Insightalyst

The U.S. Food and Drug Administration (FDA) announced in August that it has finalized the guidance document titled “Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors” to promote clarity on procedures and expectations for stakeholders carrying out informed consent in clinical investigations of FDA-regulated products. This guidance takes the place of “A Guide to Informed Consent,” issued in September 1998, and finalizes the 2014 draft guidance titled, “Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors.” The informed consent guidance does not address future potential changes to FDA’s informed consent regulations that may result from the FDA’s harmonization efforts with the 2018 Common Rule.

On June 6, 2023, The U.S. Food and Drug Administration (FDA) announced the availability of the draft guidance titled “E6(R3) Guideline for Good Clinical Practice.” This E6(R3) update aims to provide flexible, modern, and clear Good Clinical Practice (GCP) for conducting clinical research. The draft guidance is adopted from the International Council for Harmonisation’s (ICH) recently updated E6(R3) draft guideline. As a founding member of ICH, FDA plays a major role in the development of each of the ICH guidelines, which FDA then adopts and issues as guidance for industry.

Building on recommendations to facilitate decentralization of clinical trials during the COVID-19 public health emergency, the U.S. Food and Drug Administration (FDA or the Agency) issued the draft guidance titled, Decentralized Clinical Trials for Drugs, Biological Products, and Devices on May 2, 2023. A decentralized clinical trial (DCT) is a clinical trial where some or all trial-related activities occur at locations other than traditional clinical research sites.

The U.S. Food and Drug Administration (FDA) published a final guidance, “A Risk-Based Approach to Monitoring of Clinical Investigations, Questions and Answers, Guidance for Industry.” The guidance provides sponsors with information about implementing a risk-based approach to monitoring clinical studies of human drugs, biologics, medical devices, and combinations of these products. As the recommendations are intended for sponsors, they apply directly to UNC investigators who initiate and conduct clinical investigations (that is, sponsor-investigators).

It can be challenging to navigate the Department of Health and Human Services (HHS) regulations for the protection of human subjects (“The Common Rule”) in a rapidly changing landscape of biomedical and health-related research. The UNC Chapel Hill required CITI Human Subjects Protection (HSP) Training and CITI HSP supplemental training modules provides a comprehensive review of HHS Common Rule requirements, but if you are looking for additional educational resources, the HHS Office of Human Research Protection (OHRP) offers educational materials to further human subjects protection.

On September 26, 2022, the U.S. Food and Drug Administration (FDA) announced in the Federal Registry the newly published draft guidance titled, “Ethical Considerations for Clinical Investigations of Medical Products Involving Children.” The goal of this guidance is to provide FDA’s perspective on the ethical considerations for including children in clinical trials.

As part of its obligations under the 21st Century Cures Act, the U.S. Food and Drug Administration (FDA) announced, on September 28, 2022, two proposed rules aimed at harmonizing, to the “extent practicable and consistent with statutory provisions,” certain sections of the agency’s regulations on human subject protections and Institutional Review Boards (IRBs) with the “Federal Policy for the Protection of Human Subjects” (revised Common Rule).

On April 8, 2022, the U.S. Food and Drug Administration (FDA) adopted and issued the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E8(R1) General Considerations for Clinical Studies. ICH E8 guidelines sets out general scientific principles for the conduct, performance, and control of clinical trials, and addresses a wide range of topics in trial design and execution. This revision is the first major revision since 1997 and marks the initial step in the ICH’s Good Clinical Practice Renovation project and will continue with the revision of E6(R2) guidelines on Good Clinical Practice (GCP).

On September 30, 2021, the U.S. Food and Drug Administration (FDA) issued new draft guidance, Investigator Responsibilities—Safety Reporting for Investigational Drugs and Devices. This draft guidance addresses how investigators must assess and report adverse events to ensure participant safety in drug and device studies.

Insightalyst: FDA Informed Consent Guidance

Insightalyst: FDA Draft Guidance — ICH E6(R3)

Insightalyst: FDA Draft Guidance on Decentralized Clinical Trials for Drugs, Biological Products, and Devices

Insightalyst: Final FDA Question-and-Answer Guidance on a Risk-Based Approach to Monitoring Clinical Investigations

Insightalyst: Human Subjects Protection Educational Resources

Insightalyst: FDA Issues Draft Guidance on Protecting Children Who Participate in Clinical Trials

Insightalyst: FDA Announces Proposed Rules to harmonize with the revised Common Rule

Insightalyst: FDA Issues ICH E8 Revision

Insightalyst: FDA Draft Investigator Responsibilities Guidance