SunHawk Consulting and Couture Compliance Have Joined Forces
By Sarah Couture RN, CHC, CHRC, CHPC (Principal at Couture Consulting LLC in Indianapolis, IN.); Katy Wane, JD, MPH, CHC; and Joe Zielinski, JD, CHC, CHPC, CHRC
Originally Posted on: Compliance Cosmos
Clinical research is on the rise in all types of provider organizations. With the promise of new and more effective therapies as well as the strong reputation often associated with organizations performing clinical research, more and more provider organizations—from small urgent care groups to physician practices to post-acute care providers—are pursuing involvement in clinical research. Many skilled nursing facility (SNF) organizations are now involved in clinical research. In many ways, driven out of the recent COVID-19 pandemic that impacted all SNFs, geriatric and long-term care residents are increasingly the subjects of many research studies to advance care. Academic medical centers, pharmaceutical companies, and public health organizations are partnering with SNFs on a wide range of geriatric care and treatment options, including but not limited to, influenza vaccine comparison, COVID-19 treatment, discharge planning, in-home dialysis, quality of life, and public health surveillance studies regarding infectious diseases.
With the increased focus on geriatric medicine from a regulatory, public health, and clinical research compliance perspective, compliance professionals in SNFs must be aware of the potential for clinical research in their organizations. They must take steps to learn more and prepare for research compliance as part of their compliance programs. Because SNF involvement in clinical research is newer, many SNF compliance professionals may not be as familiar with clinical research-specific regulations and other research compliance implications. Of course, the SNF compliance professional will have to align and address research-specific regulations considering the long-term care Requirements of Participation and other relevant SNF compliance implications, including privacy, contracting, quality and equitable care, and survey requirements.
While numerous and complex regulations govern clinical research, this article intends to briefly introduce and ensure the SNF compliance professional is aware of the primary regulatory concepts to allow further study. A tenet of research compliance with historical and practical foundations involves human subject protections rules. While informed consent is essential in every study, it is even more of a concern in the geriatric population related to mental status and the ability and capacity of an individual to provide informed consent. SNFs must ensure compliance with research privacy rules—including but not limited to HIPAA—to protect not only protected health information and patient data privacy rights but also potential biological samples. When investigational drugs or devices are being studied, U.S. Food and Drug Administration regulations apply. Conflicts of interest risks must be managed to ensure appropriate care and safeguard the integrity of the study. The research must be designed and conducted according to good clinical research practice standards. If the study is grant-funded, specific grants management requirements apply. Research billing is a compliance risk area, as items that are promised free to the patient or paid for or provided by the sponsor should not be billed to a payer, whether Medicare, Medicaid, or private insurance. Finally, the biosafety/biosecurity of the investigational item should be prioritized and managed according to informed policy and procedure.
There is a wide range of challenges regarding clinical research in a SNF, and this article focuses on the following challenges: (1) external research teams; (2) institutional review board (IRB) approval; (3) informed consent; (4) survey items (care issues); (5) time and resources; (6) charting and documentation; (7) billing and payment; and (8) privacy/data security.
In the authors’ experience, most SNFs do not employ clinicians who perform the duties of the principal investigator of a clinical research study. As such, the research performed in SNFs is generally conducted by external research teams, likely from an academic medical center, university, or pharmaceutical or medical device manufacturer. The compliance team should screen external individuals performing research within a SNF to ensure each research team member is appropriately licensed and not excluded, sanctioned, or debarred by any federal or state entity.
The Common Rule requires that an IRB must approve research that meets the definition of human subjects research. A vast majority of academic institutions and academic medical centers have their own IRBs, while most SNFs do not. Commercial IRBs also exist for those investigators who may not be affiliated with an organization with its own IRB.
You should request documentation of IRB approval of the research study. IRB approval is needed for both lower-risk studies, such as those that only involve medical record reviews or surveys/questionnaires, and those that are high-risk, such as research that involves the introduction of an investigational drug, device, or clinical protocol. IRBs perform federal regulatory required tasks when reviewing clinical research, including, but not limited to, determining the requirement of informed consent and conducting a risk/benefit analysis of the study and the proposed study population. Absent IRB approval, the SNF cannot allow the research to occur within its setting.
A simple definition of informed consent for clinical research is a voluntary agreement to participate. In certain circumstances, an IRB may grant a waiver of informed consent. A waiver of informed consent occurs most frequently in low-risk, retrospective, chart-review research studies.
If required by an IRB, a SNF cannot allow research to take place if there is no informed consent. Informed consent in a SNF can be challenging due to the mental capacity of the residents. In addition to what informed consent requires, a SNF should assist the research team in performing an assessment of the resident’s understanding of the consent’s elements. If the residents have sufficient capacity, they can sign with proper education. If the resident lacks capacity, then the researchers will need consent from the resident’s guardian or power of attorney (POA). The SNF can assist the researchers in contacting the appropriate guardian or POA. If none are options, then the researchers will need to obtain court approval for resident participation.
