partnering with an institution with an established IRB or an independent IRB service provider. These can provide expertise, efficiency, and support throughout the review and approval process.
Alternatives to IRB Review for Private Companies
In some cases, private companies may be able to conduct research without obtaining IRB approval. However, it's important to carefully assess whether your study meets the criteria for exemption or if alternative oversight mechanisms are appropriate.
Some research activities that may not require IRB review include:
Quality improvement or program evaluation studies that are not designed to contribute to generalizable knowledge
Market research or consumer surveys that do not collect sensitive personal information
Observational studies that do not involve interventions or interactions with participants and do not use identifiable private information
If you think your study is exempt from IRB review, consult regulatory experts or an IRB representative to confirm your assessment. Sometimes, you may need to submit a brief application or determination form to document the exemption.
Another alternative to traditional IRB review is to use a centralized or independent IRB. These IRBs are not affiliated with a specific institution and can provide review services for multiple studies or sites. An independent IRB can be beneficial for multi-site studies or companies without access to an IRB.
Additionally, some research activities may be overseen by other regulatory bodies or review committees, such as:
Privacy boards for studies involving protected health information (PHI)
Biosafety committees for research involving biohazardous materials
Radiation safety committees for studies using ionizing radiation
In these cases, you may need to obtain approval from these specialized committees in addition to or instead of IRB review.
Whether a study requires IRB review or qualifies for an exemption, it's crucial to protect participants' rights, safety, and welfare. This includes obtaining informed consent, maintaining data confidentiality, and adhering to ethical principles throughout the research process.
If you're unsure about the IRB requirements for your study, seek guidance from regulatory experts, professional organizations, or an experienced IRB. By understanding your obligations and proactively addressing ethical and regulatory considerations, you ensure the integrity of your research and minimize risks to your company and participants.
Do Private Companies Need IRB Approval for FDA-Regulated Research?
If your company is conducting research on products regulated by the FDA, such as drugs, devices, or biologics, you must obtain IRB approval. This requirement applies even if your company is not affiliated with an academic institution or hospital.
The FDA regulations for human subjects protection, outlined in 21 CFR Parts 50 and 56, mandate IRB review and approval for all clinical investigations involving FDA-regulated products. These regulations apply to sponsor-initiated and investigator-initiated studies, regardless of the funding source or the study site.
When research involves FDA-regulated products, the IRB must review and approve the study protocol, informed consent documents, and other study materials before the research can begin.
Obtaining IRB approval for FDA-regulated research is not only a legal requirement but also an ethical obligation. The IRB serves as an independent oversight body to ensure that the study is conducted in accordance with ethical principles, such as respect for persons, beneficence, and justice.
Failing to obtain IRB approval for FDA-regulated research can result in serious consequences, including:
Rejection of study data by the FDA during product review and approval processes
Regulatory enforcement actions, such as warning letters, fines, or product seizures
Legal liability for non-compliance with human subjects protection regulations
Reputational damage and loss of public trust in the company and its products
To avoid these risks and comply with FDA regulations, organizations must establish policies and procedures for obtaining IRB review and approval for all research involving human subjects and FDA-regulated products.
This may involve partnering with an academic institution or hospital with an established IRB, contracting with an independent IRB service provider, or establishing an internal IRB if your company has the necessary expertise and resources.
When selecting an IRB for your FDA-regulated research, consider the IRB's experience with similar studies, familiarity with FDA regulations, and ability to provide timely and efficient review services. You should also check if the IRB is registered with the FDA and has the appropriate composition and expertise to review your study.
In addition to obtaining initial IRB approval, comply with ongoing IRB oversight requirements throughout the study. This includes submitting progress reports, reporting adverse events and protocol deviations, and obtaining IRB approval for any changes to the study protocol or informed consent documents.
How Can Private Companies Obtain IRB Approval?
If a private company needs IRB approval, there are several options to consider.
Partner with an Academic Institution
One approach is collaborating with a university or hospital with an established IRB. Many academic institutions have long-standing IRBs with extensive experience reviewing research protocols across various disciplines.
Partnering with an academic institution allows you to leverage their IRB's expertise and infrastructure. You can work with the institution's researchers or sponsor your study under the oversight of their IRB.
Use an Independent IRB
Another option for private companies is to use an independent IRB. These IRBs operate independently of academic institutions and offer review services for a fee.
Independent IRBs serve companies and organizations that do not have their own institutional IRBs. They can be beneficial for small to mid-sized companies or those conducting research in multiple locations.
When selecting an independent IRB, consider its experience with your type of research, turnaround times, and fees. You can search for independent IRBs online or consult industry associations or regulatory affairs professionals for recommendations.
