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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.

LINKS:
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.

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