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About Institutional Review Boards (IRB)

An Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects. The purpose of the IRB is to ensure that all human subject research be conducted in accordance with all federal, institutional, and ethical guidelines.

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Institutional Review Boards Frequently Asked Questions – Information Sheet

Agency for Healthcare Research and Quality -clinical guidelines and recommendations
The Agency for Healthcare Research and Quality’s (AHRQ) mission is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used.

Association for Clinical Research Professionals
ACRP supports clinical research professionals through membership, training and development, and certification. Founded in 1976, ACRP is a Washington, DC-based non-profit organization with more than 13,000 members who work in clinical research in more than 70 countries. ACRP’s vision is that clinical research is performed ethically, responsibly, and professionally everywhere in the world. ACRP’s mission is to promote excellence in clinical research.

Centerwatch
Helping people connect with clinical trials around the world

Centre for Information Technology
IT company that supports biomedical research

ClinicalTrials.gov
ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Learn more about clinical studies and about this site, including relevant history, policies, and laws.

Collaborative Institutional Training Initiative
Runs training courses.

Council for International Organisations of Medical Sciences – associate partner of UNESCO
The Council for International Organizations of Medical Sciences (CIOMS) is an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949

Food and Drug Administration home page
Internationally recognised US regulatory body for the food and drug industry. Also covers supplements and related items.

International Conference on Harmonisation
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration

Medilexicon
Lexicon of medical terminology

National Institutes of Health main website
A part of the U.S. Department of Health and Human Services, NIH is the largest biomedical research agency in the world.

Office for Human Research Protections
The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP is part of the Office of the Assistant Secretary for Health in the Office of the Secretary of HHS.

Office of the Inspector General – US Department of Health and Human Services
Office of Inspector General’s (OIG) mission is to protect the integrity of Department of Health & Human Services (HHS) programs as well as the health and welfare of program beneficiaries

On line form submission for FWAs and IRB applications.
On line form submission for FWAs and IRB applications.

Physicians’ Desk Reference.
Physicians’ Desk Reference – resource for doctors covering eprescribing, drug information and related topics.

RegSource
Provides regulatory information from organisations around the world.

Society for clinical data management
Society for clinical data management

Society for clinical research associates
The Society of Clinical Research Associates (SOCRA) is a non-profit, charitable and educational membership organization committed to providing education, certification, and networking opportunities to all persons involved in clinical research activities

THE BELMONT REPORT ETHICAL PRINCIPLES AND GUIDELINES FOR THE PROTECTION OF HUMAN SUBJECTS OF RESEARCH
On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles. In carrying out the above, the Commission was directed to consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in such research and (iv) the nature and definition of informed consent in various research settings.

World Medical Association
Since it was founded in 1947, a central objective of the WMA has been to establish and promote the highest possible standards of ethical behaviour and care by physicians. In pursuit of this goal, the WMA has adopted global policy statements on a range of ethical issues related to medical professionalism, patient care, research on human subjects and public health. WMA Council and its standing committees regularly review and update existing policies and continually develop new policy on emerging ethical issues.

World Medical Association Declaration of Helsinki
The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.

Regulations and Guidance

Office for Human Research Protections (OHRP), U.S. Department of Health and Human Services: OHRP Home Page

45 CFR 46
Federal Policy for the Protection of Human Subjects (Basic DHHS Policy for Protection of Human Research Subjects)

FWA Instructions
This is a link to step-by-step instructions for how to file an FWA in the USA.

Decision Charts
The Office for Human Research Protections (OHRP) provides graphic aids as a guide for institutional review boards (IRBs), investigators and others who determine whether an activity is research involving human subjects and thus requires review by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46.

U.S. Food and Drug Administration (FDA)

FDA Home page | FDA Industry Portal | Center for Drug Evaluation in Research (CDER) | Center for Devices and Radiological Health (CDRH) | Pediatric Medical Devices

International Organizations

GCP – Good Clinical Practices
ICH Good Clinical Practices (GCP) – This is a link to the FDA division responsible for overseeing Good Clinical Practice (GCP). GCP is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials.

International Conference on Harmonisation (ICH)
This website offers access to all guidance documents produced by ICH.

Council for International Organizations of Medical Sciences
The Council for International Organizations of Medical Sciences (CIOMS) is an international, non-government, nonprofit organization established jointly by WHO and UNESCO in 1949.

World Medical Association
The World Medical Association (WMA) is an international organization representing physicians. The organization was created to ensure the independence of physicians and to work for the highest possible standards of ethical behavior and care by physicians at all times.

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.

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).

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.

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.

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.

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.

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.

Centerwatch
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.

Association for Accreditation of Human Research Protection Programs (AAHRPP)
Federal Register Notices
NexCura Clinical Trial Recruitment
Nuremberg Code
Office for Human Research Protections
Office of Research Integrity
PDR Online
Regsource.com
Society for Clinical Data Management
Society for Clinical Research Associates

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