¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾«Æ· Children's Office of Human Subjects Protection
- Overview
- Resources for Patients
- Training for Researchers
About Our Office of Human Subjects Protection
Whether your child is invited to participate in a research project, or you’re a ¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾«Æ· associate or research professional, it’s important to learn about the extensive human subject protection safeguards we have in place at all ¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾«Æ· facilities.
The ¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾«Æ· Children's Office of Human Subjects Protection and itsÌýInstitutional Review Boards (IRBs)Ìýensure that all ¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾«Æ· 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 ¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾«Æ· 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 ¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾«Æ· institutions to:
¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾«Æ· Children's Office of Human Subjects Protection
Independent Accreditation
¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾«Æ· is proud to be fully accredited by the Association for the Accreditation of Human Research Protection Programs.
Resources for Study Participants
¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾«Æ· 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 ¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾«Æ· Office of Human Subjects Protection (NOHSP) helps ensure that all clinical trials involving human subjects — at every ¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾«Æ· facility — are conducted in accordance with the highest safety standards; all applicable laws and ¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾«Æ· policies; and generally accepted precepts of ethical conduct.
General Information for Families
Resources about participating in medical research:
- Becoming a Research Volunteer (in English)
- Becoming a Research Volunteer (in Spanish)
- Ìý(U.S. Food & Drug Administration)
- Ìý(National Cancer Institute)
- (KidsHealth)
Regulations
Resources about the regulations that govern human subject protection in medical research:
(U.S. Department of Health & Human Services 45CFR56)
(U.S. Food & Drug Administration)
(U.S. Food & Drug Administration)
(U.S. Department of Health & Human Services 45CFR160Ìýand 164)
Ethics
Resources that help you learn about ethical issues surrounding human subject protection in medical research:
Essential Documents
Agencies
Organizations
- Ìý(APA) Ethics Office
- Ìý(PRIMR)
- ÌýGeorgetown University
- ÌýEthical Standards and Procedures for Research on Human Beings
- ÌýEthics Unit
Publications
- Ìý(NIH)
Training: Human Subjects Protection
For Research Professionals
¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾«Æ· 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 ¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾«Æ·-based research (¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾«Æ· associates and non-associates), web-based coursework is required.
View the NOHSP Educational Curriculum
Required web-based training is available through: