What patients and families need to know
The Children's Research Institute
Office for the Protection of Human Subjects and Institutional Review Board
Children’s National and the Children’s Research Institute are committed to conducting and promoting scientifically and ethically sound research that will lead to improved prevention, diagnosis, and treatment of childhood diseases. The Children’s National Human Research Protection Program (HRPP) was established to ensure that the rights and welfare of the children and others who participate in research activities are adequately protected.
The HRPP is administered by the Office for the Protection of Human Subjects (OPHS). OPHS is responsible for the regulatory compliance and administration of the Institutional Review Board (IRB) process. Our office serves as the liaison between the IRB committees and the research investigators, documents compliance with federal research regulations, provides consults and regulatory compliance support, and educates the Children's National research community about the ethical and safe conduct of research.
The IRB is an independent committee of scientists and nonscientists, Children’s National personnel and unaffiliated individuals with the expertise and diversity to review and evaluate human research protocols and ensure that they are conducted according to the highest ethical standards. Committee decisions whether or not to approve studies are based on federal regulations and established ethical principles.
Research protocols involving human volunteers cannot be implemented without IRB review and approval. Each study also must be reviewed at least annually to ensure that the risks and benefits to participants have not changed. Any and all alterations to an approved research protocol also must be reviewed and approved by the IRB.
Children’s National currently has three (3) IRB Committees:
Meets the first Thursday of the month
Meets the third Wednesday of the month
Meets the fourth Wednesday of the month
Children’s National has been recognized by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) for meeting its rigorous standards for ethics, quality, and protections of research participants. AAHRPP accreditation was awarded to Children’s National in March, 2011, and signifies our commitment to scientifically and ethically sound research and to continuous improvement of our program.
Visit the AAHRPP website at www.aahrpp.org for more on the Human Research Protection Program accreditation process.
Human Research Protection Training
Human Research Protection Training
Children’s National is committed to conducting research that is ethically sound, scientifically valid, and compliant with all federal, state, and local regulations. To help achieve this goal, investigators and research staff engaged in the conduct of human subjects research must complete mandatory online training through the Collaborative Institutional Training Initiative (CITI).
CITI User Accounts
Go to www.citiprogram.org to register and complete the Human Subjects Research training requirements.
Individuals should select their Human Subjects Research curricula based on the type(s) of research in which they are engaged: Biomedical research, Social/Behavioral research, and/or Research with data or laboratory specimens ONLY. The Good Clinical Practice Course is required for individuals who are engaged in Biomedical research or greater-than-minimal-risk Social/Behavioral research.
- Individuals must achieve a minimum aggregate score of 80 percent on the module quizzes to pass a course.
- CITI training in human subjects research must be renewed every two years.
Individuals who have completed CITI training through another institution should log into their existing CITI account and “affiliate” with Children’s National. The Office for the Protection of Human Subjects will determine if additional modules or courses are required.
CITI User Resources
- Instructions for new users are available at the following link: Instructions for CITI—New Users
- Instructions for previously registered users are available at the following link: Instructions for CITI—Registered Users
- If you have questions about which CITI Human Subjects Research course(s) you should complete, contact Kay Ayers in the Office for the Protection of Human Subjects at email@example.com (link sends e-mail) or 301-565-8452.
- If you forget your login information, please use the link on the home page to request the information from CITI.
- CITI Website
- Instructions for CITI — New Users
- Instructions for CITI — Registered Users
IRBear Electronic Submission
Children’s National uses the Institutional Review Board Electronic Application Review (IRBear) system for the submission, review, tracking, and management of new research protocols and amendments and continuing reviews of approved protocols.
IRBear is available on the internet to individuals with valid accounts at www.irbear.org.
IRBear User Accounts
- CITI training in Human Subjects Research is a prerequisite to receiving an IRBear account.
- You do not have to be a Children’s National employee to become an IRBear user. However, new IRBear accounts for non-employees must be requested by a Children’s National investigator or study coordinator.
- To request an IRBear account or to reset your IRBear password, contact Kay Ayers in the Office for the Protection of Human Subjects at firstname.lastname@example.org (link sends e-mail) or 301-565-8452.
IRBear User Resources
- IRBear training for general users is offered by the Office for the Protection of Human Subjects. Contact Kay Ayers at email@example.com (link sends e-mail) or 301-565-8452 for a schedule of classes or to arrange training for your division/department or research team.
- A manual is available to assist study staff (investigators, co-investigators, study coordinators, and others who prepare submissions to the IRB) create and submit a new protocol application using the IRBear system. Use this link to access the manual: IRBear Study Staff User Manual