Regulatory Resources

Ensure compliance with the latest information

Below is a list of national and international regulatory sites to help you ensure compliance. If you have any questions about WIRB's regulatory compliance policies, please review our Guide for Researchers, or contact us.

Food and Drug Administration (FDA)
The FDA home page provides a wealth of information on all aspects of the drug and device approval processes, including the protection of human subjects.
More FDA Links
FDA Center for Drug Evaluation and Research (CDER) clinical investigator information
This site contains important information for the conduct of FDA-regulated studies.

FDA's Office of Good Clinical Practice (GCP) in FDA-regulated clinical trials
The FDA's regulations for the conduct of clinical trials address both good clinical practice and human subject protection. This site also has documents on International Conference on Harmonization (ICH) GCP guidance on which FDA has collaborated and that have been adopted as official FDA guidance.

FDA industry portal
Find links to areas of the FDA website that are most likely to be of interest to industry, categorized in a logical and user-friendly format.

FDA safety reporting portal
This portal is for reporting product safety issues to the FDA and NIH.

FDA guidance on long-term follow-up in gene therapy clinical trials
This page provides risk-based guidance and examples regarding long-term follow-up in gene transfer trials.

Office for Human Research Protections (OHRP)
The OHRP oversees biomedical and behavioral research involving human subjects conducted or supported by the U.S. Department of Health and Human Services (HHS).
More OHRP Links
OHRP—Federalwide Assurance (FWA)
This page contains the information necessary to file an Federalwide Assurance (FWA), required for all sites engaged in federally-funded research.

OHRP— International regulations
This page details more than 1,000 laws, regulations, and guidelines on human subject protections in over 100 countries and from several international organizations.

OHRP—Policy and guidance library
This page contains a variety of documents, definitions, and FAQs to assist the research community in complying with HHS regulations.

Health Canada
Health Canada is Canada's federal department responsible for helping Canadians maintain and improve their health, while respecting individual choices and circumstances. Its website is a resource for a wide variety of regulations and guidelines concerning drug and medical trials in Canada and other issues of interest to investigators and sponsors.
More Health Canada Links
Health Canada FAQ
Find answers to questions about Canadian regulations for clinical trials of drug and health products.

Tri-Council Policy Statement (TCPS) Training
The Canadian Panel on Research Ethics (PRE) provides an online tutorial on TCPS titled “TCPS 2: Course on Research Ethics (CORE)."

International Conference on Harmonisation (ICH)
The International Conference on Harmonisation website provides access to all available guidance issued by the ICH organization.
More ICH Links
The ICH guideline for good clinical practice (E6)
The ICH GCP guidelines provide a unified standard for the European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

National Institutes of Health (NIH)
The NIH home page details their efforts to understand, protect, and improve the health of living systems.
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NIH Office of Human Subjects Research—Regulations and Ethical Guidelines
The NIH Office of Human Subjects Research provides links to several important documents regarding the treatment of human subjects, including the Belmont Report, the Nuremberg Code, and the Helsinki Declaration.

NIH—Information for Researchers on the HIPAA Privacy Rule
This site provides links to valuable guidance on the effect of the HIPAA Privacy Rule on research.

NIH—Certificate of Confidentiality Kiosk
The NIH encourages the appropriate use of Certificates of Confidentiality as an important tool to protect the privacy of research study participants. The NIH provides information here for investigators working on sensitive biomedical, behavioral, clinical, or other types of research.

NIH—Safety Reporting Portal
This portal is for reporting product safety issues to the FDA and NIH.

NIH—rDNA Research Guidelines
This site provides guidelines for research involving recombinant DNA molecules.

NIH—Informed Consent for Gene Transfer Research
This site provides guidance on risk communication and informed consent for gene transfer research, including five 'specific requirements'.

NIH—Office of Extramural Research Online Tutorial "Protecting Human Research Participants
The NIH Office of Extramural Research provides an online tutorial called "Protecting Human Research Participants".

World Health Organization (WHO)
The World Health Organization has a site created to aid persons, both inside and outside of WHO, who are seeking information about bioethics, including the ethical aspects of healthcare delivery and planning as well as the ethics of clinical care, research, and biotechnology.
More WHO Links
WHO—International biosafety regulations
This page lists biosafety publications, with tabbed access to resources in various languages.

World Medical Association (WMA)
The WMA issued the Declaration of Helsinki and is responsible for its updates.

Council for International Organizations of Medical Science (CIOMS)
Find studies and articles, purchase books, and the read the latest news, including information about bioethics and health policies, drug development and use, and adverse drug reactions.

Collaborative Institutional Training Initiative (CITI)
Investigators submitting research to WIRB can meet our human subject training requirement through CITI online training. Select your own institution or Western IRB to register on the site.

The Center for Information & Study On Clinical Research Participation (CISCRP)
Whether you’re participating in a study, are considering participating, or just want to be informed, the CISCRP Education Center has helpful information and resources for you.

Thomson-Centerwatch publishes a handbook titled “Protecting Study Volunteers in Research - A Manual for Investigative Sites” by Drs. Dunn and Chadwick
(ISBN 1-930624-44-1). The book can be purchased through the publisher, Thomson-Centerwatch.