Ethical and Scientific Issues in Studying the Safety of Approved Drugs


An uncorrected copy, or prepublication, is an uncorrected proof of the book. We publish prepublications to facilitate timely access to the committee's findings. The final version of this book has not been published yet. You can pre-order a copy of the book and we will send it to you when it becomes available.

Download a PDF of "Ethical and Scientific Issues in Studying the Safety of Approved Drugs" by the Institute of Medicine for free. The FDA requested that the IOM examine the ethical and informed consent issues that should be considered when conducting clinical trials to evaluate drug .

We will not charge you for the book until it ships. Pricing for a pre-ordered book is estimated and subject to change. All backorders will be released at the final established price. If the price decreases, we will simply charge the lower price. Applicable discounts will be extended.

Report at a Glance

An ebook is one of two file formats that are intended to be used with e-reader devices and apps such as Amazon Kindle or Apple iBooks. A PDF is a digital representation of the print book, so while it can be loaded into most e-reader programs, it doesn't allow for resizable text or advanced, interactive functionality.

  • When love is not enough.
  • Ethical and Scientific Issues in Studying the Safety of Approved Drugs - NCBI Bookshelf.
  • Sign of the Cross.

The eBook is optimized for e-reader devices and apps, which means that it offers a much better digital reading experience than a PDF, including resizable text and interactive features when available. If an eBook is available, you'll see the option to purchase it on the book page. View more FAQ's about Ebooks.

Each report has been subjected to a rigorous and independent peer-review process and it represents the position of the National Academies on the statement of task. The FDA requested that the IOM examine the ethical and informed consent issues that should be considered when conducting clinical trials to evaluate drug safety.

IPPCR 2015: Clinical Research from the Patient's Perspective & Study Participant Selection

IOM Institute of Medicine. The National Academies Press.

Ethical and Scientific Issues in Studying the Safety of Approved Drugs

The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. Turn recording back on. National Center for Biotechnology Information , U.

National Academies Press US ; Copyright by the National Academy of Sciences.

You may request permission to:. Yes, I agree This site uses cookies. Resource Description Namespaces http: Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. Bloch Law Library Borrow it. For questions about using the Copyright. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market.

For more information, see the Bookshelf Copyright Notice. Hardcopy Version at National Academies Press. Similar articles in PubMed.

American Society of Clinical Oncology policy statement: American Society of Clinical Oncology..