About Our Office of Human Subjects Protection
Whether your child is invited to participate in a research project, or you’re a Nemours associate or research professional, it’s important to learn about the extensive human subject protection safeguards we have in place at all Nemours facilities.
The Nemours Children's Office of Human Subjects Protection and its Institutional Review Boards (IRBs) ensure that all Nemours human research activities meet or exceed the highest ethical standards for protecting the rights and welfare of everyone who volunteers to participate.
Contact Us
We want to hear from you if you:
- Have questions about what to do if you or your child is injured as a research participant
- Would like to offer input or obtain information about the Nemours research programs
- Cannot reach the investigator
- Would like to talk to someone who is not directly involved with conducting this research
Send questions, comments, concerns, or complaints about the protection of human subjects participating in research at Nemours institutions to:
Nemours Children's Office of Human Subjects Protection
Contact Us
Nemours Office of Human Subjects Protection Administration
Nemours IRB 1 Administration
Nemours IRB 2 Administration
Independent Accreditation
Nemours is proud to be fully accredited by the Association for the Accreditation of Human Research Protection Programs.
Learn More
Resources for Study Participants
Nemours research scientists and physicians have helped develop many of today’s most advanced treatments to improve the health of children. When a new drug, device or procedure shows great enough potential, it must be carefully tested to be certain that it’s safe and effective. These tests are called clinical trials, and the patients who choose to participate in them are called human subjects.
The Nemours Office of Human Subjects Protection (NOHSP) helps ensure that all clinical trials involving human subjects — at every Nemours facility — are conducted in accordance with the highest safety standards; all applicable laws and Nemours policies; and generally accepted precepts of ethical conduct.
General Information for Families
Resources about participating in medical research:
- Becoming a Research Volunteer (in English) (PDF)
- Becoming a Research Volunteer (in Spanish) (PDF)
- Children in Clinical Studies (U.S. Food & Drug Administration)
- Patient Safety in Clinical Trials (National Cancer Institute)
- Is a Clinical Trial Right for Your Child? (KidsHealth)
Regulations
Resources about the regulations that govern human subject protection in medical research:
- Protection of Human Subjects
(U.S. Department of Health & Human Services 45CFR56) - Good Clinical Practice/Clinical Trials
(U.S. Food & Drug Administration) - Office of Pediatric Therapeutics
(U.S. Food & Drug Administration) - HIPAA Privacy Rule
(U.S. Department of Health & Human Services 45CFR160 and 164)
Ethics
Resources that help you learn about ethical issues surrounding human subject protection in medical research:
Essential Documents
Agencies
- US Food & Drug Administration
- Secretary's Advisory Committee on Human Research Protection
- Office of Research Integrity
- National Institutes of Health (NIH) Bioethics Resources
Organizations
- American Association for the Advancement of Science (AAAS)
- American Nurses Association (ANA) The Center for Ethics and Human Rights
- American Psychological Association (APA) Ethics Office
- Public Responsibility in Medicine and Research (PRIMR)
- Kennedy Institute of Ethics Georgetown University
- World Health Organization Ethical Standards and Procedures for Research on Human Beings
- World Medical Association Ethics Unit
Publications
Training: Human Subjects Protection
For Research Professionals
Nemours encourages all associates to educate themselves about the ethics and regulations regarding the protection of human subjects in research. For anyone involved in the conduct of Nemours-based research (Nemours associates and non-associates), web-based coursework is required.
View the NOHSP Educational Curriculum (PDF)
Required web-based training is available through:
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