Bioethics Resources
I. Ethics of Human Subjects Research
II. Ethics and Health Policy
III. Ethics and Genetics
I. Ethics of Human Subjects Research
- Research Involving Human Subjects at the Clinical Center: Structure and Process - Policy M93-1 of the Clinical Center regarding the concern that must be given to the rights and welfare of human subjects in the design and approval of biomedical studies. Users outside NIH can access an older version.
- Informed Consent - Policy M77-2 of the Clinical Center regarding obtaining informed consent from individuals who come to the Clinical Center to participate in research.
Philosophical Background
- Belmont Report - Ethical Principles and Guidelines for the Protection of Human Subjects of Research (April 18, 1979).
Federal Regulations
- 45-CFR-46 - Protection of Human Subjects (The Common Rule) - (Code of Federal Regulations effective August 19, 1991).
- Bioethics and the NIH - This page is an effort to bring together all web-based resources at the NIH having to do with bioethics.
Special Issues
Subjects with Limited Capacity
- Research Involving Individuals with Questionable Capacity to Consent: Points to Consider - a report by the Office of Extramural Research.
- Consent Process in Research Involving Impaired Human Subjects - Policy M87-4 of the Clinical Center regarding a new policy for 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.
Children
- Question and Answers about the NIH Policy and Guidelines on the Inclusion of Children as Participants in Studies Involving Human Subjects.
- Research Involving Children and Children's Assent to Research - Policy M92-5 of the Clinical Center 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.
Stored Biological Samples
- Research on Human Specimens guidebook, provided by the National Cancer Institute (NCI) of the NIH.
Stem Cells
- NIH Stem Cell Information - draft guidelines for research, primers, testimony, and press releases.
Clinical Center Medical Policies
- Advance Directives - Policy M92-7 of the Clinical Center regarding the education of patients, their families, Clinical Center staff, and others in the use of advance directives.
- Do Not Resuscitate (DNR) Orders and Limited Treatment Orders - Policy M91-7 of the Clinical Center 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.
- Organ and Tissue Donation - Policy M94-6 of the Clinical Center on the donation of organs and tissues (including corneas) by Clinical Center patients.
- Restraint and Seclusion - Policy M94-10 of the Clinical Center regarding the use of restraints and seclusion in clinical care.
- HIV Testing - Policy M89-1 of the Clinical Center regarding current policy on HIV testing.
- Administration of Blood Products to Jehovah's Witnesses - Policy M93-11 of the Clinical Center regarding the administration of blood products to members of the Jehovah's Witness faith.
- Reporting Child Abuse/Neglect in the Clinical Center - Policy M94-5 of the Clinical Center regarding the reporting of suspected child abuse or neglect.
- Reporting Vulnerable Adult Abuse, Neglect, Self-Neglect or Exploitation - Policy M97-5 of the Clinical Center regarding the reporting of abuse, neglect, self-neglect or exploitation of Clinical Center "vulnerable adult" patients.
II. Ethics and Health Policy
- HIPAA Privacy Rule and its Impact on Research - on the Department of Health and Human Services Health Privacy Rule.
- Reports by the Office of Legislative Policy and Analysis.
III. Ethics and Genetics
- Ethical, Legal and Social Implications Program of the National Human Genome Research Institute (NHGRI).
- Executive Order To Prohibit Discrimination in Federal Employment Based on Genetic Information - NGHRI (February 8, 2000).
