Can a Small Practice Run a Clinical Trial?

Why More Private Practices Are Exploring Clinical Research

Many physicians assume clinical trials are limited to large hospitals and academic medical centers. However, small medical practices can participate in clinical research and, in some cases, serve as research sites for sponsored studies.

Done correctly, participation can offer opportunities for professional growth, patient benefit, and new revenue streams. But it also raises regulatory, ethical, and liability issues.

Before launching a clinical trial, practices must evaluate staffing, regulatory obligations, patient privacy requirements, insurance coverage, and contractual responsibilities.

Is Running a Clinical Trial Realistic for a Small Practice?

Small practices can participate in clinical trials, but feasibility depends on the study’s scope, available infrastructure, and staff capacity. Conducting a clinical trial involves substantial administrative oversight and regulatory responsibilities, from protocol compliance to data management.

Many small practices participate in Phase II, Phase III, or post-market studies sponsored by pharmaceutical companies, medical device manufacturers, or research organizations. Practices that already serve a consistent patient population within a particular specialty may be especially attractive research sites because they can help recruit qualified participants.

So, a practice’s first step should be to consider the following:

• Staffing and training: Are there qualified, available personnel to manage clinical trial protocols and maintain research documentation?
• Facilities and equipment: Does your practice have the physical capacity to conduct visits, store samples, or maintain secure records?
• Time and reimbursement: Will study payments adequately cover the administrative, staffing, compliance, and documentation requirements associated with the trial?

Many small practices begin by partnering with a contract research organization (CRO) or sponsor that provides training, oversight, and logistical support. Others start as sub-investigators in multicenter studies to gain experience.

FDA Requirements for Small Practice Clinical Trials

The Food and Drug Administration (FDA) regulates clinical trials involving drugs, biologics, and certain medical devices. The specific requirements that apply will depend on the type of study, the investigational product, and the role of the practice in the research.

If a study involves a new drug, biologic, medical device, or a new use of an approved product, it may require an Investigational New Drug (IND) application or Investigational Device Exemption (IDE) before the research can begin.

However, not every clinical trial requires the practice itself to submit an IND or IDE application. In many industry-sponsored studies, the sponsor is responsible for obtaining the necessary FDA authorizations, while the practice participates as a research site. Practices should understand the division of responsibilities and confirm who is responsible for regulatory submissions, monitoring, reporting, and other compliance obligations.

The principal investigator (PI) remains responsible for the study’s conduct at the practice level. This includes following the approved study protocol, maintaining required records, reporting safety concerns and adverse events, and ensuring that research activities comply with applicable FDA requirements and protect participant safety.

Failure to comply with FDA requirements can result in regulatory action, disqualification from future research participation, and potential liability exposure. The FDA may also inspect research records, facilities, and study documentation to evaluate compliance.

Why IRB Approval Is Required Before Enrollment

Every clinical trial involving human participants must be reviewed and approved by an Institutional Review Board (IRB). The IRB is an independent ethics committee that ensures the study protects participant rights and welfare based on guidance from the Office for Human Research Protections (OHRP).

You do not need your own IRB. Small practices may use central or commercial IRBs that provide regulatory and ethical review services for independent researchers. Many sponsors have established relationships with central IRBs, which can simplify the review process for participating practices.

Before patient enrollment begins, the IRB must review the study protocol, informed consent documents, and any recruitment materials. This includes assessing the risks and benefits of the research and providing independent evaluations of ethical issues, such as privacy. IRB oversight continues throughout the study and may require ongoing reporting, protocol amendments, and review of adverse events.

IRB approval is a legal prerequisite to conducting most human research in the United States, regardless of practice size.

Informed Consent Requirements for Research Participants

Obtaining informed consent from participants is both an ethical cornerstone and a regulatory requirement. The process must ensure that participants understand the study’s purpose and procedures, the potential risks and benefits, and their right to withdraw at any time.

Practices should use IRB-approved consent documents and establish procedures for documenting consent discussions. They must also train staff to discuss consent thoroughly and document the process correctly. Improper consent procedures can expose the practice to regulatory penalties and malpractice claims.

Informed consent is an ongoing process rather than a single signed document. Participants should have an opportunity to ask questions, receive understandable explanations of study procedures, and obtain updated information if the study changes.

HIPAA Compliance and Patient Data Protection in Clinical Research

Clinical trials involve handling sensitive health information, so HIPAA (the Health Insurance Portability and Accountability Act) applies. Researchers must obtain proper authorizations for the use and disclosure of protected health information (PHI) and implement safeguards for data security and confidentiality (e.g., encrypted storage, limited access, secure transmission).

