Service(s) Related to Post:  Clinical Trial Consulting Services

On January 18, 2017, the U.S. Department of Health and Human Services (HHS) together with 15 other federal agencies, released a lengthy final rule to revise the federal policy for the protection of human subjects in clinical studies. While the new rule will be reviewed by the Trump administration in the coming months, it is likely that the provisions of the rule will ultimately be implemented.

How the final rule affects the role of Institutional Review Boards (IRBs) in clinical studies:

One of the most notable proposal outlined in the HHS was the requirement that all institutions participating in clinical studies or cooperative studies use a single IRB as the reviewing body for the clinical study. In the Final Rule, HHS ultimately adopted a modified version of the proposal, requiring a single IRB to be used for all clinical or cooperative research studies. The lead institution will have the authority to propose the reviewing IRB, subject to the acceptance of the federal agency supporting the research.

What consents are needed from current clinical study subjects to use data collected from them in the study for future research:

The HHS proposed to adapt the informed consent regulations in an effort to shorten consent forms and make it easier for research subjects to locate the key information necessary to make informed decisions regarding their participation in clinical research studies. Further, informed consent forms used in clinical studies must be publicly available in a bid to improve transparency.

The following list includes the most important changes to the Common Rule proposed by HHS to protect human subjects in clinical studies:

• Improving informed consent to better assure that participants are appropriately informed in clinical studies,
• Requiring informed consent for secondary research and de-identified biospecimens,
• Mandating that research sites engaged in clinical research rely on a single institutional review board (IRB),
• Eliminating continuing review in certain circumstances,
• Extending the Common Rule to cover all clinical studies conducted in U.S. institutions receiving funding from a Common Rule agency, regardless of the funding source for the trial itself,
• Requiring new privacy standards to strengthen data protection and minimize information risks in clinical studies,
• Creating revised categories of exempt research and better calibrating the level of review to the level of risk.

In summary, Compliance with the new Common Rule regulations will be required as of January 19, 2018, with the exception of the rules mandating oversight of clinical studies by a single IRB, which will require compliance by January 20, 2020.

Our clients often face the challenge of substantiating the safety of their ingredients or the efficacy of their desired health claims. Sometimes supporting claims through a clinical study is the only option. From protocol development to sourcing the most qualified and cost effective Contract Research Organization (CRO), we help our clients to complete the entire process to get their clinical research started. We have a wide range of experience designing and facilitating double-blind, placebo-controlled trials and provide the following services:

• Clinical research strategy development

• Protocol development and/or review

• Identification of suitable Contract Research Organizations (CROs)

• Clinical trial applications

• Feasibility assessments

• Regulatory applications and product approvals

• Health claim strategy and substantiation

dicentra is a professional consulting firm that specializes in addressing all matters related to safety, quality and compliance for all product categories in the health sciences and food industries. We evaluate, implement, and provide all the necessary support for your products and operations to gain market access and build confidence in your brand. Contact dicentra at 1-866-647-3279 or visit www.dicentra.com to learn more about us and our services in Label Development for Food & Beverage products.