SUBSCRIPTION

Medical Research Law & Policy Report

Medical Research Law & Policy Report® is a smart, risk-avoidance tool for entities engaged in clinical research, including hospitals, universities, contract research organizations, and pharmaceutical, biotech, and healthcare products companies — as well as those who advise or represent them.

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OVERVIEW

EXPERT NEWS & COMMENTARY

Track the complex interplay of federal and state agencies and governing bodies that regulate this expanding, fast-changing field.


TRUSTED LEGAL ANALYSIS

Enhance your practice with explanations and discussions of complex and emerging issues by leading experts — and gain an insider's perspective. Be informed of the latest enforcement actions taken by federal and state agencies and governing bodies that regulate the field, such as the National Institutes of Health (NIH), Food & Drug Administration (FDA), Office for Human Research Protections (OHRP), HHS Office of Inspector General (OIG), Department of Justice (DOJ), and Office of Research Integrity (ORI).

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POWERFUL RESEARCH TOOLS

Analyze specific compliance topics, complete with case studies, interviews with experts, and tips from leaders in the industry. In addition, access the quick-read highlights and topical listings to zero in on your interests.


TOPICS COVERED

  • Accreditation
  • Bioterrorism
  • Clinical trial mishaps
  • Cloning
  • Conflicts of interest
  • Data monitoring committees
  • Genetic research
  • Human subject protections
  • Informed consent
  • Institutional review board activities
  • Intellectual property rights
  • Patients' rights
  • Privacy and security
  • Scientific misconduct
  • Stem cell research
Key Laws and Regulations
  • False Claims Act
  • Federal Food, Drug, and Cosmetic Act provisions relating to research
  • Health Insurance Portability and Accountability Act (HIPAA) provisions relating to research
  • Human subject protection-regulations (the Common Rule)

SPECIFICATIONS

Product Structure

Notification: current reports providing news and developments.

Formats and Frequency

Print and Web notification formats are issued and available twice-monthly. Print current reports are indexed every six months, culminating annually. Web current reports are archived to 03.20.2002. 

Email summaries providing the highlights and table of contents for each report, with URLs to full text articles and documents, are also available.