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Clinical Research Regulatory Information

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The NICHD supports many types of clinical research studies including those that involve researchers who directly observe people, those that collect data to answer scientific or medical questions about the safety or potential benefit of an intervention, such as a medication, device, teaching concept, training method, or behavioral change, and those that examine the dynamics of populations. Federally funded clinical research includes many safeguards to protect those who volunteer to take part in trials and studies. These protections are developed by various organizations and are implemented throughout the research process. Some major organizations with an interest in clinical research regulations are described in the table below; links to any relevant regulatory information, including laws, regulations, policies, and guidances sponsored by the organizations, are also included.

Organization Description and Role in Clinical Research Regulation
Food and Drug Administration (FDA) The FDA is the federal agency responsible for ensuring that: foods are safe, wholesome, and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe. The FDA provides oversight through the development and release of regulations, policies, and guidance documents.

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International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use The ICH is a collaboration with regulatory authorities from Europe, Japan, and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration. The group seeks to find ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration in order to reduce the need to duplicate the testing carried out during the research and development of new medicines.

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National Institutes of Health (NIH) The NIH is part of the U.S. Department of Health and Human Services (DHHS), and is the primary Federal agency for conducting and supporting biomedical and biobehavioral research. The NIH oversees clinical research through the development and release of policies and guidances.

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Office of Human Research Protections (OHRP) OHRP protects the rights, welfare, and well-being of subjects involved in research conducted or supported by the federal government and helps ensure that such research is carried out in accordance with specific regulations. OHRP provides leadership in the protection of human subjects participating in clinical research by providing clarification and guidance, developing educational programs and materials, and maintaining regulatory oversight.

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Council for International Organizations of Medical Sciences (CIOMS) This international, non-governmental, non-profit organization was jointly established by the World Health Organization and the United Nations Educational, Scientific, and Cultural Organization.Its goals include facilitating and promoting international activities in biomedical sciences, maintaining collaborative relations with the United Nations and its specialized agencies, and serving the scientific interests of the international biomedical community in general. To achieve its objectives, CIOMS has initiated programs in Bioethics, Health Policy, Ethics and Human Values, Drug Development and Use, and International Nomenclature of Diseases.

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World Health Organization (WHO) The WHO is the directing and coordinating authority for health within the United Nations' system and is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries and monitoring and assessing health trends. WHO has drafted International Health Regulations (IHR), which are international legal instruments binding on 194 countries across the globe.

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World Medical Association (WMA) This international organization representing physicians was formed to ensure the independence of physicians and to work for the highest possible standards of ethical behavior and care by physicians. The WMA provides ethical guidance to physicians through its Declarations, Resolutions, and Statements.

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Each of these organizations is responsible for providing the research community with certain regulatory information, and each has varying levels of authority in clinical research. Some have the ability to develop and implement laws and regulations, which must be followed by investigators, while others can only develop policies and provide guidance(s). The NICHD examined clinical research documents in four areas, defined below.

Law A law is developed and passed by a legislative body and signed by an executive authority. Federal laws in the United States are passed by the Congress, signed by the President and published in the United States Code.
Regulation A regulation is a clarification of a law that is developed by the executive branch of the government and is binding. Courts treat regulations as legally binding. Federal regulations are published in the Code of Federal Regulations (CFR).
Policy Policies are developed by individual agencies or other entities to interpret laws and regulations and provide additional guidance. Policies are not binding in a court of law, but adherence to policies may be a condition of accepting an award or contract.
Guidance Guidance documents represent an organization's current thinking on a particular subject. They do not represent or confer any rights for or on any person and do not operate to bind anyone. Alternative approaches may be used if they satisfy the requirements.

The tables below summarize the various safeguards which must be considered by all investigators in the clinical research process. Tables are organized by specific topic areas and organizations for each type of regulatory measure (law, regulation, policy and guidance). Specific topic areas include:

  • Institutional Review Boards (IRBs)
  • Independent Data Monitoring Committees
  • Adverse Events (AE) Reporting
  • Informed Consent and Health Insurance Portability and Accountability Act (HIPAA)
  • Investigational New Drugs (IND) & Devices
  • General Responsibilities of Principal Investigators

Safeguard Laws and Regulations

Topic Area Org. Name of Law or Regulation
Institutional Review Boards (IRBs)

FDA

  • CFR: Title 21 Part 50; Sec 50.50
  • IRB Regulations

Access and Additional Information

OHRP

  • DHHS's CFR: Title 45 Part 46, regarding the protection of human subjects

Access and Additional Information

Adverse Events (AE) Reporting

FDA

  • Investigational New Drug (IND) Safety Reporting Regulations, which include information regarding life-threatening adverse drug experiences and serious adverse drug experiences

Access and Additional Information

OHRP

  • DHHS's CFR: Title 45 Part 46.103(b)(5) regarding written procedures for ensuring prompt reporting for unanticipated problems involving risks to subjects
  • DHHS's CFR: Title 45 Part 46.111(a) IRB determinations regarding risk and data monitoring

