Overview
Key players across the healthcare industry—including sponsors, contract research organizations (CROs), research sites, regulators and patient advocates—are well aware of the challenges associated with the prompt and effective identification and enrollment of study subjects. In this context, stakeholders should consider several important factors when developing and implementing study pre-screening and recruitment activities.
In Depth
Delays or failures in launching clinical trials can lead to millions of dollars in costs for sponsors and impede access to new or improved therapies and diagnostics for patients. As services and initiatives designed to address these challenges proliferate, it is important to consider key factors that can trigger legal, operational and business risks.
- Data Use and Sharing. It is important to consider what data will be collected, used and shared for purposes of identifying potentially eligible study subjects. For example, does the service or initiative involve collecting electronic medical records, genetic testing results or other protected health information (PHI) from HIPAA-regulated covered entities or business associates? Will individually identifiable health information be collected from non-HIPAA-regulated entities, such as providers of direct-to-consumer mobile medical apps or genetic testing services? Will the service or initiative involve disseminating study recruitment materials through digital and other channels, as well as collecting pre-screening information from individuals through a web form?Confirming the data sources is critical for purposes of identifying applicable privacy, human subject protection and other laws and implementing appropriate pathways to collect, use and share data for the pre-screening platform in accordance with such laws. In the event the service or initiative involves collecting PHI subject to HIPAA, note that various pathways may be available under the HIPAA Privacy Rule. However, these pathways may involve regulatory ambiguities and operational complexities. There has been a growing recognition of the need for updated privacy paradigms under HIPAA to support scalable, standing pre-screening and recruitment initiatives, including by the Secretary’s Advisory Committee on Human Research Protections (SACHRP). Alternatively, if the service or initiative includes collecting non-HIPAA-regulated health and other personal information, it is important to consider what, if any, consents or notices are required under applicable law.Additionally, note that consent or authorization for purposes of complying with privacy laws is distinct from informed consent that may be required under human subject protection laws. Whether informed consent is required for pre-screening activities that are limited to administering surveys or questionnaires should be evaluated based on the specific facts and circumstances and applicable human subject protection laws.
- IRB Review. Requirements for institutional review board (IRB) review and approval may stem from applicable laws and regulations, contracts, industry practices or risk mitigation objectives. For example, pre-screening and recruitment platforms for U.S. Food and Drug Administration (FDA)-regulated clinical investigations may be subject to the Federal Food, Drug, and Cosmetic Act and FDA human subject protection regulations, which include certain requirements for IRB review. Insofar as the platform supports pre-screening and recruitment for federally funded human subjects research, IRB review requirements under the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) may apply. Stakeholders should also consider applicable state human subject protection laws or contracts, which may require compliance with standards such as the good clinical practice guidelines laid out by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Under these myriad requirements, any collection, use or disclosure of PHI or personal information and any proposed scripts, questionnaires or recruitment materials may need to undergo IRB review and approval.
- Future Use. Consider whether the service or initiative will collect information to pre-screen and recruit individuals for specific studies only or whether there is also a desire to store and use information to pre-screen and recruit individuals for future studies. These considerations will inform the nature of any privacy or ethical consents and IRB review that may be required, as well as the contractual rights that the operator of the service or initiative, data source, sponsor or other stakeholders will need to negotiate. Note that commercial IRBs may have varying policies regarding requests for standing approvals or other determinations that are requested in the context of scalable pre-screening and recruitment initiatives.
- Basis for Payment. It is critical to analyze the basis for any payment that may be provided to participating data sources (such as healthcare providers) or to the operator of the service or initiative. For example, compensation arrangements that are based on the number of individuals who are referred to a study site or who are randomized or enrolled into a study should be assessed under applicable human subject protection laws, IRB requirements and potentially relevant federal and state anti-kickback and similar healthcare fraud and abuse laws. Analysis under such fraud and abuse laws, in particular, depends heavily on the facts and circumstances of each financial arrangement, and the manner in which they might apply to any given arrangement can be less obvious than in other settings in the healthcare industry.
- Looking Past Eligibility Determinations. Identifying a potentially eligible study subject is only part of the picture. Consider how and where the individual would participate in the study once enrolled. Does the pre-screening and recruitment service or initiative identify only eligible study subjects who are in close proximity to an existing study site, or would they participate through the healthcare provider that disclosed their medical records to the operator of the pre-screening service or initiative? If the latter, does the healthcare provider have the expertise and compliance infrastructure necessary to conduct the research study, and will it contract directly with the applicable sponsor or CRO? What, if any, role will the operator of the pre-screening and recruitment service or initiative play in this phase? These considerations may also inform the kinds of research that the service or initiative will support (e.g., decentralized clinical trials, low-interventional studies or biobanking studies). See also our On The Subject titled, FDA Issues Draft Guidance on Decentralized Clinical Trials for Drugs, Biological Products and Devices.
With FDA taking additional steps to increase diversity among clinical trial participants and as technology makes it easier to extract insights from data sets and engage with individuals, opportunities are plentiful for pre-screening and recruitment initiatives. In this evolving context, it is critical for stakeholders to anticipate and address the myriad legal requirements and practical challenges associated with finding and enrolling eligible study subjects.