There are several possible survey-related risks regarding research in your SNF. Two of the most important are (1) discovery of substandard care and/or inadequate treatment of residents and (2) placebos (residents not actually receiving treatment). There are multiple ways to assess the risk, including but not limited to, IRB review, root cause analysis, a risk assessment, or consulting with the facility’s medical director.
To help minimize the aforementioned risks, a SNF can utilize both internal and external resources. Examples of internal resources include (1) policies and procedures regarding research, (2) quality assurance and performance improvement (QAPI) committee review and monitoring, (3) compliance work plan including auditing and monitoring, and (4) training. External resources include partnering with an IRB and/or with an outside consultant with clinical research expertise.
A way to help protect a SNF and its residents regarding these risks, the SNF should include having a committee or subcommittee that is dedicated to clinical research that is (1) monitoring the risk of outside research and (2) reviewing, approving, and tracking outside research. A SNF can utilize its compliance department and/or QAPI committee to handle this. Generally, outside (or internal research) should be declined when there is a risk related to (1) potential for harm to residents; (2) unequal treatment (e.g., only some residents receive drug(s); and (3) the proposed research would result in a survey tag.[1]
Perhaps the toughest challenge—especially in today’s climate with staffing as challenging as it is—is time. You will need to determine if the SNF has sufficient staff to allow for the proposed research while still providing appropriate and required care for its residents. Further, a SNF must consider the additional time required to complete and document research appropriately. Another item the SNF must determine is who—the SNF or the research sponsor—should be responsible for paying for staff time utilized in research. If the research requires SNF staff to undergo training prior to the start of the study, that time for your staff must also be considered and how that time will be compensated.
Documentation is a routine challenge in research. You need to determine not just what needs to be charted but where it will be charted, as research records may exist outside the patients’ medical records. Generally, a SNF should document (1) what is being done (care, treatment, therapy, medication, etc.), (2) informed consent, (3) any impacts on the resident (negative or positive), and (4) any change in behaviors (negative or positive).
Beyond ensuring the charting is done appropriately and documented in the correct place, a SNF must determine who (1) is doing the charting, and (2) who is verifying its completeness and accuracy. A SNF’s compliance program or QAPI committee can help by reviewing this information to verify it is sufficient.
In the authors’ experience, the majority of research coming into SNFs will not include billable services; however, these are things you need to be aware of.
Another crucial issue is clinical research billing/payment. A SNF needs to decide whether the research being done is billable and, if it is, who should pay for it. The core of coverage and decision-making for clinical research billing is found in National Coverage Determination (NCD) 310.1: Routine Costs in Clinical Trials.[2] NCD 310.1 indicates that Medicare covers routine costs in qualifying clinical trials, including care that would be provided outside of the trial, administration of the investigational item, and items and services to prevent, detect, and manage side effects of the investigational item. Medicare does not cover the investigational item itself (unless it is covered outside the study), items and services that are for research purposes only, such as those that are performed solely to collect data, and items and services that are paid for or provided by the sponsor or that are promised free to the patient in the informed consent. Each state that Medicaid also has clinical research coverage rules to consider. A SNF should pay particular attention to how Medicare and Medicaid treat the elements of the research and whether they are considered part of the daily rate and develop controls to ensure appropriate billing. A particular concern would be if the sponsor provided such significant funding related to the study that billing the daily rate would appear to be double billing (i.e., billing Medicare/Medicaid for something you already paid for).
Of course, payments from sponsors should also be considered related to Anti-Kickback Statute risks. Just like all other contractual arrangements between SNFs and vendors and clinical providers, the compensation cannot exceed the fair market value rate for the service provided. Payments that exceed fair market value could be interpreted as an inducement and could also appear as a “pay-to-play” type arrangement. The compliance department should carefully review clinical research budgets in conjunction with finance and revenue cycle team members.
A potentially overlooked area when allowing research in a SNF is privacy and/or security concerns. A SNF must ensure that any research performed in the facility follows both HIPAA and the Health Information Technology for Economic and Clinical Health Act, along with other federal and state privacy statutes.
There are specific HIPAA requirements related to research. The use and disclosure of protected health information (PHI) for research purposes is only permitted under specific circumstances. A SNF cannot release a resident’s PHI without their authorization—except under limited exceptions outlined in HIPAA. We recommend that the SNF develop a thorough understanding of research privacy regulations and ensure that controls are in place to maintain compliance. In addition to considering privacy concerns, a SNF must also be concerned with data security. If a SNF decides to allow outside researchers to access their electronic medical records or other systems, the SNF must ensure appropriate security controls are in place to protect the data and that agreements are in place before starting the research. A best practice for SNFs is to consult their IT security team and legal counsel to ensure appropriate agreements are in place. Agreements that may need to be drafted include—but are not limited to—data use agreements and business associate agreements.
