Developments in Regulation of Laboratory Developed Tests

On October 2, 2014 FDA issued its “Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” (“LDT Guidance”) to clarify FDA’s enforcement objectives with regard to LDTs. An LDT is a subset of in vitro diagnostic devices (“IVDs”), and FDA will consider an IVD an LDT when it is used, designed, and manufactured by only a single laboratory. Since 1976, when the U.S. Congress amended the Food Drug and Cosmetics Act (“FD&C”) and made explicit that IVDs were devices under the Act, FDA has generally exercised enforcement discretion with respect to LDTs.

Under the current regulatory scheme, The Centers for Medicare and Medicaid Services (“CMS”) regulates laboratories under the Clinical Laboratory Improvement Amendments (“CLIA”), but not LDTs or their accuracy. In the LDT Guidance, FDA notes its “concerns regarding the lack of independent review of the evidence of clinical validity of LDTs,” and indicates the Agency’s intent to phase select categories of LDTs into the regulatory curtilage of devices.

Reference is made to the role of institutional review boards (“IRBs”) as they relate to studies of LDTs. For clinical investigations of LDTs conducted under clinical protocols requiring IRB approval, the Draft Guidance indicates the Agency’s intent to continue its enforcement of investigational device requirements under 21 CFR Part 812. For IVD studies not exempt from Part 812, the IRB will make a device risk assessment as part of its study review. Language within the Draft Guidance tracks language from the “Criteria for IRB Approval of Research” found in 21 CFR 56.111 as well as elements of informed consent found in regulations governing protection of human subjects at 21 CFR 50.25, further highlighting the IRB’s role of ensuring that subjects have adequate information to make an informed decision about participation in clinical research involving LDTs.

While studies of many LDTs may be exempt from 21 CFR 812’s requirements, research participants must still be apprised of the investigational nature of unapproved medical devices as well as alternatives to study participation. As changes to FDA’s LDT oversight framework take effect, Sterling will continue to focus on unique issues impacting the welfare of participants in studies involving LDTs. If you would like to learn more about Sterling services, please This email address is being protected from spambots. You need JavaScript enabled to view it. .

Article submitted by Royce DuBiner, JD, LLM


The Future of Homeopathic Product Regulation

On March 27, 2015 FDA solicited comments on the future of Homeopathic Product Regulation via a Notice of Proposed Rulemaking (“NPRM”) that sought input on current enforcement policies from scientific, risk, and process perspectives. Homeopathic drugs are currently exempt from many of the requirements of non-homeopathic drugs under the Food Drug & Cosmetic Act, and FDA regulates based on the Compliance Policy Guide (CPG) 400.400, “Conditions Under Which Homeopathic Drugs May Be Marketed.”

The research community might one day see homeopathic products undergoing the same approval and labeling process as non-homeopathic drugs. If this happens, IRBs must be prepared to address the issues of informed consent and subject safety. Question #8 in the NPRM asks, “do consumers and health care providers have adequate information to make informed decisions about drug products labeled as homeopathic.” This question is at the heart of the informed consent process and IRBs reviewing studies of homeopathic drugs would apply the same elements of informed consent found in regulations at 21 C.F.R. § 50.25 as used in the informed consent process for studies of other FDA-regulated products. Any informed consent must include a description of reasonably foreseeable risks, benefits to the subject which may be reasonably expected, and disclosure of appropriate alternative procedures or courses of treatment that might be advantageous (among other required elements). Also, when IRBs approve a study protocol the Board adheres to the requirements found in 21 CFR 56.111 for “Criteria for IRB Approval of Research.” In order for research to be approved the risk to the subjects must be minimized and risk to the subjects must be reasonable in relation to anticipated benefits. Because of the untested nature of many homeopathic products, the IRB’s responsibilities for ensuring adequate informed consent and making risk-based determinations would be essential.

Ensuring that any future clinical trials involving homeopathic drugs respect the subjects’ safety and right to be fully informed through an approved informed consent may prove challenging for a previously unregulated industry, but Sterling IRB’s primary concern is the welfare of study participants in ethically sound research. If you would like to learn more about Sterling services, please This email address is being protected from spambots. You need JavaScript enabled to view it. .

