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You are a member of your hospital REB and you are asked to review the attached protocol: “A multi-center, prospective randomized trial to evaluate routine use of a silastic spring-loaded silo for infants with gastroschisis”

  • Is there equipoise in this study question?

  • Please review the protocol according to the 7 requirements described in Emanual’s article.

    • Value

    • Scientific validity

    • Fair subject selection

    • Favorable risk-benefit ratio

    • Independent review

    • Informed consent

    • Respect for potential and enrolled subjects.

Would you recommend approval of this study in your hospital?

  • Martha is a 10-year-old girl with a Pectus Excavatum and comes to you for repair. You are part of a multicenter trial comparing the Nuss procedure to the Ravitch procedure. You explain the study protocol to the parents. The study involves the usual pre-op tests, but also a pre and post OR CAT scan and some self-image questionnaires. Both parents have read the consent form carefully and are willing to enroll Martha in the study. They think it is a good educational experience for Martha, teaching her the value of altruism. The research nurse talks to Martha to get her assent. Martha is claustrophobic and afraid of the CT scanner. She was brought to the CT scanner a few years ago when she had abdominal pain to rule out appendicitis. She required sedation to complete the study. She refuses to be part of the study.

    The parents are trying to reason with her and are telling her that she will be helping others. Martha still refuses.

    • What should you do?

    • How important is assent in pediatric surgery research? 

Workshop 8

Topic: Pediatric surgical research and innovation
Curricular objectives

  1. To develop a framework for understanding ethical issues raised by performing research and implementing innovations in children
  2. To understand the concept of clinical equipoise
  3. To understand the concept of assent and disclosure
  4. To understand the procedural requirements for conducting a pediatric clinical research study.

Ethical messages:

  • The importance of value and validity, informed consent, risk-benefit ratio, justice in subject selection, protection of the research subject especially vulnerable population in research and innovation.

Pre-workshop readings:

  1. Frader JE, Flanagan-Klygis E. Innovation and research in pediatric surgery. Sem Ped Surg 2001;10:198-204
  2. Grodin MA, Alpert JJ. Children as participants in medical research. Ped Clinics NA 1988;35:1389-1401
  3. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical?   JAMA 2000;283:2701-1711
  4. Freedman B. Equipoise and the ethics of clinical research.   NEJM 1987;317:141-145

Paradigm case:

  1. Clinical trial: a randomized control trial in babies with gastroschisis; spring-loaded silo vs. primary closure.
  2. Martha, a 10-year-old, does not want to participate in a study

Teaching modality:
Interactive presentation, then trainees with be asked to act as REB members to discuss the 1 protocol and decided on its acceptability and discussion of a case.

CanMeds competencies targeted:
Medical expert