Patient Advocate

Tomas Silber, MD is the Research Subject Advocate (RSA) for the research center and is available to answer questions for children and parents participating in research

What is an RSA?
An RSA is a professional trained to assist and advocate for children, adolescents and their parents as they are participating in research at Children's Hospital. Children's National Medical Center is proud of its research and advocacy track record and is committed to both scientific and ethical excellence. The RSA is completely independent from the research scientist and investigators. He/she functions as an advisor.

Why an RSA?
The National Institutes of Health funds the RSA position to ensure that the all investigators follow the federal regulations and policies for the protections of human subjects participating in clinical research. The RSA position assures that whoever participates in research has maintained their legal rights to respectful, ethical and completely voluntary and informed participation in the research.

Who is the RSA?
Dr. Tomas Jose Silber, a board-certified pediatrician, sub-boarded in Adolescent Medicine, with a master degree in bioethics from George Washington University. Dr. Silber is also the Director of the Office of Ethics at CNMC and is fluent in Spanish and German.

When should we see the RSA?
Whenever you have a question or concern about how the research you are participating in is conducted.

What can the RSA do for you?

  • He assists families who need help when they are asked to sign an informed consent* and any time thereafter.
  • As a matter of fact, you may see him around observing how the process of obtaining your consent/assent is obtained, to ensure that it is done to your satisfaction.
  • Even before the informed consent is given to you for signature, The RSA has taken care of advising researchers on how to make sure that the consent form explains to you all of the following:
    1. any risk possible involved
    2. anticipated benefit (to the participant and others)
    3. the importance of the knowledge expected to result from the research
    4. the procedures involved
    5. the alternatives to participation
    6. confidentiality
    7. cost (if any)
    8. compensation
    9. sharing of findings
    10. assent for minors (ages 7 to 17)**
  • In summary, the RSA's function is to collaborate with research subjects, research staff and researchers in the common goal of assuring research integrity.

Where can the RSA be reached?
By phone: 202-476-3066
By E-mail: tsilber@cnmc.org
By appointment: at the PCRC - 3rd floor

How does the RSA fulfill his advocacy duties?

  • Reviewing all PCRC protocols and consent forms prior to their submission for approval by the GCRC scientific advisory committee.
  • Advising about consent language and ensuring appropriate translations and availability of bilingual staff or translators when needed.
  • Assisting investigators in formulating and reviewing data and safety monitoring plans.
  • Providing educational material for research subjects and their families.
  • Functioning as a liaison to the Institutional Review Board (IRB) that has to approve all research projects at Children's National Medical Center
  • Monitoring periodically all active PCRC protocols to assure that studies are conducted in accordance with the IRB approved protocol and monitoring plan.
  • Ensuring that any adverse event involving a clinical trial is reported in accordance with NIH, FDA or other regulatory agency policies and regulations.
  • Addressing potential conflicts of interest involving PCRC investigators.
  • Designing and implementing questionnaires for patients and parents participating in research protocols (written or by interview) to learn: how recruitment is perceived, how informed consent is understood, the way assent is being obtained.


* "Informed consent is a process of information exchange, not merely the procurement of signature on a form." (Children's Hospital Institutional Review Board. Manual of Policies and Procedures).
Permission by a parent or legal guardian is required before any child can participate in research (Consent). For this to be valid, the research needs to be fully explained and risks, benefits and alternatives should be disclosed (Informed). It is legally required.
** Assent is not a legal requirement, but it is a way of showing respect for the will of children by explaining, in a way they can understand, what their parents have consented to. For non-therapeutic research, a minor's decision not to participate is valid and acceptable.