Article submitted by Royce DuBiner, JD, LLM


Sterling IRB 2015 Winter Holiday Closures

Sterling IRB will be closed in observance of the following holidays:

  • Thanksgiving – Wednesday, November 25, 2015 (Closing at 1:00 PM EST)
  • Thanksgiving – Thursday, November 26, 2015
  • Thanksgiving – Friday, November 27, 2015
  • Christmas Eve – Thursday, December 24, 2015 (Closing at 1:00 PM EST)
  • Christmas Day – Friday, December 25, 2015
  • New Year’s Eve – Thursday, December 31, 2015 (Closing at 1:00 PM EST)
  • New Year’s Day (2016) - Friday, January 1, 2016

ResearchKit™ and The IRB’s Role in Electronic Informed Consent

On March 12, 2015 Apple Inc. released ResearchKit™, an open source application for iOS devices such as the iPhone and iPad, to assist investigators and sponsors in the conduct of human subjects research. One of the components of ResearchKit is an interactive interface for electronic informed consent (“eIC”).

Apple’s ResearchKit shows incorporation of concepts from FDA’s March 2015 Draft Guidance on Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers (“Draft Guidance”). In the Draft Guidance, FDA clarifies requirements set forth in 21 CFR parts 11, 50, and 56 as they pertain to eIC. Highlighted concepts from the Draft Guidance include the following.

  • When FDA evaluates a system utilizing electronic signatures, FDA requires “at least two distinct identification components such as an identification code and password.”[1] Biometric signatures are accepted as well, an example of which is the fingerprint reader incorporated on many Apple devices.[2]
  • Interactive ease of use for research participants is of paramount importance.[3] The Draft Guidance explains that participants should be able to navigate forward and backward, stop, continue at a later time, and ask questions about their role in the study.[4]
  • Participants’ reading comprehension of the informed consent document may be enhanced through the use of visual aids such as diagrams and graphics.[5]
  • Capabilities should exist that allow informed consent documentation to be made available to the participant in physical form and eIC applications must be able to push notifications to participants if the consent form has been amended.
  • An IRB “must review and approve the eIC and any amendments to the eIC.” FDA also urges investigators and developers to work with and consult the IRB before finalizing the project development to ensure that the format and contents of the application are ethically sound.[6]

Github, an online coding website for ResearchKit, references eIC in its Best Practices section. Github stresses that primary guidance for the design of the informed consent component of ResearchKit should come from an IRB, stating that “the consent functionality in the Research Kit framework is only intended as a tool; the details of the Consent functionality in your application are your responsibility.” Even within the informed consent template on the developer site, IRB review of the application before dissemination is stressed. The Best Practices on Github are merely guideposts for developers; the requirements of a reviewing IRB may exceed those detailed on the site. An application to be used for human subjects research is allowed on the App Store only if the application has been approved by an IRB beforehand. While Apple supplies code for ResearchKit, the company does not maintain an IRB to review ResearchKit apps.

New research-related developments like ResearchKit can improve the research participant’s experience while decreasing administrative challenges for sponsors and investigators. Sterling IRB has experience with review of eICs and has helped researchers ensure that applicable regulatory requirements are met as studies transition from using traditional paper-based informed consent processes to use of eIC. Sterling IRB would be happy to work with you to explore how using eIC can benefit your study’s subjects and your study team. If you would like to learn more about Sterling services, please This email address is being protected from spambots. You need JavaScript enabled to view it. .

Article submitted by Royce DuBiner, JD, LLM

[1] 21 CFR 11.200 (a)(1).
[2] 21 CFR 11.200 (b)
[3] Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers Guidance for Industry, FDA Draft Guidance, March (2015), at 3.
[4] Id., at 4.
[5] Id., at 6.
[6] Id., at 7.

Sterling IRB Exhibiting at 2015 Global Site Solutions Summit in Amelia Island, FL

Sterling will be exhibiting at the Global Site Solutions Summit this year at the Omni Amelia Island Plantation Resort in Amelia Island, FL. Please stop by to visit us any time between October 8th – 11th and enter to win an iPad Mini. We’ll be located in booth number 47. If you’d like to schedule a meeting to discuss our services and capabilities at the conference, please contact Kathye Richards, CIP, Vice President of Client Services at 678-501-7806 or This email address is being protected from spambots. You need JavaScript enabled to view it. .



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