Clinical research in SNFs has become an essential avenue for advancing healthcare in our country. If your SNF is not yet participating in any clinical research studies, there is a good chance that you could be soon. Ensure compliance involvement in leadership and strategy discussions to promote compliance program awareness of potential clinical research strategies and opportunities. Also, research compliance training should be pursued, as it is imperative that the compliance team be well-educated in clinical research concepts. While the seven elements are the same, the risks—as previously discussed—are very specific and nuanced. HCCA offers a Research Compliance Academy twice each year, as well as an annual Research Compliance Conference. Several other organizations and vendors offer webinars and additional training resources specific to clinical research.
If your organization is not yet involved in clinical research, take proactive steps now to understand how you should prepare for clinical research and begin laying the proper foundation for compliant and effective clinical research. If your organization is involved in clinical research or planning to do so very soon, prioritize developing an effective research compliance program that engages operations. Start by educating leadership regarding research compliance risks and the controls needed to promote participant safety, quality of research, and regulatory compliance. This education should combine both formal training, such as a SNF research compliance training session or module, and regular communications at various meetings and via routes such as emails and newsletters. The CITI (Collaborative Institutional Training Initiative) Program is an excellent external resource available to all types of organizations which provides training on a variety of research topics, including research ethics and compliance.[3]
To ensure ongoing engagement, include regular content regarding clinical research compliance in your compliance communication and training plan. As leadership understands the risks and necessary controls, work with them to ensure that operations managers and teams are provided with the right resources to be compliant. These resources include—but are not limited to—policies and procedures and education and training that discuss the risks and instruct teams on what to do and how to operate regarding that risk (see discussion of regulations and risks above). For example, it is vital to have policies and procedures and accompanying education and training for staff regarding human subject protections, such as how to consent to the patient, ongoing monitoring, patient rights, reporting issues, etc. It is also important for operations to perform monitoring to ensure compliance and promote a culture of accountability and transparency. Remember, it is the responsibility of the operations department to develop and implement these controls, and compliance should be a resource that provides as-needed advice to operations. This allows compliance to remain objective so that compliance can perform auditing over time.
Evolve your compliance program to include clinical research risk assessment. Ensure clinical research-related risks are included in the risk assessment and prioritization and that operational leaders and managers overseeing research are involved in the risk assessment process.[4] From there, include high-priority research compliance risks in the compliance work plan. Also, examine your compliance program’s operational engagement strategy, including but not limited to the compliance committee, to ensure clinical research stakeholders are included; a research compliance subcommittee may benefit your organization. Review the code of conduct and compliance policies and procedures to confirm they include research compliance elements. Also, the education and training plan and content should be updated to include research compliance risks. Audits and investigations should be conducted by those who understand the research subject matter, so ensure auditors and investigators are appropriately qualified and/or engage a third-party firm to assist with research compliance-related audits and investigations. In regular reports to leadership and the board of directors, include relevant updates and content regarding research compliance.
Develop an inclusive approach to research compliance that prevents silos and promotes collaboration. The compliance team can help champion communication and partnership between the various areas where research compliance risks exist (i.e., clinical care, pharmacy, billing, IT, etc.) and with legal, HR, and other support functions. As previously discussed, this collaboration may best occur through the research compliance committee and/or other committees that may already exist. Communication, transparency, and collaboration are keys to ensuring the compliant conduct of clinical research.
Compliance can also help leadership promote a culture of compliance and accountability. Be intentional to communicate the availability of the compliance team to be thought partners and report concerns. Engage leaders and managers in their responsibility to encourage transparency, reporting, and nonretaliation. And discuss with leadership the significance of accountability when issues are identified. This helps protect patients, ensures compliance in all risk areas, and communicates that noncompliance will not be tolerated.
The benefits of clinical research in the skilled nursing population are numerous and can significantly contribute to the long-term development of healthcare advances. With the conduct of clinical research also comes numerous regulatory obligations and potential risks to patients. SNFs can best help mitigate these risks and provide research opportunities to patients by ensuring an informed leadership and management team and an effective research compliance strategy and program.
1 This is not a complete list of reasons why outside research (or internal research) should be declined. A skilled nursing facility should consult with its legal counsel to determine when to decline outside research (or internal research).
2 Centers for Medicare & Medicaid Services, “Routine Costs in Clinical Trials,” May 27, 2024, https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=1&ncdver=3&bc=0.
3 CITI Program, home page, accessed March 10, 2025, https://about.citiprogram.org/.
4 Sarah M. Couture and Katherine Cohen, “Research is risky business: Effective risk assessments for your research compliance program,” Compliance Today, September 2024, https://compliancecosmos.org/research-risky-business-effective-risk-assessments-your-research-compliance-program.
Copyright 2024 Compliance Today, a publication of the Health Care Compliance Association (HCCA)
