Minimize Risks to Special Populations in Clinical Trials

Advise healthcare clients on key regulatory and compliance considerations for clinical trials involving so-called special populations of research subjects like pregnant women, human fetuses, neonates, prisoners, and children. Understand how the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) set standards to protect these populations from undue influence when serving as research subjects in clinical trials.

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Related Content

• Master Clinical Trial Agreement
  Use this template to expedite negotiating and drafting an agreement between a drug or medical device manufacturer (sponsor) and a healthcare institution taking on responsibility for conducting a clinical trial on behalf of the sponsor.
• Informed Consent for Clinical Trials Form
  Build your trial-specific participant consent form with this basic template used to provide clinical trial participants required sufficient information to make an effective consent to participate in a study. The template includes practical guidance, drafting notes, and optional clauses.
• Right-to-Try and Expanded Access to Experimental Drugs Checklist
  Rely on this checklist to ensure your healthcare clients comply with right-to-try and expanded access provisions of the 21st Century Cures Act and the Right to Try Act of 2018 when providing medications to ill patients not otherwise able to participate in clinical trials.

Practical Guidance Updates
Featuring the latest updates from your Practical Guidance account.   

• Post-Dobbs HHS Guidance Brings Privacy Considerations
  Advise healthcare clients on data privacy implications following the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, 2022 U.S. LEXIS 3057 (June 24, 2022).
• Legal Developments provide the latest updates and analyses of emerging topics impacting healthcare. Visit the Legal Developments page to see breaking healthcare legal news—notably on the U.S. Supreme Court’s Dobbs decision—and related Practical Guidance content.
• Listen Up! The Practical Guidance Podcast features interviews with industry-leading attorneys on cutting edge issues in the law: NFTs, Cannabis, COVID-19, and more. Catch the most recent episode on the podcast platform of your choice.
• The Practical Guidance Journal Summer 2022 Edition leads with an article on ransomware issues in the healthcare industry and includes LexisNexis Legal & Professional resources to support the people of Ukraine.
• Check out the new Practical Guidance Author Center! Learn about the 1500+ leading attorney authors contributing to our 21 practice areas, and find out how you can Become a Practical Guidance Author.​​​​​​
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