Regulations & Guidance

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

	45 CFR 46	Federal Policy for the Protection of Human Subjects (Basic DHHS Policy for Protection of Human Research Subjects)
	FWA Program	Federal Wide Assurance Program – The Federal Policy (Common Rule) for the protection of human subjects at requires that each institution “engaged” in Federally-supported human subject research file an “Assurance” of protection for human subjects. The Assurance formalizes the institution’s commitment to protect human subjects. The requirement to file an Assurance includes both “awardee” and collaborating “performance site” institutions.
	FWA Instructions	This is a link to step-by-step instructions for how to file an FWA in the USA and the actual form.
	HIPAA	Office of Civil Rights (OCR) – The Department of Health and Human Services, through the Office for Civil Rights enforces the privacy rule, Health Insurance Portability and Accountability Act (HIPAA)
	Financial Relationships	The Department of Health and Human Services (HHS) announces a final guidance document for Institutional Review Boards (IRBs), investigators, research institutions, and other interested parties, entitled “Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Protection”.
	Coded Private Information or Specimen	This is a link to a document applying to research involving coded private information or human biological specimens that is conducted or supported by (HHS)Department of Health and Human Services.
	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 that require review by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46.
	International Guidance	The Office for Human Research Protections has developed an International Compilation of Human Research Protections which lists the laws, regulations, and guidelines of over 50 countries where DHHS funded or supported research is conducted.
	Informed Consent FAQs	These FAQs provide guidance on OHRP’s current thinking on Informed Consent and should be viewed as recommendations unless special regulatory requirements are cited. The use of the word “must” in OHRP guidance means that something is required under HHS regulations at 45 CFR part 46. The use of the word “should” in OHRP guidance means that something is recommended or suggested, but not required.

U.S. Food and Drug Association (FDA) – FDA Home page http://www.fda.gov

FDA Industry Portal http://www.fda.gov/oc/industry/

Center for Drug Evaluation in Research (CDER) http://www.fda.gov/cder/

Center for Devices and Radiological Health Devices (CDRH) http://www.fda.gov/cdrh/

Pediatric Medical Devices http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ucm135104.htm

Center for Biologics Evaluation in Research (CBER) http://www.fda.gov/cber/

	21 CFR 50	Protection of Human Subjects, including general requirements for Informed Consent
	21 CFR 54	Financial Disclosure by Clinical Investigators
	21 CFR 56	Institutional Review Boards
	21 CFR 312	Investigational New Drug Application
	21 CFR 812	Investigational Device Exemptions
	Monitoring Clinical Trials	FDA Guidance for Monitoring Clinical Investigations.The purpose of this guideline is to present acceptable approaches to monitoring clinical investigations.
	Guidance for Institutional Review Boards and Clinical Investigators 1998 Update	This document represents the agency’s current guidance on protection of human subjects of research. It is published as Level 2 guidance in accordance with the FDA “Good Guidance Practices.”
	FDA Information Sheets	FDA Information Sheets, Guidance for Institutional Review Boards, and Clinical Investigators

HIPAA

Additional HIPAA information may be found in the following online resources:

Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule

NIH HIPAA FAQs

California Office of Health Information Integrity

National Institutes of Health (NIH) http://www.nih.gov

NIH Office of Biotechnology Activities has published a resource on informed consent in gene transfer research. http://oba.od.nih.gov/rdna/informed_consent_intro.html
NIH policy on the inclusion of women and minorities as subjects in clinical research
Guidelines on Women and Minorities
Guidelines on the inclusion of children in research involving human subjects, including, but not limited to, clinical trials, supported or conducted by the NIH.
Inclusion of Children Policy Implementation
A statement from NIH offering points to consider to assist IRBs and clinical investigators in their efforts to protect research participants who are or may become decisionally impaired.
Research Involving Individuals with Questionable Capacity to Consent: Points to Consider
Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level.
http://grants1.nih.gov/grants/policy/policy.htm

International Organizations

	GCP – Good Clinical Practices http://www.fda.gov/oc/gcp/	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) http://www.ich.org/	This website offers access to all guidance documents produced by ICH
	Council For International Organizations of Medical Sciences http://www.cioms.ch	The Council for International Organizations of Medical Sciences (CIOMS) is an international, non-government, non-profit organization established jointly by WHO and UNESCO in 1949.
	World Medical Association http://www.wma.net	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.
	International Bioethics Committee, United Nations Educational and Cultural Organization http://www.unesco.org/ibc/	The main objective of UNESCO is to contribute to peace and security in the world by promoting collaboration among nations through education, science, culture and communication in order to further universal respect for justice, for the rule of law and for the human rights and fundamental freedoms which are affirmed for the peoples of the world, without distinction of race, sex, language or religion, by the Charter of the United Nations.