A researcher asks an irb to waive the requirement for parental permission for a study conducted in schools because the nature of the research requires participation of all the children present

General
1

a researcher asks an irb to waive the requirement for parental permission for a study conducted in schools because the nature of the research requires participation of all the children present in classrooms on the day the research will take place. assuming that the basic research design could be approved by the irb and the school, which of the following requirements must be met before an irb could waive parental permission?

2

A researcher asks an IRB to waive the requirement for parental permission for a study conducted in schools because the nature of the research requires participation of all the children present in classrooms on the day the research will take place. Assuming that the basic research design could be approved by the IRB and the school, which of the following requirements must be met before an IRB could waive parental permission?

Answer:

In order for an Institutional Review Board (IRB) to waive the requirement for parental permission in a study involving children, several specific conditions must be met according to federal regulations. These requirements are generally aligned with the Common Rule (45 CFR 46), specifically subparts A and D related to research with children. Here are the conditions that must be satisfied:

  1. Minimal Risk:

    • The research must involve no more than minimal risk to the participants. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during routine physical or psychological examinations.

  2. Rights and Welfare of Participants Protected:

    • The waiver or alteration will not adversely affect the rights and welfare of the participants. Ethical research practices must ensure that not obtaining parental permission will not negatively impact the children’s legal rights or welfare.

  3. Impracticability Without the Waiver:

    • The research could not practically be carried out without the waiver or alteration of parental permission. This usually pertains to situations where obtaining individual parental consent would be highly cumbersome or impossible, such as when studying the entire population present on a specific day.

  4. Provide Additional Pertinent Information When Appropriate:

    • If appropriate, additional pertinent information must be provided to the participants after their participation. This might involve debriefing the participants and informing them about the nature of the research, especially if there was an element of deception involved.

  5. Alternative Protective Mechanisms:

    • There should be alternative mechanisms in place to protect the children involved. This could involve obtaining assent from the children themselves or having other forms of oversight, such as permission from school officials or other responsible parties, ensuring that the children are not exposed to anything potentially harmful.

Each of these conditions must be carefully considered and documented in the IRB’s decision-making process to justify waiving parental permission. This ensures that the ethical standards of research are maintained while allowing the study to proceed where it would be otherwise unfeasible.