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.
- General Necessity: Private companies conducting research involving human subjects (e.g., clinical trials, surveys, or use of medical data) generally need Institutional Review Board (IRB) approval.
- Welfare Protection: The IRB ensures the protection of participants' rights and welfare by reviewing research protocols, informed consent forms, and study procedures.
- High Risks: Failing to obtain IRB approval can lead to serious consequences such as regulatory penalties, legal actions, reputational damage, and difficulties in publishing.
- Core Benefits: IRB approval demonstrates ethical research practices, enhances credibility, and ensures compliance with global 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 process involves submitting a detailed protocol describing study objectives and procedures. Submitting to IRB review enhances findings' credibility 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, or generate identifiable private information or biospecimens.
Clinical Trials
Testing the safety or efficacy of drugs, devices, or other medical interventions.
Survey Research
Collecting personal data through surveys, interviews, or focus groups.
Data Analysis
Research using identifiable medical records, biological specimens, or private info.
Secondary Use
Using data initially collected for one purpose for future research studies.
Consequences of Not Obtaining IRB Approval
Failing to obtain approval can lead to regulatory penalties, fines, and legal action by study participants or their representatives.
Loss of public trust, inability to publish research findings, and difficulty securing funding or partnerships for future studies.
Benefits of Obtaining IRB Approval
Ensures Ethical Conduct
Assessments prevent exploitation, coercion, or undue influence in the research process.
Protects Participant Rights
Safeguards autonomy, privacy, and well-being through informed consent review.
Enhances Credibility
Demonstrates adherence to regulatory requirements, increasing trust among funders and the scientific community.
Mitigates Risk
Ensures compliance with FDA or HIPAA requirements, preventing costly legal challenges.
How Does the IRB Review Process Work?
When submitting a proposal, the IRB evaluates scientific merit, team qualifications, participant recruitment, and informed consent documentation. The IRB may take one of three actions:
- Approve: Allowing the study to proceed as submitted.
- Recommend Modifications: Requiring changes to protocol or consent before approval.
- Disapprove: If the study does not meet ethical or regulatory standards.
Alternatives to IRB Review
Some activities may not require full review, such as quality improvement studies or market research that doesn't collect sensitive info. Alternative oversight bodies include privacy boards for studies involving PHI or biosafety committees.
FDA-Regulated Research
If conducting research on products regulated by the FDA (drugs, devices, biologics), you must obtain IRB approval per 21 CFR Parts 50 and 56. Failure to comply can result in the rejection of study data during product review and severe regulatory enforcement.
How Can Private Companies Obtain IRB Approval?
Partner with Academic Institutions
Leverage the expertise and infrastructure of a university or hospital with an established IRB.
Use an Independent IRB
Contract with independent services that offer fee-based review, ideal for small to mid-sized companies.
Establish an Internal IRB
Viable for large companies with extensive programs, though it requires significant expertise and SOP development.
Regardless of the path, ensure compliance with applicable laws and regulations.
Strategies for Streamlining Approval
Plan ahead by engaging with the IRB early. Provide comprehensive, plain-language documentation to avoid delays. Collaborating with experienced partners can help you anticipate challenges and ensure timely submissions.
Is IRB Approval Worth the Effort?
Obtaining IRB approval requires time, but the benefits far outweigh the costs. It ensures scientific validity and protects your brand's reputation. Neglecting review can lead to legal liability and jeopardize research acceptability.
Innovative solutions like affordable wearable-powered clinical trials can make IRB compliance more achievable by automating data collection. For those interested in exploring cutting-edge opportunities, joining a study with a trusted partner is a valuable first step.
At Reputable Health, we offer innovative solutions to streamline the IRB process. Book a call today and let’s help you conduct research efficiently and ethically.