Establish an Internal IRB
Establishing an internal IRB may be viable for larger companies with extensive research programs. An internal IRB is a committee established within the company to review and oversee its research studies.
However, establishing an internal IRB requires significant resources and expertise. The company must have qualified individuals to serve on the IRB, develop standard operating procedures, and maintain compliance with regulatory requirements.
The benefits of an internal IRB include greater control over the review process, faster turnaround times, and the ability to align the IRB's policies with the company's research priorities. Be that as it may, establishing and maintaining an internal IRB also involves ongoing responsibilities and costs.
Before establishing an internal IRB, companies should carefully assess their research volume, regulatory obligations, and available resources. They should also consult legal and regulatory experts to ensure compliance with applicable laws and regulations.
Regardless of your approach, obtaining IRB approval requires careful planning and attention to detail. Develop a comprehensive research protocol, informed consent documents, and other study materials that meet ethical and regulatory standards.
You should also allocate sufficient time and resources for the IRB review process, which can take several weeks or months, depending on the complexity of your study and the IRB's workload.
Throughout the research process, maintain open communication with the IRB and promptly address any concerns or requests for additional information. You should also have systems to monitor ongoing compliance with IRB requirements and report any adverse events or protocol deviations.
Strategies for Streamlining IRB Approval for Private Companies
Navigating the IRB approval process can be challenging for private companies, especially those new to human subjects research. However, there are several strategies you can employ to streamline the process and minimize delays.
Plan Ahead
One way to expedite IRB approval is to engage with the IRB early in the research design process. By consulting with IRB staff or members during protocol development, you can identify potential ethical or regulatory issues and address them proactively.
Early engagement also allows you to familiarize yourself with the IRB's submission requirements, review timelines, and meeting schedules. This can help you plan your research activities more efficiently and avoid unexpected delays.
Provide Comprehensive Documentation
Another strategy for streamlining IRB approval is to submit well-organized, complete documentation. This includes a detailed research protocol, informed consent documents, recruitment materials, and other relevant supporting information.
Your protocol should clearly describe the study's objectives, methodology, and procedures for protecting participants. Use clear, concise language and avoid jargon or technical terms that may be unfamiliar to IRB reviewers.
Your informed consent documents should be in plain language and cover all required elements, such as the study's purpose, risks, benefits, and procedures to ensure confidentiality. Use templates or examples provided by the IRB to ensure your documents meet their standards.
Collaborate with Experienced Partners
Finally, consider partnering with organizations that are experts in navigating the IRB approval process. These partners can provide valuable guidance and support throughout the research lifecycle, from protocol development to study closeout.
Look for partners with a proven track record of conducting high-quality, compliant research and a deep understanding of the regulatory landscape. They can help you anticipate and address potential challenges, ensure timely submission of required documents, and maintain ongoing communication with the IRB.
Is IRB Approval Worth the Effort for Private Companies?
Obtaining IRB approval requires time, effort, and resources. However, the benefits of IRB oversight far outweigh the costs for private companies conducting research with human subjects.
IRB review ensures your research is ethically sound, legally compliant, and scientifically valid. It demonstrates your commitment to protecting participants' rights, which can enhance trust and credibility among stakeholders.
Moreover, IRB approval is often a prerequisite for publishing research findings, securing funding, and collaborating with academic institutions or other partners. It can also help mitigate legal and reputational risks associated with non-compliant or unethical research practices.
Neglecting IRB review can have serious consequences, including regulatory penalties, legal liability, and damage to your company's reputation. In some cases, it may even jeopardize the validity and acceptability of research results.
Fortunately, there are ways to streamline the IRB process and make it more manageable for private companies. Partnering with experienced IRBs, providing comprehensive documentation, and engaging with IRB staff early in the research design process can help expedite approval and avoid delays.
Moreover, innovative solutions like affordable wearable-powered clinical trials can make IRB compliance more achievable for private companies. These technologies enable remote data collection, real-time monitoring, and automated compliance checks, reducing the burden on researchers and participants.
For companies interested in exploring cutting-edge research opportunities while maintaining regulatory standards, joining a study with a trusted partner can be valuable. These collaborations provide access to expert guidance, advanced technologies, and a network of qualified participants, all within a compliant and ethical framework.
Ultimately, IRB approval is necessary for private companies committed to conducting high-quality, impactful research. By prioritizing ethical oversight and embracing innovative solutions, you can navigate the IRB process efficiently and unlock the full potential of your research endeavors.
At Reputable Health, we offer innovative solutions to streamline this process, helping you conduct research efficiently and ethically.
Book a call today, and let’s help you fast-track your IRB approval process.