Practices should understand what patient information will be shared with sponsors, CROs, or other research partners and ensure appropriate agreements are in place. Depending on how the study is structured, separate HIPAA authorizations may be required for research-related uses and disclosures of protected health information.

If research data will be shared with a sponsor or CRO, a business associate agreement (BAA) may also be required. Data breaches in a research context can carry both regulatory and reputational consequences.

Common Legal Agreements in Clinical Trials

Participating in a clinical trial typically requires more than regulatory compliance. Small practices may also need to enter into several legal agreements that define the responsibilities of the practice, sponsor, and other research partners.

Some of the most common agreements include:

• Clinical Trial Agreements (CTAs): These agreements govern the relationship between the practice and the study sponsor. They often address payment terms, study responsibilities, record retention requirements, publication rights, confidentiality obligations, and responsibility for participant injuries.
• Confidentiality Agreements: Sponsors frequently require practices to protect proprietary information related to the study protocol, investigational product, or research data before participating in a trial.
• Business Associate Agreements (BAAs): Depending on how protected health information is shared during the study, HIPAA may require a BAA between the practice and certain research partners.

Before signing any research-related agreement, practices should carefully review the allocation of risk, indemnification provisions, insurance requirements, and compliance obligations. Unfavorable contract terms can create significant legal and financial exposure long after the study concludes.

Our team of healthcare attorneys can manage this review for you. Book a consultation today. 

Managing Liability Risks When Conducting Clinical Trials

Running a clinical trial increases exposure to potential liability. Common issues arise when there are:

• Adverse events or patient injury
• Protocol deviations or FDA violations
• Privacy or consent disputes

Before initiating a study, a practice should ensure:

• It has professional liability insurance (and any separate clinical trial coverage) that extends to research activities
• Any sponsor agreement clearly allocates responsibility for subject injuries and indemnification
• Staff are trained in Good Clinical Practice (GCP) to reduce compliance risk

Practices should also carefully review any clinical trial agreements to determine how they address payment terms, data ownership, publication rights, indemnification, and responsibility for participant injuries.

Many malpractice insurers require prior notice or approval before a clinician participates in a study, so review your policy early.

Benefits of Clinical Research for Small Medical Practices

Clinical research can bring significant benefits to small practices. Trials can create new revenue streams through study sponsorships or per-patient payments, provide professional growth, build the practice’s reputation as a research-oriented clinic, improve patients’ access to cutting-edge treatments, and advance medical knowledge in your field.

Practices should carefully evaluate whether participation aligns with their specialty, patient population, staffing resources, and long-term business goals.

Checklist for Small Practices Considering Clinical Research

Before launching a clinical trial, small practices should evaluate whether they have the infrastructure, compliance processes, and resources necessary to conduct research responsibly. Consider the following questions:

• Do you have the necessary staff and research expertise? Ensure your practice has personnel who can manage study protocols, maintain documentation, coordinate participant visits, and meet ongoing compliance obligations.
• Have you determined which FDA requirements apply to the study? Depending on the type of research, the study may be subject to FDA regulations, including requirements related to investigational drugs, biologics, or medical devices.
• Have you secured IRB approval? Most clinical trials involving human participants require review and approval by an Institutional Review Board before enrollment can begin.
• Are your privacy and data security measures research-ready? Clinical trials often involve the collection, storage, and sharing of protected health information, which requires HIPAA compliance and data security safeguards.
• Does your insurance coverage extend to research activities? Review malpractice policies and any available clinical trial coverage to understand what is and is not covered before participating in a study.
• Have your research agreements been reviewed by legal counsel? Clinical trial agreements, sponsor contracts, confidentiality provisions, and indemnification clauses can create significant obligations and should be carefully reviewed before signing.

Completing this checklist before enrolling participants can help identify potential compliance gaps and reduce legal, operational, and financial risks as your practice enters clinical research.

Legal and Compliance Considerations Before Launching a Clinical Trial

Running a clinical trial in a small practice is demanding but achievable. It requires careful planning, regulatory diligence, and sound legal guidance.

Before proceeding, practitioners should talk with a healthcare lawyer to evaluate regulatory requirements, review clinical trial agreements, assess liability exposure, and develop compliant research policies and procedures. With the proper support, even small practices can safely and effectively participate in advancing clinical research. Our team at Jackson LLP is here to help.

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Frequently Asked Questions About Clinical Trials