Although a significant percentage of Wisconsin’s population lives outside of the main metro areas, access to clinical research studies has been primarily limited to trials initiated by the two academic medical health centers located in Milwaukee and Madison.

However, the availability and adoption of digital health technologies (DHTs) – such as software and digital applications, electronic sensors, and computing platforms – is increasing. As a result, clinical research studies can incorporate one or more components of telehealth applications or home visits, whereas other clinical investigations can be performed fully remotely.^[1]

The Clinical Trials Transformation Initiative (CTTI), a public-private partnership established by the U.S. Food and Drug Administration (FDA) and Duke University, expects “patient centered and easily accessible” clinical study designs by the end of the decade.^[2]

This article provides an introductory summary to the current legal and regulatory framework of clinical trials, including applicable FDA guidance, and key aspects of the informed consent process.

Human Subject Research

Clinical trials commonly use human subjects to conduct research. Human subject research may be initiated by industry sponsors, investigators employed by academic health care centers, nonprofit organizations, or federal agencies.

For federal agencies, the protection of human subject is regulated through 45 CFR Part 46 (Common Rule), and regulatory compliance is overseen by the Office of Human Research Protection (OHRP) within the Department of Health and Human Services (DHHS).

• 45 CFR 46.102(e)(1) defines “human subject” as “a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”
• Under 45 CFR 46.102(l), activities that qualify as “research” include “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

An important category of human-subject research in clinical trials is what the National Institutes of Health defines as clinical research – studies designed “to evaluate the effects of interventions on health-related biomedical and behavioral outcomes.”

The conduct of clinical trials by industry sponsors and academic investigators in alignment with federal regulations and good clinical practice is overseen by the FDA, and in accordance with the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 50.

When assessing a specific clinical trial, the following aspects are critical to evaluate:

• Through the Federalwide Assurance (FWA) – which is a statement of ethical principles – institutions and organizations that conduct human subject research in accordance with the Common Rule make a commitment to protect the rights and welfare of human subject research participants. A list of Wisconsin entities with active FWAs is published on the National Institutes of Health website.
• Investigators that conduct clinical trials need to secure Institutional Review Board (IRB) approval of the proposed clinical investigations prior to enrollment of any study participants. Under 21 CFR 56.102(g), IRBs are committees designated by public or private entities that conduct initial and periodic review of biomedical research involving human subjects. Following review and analysis of the study protocol and all other study documents, such as the informed consent form, in accordance with 21 CFR 56.102(m), the IRB can determine whether the clinical investigation may be activated.
• To promote transparency and public access, sponsors and/or investigators must register all interventional clinical trials of FDA-regulated products on ClinicalTrials.gov within 21 days after the first participant enrolls. They must also submit the study results within one year after the study’s primary completion date.^[3]

The Decentralized Clinical Trial (DCT) Umbrella

In addition to the traditional, academic health care center-oriented clinical trials, the advent of digital health technologies (DHTs) has introduced new opportunities and challenges for the clinical research industry and regulatory bodies.^[4]

One such FDA initiative was the development of the “Framework for the Use of Digital Health Technologies in Drug and Biological Product Development.” According to this framework, a main objective of the FDA was engagement with industry “to promote shared learning and consistency regarding DHT-based policy, procedure, and analytic tool development.”^[5]

• In September 2024, the FDA released a Final Guidance document titled “Conducting Clinical Trials with Decentralized Elements” to provide recommendations related to remote clinical trials and implementation of DHTs. Specifically, the guidance includes recommendations regarding DCT design and conduct, remote clinical trial visits and clinical trial related activities, DHTs, packaging and shipping of investigational products, and electronic systems used when conducting DCTs.
• One of the more common decentralized elements, telemedicine, is allowable under the Wis. Admin. Code § Med 24. However, physicians can only provide diagnosis and treatment through telehealth if certain requirements are met, such as holding a Wisconsin medical license, a patient’s access to physician’s name and contact information, documented patient evaluation, properly conducted informed consent, and preparation and maintenance of a patient health care record.^[6] When a clinical trial protocol includes research-specific assessments performed by a local health care provider, that provider must work with the industry sponsor and/or the academic clinical research group to receive study-specific training and to understand the protocol requirements and safety reporting obligations.

The Electronic Informed Consent Process (eIC)^[7]

A crucial aspect of clinical investigations is the completion of the informed consent process prior to study participation. Under 45 CFR 46.116(b), a valid informed consent process requires a well-defined set of study details that need to be provided to each potential study participant or their legally authorized representative (LAR).

For example, each potential study subject will need to be provided with the following information: detailed description of study procedures, discussion of reasonably foreseeable risks, potential benefits, collection and use of identifiable private information or biological samples, any compensation, and contact information in case adverse reactions might occur.^[8]

Further, each study participant needs to be aware of the voluntary aspect of participation and the fact that their consent can be withdrawn at any time.^[9]

In addition to the general informed consent conditions listed above, there are other considerations for the patient-oriented eIC processes, according to the FDA Guidance on the Use of Electronic Informed Consent:

• When conducting the eIC, clinical research personnel need to ensure adequate protection to potential study participants by facilitating information exchange via electronic systems and processes that are approved by the IRB. The guidance specifically lists various electronic tools which can be used individually or in combination during the eIC to relay a comprehensive study overview to potential study participants.
• In contrast with the traditional informed consent processes, when the study participant and study team member meet in person to discuss study details, study teams should facilitate completion of the eIC process through an electronic method that is familiar and accessible to study participants. Also, throughout the eIC process, study team members should allow flexibility to accommodate requests for the use of various remote tools.
• Because the potential participant and the study team member obtaining consent are not in the same physical location, the study team must confirm the participant’s identity to ensure that the person completing the informed consent process and providing the electronic signature is the person who will take part in the study.
• Overall, it is critical to accurately document the eIC process and obtain valid electronic signatures, as the eIC data falls within the scope of any future routine or for-cause regulatory inspections. In Wisconsin, electronic signatures are recognized; an electronic record can satisfy the legal requirement under Wis. Stat. section 137.15(4), if a signature is required.

Outlook for the Wisconsin Health Care community

As a greater number of academic health centers, pharmaceutical companies, and clinical research organizations expand their portfolio of clinical research activities, Wisconsin health law attorneys might see a gradual increase in clients who will inquire about study participation and the informed consent process.

In addition, during study development and design, sponsors of multi-site clinical investigations who plan to conduct clinical trials at Wisconsin sites will need to examine applicable statutory provisions attached to planned, decentralized elements.

Finally, local clinics and health care providers might conduct various study activities via collaborative agreements with organizations engaged in clinical research and will have unique needs while navigating the growing interest in DCTs.

The author would like to thank Atty. Tatiana Shirasaki for the photo.

This article was originally published on the State Bar of Wisconsin’s Health Law Blog. Visit the State Bar sections or the Health Law Section webpages to learn more about the benefits of section membership.

Endnotes

[1] U.S. Food and Drug Administration (FDA), Digital Health Technologies (DHTs) for Drug Development, July 31, 2025. ↩

[2] Clinical Trials Transformation Initiative, CTTI Vision for Clinical Trials in 2030. ↩

[3] 42 CFR Part 11 Subpart A. ↩

[4] FDA Guidance Document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, December 2023. ↩

[5] FDA, Digital H​ealth Technologies (DHTs) for Drug Development, July 31, 2025. ↩

[6] Wis. Admin. Code § Med 24.07. ↩

[7] FDA, Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers, December 2016. ↩

[8] 45 CFR 46.116(b). ↩

[9] 45 CFR 46.116(b)(8). ↩