About Institutional Review Boards
An Institutional Review Board (IRB) is a committee of scientists, non-scientists, and community members who are required by federal law to review all research involving humans as study participants.
The IRB’s job is to determine if the research complies with federal and state regulations regarding the protection of human research participants. This includes assuring that:
- The study will be conducted in an ethical manner
- It has scientific merit
- The risks of the research are outweighed by the benefits
An IRB may approve, disapprove, or require revisions to the research it reviews, and it must review all ongoing research at least once each year.
IRBs at Nemours Children's
Nemours has two IRBs. Each is constituted to comply with the membership requirements of the Office of Human Research Protections (OHRP) and the Food and Drug Administration (FDA) and has sufficient expertise to allow them to review most types of human subjects research.
Our IRB members bring a variety of perspectives to the research review process and may include:
- Faculty from a wide range of clinical disciplines and specialties
- Local nonscientific community members
- Legal advisers
- Nurses
- Pharmacists
The IRBs may also seek outside consultation to supplement the collective expertise of its existing members.
Membership details of our IRBs:
- IRB 1: Delaware Valley (PDF)
- IRB 2: Florida (PDF)
Our IRBs work with the Nemours Office of Human Subjects Protection (NOHSP) to represent the interests of special and vulnerable populations, especially children.
All research involving human subjects conducted at Nemours operating entities must be submitted for review and approval by the appropriate Nemours IRB before an investigator may begin the research.
Does It Qualify as Research?
Questions about whether a project is or is not research must be addressed by the IRB. The US Department of Health and Human Services (DHHS) defines research as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge”
Not all projects fit easily into this definition of research. However, all relevant federal regulations and Nemours policy make it clear that the ultimate decision about whether a given project constitutes research rests with the IRB.
Investigators may not act on any IRB decision unless it is documented by the IRB chair or co-chair. Opinions offered outside of the accepted review process may not be used as justification by an investigator to initiate research involving human subjects.
Independent Accreditation
Nemours is proud to be fully accredited by the Association for the Accreditation of Human Research Protection Programs.
Learn More
For Researchers: Prepare Your Application
All applications to the IRB must be submitted through IRBNet, our electronic IRB records system, which houses all the forms, resources and templates needed to submit an application.
If you’re not familiar with IRBNet, these resources can help guide you through the process:
- IRBNet Training: Initial Study Submission (PDF)
- IRBNet Training: Subsequent Package Submission (PDF)
- IRBNet: Application Assistance (DOC)
Your application may require approval from one or more committees, including:
- Clinical Research Review Committee (CRRC)
- Institutional Biosafety Committee
- Research Radiation Committee
Only complete applications will be forwarded to the IRB for review. Applications must be received via IRBNet by 5 p.m. the day of the deadline.
Checklists
We maintain detailed checklists to help research teams and IRB reviewers ensure that applications comply with all applicable Nemours policies for research involving human subjects. These resources can be accessed through Nemours internal sites and IRBNet. For more information, or to obtain login credentials, contact Robin Steinman at (904) 697-4022.
Parental Permission, Informed Consent & Assent
Informed consent in research is a process that enables an individual (or parent or guardian) to make an autonomous decision about participation in a research study. Informed consent in pediatrics includes parental permission and, as applicable, the assent of the child.
Keep these distinctions in mind:
- Consent: pertains to what a person may do autonomously
- Permission: is granted on behalf of another
- Assent: is a child’s affirmative agreement to participate
Required documentation of the process includes the signed, IRB-approved, informed consent, parental permission and assent forms, as well as a summary of the encounter in the medical and/or research record. The Nemours templates for these forms, plus short forms for enrollment of non-English-speaking participants, are located in the reference library in IRBNet.
Online Resources for Explaining Medical Terms to Families
Nonmedical glossary of medical terms (Stanford University)
Medline Plus (NIH)
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
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