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About Nemours Office of Human Subjects Protection (NOHSP)
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 Office of Human Subjects Protection (NOHSP) 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 Office of Human Subjects Protection
(302) 298-7613
NOHSP@nemours.org
Contact Our Administrations
Robert Colnes
Director
(302) 298-7613
robert.colnes@nemours.org
Suzanne Murphy, PhD
Associate Director
(904) 697-4022
suzanne.murphy@nemours.org
Monica Pyewell
Administrative Assistant
(302) 651-5539
monica.pyewell@nemours.org
Carlos Rose, MD, CIP
Chair
(302) 651-6807
carlos.rose@nemours.org
Camille Varacchi, CIM
Coordinator
(302) 651-6807
camille.varacchi@nemours.org
Tim Wysocki, PhD
CIP
(904) 697-3415
timothy.wysocki@nemours.org
Laurie Ward, CIM
Coordinator
(904) 697-3415
laurie.ward@nemours.org
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.
Resources about participating in medical research:
- Becoming a Research Volunteer (in English) (PDF)
- Becoming a Research Volunteer (in Spanish) (PDF)
- Parent's Guide to Medical Research (Children's Hospital Boston) (Select "View Site Tutorial" on left)
- Children in Clinical Studies (U.S. Food & Drug Administration)
- Patient Safety in Clinical Trials (National Cancer Institute)
- Learn About Clinical Studies (National Institutes of Health)
- Is a Clinical Trial Right for Your Child? (KidsHealth)
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)
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
- Online Ethics Center for Engineering and Science at Case Western Reserve 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 employees and non-employees), web-based coursework is required.
View the NOHSP Educational Curriculum (PDF) »
Required web-based training is available through:
Contact Us
Please direct questions, comments, concerns, or complaints about the protection of human subjects participating in research at Nemours institutions to:
Nemours Office of Human Subjects Protection
(302) 298-7613
NOHSP@nemours.org
Nemours is proud to be fully accredited by the Association for the Accreditation of Human Research Protection Programs.
Nemours Office of Human Subjects Protection
Robert Colnes
Director
robert.colnes@nemours.org
Suzanne Murphy
Associate Director
suzanne.murphy@nemours.org
Monica Pyewell
Administrative Assistant
monica.pyewell@nemours.org
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