National Institutes of Health Clinical Center


General Resources

Office of Human Subjects Research Protections (OHSRP)
Guidance for NIH employees and grantees

Office for Human Research Protections (OHRP)
Guidance for research supported by the US Department of Health and Human Services (HHS)

Bioethics Information Resources
Electronic bioethics resources organized by the National Library of Medicine (NLM)

Fogarty International Center
NIH center for global health research

Food and Drug Administration (FDA)
Clinical trials guidance from the FDA

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Policies, Guidance and Other Documents

NIH Guidance

The Inclusion of Children as Participants in Studies Involving Human Subjects: Q&A
Question and answers about the NIH policy and guidelines on the inclusion of children as participants in studies Involving human subjects.

Research Involving Individuals with Questionable Capacity to Consent: Points to Consider
A report by the Office of Extramural Research.

Research on Human Specimens: Are You Conducting Human Subjects Research? PDF Icon (2.21 MB)
Good Clinical Practice Resource Guide provided by the National Institute of Allergy and Infectious Diseases (NIAID)

NIH Stem Cell Information
Draft guidelines for research, primers, testimony, and press releases.

Ethical, Legal and Social Implications Program of the National Human Genome Research Institute (NHGRI)
A description of the ELSI program of NHGRI

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Federal Regulations and Guidance

45-CFR-46 - Protection of Human Subjects (The Common Rule)
Code of Federal Regulations effective August 19, 1991

HIPAA Privacy Rule and its Impact on Research
On the Department of Health and Human Services Health Privacy Rule.

Executive Order To Prohibit Discrimination in Federal Employment Based on Genetic Information
An executive order signed by President Clinton in 2000

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Philosophical Background

The Belmont Report
Ethical Principles and Guidelines for the Protection of Human Subjects of Research (April 18, 1979)

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Clinical Center Policies

M93-1 Research Involving Human Subjects at the Clinical Center: Structure & Process PDF Icon (85 KB)
Policy regarding the concern that must be given to the rights and welfare of human subjects in the design and approval of biomedical studies.

M77-2 Informed Consent at the Clinical Center PDF Icon (60 KB)
Policy regarding obtaining informed consent from individuals who come to the Clinical Center to participate in research.

M87-4 Consent Process in Research Involving Impaired Human Subjects at the Clinical Center PDF Icon (23 KB)
Policy regarding the consent process in clinical research with patients who are or will become cognitively impaired. The purposes of the policy are: 1) to protect the rights and welfare of such subjects, and 2) to encourage needed research in diseases that carry great cognitive deficits.

M92-5 Research Involving Children and Children's Assent to Research at the Clinical Center PDF Icon (41 KB)
Policy regarding research involving children and children's assent to that research, and the route by which certain proposed studies are sent to the Secretary, DHHS.

M92-7 Advance Directives PDF Icon (27 KB)
Policy regarding the education of patients, their families, Clinical Center staff, and others in the use of advance directives.

M91-7 Do Not Resuscitate (DNR) Orders and Limited Treatment Orders PDF Icon (39 KB)
Policy regarding situations in which it may be considered appropriate not to provide cardiopulmonary resuscitation, and introduces the phase "limited treatment order" to clarify and honor patient preferences regarding emergency and end of life care. Explicit limited treatment orders should help prevent the ambiguous and potentially dangerous practice of "partial" or "limited" codes.

M94-6 Organ and Tissue Donation PDF Icon (49 KB)
Policy on the donation of organs and tissues (including corneas) by Clinical Center patients.

M 94-10 Restraint and Seclusion PDF Icon (359 KB)
Policy regarding the use of restraints and seclusion in clinical care.

M89-1 HIV Testing PDF Icon (29 KB)
Policy regarding current policy on HIV testing.

M93-11 Administration of Blood Products to Jehovah's Witnesses PDF Icon (16 KB)
Policy regarding the administration of blood products to members of the Jehovah's Witness faith.

M94-5 Reporting Child Abuse/Neglect in the Clinical Center PDF Icon (27 KB)
Policy regarding the reporting of suspected child abuse or neglect.

M97-5 Reporting Vulnerable Adult Abuse, Neglect, Self-Neglect or Exploitation PDF Icon (34 KB)
Policy regarding the reporting of abuse, neglect, self-neglect or exploitation of Clinical Center "vulnerable adult" patients.

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