Studies in which the researcher proposes to enroll their own children should provide clear justification as to why their children should be enrolled and should explain how they plan to protect their own children and the integrity of the research.

Suggestions for minimizing pressure on your child and protecting data integrity include:

  • Have another member of the study team obtain consent and collect data
  • The other parent of the child gives consent, rather than the researcher-parent
  • If the researcher-parent will give permission for their child to participate in the research, it is suggested that a third party who is not involved in the research be present during the consent process.
  • Have another study team member interact with the child of the researcher or review data relating to the researcher's child and their participation

Questions to consider when proposing to conduct research with your own children include[1]:

  1. Why do I want my child to participate in my study?
  2. How will participation affect my relationship with my child in the present or future?
  3. Is this a joint decision that both parents support?
  4. Might my child feel pressure from me to participate?
  5. How will I avoid my child’s feeling that s/he has let me down if s/he decides not to participate or to withdraw before the study is over?
  6. What procedural safeguards will I implement to ensure that the data related to my child is handled and analyzed in the same way as data collected from other participants?

 Questions for consent monitors to discuss with the child when obtaining assent and parental permission include:

  1. Why do you want to be in this study?
  2. Do you feel that you can say “no” if you do not want to be in this study?
  3. Do you feel like you could choose to stop being in the study whenever you wanted to?
  4. Your mom or dad might hear or see information gathered from you in this study. Is that okay with you?
  5. Would you feel comfortable with me checking in with you again? (for studies with more than one visit.)

 


[1] Children Enrolled in Parent’s Research: A Uniquely Vulnerable Group in Need of Oversight and Protection. IRB Ethics and Human Research