Access and Additional Information

Informed Consent and Health Insurance Portability & Accountability Act (HIPAA)

FDA

  • Part 50 Protection of Human Subjects: Subpart B—Informed Consent of Human Subjects

Access and Additional Information

DHHS

  • Office for Civil Rights - HIPAA: Medical Privacy - National Standards to Protect the Privacy of Personal Health Information

Access and Additional Information

Investigational New Drugs (IND) & Devices

FDA

  • IND Safety Reporting Regulations, which includes information regarding life-threatening adverse drug experiences and serious adverse drug experiences
  • CFR Sections on Requirement for an IND and IND Content and Format available in the FDA Center for Devices and Radiological Health site

Access and Additional Information

General Responsibilities of Principal Investigators

FDA

  • CFR: Title 21 Part 312 Subpart D

Access and Additional Information

Safeguard Policy and Guidance

Topic Area Org. Name of Policy or Guidance
Institutional Review Boards (IRBs)

FDA

  • Guidance for Sponsors, Clinical Investigators, and IRBs; Waiver of IRB Requirements for Drug and Biological Product Studies

Access and Additional Information

ICH

  • Guideline for Good Clinical Practice E6 (R1): Sections 1.31, 3

Access and Additional Information

NIH

  • Revised Policy for IRB Review of Human Subjects Protocols in Grant Applications

Access and Additional Information

OHRP

  • IRB Guidebook

Access and Additional Information

Independent Data Monitoring Committees

FDA

  • Guidance on Data Monitoring Committees
  • Guidance for Clinical Trial Sponsors Establishment and Operation of Clinical Trial Data Monitoring Committees

Access and Additional Information

ICH

  • Guideline for Good Clinical Practice E6 (R1): Sections 1.25, 5.5

Access and Additional Information

NIH

  • NIH Policy for Data and Safety Monitoring
  • NICHD Policy Document on Clinical Research Monitoring

Access and Additional Information

OHRP

  • Guidance on Data Safety Monitoring Boards (DSMBs), Data Monitoring Committees (DMCs), other similar bodies or sponsors

Access and Additional Information

Adverse Events (AE) Reporting

ICH

  • Clinical Safety Data Management Definitions and Standards for Expedited Reporting E2A
  • Guideline for Good Clinical Practice E6 (R1): Section 5.17

Access and Additional Information

NIH

  • Guidance on Reporting AEs to IRBs for NIH Supported Multicenter Clinical Trials
  • Genetic Modification Clinical Research Information System (GemCRIS) provides AE reporting templates

Access and Additional Information

OHRP

  • Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and AEs

Access and Additional Information

Informed Consent and Health Insurance Portability & Accountability Act (HIPAA)

ICH

  • Guideline for Good Clinical Practice E6 (R1): Sections 1.28, 4.8

Access and Additional Information

NIH

  • HIPAA Overview and Resources
  • Certificates of Confidentiality Kiosk and Information
  • National Cancer Institute (NCI) Guidance on Children's Assent
  • National Library of Medicine (NLM) information on Clinical Research involving Human Subjects

Access and Additional Information

OHRP

  • Policy Guidance by topic: Informed Consent

Access and Additional Information

CIOMS

  • International Ethical Guidelines for Biomedical Research Involving Human Subjects

Access and Additional Information

Investigational New Drugs (IND) & Devices

FDA

  • Guidance for Industry, Investigators, and Reviewers Exploratory IND Studies

Access and Additional Information

ICH

  • Guideline for Good Clinical Practice E6 (R1): Sections 4.6, 5.12, 5.13

Access and Additional Information

NIH

  • NIH Grants Policy Statement : Section titled "Investigational New Drug Applications/ Invesitgational Device Exceptions"

Access and Additional Information

General Responsibilities of Principal Investigators

FDA

  • FDA Guidance Documents
  • Format for study protocols with an IND

Access and Additional Information

ICH

  • Guideline for Good Clinical Practice E6 (R1)
  • ICH E3: Guideline for Industry Structure and Content of Clinical Study Reports

Access and Additional Information

NIH

  • Guidelines for the conduct of clinical research within the NIH Intramural Research Program
  • NIH Office of Extramural Research Ethical Guidelines and Regulations
  • NIH Office of Extramural Research Guidelines for Research Involving Vulnerable Populations

Access and Additional Information

OHRP

  • Policy Guidance by topic

Access and Additional Information

CIOMS

  • International Ethical Guidelines for Biomedical Research Involving Human Subjects

Access and Additional Information

WHO

  • A compilation of publications regarding Clinical Trials

Access and Additional Information

WMA

  • Declaration of Helsinki, which provides a set of ethical principles for the medical community regarding human experimentation

Access and Additional Information

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Last Updated Date: 12/21/2011
Last Reviewed Date: 12/21/2011
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